@prefix : <http://www.noel-garcia.org/ontologies/medical-devices#> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix xml: <http://www.w3.org/XML/1998/namespace> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@base <http://www.noel-garcia.org/ontologies/medical-devices#> .

<http://www.noel-garcia.org/ontologies/medical-devices> rdf:type owl:Ontology ;
                                                         owl:versionIRI <http://www.noel-garcia.org/ontologies/medical-devices/1.0.0> ;
                                                         <http://purl.org/dc/terms/bibliographicCitation> "Noël García Pou (2026) - Medical Devices Ontology - UOC Project"@en ;
                                                         <http://purl.org/dc/terms/created> "2026-04-04" ;
                                                         <http://purl.org/dc/terms/creator> "Noël García Pou" ;
                                                         <http://purl.org/dc/terms/description> "European high-risk medical devices."@en ;
                                                         <http://purl.org/dc/terms/issued> "2026-04-27"^^xsd:date ;
                                                         <http://purl.org/dc/terms/license> <https://creativecommons.org/licenses/by/4.0/> ;
                                                         <http://purl.org/dc/terms/publisher> "Noël García Pou" ;
                                                         <http://purl.org/dc/terms/source> "http://www.noel-garcia.org/ontologies/medical-devices"^^xsd:anyURI ;
                                                         <http://purl.org/dc/terms/title> "PAC2 - Medical Devices and Incidents"@en ;
                                                         <http://purl.org/vocab/vann/preferredNamespacePrefix> "mdo" ;
                                                         <http://purl.org/vocab/vann/preferredNamespaceUri> "http://www.noel-garcia.org/ontologies/medical-devices" ;
                                                         owl:versionInfo "1.0.0" ;
                                                         <https://schema.org/logo> "https://upload.wikimedia.org/wikipedia/commons/a/a3/Logo_blau_uoc.png"^^xsd:anyURI ;
                                                         <https://w3id.org/mod#createdWith> <https://chowlk.linkeddata.es/> ;
                                                         <https://w3id.org/mod#status> "Project submission"@en .

#################################################################
#    Annotation properties
#################################################################

###  http://purl.org/dc/terms/bibliographicCitation
<http://purl.org/dc/terms/bibliographicCitation> rdf:type owl:AnnotationProperty .


###  http://purl.org/dc/terms/contributor
<http://purl.org/dc/terms/contributor> rdf:type owl:AnnotationProperty .


###  http://purl.org/dc/terms/created
<http://purl.org/dc/terms/created> rdf:type owl:AnnotationProperty .


###  http://purl.org/dc/terms/creator
<http://purl.org/dc/terms/creator> rdf:type owl:AnnotationProperty .


###  http://purl.org/dc/terms/description
<http://purl.org/dc/terms/description> rdf:type owl:AnnotationProperty ;
                                       rdfs:range xsd:string .


###  http://purl.org/dc/terms/issued
<http://purl.org/dc/terms/issued> rdf:type owl:AnnotationProperty .


###  http://purl.org/dc/terms/license
<http://purl.org/dc/terms/license> rdf:type owl:AnnotationProperty .


###  http://purl.org/dc/terms/publisher
<http://purl.org/dc/terms/publisher> rdf:type owl:AnnotationProperty .


###  http://purl.org/dc/terms/source
<http://purl.org/dc/terms/source> rdf:type owl:AnnotationProperty .


###  http://purl.org/dc/terms/title
<http://purl.org/dc/terms/title> rdf:type owl:AnnotationProperty .


###  http://purl.org/vocab/vann/preferredNamespacePrefix
<http://purl.org/vocab/vann/preferredNamespacePrefix> rdf:type owl:AnnotationProperty .


###  http://purl.org/vocab/vann/preferredNamespaceUri
<http://purl.org/vocab/vann/preferredNamespaceUri> rdf:type owl:AnnotationProperty .


###  http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled
<http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> rdf:type owl:AnnotationProperty .


###  http://www.w3.org/2000/01/rdf-schema#sameAS
rdfs:sameAS rdf:type owl:AnnotationProperty .


###  http://www.w3.org/2000/01/rdf-schema#sameAs
rdfs:sameAs rdf:type owl:AnnotationProperty .


###  http://www.w3.org/2002/07/owl#priorVersion
owl:priorVersion rdf:type owl:AnnotationProperty .


###  http://www.w3.org/2002/07/owl#versionIRI
owl:versionIRI rdf:type owl:AnnotationProperty .


###  http://www.w3.org/2002/07/owl#versionInfo
owl:versionInfo rdf:type owl:AnnotationProperty .


###  https://schema.org/logo
<https://schema.org/logo> rdf:type owl:AnnotationProperty .


###  https://w3id.org/mod#createdWith
<https://w3id.org/mod#createdWith> rdf:type owl:AnnotationProperty .


###  https://w3id.org/mod#status
<https://w3id.org/mod#status> rdf:type owl:AnnotationProperty .


#################################################################
#    Datatypes
#################################################################

###  http://www.w3.org/2001/XMLSchema#date
xsd:date rdf:type rdfs:Datatype .


#################################################################
#    Object Properties
#################################################################

###  http://www.noel-garcia.org/ontologies/medical-devices#affectedDeviceType_
:affectedDeviceType_ rdf:type owl:ObjectProperty ;
                     owl:inverseOf :isAffectedTypeIn ;
                     rdf:type owl:FunctionalProperty ,
                              owl:AsymmetricProperty ,
                              owl:IrreflexiveProperty ;
                     rdfs:domain :Risk ;
                     rdfs:range :Device ;
                     rdfs:comment "Specifies the type of affected device."@en ;
                     rdfs:label "affected device type"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#hasActionType
:hasActionType rdf:type owl:ObjectProperty ;
               owl:inverseOf :isActionTypeOf ;
               rdf:type owl:FunctionalProperty ,
                        owl:AsymmetricProperty ,
                        owl:IrreflexiveProperty ;
               rdfs:domain :CorrectiveAction ;
               rdfs:range :ActionType ;
               rdfs:comment "Specifies the type of corrective action."@en ;
               rdfs:label "has action type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#hasCorrectiveAction
:hasCorrectiveAction rdf:type owl:ObjectProperty ;
                     owl:inverseOf :relatedToIncident ;
                     rdf:type owl:AsymmetricProperty ,
                              owl:IrreflexiveProperty ;
                     rdfs:domain :Incident ;
                     rdfs:range :CorrectiveAction ;
                     rdfs:comment "Links an incident with its corrective action."@en ;
                     rdfs:label "has corrective action"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#hasDeviceType
:hasDeviceType rdf:type owl:ObjectProperty ;
               owl:inverseOf :isDeviceTypeOf ;
               rdf:type owl:FunctionalProperty ,
                        owl:AsymmetricProperty ,
                        owl:IrreflexiveProperty ;
               rdfs:domain :Device ;
               rdfs:range :DeviceType ;
               rdfs:comment "The type of the device."@en ;
               rdfs:label "has device type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#hasIncidentRecorded
:hasIncidentRecorded rdf:type owl:ObjectProperty ;
                     owl:inverseOf :involvesDevice ;
                     rdf:type owl:AsymmetricProperty ,
                              owl:IrreflexiveProperty ;
                     rdfs:domain :Device ;
                     rdfs:range :Incident ;
                     rdfs:comment "Links a device with its known incidents."@en ;
                     rdfs:label "has incident recorded"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#hasIncidentType
:hasIncidentType rdf:type owl:ObjectProperty ;
                 owl:inverseOf :isIncidentTypeOf ;
                 rdf:type owl:FunctionalProperty ,
                          owl:AsymmetricProperty ,
                          owl:IrreflexiveProperty ;
                 rdfs:domain :Incident ;
                 rdfs:range :IncidentType ;
                 rdfs:comment "Specifies the type of an incident."@en ;
                 rdfs:label "has incident type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#hasManufacturer
:hasManufacturer rdf:type owl:ObjectProperty ;
                 owl:inverseOf :isManufacturerOf ;
                 rdf:type owl:FunctionalProperty ,
                          owl:AsymmetricProperty ,
                          owl:IrreflexiveProperty ;
                 rdfs:domain :Device ;
                 rdfs:range :Manufacturer ;
                 rdfs:comment "Links a device to the manufacturer responsible for it."@en ;
                 rdfs:label "has manufacturer" .


###  http://www.noel-garcia.org/ontologies/medical-devices#hasProbability
:hasProbability rdf:type owl:ObjectProperty ;
                owl:inverseOf :isProbabilityOf ;
                rdf:type owl:FunctionalProperty ,
                         owl:AsymmetricProperty ,
                         owl:IrreflexiveProperty ;
                rdfs:domain :Risk ;
                rdfs:range :ProbabilityLevel ;
                rdfs:comment "Indicates how likely a risk is to occur."@en ;
                rdfs:label "has probability" .


###  http://www.noel-garcia.org/ontologies/medical-devices#hasReported
:hasReported rdf:type owl:ObjectProperty ;
             owl:inverseOf :reportedBy ;
             rdf:type owl:AsymmetricProperty ,
                      owl:IrreflexiveProperty ;
             rdfs:domain :Manufacturer ;
             rdfs:range :Incident ;
             rdfs:comment "Relates an organization to the incidents they have reported."@en ;
             rdfs:label "has reported"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#hasRisk
:hasRisk rdf:type owl:ObjectProperty ;
         owl:inverseOf :isManifestedIn ;
         rdf:type owl:AsymmetricProperty ,
                  owl:IrreflexiveProperty ;
         rdfs:domain :Incident ;
         rdfs:range :Risk ;
         rdfs:comment "Associates an incident with a specific risk."@en ;
         rdfs:label "has risk" .


###  http://www.noel-garcia.org/ontologies/medical-devices#hasRiskCategory
:hasRiskCategory rdf:type owl:ObjectProperty ;
                 owl:inverseOf :isRiskCategoryOf ;
                 rdf:type owl:FunctionalProperty ,
                          owl:AsymmetricProperty ,
                          owl:IrreflexiveProperty ;
                 rdfs:domain :Risk ;
                 rdfs:range :RiskCategory ;
                 rdfs:comment "Specifies the category of a risk."@en ;
                 rdfs:label "has risk category" .


###  http://www.noel-garcia.org/ontologies/medical-devices#hasRiskClass
:hasRiskClass rdf:type owl:ObjectProperty ;
              owl:inverseOf :isRiskClassOf ;
              rdf:type owl:FunctionalProperty ,
                       owl:AsymmetricProperty ,
                       owl:IrreflexiveProperty ;
              rdfs:domain :Device ;
              rdfs:range :DeviceRiskClass ;
              rdfs:comment "Defines the regulatory risk classification of a device."@en ;
              rdfs:label "has risk class" .


###  http://www.noel-garcia.org/ontologies/medical-devices#hasRiskType
:hasRiskType rdf:type owl:ObjectProperty ;
             owl:inverseOf :isRiskTypeOf ;
             rdf:type owl:FunctionalProperty ,
                      owl:AsymmetricProperty ,
                      owl:IrreflexiveProperty ;
             rdfs:domain :Risk ;
             rdfs:range :RiskType ;
             rdfs:comment "Specifies the type of risk."@en ;
             rdfs:label "has risk type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#hasSeverity
:hasSeverity rdf:type owl:ObjectProperty ;
             owl:inverseOf :isSeverityOf ;
             rdf:type owl:FunctionalProperty ,
                      owl:AsymmetricProperty ,
                      owl:IrreflexiveProperty ;
             rdfs:domain :Risk ;
             rdfs:range :SeverityLevel ;
             rdfs:comment "Indicates the severity level of a risk."@en ;
             rdfs:label "has severity" .


###  http://www.noel-garcia.org/ontologies/medical-devices#involvesDevice
:involvesDevice rdf:type owl:ObjectProperty ,
                         owl:FunctionalProperty ,
                         owl:AsymmetricProperty ,
                         owl:IrreflexiveProperty ;
                rdfs:domain :Incident ;
                rdfs:range :Device ;
                rdfs:comment "Associates an incident with the device involved."@en ;
                rdfs:label "involves device" .


###  http://www.noel-garcia.org/ontologies/medical-devices#isActionTypeOf
:isActionTypeOf rdf:type owl:ObjectProperty ,
                         owl:AsymmetricProperty ,
                         owl:IrreflexiveProperty ;
                rdfs:domain :ActionType ;
                rdfs:range :CorrectiveAction ;
                rdfs:comment "Links the type of a corrective measure to its actions."@en ;
                rdfs:label "is action type of"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#isAffectedTypeIn
:isAffectedTypeIn rdf:type owl:ObjectProperty ;
                  rdfs:domain :Device ;
                  rdfs:range :Risk ;
                  rdfs:comment "Relates a device type to the incidents or actions that have affected that category."@en ;
                  rdfs:label "is affected type in" .


###  http://www.noel-garcia.org/ontologies/medical-devices#isDeviceTypeOf
:isDeviceTypeOf rdf:type owl:ObjectProperty ,
                         owl:AsymmetricProperty ,
                         owl:IrreflexiveProperty ;
                rdfs:domain :DeviceType ;
                rdfs:range :Device ;
                rdfs:comment "Connects a device type to its medical devices."@en ;
                rdfs:label "is device type of"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#isIncidentTypeOf
:isIncidentTypeOf rdf:type owl:ObjectProperty ,
                           owl:AsymmetricProperty ,
                           owl:IrreflexiveProperty ;
                  rdfs:domain :IncidentType ;
                  rdfs:range :Incident ;
                  rdfs:comment "Links an incident type to the incidents."@en ;
                  rdfs:label "is incident type of"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#isManifestedIn
:isManifestedIn rdf:type owl:ObjectProperty ,
                         owl:AsymmetricProperty ,
                         owl:IrreflexiveProperty ;
                rdfs:domain :Risk ;
                rdfs:range :Incident ;
                rdfs:comment "Links a risk with its possible incidents."@en ;
                rdfs:label "is manifested in"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#isManufacturerOf
:isManufacturerOf rdf:type owl:ObjectProperty ,
                           owl:InverseFunctionalProperty ,
                           owl:AsymmetricProperty ,
                           owl:IrreflexiveProperty ;
                  rdfs:domain :Manufacturer ;
                  rdfs:range :Device ;
                  rdfs:comment "Links a manufacturer with its devices."@en ;
                  rdfs:label "is manufacturer of"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#isProbabilityOf
:isProbabilityOf rdf:type owl:ObjectProperty ,
                          owl:InverseFunctionalProperty ,
                          owl:AsymmetricProperty ,
                          owl:IrreflexiveProperty ;
                 rdfs:domain :ProbabilityLevel ;
                 rdfs:range :Risk ;
                 rdfs:comment "Relates a probability level to a specific risk."@en ;
                 rdfs:label "is probability of"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#isRiskCategoryOf
:isRiskCategoryOf rdf:type owl:ObjectProperty ,
                           owl:AsymmetricProperty ,
                           owl:IrreflexiveProperty ;
                  rdfs:domain :RiskCategory ;
                  rdfs:range :Risk ;
                  rdfs:comment "Links a risk category its risks."@en ;
                  rdfs:label "is risk category of"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#isRiskClassOf
:isRiskClassOf rdf:type owl:ObjectProperty ,
                        owl:AsymmetricProperty ,
                        owl:IrreflexiveProperty ;
               rdfs:domain :DeviceRiskClass ;
               rdfs:range :Device ;
               rdfs:comment "Relates a risk class to its devices."@en ;
               rdfs:label "is risk class of"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#isRiskTypeOf
:isRiskTypeOf rdf:type owl:ObjectProperty ,
                       owl:AsymmetricProperty ,
                       owl:IrreflexiveProperty ;
              rdfs:domain :RiskType ;
              rdfs:range :Risk ;
              rdfs:comment "Connects a risk type to the risks that have that type."@en ;
              rdfs:label "is risk type of"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#isSeverityOf
:isSeverityOf rdf:type owl:ObjectProperty ,
                       owl:InverseFunctionalProperty ,
                       owl:AsymmetricProperty ,
                       owl:IrreflexiveProperty ;
              rdfs:domain :SeverityLevel ;
              rdfs:range :Risk ;
              rdfs:comment "Connects a severity value with the risk that have its value."@en ;
              rdfs:label "is severity of" .


###  http://www.noel-garcia.org/ontologies/medical-devices#relatedToIncident
:relatedToIncident rdf:type owl:ObjectProperty ,
                            owl:AsymmetricProperty ,
                            owl:IrreflexiveProperty ;
                   rdfs:domain :CorrectiveAction ;
                   rdfs:range :Incident ;
                   rdfs:comment "Links a corrective action to the incident it addresses."@en ;
                   rdfs:label "related to incident" .


###  http://www.noel-garcia.org/ontologies/medical-devices#reportedBy
:reportedBy rdf:type owl:ObjectProperty ,
                     owl:FunctionalProperty ,
                     owl:AsymmetricProperty ,
                     owl:IrreflexiveProperty ;
            rdfs:domain :Incident ;
            rdfs:range :Manufacturer ;
            rdfs:comment "Indicates the manufacturer that reported the incident."@en ;
            rdfs:label "reported by" .


#################################################################
#    Data properties
#################################################################

###  http://purl.org/dc/terms/description
<http://purl.org/dc/terms/description> rdf:type owl:DatatypeProperty ;
                                       rdfs:domain [ rdf:type owl:Class ;
                                                     owl:unionOf ( :CorrectiveAction
                                                                   :Incident
                                                                   :Risk
                                                                 )
                                                   ] .


###  http://www.noel-garcia.org/ontologies/medical-devices#actionDate
:actionDate rdf:type owl:DatatypeProperty ,
                     owl:FunctionalProperty ;
            rdfs:domain :CorrectiveAction ;
            rdfs:range xsd:date ;
            rdfs:comment "Date when the corrective action was initiated."@en ;
            rdfs:label "action date" .


###  http://www.noel-garcia.org/ontologies/medical-devices#affectedDeviceType
:affectedDeviceType rdf:type owl:DatatypeProperty ,
                             owl:FunctionalProperty ;
                    rdfs:domain :Risk ;
                    rdfs:range xsd:string ;
                    rdfs:comment "The type of the device related."@en ;
                    rdfs:label "affected device type"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#authorizationNumber
:authorizationNumber rdf:type owl:DatatypeProperty ,
                              owl:FunctionalProperty ;
                     rdfs:domain :Manufacturer ;
                     rdfs:range xsd:string ;
                     rdfs:comment "Official authorization number assigned to a manufacturer."@en ;
                     rdfs:label "authorization number" .


###  http://www.noel-garcia.org/ontologies/medical-devices#closureDate
:closureDate rdf:type owl:DatatypeProperty ,
                      owl:FunctionalProperty ;
             rdfs:domain :CorrectiveAction ;
             rdfs:range xsd:date ;
             rdfs:comment "Date when the corrective action was completed."@en ;
             rdfs:label "closure date" .


###  http://www.noel-garcia.org/ontologies/medical-devices#competentAuthority
:competentAuthority rdf:type owl:DatatypeProperty ,
                             owl:FunctionalProperty ;
                    rdfs:domain :Manufacturer ;
                    rdfs:range xsd:string ;
                    rdfs:comment "Authority responsible for regulatory oversight."@en ;
                    rdfs:label "competent authority" .


###  http://www.noel-garcia.org/ontologies/medical-devices#correctiveActionTaken
:correctiveActionTaken rdf:type owl:DatatypeProperty ,
                                owl:FunctionalProperty ;
                       rdfs:domain :Incident ;
                       rdfs:range xsd:boolean ;
                       rdfs:comment "Indicates whether a corrective action has been taken in response to the incident."@en ;
                       rdfs:label "corrective action taken" .


###  http://www.noel-garcia.org/ontologies/medical-devices#countriesAffected
:countriesAffected rdf:type owl:DatatypeProperty ;
                   rdfs:domain :CorrectiveAction ;
                   rdfs:range xsd:string ;
                   rdfs:comment "Countries impacted by the corrective action."@en ;
                   rdfs:label "countries affected" .


###  http://www.noel-garcia.org/ontologies/medical-devices#country
:country rdf:type owl:DatatypeProperty ,
                  owl:FunctionalProperty ;
         rdfs:domain :Manufacturer ;
         rdfs:range xsd:string ;
         rdfs:comment "Country where the manufacturer is located."@en ;
         rdfs:label "country" .


###  http://www.noel-garcia.org/ontologies/medical-devices#countryReported
:countryReported rdf:type owl:DatatypeProperty ,
                          owl:FunctionalProperty ;
                 rdfs:domain :Incident ;
                 rdfs:range xsd:string ;
                 rdfs:comment "The country where the incident was reported."@en ;
                 rdfs:label "country reported" .


###  http://www.noel-garcia.org/ontologies/medical-devices#detectionDate
:detectionDate rdf:type owl:DatatypeProperty ,
                        owl:FunctionalProperty ;
               rdfs:domain :Incident ;
               rdfs:range xsd:date ;
               rdfs:comment "The date when the incident or risk was first detected."@en ;
               rdfs:label "detection date" .


###  http://www.noel-garcia.org/ontologies/medical-devices#deviceName
:deviceName rdf:type owl:DatatypeProperty ,
                     owl:FunctionalProperty ;
            rdfs:domain :Device ;
            rdfs:range xsd:string ;
            rdfs:comment "The commercial name of the medical device."@en ;
            rdfs:label "device name" .


###  http://www.noel-garcia.org/ontologies/medical-devices#devicesAffected
:devicesAffected rdf:type owl:DatatypeProperty ;
                 rdfs:domain :CorrectiveAction ;
                 rdfs:range xsd:integer ;
                 rdfs:comment "Number of devices impacted."@en ;
                 rdfs:label "devices affected" .


###  http://www.noel-garcia.org/ontologies/medical-devices#eudamedFSCARef
:eudamedFSCARef rdf:type owl:DatatypeProperty ,
                         owl:FunctionalProperty ;
                rdfs:domain :CorrectiveAction ;
                rdfs:range xsd:string ;
                rdfs:comment "Reference identifier of the corrective action in EUDAMED."@en ;
                rdfs:label "eudamed f s c a ref" .


###  http://www.noel-garcia.org/ontologies/medical-devices#eudamedIncidentRef
:eudamedIncidentRef rdf:type owl:DatatypeProperty ,
                             owl:FunctionalProperty ;
                    rdfs:domain :Incident ;
                    rdfs:range xsd:string ;
                    rdfs:comment "Reference identifier of the incident in EUDAMED."@en ;
                    rdfs:label "eudamed incident ref" .


###  http://www.noel-garcia.org/ontologies/medical-devices#eudamedSRN
:eudamedSRN rdf:type owl:DatatypeProperty ,
                     owl:FunctionalProperty ;
            rdfs:domain :Manufacturer ;
            rdfs:range xsd:string ;
            rdfs:comment "Single Registration Number assigned in EUDAMED."@en ;
            rdfs:label "eudamed s r n" .


###  http://www.noel-garcia.org/ontologies/medical-devices#eventDate
:eventDate rdf:type owl:DatatypeProperty ,
                    owl:FunctionalProperty ;
           rdfs:domain :Incident ;
           rdfs:range xsd:date ;
           rdfs:comment "Date when the incident occurred."@en ;
           rdfs:label "event date" .


###  http://www.noel-garcia.org/ontologies/medical-devices#imdrfCode
:imdrfCode rdf:type owl:DatatypeProperty ,
                    owl:FunctionalProperty ;
           rdfs:domain :Risk ;
           rdfs:range xsd:string ;
           rdfs:comment "Code assigned according to IMDRF risk classification."@en ;
           rdfs:label "imdrf code" .


###  http://www.noel-garcia.org/ontologies/medical-devices#intendedPurpose
:intendedPurpose rdf:type owl:DatatypeProperty ,
                          owl:FunctionalProperty ;
                 rdfs:domain :Device ;
                 rdfs:range xsd:string ;
                 rdfs:comment "The intended use of the device."@en ;
                 rdfs:label "intended purpose" .


###  http://www.noel-garcia.org/ontologies/medical-devices#isActive
:isActive rdf:type owl:DatatypeProperty ,
                   owl:FunctionalProperty ;
          rdfs:domain :Device ;
          rdfs:range xsd:boolean ;
          rdfs:comment "Indicates whether the device requires energy to operate."@en ;
          rdfs:label "is active" .


###  http://www.noel-garcia.org/ontologies/medical-devices#isIVD
:isIVD rdf:type owl:DatatypeProperty ,
                owl:FunctionalProperty ;
       rdfs:domain :Device ;
       rdfs:range xsd:boolean ;
       rdfs:comment "Indicates whether the device is an in vitro diagnostic device."@en ;
       rdfs:label "is i v d" .


###  http://www.noel-garcia.org/ontologies/medical-devices#isImplantable
:isImplantable rdf:type owl:DatatypeProperty ,
                        owl:FunctionalProperty ;
               rdfs:domain :Device ;
               rdfs:range xsd:boolean ;
               rdfs:comment "Indicates whether the device is implantable."@en ;
               rdfs:label "is implantable" .


###  http://www.noel-garcia.org/ontologies/medical-devices#isReusable
:isReusable rdf:type owl:DatatypeProperty ,
                     owl:FunctionalProperty ;
            rdfs:domain :Device ;
            rdfs:range xsd:boolean ;
            rdfs:comment "Indicates whether the device can be reused."@en ;
            rdfs:label "is reusable" .


###  http://www.noel-garcia.org/ontologies/medical-devices#outcome
:outcome rdf:type owl:DatatypeProperty ,
                  owl:FunctionalProperty ;
         rdfs:domain :Incident ;
         rdfs:range xsd:string ;
         rdfs:comment "Result or consequence of the incident."@en ;
         rdfs:label "outcome" .


###  http://www.noel-garcia.org/ontologies/medical-devices#patientAge
:patientAge rdf:type owl:DatatypeProperty ,
                     owl:FunctionalProperty ;
            rdfs:domain :Incident ;
            rdfs:range xsd:integer ;
            rdfs:comment "Age of the patient involved in the incident."@en ;
            rdfs:label "patient age" .


###  http://www.noel-garcia.org/ontologies/medical-devices#patientSex
:patientSex rdf:type owl:DatatypeProperty ,
                     owl:FunctionalProperty ;
            rdfs:domain :Incident ;
            rdfs:range xsd:string ;
            rdfs:comment "Sex of the patient involved."@en ;
            rdfs:label "patient sex" .


###  http://www.noel-garcia.org/ontologies/medical-devices#regulatoryFramework
:regulatoryFramework rdf:type owl:DatatypeProperty ,
                              owl:FunctionalProperty ;
                     rdfs:domain :Device ;
                     rdfs:range xsd:string ;
                     rdfs:comment "The regulatory framework under which the device is classified, MDR or IVDR."@en ;
                     rdfs:label "regulatory framework" .


###  http://www.noel-garcia.org/ontologies/medical-devices#reportDate
:reportDate rdf:type owl:DatatypeProperty ,
                     owl:FunctionalProperty ;
            rdfs:domain :Incident ;
            rdfs:range xsd:date ;
            rdfs:comment "Date when the incident was reported."@en ;
            rdfs:label "report date" .


###  http://www.noel-garcia.org/ontologies/medical-devices#riskName
:riskName rdf:type owl:DatatypeProperty ,
                   owl:FunctionalProperty ;
          rdfs:domain :Risk ;
          rdfs:range xsd:string ;
          rdfs:comment "Name describing the risk."@en ;
          rdfs:label "risk name" .


###  http://www.noel-garcia.org/ontologies/medical-devices#scope
:scope rdf:type owl:DatatypeProperty ,
                owl:FunctionalProperty ;
       rdfs:domain :CorrectiveAction ;
       rdfs:range xsd:string ;
       rdfs:comment "Scope of the corrective action."@en ;
       rdfs:label "scope" .


###  http://www.noel-garcia.org/ontologies/medical-devices#status
:status rdf:type owl:DatatypeProperty ,
                 owl:FunctionalProperty ;
        rdfs:domain :CorrectiveAction ;
        rdfs:range xsd:string ;
        rdfs:comment "Current status of the corrective action."@en ;
        rdfs:label "status" .


###  http://www.noel-garcia.org/ontologies/medical-devices#udi_di
:udi_di rdf:type owl:DatatypeProperty ,
                 owl:FunctionalProperty ;
        rdfs:domain :Device ;
        rdfs:range xsd:string ;
        rdfs:comment "The unique device identifier."@en ;
        rdfs:label "udi_di" .


###  https://schema.org/#email
<https://schema.org/#email> rdf:type owl:DatatypeProperty ;
                            rdfs:domain :Manufacturer ;
                            rdfs:range xsd:string ;
                            rdfs:comment "The contact email address of the manufacturer."@en ;
                            rdfs:label "email" .


###  https://schema.org/#name
<https://schema.org/#name> rdf:type owl:DatatypeProperty ,
                                    owl:FunctionalProperty ;
                           rdfs:domain :Manufacturer ;
                           rdfs:range xsd:string ;
                           rdfs:comment "The official name of the manufacturer."@en ;
                           rdfs:label "name" .


#################################################################
#    Classes
#################################################################

###  http://www.noel-garcia.org/ontologies/medical-devices#ActionType
:ActionType rdf:type owl:Class ;
            rdfs:comment "The type of corrective action taken in response to an incident."@en ;
            rdfs:label "Action Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#ActiveDevice
:ActiveDevice rdf:type owl:Class ;
              rdfs:subClassOf :DeviceType ;
              rdfs:comment "A medical device that relies on a source of energy other than the human body."@en ;
              rdfs:label "Active Device" .


###  http://www.noel-garcia.org/ontologies/medical-devices#ActiveImplant
:ActiveImplant rdf:type owl:Class ;
               rdfs:subClassOf :DeviceType ;
               rdfs:comment "A surgically inserted medical device that relies on an external power source to function."@en ;
               rdfs:label "Active Implant" .


###  http://www.noel-garcia.org/ontologies/medical-devices#ClassA
:ClassA rdf:type owl:Class ;
        rdfs:subClassOf :DeviceRiskClass ;
        rdfs:comment "Risk Class A for in vitro diagnostic devices according to the IVDR framework."@en ;
        rdfs:label "Class A" .


###  http://www.noel-garcia.org/ontologies/medical-devices#ClassB
:ClassB rdf:type owl:Class ;
        rdfs:subClassOf :DeviceRiskClass ;
        rdfs:comment "Risk Class B for in vitro diagnostic devices according to the IVDR framework."@en ;
        rdfs:label "Class B" .


###  http://www.noel-garcia.org/ontologies/medical-devices#ClassC
:ClassC rdf:type owl:Class ;
        rdfs:subClassOf :DeviceRiskClass ;
        rdfs:comment "Risk Class C for in vitro diagnostic devices according to the IVDR framework."@en ;
        rdfs:label "Class C" .


###  http://www.noel-garcia.org/ontologies/medical-devices#ClassD
:ClassD rdf:type owl:Class ;
        rdfs:subClassOf :DeviceRiskClass ;
        rdfs:comment "Risk Class D for in vitro diagnostic devices according to the IVDR framework."@en ;
        rdfs:label "Class D" .


###  http://www.noel-garcia.org/ontologies/medical-devices#ClassI
:ClassI rdf:type owl:Class ;
        rdfs:subClassOf :DeviceRiskClass ;
        rdfs:comment "Risk Class I for medical devices according to the MDR framework."@en ;
        rdfs:label "Class I" .


###  http://www.noel-garcia.org/ontologies/medical-devices#ClassIII
:ClassIII rdf:type owl:Class ;
          rdfs:subClassOf :DeviceRiskClass ;
          rdfs:comment "Risk Class III for medical devices according to the MDR framework."@en ;
          rdfs:label "Class I I I" .


###  http://www.noel-garcia.org/ontologies/medical-devices#ClassIIa
:ClassIIa rdf:type owl:Class ;
          rdfs:subClassOf :DeviceRiskClass ;
          rdfs:comment "Risk Class IIa for medical devices according to the MDR framework."@en ;
          rdfs:label "Class I Ia" .


###  http://www.noel-garcia.org/ontologies/medical-devices#ClassIIb
:ClassIIb rdf:type owl:Class ;
          rdfs:subClassOf :DeviceRiskClass ;
          rdfs:comment "Risk Class IIb for medical devices according to the MDR framework."@en ;
          rdfs:label "Class I Ib" .


###  http://www.noel-garcia.org/ontologies/medical-devices#ContaminationRisk
:ContaminationRisk rdf:type owl:Class ;
                   rdfs:subClassOf :RiskType ;
                   rdfs:comment "A risk associated with contamination of a device by biological, chemical, or other substances."@en ;
                   rdfs:label "Contamination Risk" .


###  http://www.noel-garcia.org/ontologies/medical-devices#CorrectiveAction
:CorrectiveAction rdf:type owl:Class ;
                  rdfs:subClassOf [ rdf:type owl:Restriction ;
                                    owl:onProperty :hasActionType ;
                                    owl:cardinality "1"^^xsd:nonNegativeInteger
                                  ] ,
                                  [ rdf:type owl:Restriction ;
                                    owl:onProperty :relatedToIncident ;
                                    owl:cardinality "1"^^xsd:nonNegativeInteger
                                  ] ,
                                  [ rdf:type owl:Restriction ;
                                    owl:onProperty <http://purl.org/dc/terms/description> ;
                                    owl:cardinality "1"^^xsd:nonNegativeInteger
                                  ] ,
                                  [ rdf:type owl:Restriction ;
                                    owl:onProperty :actionDate ;
                                    owl:cardinality "1"^^xsd:nonNegativeInteger
                                  ] ,
                                  [ rdf:type owl:Restriction ;
                                    owl:onProperty :countriesAffected ;
                                    owl:cardinality "1"^^xsd:nonNegativeInteger
                                  ] ,
                                  [ rdf:type owl:Restriction ;
                                    owl:onProperty :devicesAffected ;
                                    owl:cardinality "1"^^xsd:nonNegativeInteger
                                  ] ,
                                  [ rdf:type owl:Restriction ;
                                    owl:onProperty :eudamedFSCARef ;
                                    owl:cardinality "1"^^xsd:nonNegativeInteger
                                  ] ,
                                  [ rdf:type owl:Restriction ;
                                    owl:onProperty :scope ;
                                    owl:cardinality "1"^^xsd:nonNegativeInteger
                                  ] ,
                                  [ rdf:type owl:Restriction ;
                                    owl:onProperty :status ;
                                    owl:cardinality "1"^^xsd:nonNegativeInteger
                                  ] ,
                                  [ rdf:type owl:Restriction ;
                                    owl:onProperty :closureDate ;
                                    owl:maxCardinality "1"^^xsd:nonNegativeInteger
                                  ] ;
                  rdfs:comment "An action taken to manage a safety issue related to a medical device."@en ;
                  rdfs:label "Corrective Action" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Critical
:Critical rdf:type owl:Class ;
          rdfs:subClassOf :SeverityLevel ;
          rdfs:comment "A severity level indicating life-threatening or fatal consequences."@en ;
          rdfs:label "Critical" .


###  http://www.noel-garcia.org/ontologies/medical-devices#CybersecurityRisk
:CybersecurityRisk rdf:type owl:Class ;
                   rdfs:subClassOf :RiskType ;
                   rdfs:comment "A risk related to unauthorized access, data breaches, or cyber attacks affecting a medical device."@en ;
                   rdfs:label "Cybersecurity Risk" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Device
:Device rdf:type owl:Class ;
        rdfs:subClassOf [ rdf:type owl:Restriction ;
                          owl:onProperty :hasDeviceType ;
                          owl:qualifiedCardinality "1"^^xsd:nonNegativeInteger ;
                          owl:onClass :DeviceType
                        ] ,
                        [ rdf:type owl:Restriction ;
                          owl:onProperty :hasManufacturer ;
                          owl:cardinality "1"^^xsd:nonNegativeInteger
                        ] ,
                        [ rdf:type owl:Restriction ;
                          owl:onProperty :hasRiskClass ;
                          owl:cardinality "1"^^xsd:nonNegativeInteger
                        ] ,
                        [ rdf:type owl:Restriction ;
                          owl:onProperty :deviceName ;
                          owl:cardinality "1"^^xsd:nonNegativeInteger
                        ] ,
                        [ rdf:type owl:Restriction ;
                          owl:onProperty :intendedPurpose ;
                          owl:cardinality "1"^^xsd:nonNegativeInteger
                        ] ,
                        [ rdf:type owl:Restriction ;
                          owl:onProperty :isActive ;
                          owl:cardinality "1"^^xsd:nonNegativeInteger
                        ] ,
                        [ rdf:type owl:Restriction ;
                          owl:onProperty :isIVD ;
                          owl:cardinality "1"^^xsd:nonNegativeInteger
                        ] ,
                        [ rdf:type owl:Restriction ;
                          owl:onProperty :isImplantable ;
                          owl:cardinality "1"^^xsd:nonNegativeInteger
                        ] ,
                        [ rdf:type owl:Restriction ;
                          owl:onProperty :isReusable ;
                          owl:cardinality "1"^^xsd:nonNegativeInteger
                        ] ,
                        [ rdf:type owl:Restriction ;
                          owl:onProperty :regulatoryFramework ;
                          owl:cardinality "1"^^xsd:nonNegativeInteger
                        ] ,
                        [ rdf:type owl:Restriction ;
                          owl:onProperty :udi_di ;
                          owl:cardinality "1"^^xsd:nonNegativeInteger
                        ] ;
        rdfs:comment "A medical device used for diagnostic or therapeutic purposes"@en ;
        rdfs:label "Device" ;
        rdfs:sameAs "http://dbpedia.org/resource/Medical_device"^^xsd:anyURI .


###  http://www.noel-garcia.org/ontologies/medical-devices#DeviceFailure
:DeviceFailure rdf:type owl:Class ;
               rdfs:subClassOf :RiskCategory ;
               rdfs:comment "A risk category related to malfunction or failure of a medical device."@en ;
               rdfs:label "Device Failure" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DevicePerformance
:DevicePerformance rdf:type owl:Class ;
                   rdfs:subClassOf :RiskCategory ;
                   rdfs:comment "A risk category related to issues affecting the performance of a medical device."@en ;
                   rdfs:label "Device Performance" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DeviceRiskClass
:DeviceRiskClass rdf:type owl:Class ;
                 rdfs:comment "A classification level indicating the risk associated with a medical device."@en ;
                 rdfs:label "Device Risk Class" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DeviceSafety
:DeviceSafety rdf:type owl:Class ;
              rdfs:subClassOf :RiskCategory ;
              rdfs:comment "A risk category concerning the safety aspects of a medical device."@en ;
              rdfs:label "Device Safety" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DeviceType
:DeviceType rdf:type owl:Class ;
            rdfs:comment "The type of the device"@en ;
            rdfs:label "Device Type"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#DiagnosticError
:DiagnosticError rdf:type owl:Class ;
                 rdfs:subClassOf :RiskCategory ;
                 rdfs:comment "A risk category involving incorrect diagnostic results produced by a device."@en ;
                 rdfs:label "Diagnostic Error" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DiagnosticRisk
:DiagnosticRisk rdf:type owl:Class ;
                rdfs:subClassOf :RiskType ;
                rdfs:comment "A risk involving incorrect or unreliable diagnostic results produced by a device."@en ;
                rdfs:label "Diagnostic Risk" .


###  http://www.noel-garcia.org/ontologies/medical-devices#High
:High rdf:type owl:Class ;
      rdfs:subClassOf :ProbabilityLevel ;
      rdfs:comment "A probability level indicating a high likelihood of occurrence."@en ;
      rdfs:label "High" .


###  http://www.noel-garcia.org/ontologies/medical-devices#ImplantableActiveDevice
:ImplantableActiveDevice rdf:type owl:Class ;
                         rdfs:subClassOf :ActiveDevice ,
                                         :ImplantableDevice ;
                         rdfs:comment "An active device intended to be completely or partially introduced into the body."@en ;
                         rdfs:label "Implantable Active Device" .


###  http://www.noel-garcia.org/ontologies/medical-devices#ImplantableDevice
:ImplantableDevice rdf:type owl:Class ;
                   rdfs:subClassOf :DeviceType ;
                   rdfs:comment "A device intended to be placed inside the human body."@en ;
                   rdfs:label "Implantable Device" .


###  http://www.noel-garcia.org/ontologies/medical-devices#InSituCorrection
:InSituCorrection rdf:type owl:Class ;
                  rdfs:subClassOf :ActionType ;
                  rdfs:comment "A corrective action performed directly on the device at its location without removing it."@en ;
                  rdfs:label "In Situ Correction" .


###  http://www.noel-garcia.org/ontologies/medical-devices#InVitroDiagnosticDevice
:InVitroDiagnosticDevice rdf:type owl:Class ;
                         rdfs:subClassOf :DeviceType ;
                         rdfs:comment "A device used to perform tests on samples outside the human body"@en ;
                         rdfs:label "In Vitro Diagnostic Device" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Incident
:Incident rdf:type owl:Class ;
          rdfs:subClassOf [ rdf:type owl:Restriction ;
                            owl:onProperty :hasIncidentType ;
                            owl:cardinality "1"^^xsd:nonNegativeInteger
                          ] ,
                          [ rdf:type owl:Restriction ;
                            owl:onProperty :hasRisk ;
                            owl:cardinality "1"^^xsd:nonNegativeInteger
                          ] ,
                          [ rdf:type owl:Restriction ;
                            owl:onProperty :involvesDevice ;
                            owl:cardinality "1"^^xsd:nonNegativeInteger
                          ] ,
                          [ rdf:type owl:Restriction ;
                            owl:onProperty :reportedBy ;
                            owl:cardinality "1"^^xsd:nonNegativeInteger
                          ] ,
                          [ rdf:type owl:Restriction ;
                            owl:onProperty <http://purl.org/dc/terms/description> ;
                            owl:cardinality "1"^^xsd:nonNegativeInteger
                          ] ,
                          [ rdf:type owl:Restriction ;
                            owl:onProperty :correctiveActionTaken ;
                            owl:cardinality "1"^^xsd:nonNegativeInteger
                          ] ,
                          [ rdf:type owl:Restriction ;
                            owl:onProperty :countryReported ;
                            owl:cardinality "1"^^xsd:nonNegativeInteger
                          ] ,
                          [ rdf:type owl:Restriction ;
                            owl:onProperty :detectionDate ;
                            owl:cardinality "1"^^xsd:nonNegativeInteger
                          ] ,
                          [ rdf:type owl:Restriction ;
                            owl:onProperty :eudamedIncidentRef ;
                            owl:cardinality "1"^^xsd:nonNegativeInteger
                          ] ,
                          [ rdf:type owl:Restriction ;
                            owl:onProperty :eventDate ;
                            owl:cardinality "1"^^xsd:nonNegativeInteger
                          ] ,
                          [ rdf:type owl:Restriction ;
                            owl:onProperty :outcome ;
                            owl:cardinality "1"^^xsd:nonNegativeInteger
                          ] ,
                          [ rdf:type owl:Restriction ;
                            owl:onProperty :reportDate ;
                            owl:cardinality "1"^^xsd:nonNegativeInteger
                          ] ,
                          [ rdf:type owl:Restriction ;
                            owl:onProperty :patientAge ;
                            owl:maxCardinality "1"^^xsd:nonNegativeInteger
                          ] ,
                          [ rdf:type owl:Restriction ;
                            owl:onProperty :patientSex ;
                            owl:maxCardinality "1"^^xsd:nonNegativeInteger
                          ] ;
          rdfs:comment "An event related to a medical device that may cause or has caused harm."@en ;
          rdfs:label "Incident" .


###  http://www.noel-garcia.org/ontologies/medical-devices#IncidentType
:IncidentType rdf:type owl:Class ;
              rdfs:comment "The classification of the reported incident."@en ;
              rdfs:label "Incident Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#InfectionRisk
:InfectionRisk rdf:type owl:Class ;
               rdfs:subClassOf :RiskType ;
               rdfs:comment "A risk related to the potential transmission of infections through the use of a medical device."@en ;
               rdfs:label "Infection Risk" .


###  http://www.noel-garcia.org/ontologies/medical-devices#InjuryRisk
:InjuryRisk rdf:type owl:Class ;
            rdfs:subClassOf :RiskType ;
            rdfs:comment "A risk involving physical harm or injury to a patient or user caused by a device."@en ;
            rdfs:label "Injury Risk" .


###  http://www.noel-garcia.org/ontologies/medical-devices#InterferenceRisk
:InterferenceRisk rdf:type owl:Class ;
                  rdfs:subClassOf :RiskType ;
                  rdfs:comment "A risk caused by flaws in the interaction (physical, cognitive, or logical) between the person and the device."@en ;
                  rdfs:label "Interference Risk" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Low
:Low rdf:type owl:Class ;
     rdfs:subClassOf :ProbabilityLevel ;
     rdfs:comment "A probability level indicating a low likelihood of occurrence."@en ;
     rdfs:label "Low" .


###  http://www.noel-garcia.org/ontologies/medical-devices#MalfunctionRisk
:MalfunctionRisk rdf:type owl:Class ;
                 rdfs:subClassOf :RiskType ;
                 rdfs:comment "A risk related to the failure or malfunction of a medical device."@en ;
                 rdfs:label "Malfunction Risk" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Manufacturer
:Manufacturer rdf:type owl:Class ;
              rdfs:subClassOf [ rdf:type owl:Restriction ;
                                owl:onProperty :authorizationNumber ;
                                owl:cardinality "1"^^xsd:nonNegativeInteger
                              ] ,
                              [ rdf:type owl:Restriction ;
                                owl:onProperty :competentAuthority ;
                                owl:cardinality "1"^^xsd:nonNegativeInteger
                              ] ,
                              [ rdf:type owl:Restriction ;
                                owl:onProperty :country ;
                                owl:cardinality "1"^^xsd:nonNegativeInteger
                              ] ,
                              [ rdf:type owl:Restriction ;
                                owl:onProperty :eudamedSRN ;
                                owl:cardinality "1"^^xsd:nonNegativeInteger
                              ] ,
                              [ rdf:type owl:Restriction ;
                                owl:onProperty <https://schema.org/#email> ;
                                owl:cardinality "1"^^xsd:nonNegativeInteger
                              ] ,
                              [ rdf:type owl:Restriction ;
                                owl:onProperty <https://schema.org/#name> ;
                                owl:cardinality "1"^^xsd:nonNegativeInteger
                              ] ;
              rdfs:comment "An organization responsible for producing medical devices and registering them in EUDAMED."@en ;
              rdfs:label "Manufacturer" ;
              rdfs:sameAs "http://dbpedia.org/resource/Manufacturer"^^xsd:anyURI .


###  http://www.noel-garcia.org/ontologies/medical-devices#MaterialRisk
:MaterialRisk rdf:type owl:Class ;
              rdfs:subClassOf :RiskType ;
              rdfs:comment "A risk associated with the materials used in a device."@en ;
              rdfs:label "Material Risk" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Medium
:Medium rdf:type owl:Class ;
        rdfs:subClassOf :ProbabilityLevel ;
        rdfs:comment "A probability level indicating a moderate likelihood of occurrence."@en ;
        rdfs:label "Medium" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Moderate
:Moderate rdf:type owl:Class ;
          rdfs:subClassOf :SeverityLevel ;
          rdfs:comment "A severity level indicating moderate health impact requiring intervention."@en ;
          rdfs:label "Moderate" .


###  http://www.noel-garcia.org/ontologies/medical-devices#NearMissIncident
:NearMissIncident rdf:type owl:Class ;
                  rdfs:subClassOf :IncidentType ;
                  owl:disjointWith :SeriousIncident ;
                  rdfs:comment "A Near Miss incident involving a medical device."@en ;
                  rdfs:label "Near Miss Incident" .


###  http://www.noel-garcia.org/ontologies/medical-devices#PatientHarm
:PatientHarm rdf:type owl:Class ;
             rdfs:subClassOf :RiskCategory ;
             rdfs:comment "A risk category involving injury or harm caused to a patient."@en ;
             rdfs:label "Patient Harm" .


###  http://www.noel-garcia.org/ontologies/medical-devices#ProbabilityLevel
:ProbabilityLevel rdf:type owl:Class ;
                  rdfs:comment "The likelihood of a risk occurring."@en ;
                  rdfs:label "Probability Level" .


###  http://www.noel-garcia.org/ontologies/medical-devices#ProductQuality
:ProductQuality rdf:type owl:Class ;
                rdfs:subClassOf :RiskCategory ;
                rdfs:comment "A risk category related to defects or quality issues in a medical device."@en ;
                rdfs:label "Product Quality" .


###  http://www.noel-garcia.org/ontologies/medical-devices#RadiationRisk
:RadiationRisk rdf:type owl:Class ;
               rdfs:subClassOf :RiskType ;
               rdfs:comment "A risk related to exposure to harmful radiation emitted by a device."@en ;
               rdfs:label "Radiation Risk" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Recall
:Recall rdf:type owl:Class ;
        rdfs:subClassOf :ActionType ;
        rdfs:comment "A corrective action involving the removal of a medical device from the market or its return due to safety concerns."@en ;
        rdfs:label "Recall" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Risk
:Risk rdf:type owl:Class ;
      rdfs:subClassOf [ rdf:type owl:Restriction ;
                        owl:onProperty :affectedDeviceType_ ;
                        owl:cardinality "1"^^xsd:nonNegativeInteger
                      ] ,
                      [ rdf:type owl:Restriction ;
                        owl:onProperty :hasProbability ;
                        owl:cardinality "1"^^xsd:nonNegativeInteger
                      ] ,
                      [ rdf:type owl:Restriction ;
                        owl:onProperty :hasRiskCategory ;
                        owl:cardinality "1"^^xsd:nonNegativeInteger
                      ] ,
                      [ rdf:type owl:Restriction ;
                        owl:onProperty :hasRiskType ;
                        owl:cardinality "1"^^xsd:nonNegativeInteger
                      ] ,
                      [ rdf:type owl:Restriction ;
                        owl:onProperty :hasSeverity ;
                        owl:cardinality "1"^^xsd:nonNegativeInteger
                      ] ,
                      [ rdf:type owl:Restriction ;
                        owl:onProperty <http://purl.org/dc/terms/description> ;
                        owl:cardinality "1"^^xsd:nonNegativeInteger
                      ] ,
                      [ rdf:type owl:Restriction ;
                        owl:onProperty :imdrfCode ;
                        owl:cardinality "1"^^xsd:nonNegativeInteger
                      ] ,
                      [ rdf:type owl:Restriction ;
                        owl:onProperty :riskName ;
                        owl:cardinality "1"^^xsd:nonNegativeInteger
                      ] ;
      rdfs:comment "A potential hazard associated with a medical device, classified according to IMDRF terminology."@en ;
      rdfs:label "Risk" ;
      rdfs:sameAs "http://dbpedia.org/resource/Risk"^^xsd:anyURI .


###  http://www.noel-garcia.org/ontologies/medical-devices#RiskCategory
:RiskCategory rdf:type owl:Class ;
              rdfs:comment "A category grouping different types of risks."@en ;
              rdfs:label "Risk Category" .


###  http://www.noel-garcia.org/ontologies/medical-devices#RiskType
:RiskType rdf:type owl:Class ;
          rdfs:comment "The type of risk associated with a medical device."@en ;
          rdfs:label "Risk Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#SafetyAlert
:SafetyAlert rdf:type owl:Class ;
             rdfs:subClassOf :ActionType ;
             rdfs:comment "A notification issued to inform users about potential safety issues related to a medical device."@en ;
             rdfs:label "Safety Alert" .


###  http://www.noel-garcia.org/ontologies/medical-devices#SelfTestDevice
:SelfTestDevice rdf:type owl:Class ;
                rdfs:subClassOf :DeviceType ;
                rdfs:comment "A device intended to be able to be used by people without special knowledge."@en ;
                rdfs:label "Self Test Device" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Serious
:Serious rdf:type owl:Class ;
         rdfs:subClassOf :SeverityLevel ;
         rdfs:comment "A severity level indicating significant health impact or injury."@en ;
         rdfs:label "Serious" .


###  http://www.noel-garcia.org/ontologies/medical-devices#SeriousIncident
:SeriousIncident rdf:type owl:Class ;
                 rdfs:subClassOf :IncidentType ;
                 rdfs:comment "An incident that led or could lead to serious deterioration of health or death."@en ;
                 rdfs:label "Serious Incident" .


###  http://www.noel-garcia.org/ontologies/medical-devices#SeverityLevel
:SeverityLevel rdf:type owl:Class ;
               rdfs:comment "The level of severity associated with a risk."@en ;
               rdfs:label "Severity Level" .


###  http://www.noel-garcia.org/ontologies/medical-devices#SingleUseDevice
:SingleUseDevice rdf:type owl:Class ;
                 rdfs:subClassOf :DeviceType ;
                 rdfs:comment "A device intended to be used on one individual during a single procedure."@en ;
                 rdfs:label "Single Use Device" .


###  http://www.noel-garcia.org/ontologies/medical-devices#SoftwareRisk
:SoftwareRisk rdf:type owl:Class ;
              rdfs:subClassOf :RiskType ;
              rdfs:comment "A risk caused by software errors, bugs, or failures in a medical device."@en ;
              rdfs:label "Software Risk" .


###  http://www.noel-garcia.org/ontologies/medical-devices#UserNotice
:UserNotice rdf:type owl:Class ;
            rdfs:subClassOf :ActionType ;
            rdfs:comment "A notification issued to users with instructions or information regarding the safe use of a medical device."@en ;
            rdfs:label "User Notice" .


#################################################################
#    Individuals
#################################################################

###  http://www.noel-garcia.org/ontologies/medical-devices#Active_Device_Type
:Active_Device_Type rdf:type owl:NamedIndividual ,
                             :ActiveDevice ;
                    rdfs:comment "Device category used to define its use."@en ;
                    rdfs:label "Active_Device_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Active_Implant_Type
:Active_Implant_Type rdf:type owl:NamedIndividual ,
                              :ActiveImplant ;
                     rdfs:comment "Device category used to define its use."@en ;
                     rdfs:label "Active_Implant_Type"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#Class_A
:Class_A rdf:type owl:NamedIndividual ,
                  :ClassA ;
         rdfs:comment "Standardized classification values for In Vitro Diagnostic (IVD) devices."@en ;
         rdfs:label "Class_A"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#Class_B
:Class_B rdf:type owl:NamedIndividual ,
                  :ClassB ;
         rdfs:comment "Standardized classification values for In Vitro Diagnostic (IVD) devices."@en ;
         rdfs:label "Class_B"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#Class_C
:Class_C rdf:type owl:NamedIndividual ,
                  :ClassC ;
         rdfs:comment "Standardized classification values for In Vitro Diagnostic (IVD) devices."@en ;
         rdfs:label "Class_C"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#Class_D
:Class_D rdf:type owl:NamedIndividual ,
                  :ClassD ;
         rdfs:comment "Standardized classification values for In Vitro Diagnostic (IVD) devices."@en ;
         rdfs:label "Class_D"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#Class_I
:Class_I rdf:type owl:NamedIndividual ,
                  :ClassI ;
         rdfs:comment "Standardized risk classification values for General Medical Devices."@en ;
         rdfs:label "Class_I"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#Class_III
:Class_III rdf:type owl:NamedIndividual ,
                    :ClassIII ;
           rdfs:comment "Standardized risk classification values for General Medical Devices."@en ;
           rdfs:label "Class_III" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Class_IIa
:Class_IIa rdf:type owl:NamedIndividual ,
                    :ClassIIa ;
           rdfs:comment "Standardized risk classification values for General Medical Devices."@en ;
           rdfs:label "Class_IIa"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#Class_IIb
:Class_IIb rdf:type owl:NamedIndividual ,
                    :ClassIIb ;
           rdfs:comment "Standardized risk classification values for General Medical Devices."@en ;
           rdfs:label "Class_IIb" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Contamination_Risk_Type
:Contamination_Risk_Type rdf:type owl:NamedIndividual ,
                                  :ContaminationRisk ;
                         rdfs:comment "Instance used to specify the hazard."@en ;
                         rdfs:label "Contamination_Risk_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Critical_Sev
:Critical_Sev rdf:type owl:NamedIndividual ,
                       :Critical ;
              rdfs:comment "Value used to show severity."@en ;
              rdfs:label "Critical_Sev" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Cybersecurity_Risk_Type
:Cybersecurity_Risk_Type rdf:type owl:NamedIndividual ,
                                  :CybersecurityRisk ;
                         rdfs:comment "Instance used to specify the hazard."@en ;
                         rdfs:label "Cybersecurity_Risk_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-001
:DEV-001 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :Implantable_Active_Type ;
         :hasManufacturer :MAN-001 ;
         :hasRiskClass :Class_III ;
         :deviceName "HeartMate 3 LVAD" ;
         :intendedPurpose "Ventricular assist device for end-stage heart failure" ;
         :isActive "true"^^xsd:boolean ;
         :isIVD "false"^^xsd:boolean ;
         :isImplantable "true"^^xsd:boolean ;
         :isReusable "false"^^xsd:boolean ;
         :regulatoryFramework "MDR" ;
         :udi_di "(01)00380740009095" ;
         rdfs:comment "Ventricular assist device for end-stage heart failure treatment."@en ;
         rdfs:label "HeartMate 3 LVAD"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-002
:DEV-002 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :Active_Implant_Type ;
         :hasManufacturer :MAN-001 ;
         :hasRiskClass :Class_III ;
         :deviceName "Micra AV Transcatheter Pacing System" ;
         :intendedPurpose "Leadless cardiac pacemaker for atrioventricular synchrony" ;
         :isActive "true"^^xsd:boolean ;
         :isIVD "false"^^xsd:boolean ;
         :isImplantable "true"^^xsd:boolean ;
         :isReusable "false"^^xsd:boolean ;
         :regulatoryFramework "MDR" ;
         :udi_di "(01)00380740009112" ;
         rdfs:comment "Leadless cardiac pacemaker designed for atrioventricular synchrony."@en ;
         rdfs:label "Micra AV Transcatheter Pacing System"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-003
:DEV-003 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :Implantable_Type ;
         :hasManufacturer :MAN-002 ;
         :hasRiskClass :Class_III ;
         :deviceName "Portico Transcatheter Heart Valve" ;
         :intendedPurpose "Transcatheter aortic valve replacement (TAVI)" ;
         :isActive "false"^^xsd:boolean ;
         :isIVD "false"^^xsd:boolean ;
         :isImplantable "true"^^xsd:boolean ;
         :isReusable "false"^^xsd:boolean ;
         :regulatoryFramework "MDR" ;
         :udi_di "(01)00800002222291" ;
         rdfs:comment "Transcatheter aortic valve replacement system for TAVI procedures."@en ;
         rdfs:label "Portico Transcatheter Heart Valve"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-004
:DEV-004 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :Implantable_Active_Type ;
         :hasManufacturer :MAN-006 ;
         :hasRiskClass :Class_IIb ;
         :deviceName "SYNERGY Stent System" ;
         :intendedPurpose "Drug-eluting coronary stent" ;
         :isActive "false"^^xsd:boolean ;
         :isIVD "false"^^xsd:boolean ;
         :isImplantable "true"^^xsd:boolean ;
         :isReusable "false"^^xsd:boolean ;
         :regulatoryFramework "MDR" ;
         :udi_di "(01)08714729002817" ;
         rdfs:comment "Drug-eluting coronary stent system for cardiovascular intervention." ;
         rdfs:label "SYNERGY Stent System" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-005
:DEV-005 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :Active_Implant_Type ;
         :hasManufacturer :MAN-006 ;
         :hasRiskClass :Class_III ;
         :deviceName "ACUITY X4 Quadripolar LV Lead" ;
         :intendedPurpose "Cardiac resynchronization therapy lead" ;
         :isActive "true"^^xsd:boolean ;
         :isIVD "false"^^xsd:boolean ;
         :isImplantable "true"^^xsd:boolean ;
         :isReusable "false"^^xsd:boolean ;
         :regulatoryFramework "MDR" ;
         :udi_di "(01)08714729004873" ;
         rdfs:comment "Quadripolar LV lead for cardiac resynchronization therapy."@en ;
         rdfs:label "ACUITY X4 Quadripolar LV Lead" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-006
:DEV-006 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :Single_Use_Device_Type ;
         :hasManufacturer :MAN-004 ;
         :hasRiskClass :Class_IIb ;
         :deviceName "STELLAREX Drug-Coated Balloon" ;
         :intendedPurpose "Peripheral artery drug-coated angioplasty balloon" ;
         :isActive "false"^^xsd:boolean ;
         :isIVD "false"^^xsd:boolean ;
         :isImplantable "false"^^xsd:boolean ;
         :isReusable "false"^^xsd:boolean ;
         :regulatoryFramework "MDR" ;
         :udi_di "(01)08718998000001" ;
         rdfs:comment "Drug-coated angioplasty balloon for peripheral artery treatment." ;
         rdfs:label "STELLAREX Drug-Coated Balloon" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-007
:DEV-007 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :Active_Device_Type ;
         :hasManufacturer :MAN-003 ;
         :hasRiskClass :Class_IIa ;
         :deviceName "ACUSON Sequoia Ultrasound" ;
         :intendedPurpose "Diagnostic ultrasound imaging system" ;
         :isActive "true"^^xsd:boolean ;
         :isIVD "false"^^xsd:boolean ;
         :isImplantable "false"^^xsd:boolean ;
         :isReusable "true"^^xsd:boolean ;
         :regulatoryFramework "MDR" ;
         :udi_di "(01)04054839450001" ;
         rdfs:comment "High-performance diagnostic ultrasound imaging system." ;
         rdfs:label "ACUSON Sequoia Ultrasound" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-008
:DEV-008 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :Active_Device_Type ;
         :hasManufacturer :MAN-003 ;
         :hasRiskClass :Class_IIa ;
         :deviceName "MAGNETOM Vida MRI System" ;
         :intendedPurpose "Magnetic resonance imaging system 3T" ;
         :isActive "true"^^xsd:boolean ;
         :isIVD "false"^^xsd:boolean ;
         :isImplantable "false"^^xsd:boolean ;
         :isReusable "true"^^xsd:boolean ;
         :regulatoryFramework "MDR" ;
         :udi_di "(01)04054839460002" ;
         rdfs:comment "3T magnetic resonance imaging system for advanced diagnostics." ;
         rdfs:label "MAGNETOM Vida MRI System" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-009
:DEV-009 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :Implantable_Type ;
         :hasManufacturer :MAN-010 ;
         :hasRiskClass :Class_III ;
         :deviceName "Persona Knee System" ;
         :intendedPurpose "Total knee arthroplasty implant system" ;
         :isActive "false"^^xsd:boolean ;
         :isIVD "false"^^xsd:boolean ;
         :isImplantable "true"^^xsd:boolean ;
         :isReusable "false"^^xsd:boolean ;
         :regulatoryFramework "MDR" ;
         :udi_di "(01)07612345001001" ;
         rdfs:comment "Total knee arthroplasty implant system for joint replacement." ;
         rdfs:label "Persona Knee System" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-010
:DEV-010 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :Implantable_Type ;
         :hasManufacturer :MAN-007 ;
         :hasRiskClass :Class_III ;
         :deviceName "TRITON Total Hip System" ;
         :intendedPurpose "Ceramic-on-ceramic total hip replacement" ;
         :isActive "false"^^xsd:boolean ;
         :isIVD "false"^^xsd:boolean ;
         :isImplantable "true"^^xsd:boolean ;
         :isReusable "false"^^xsd:boolean ;
         :regulatoryFramework "MDR" ;
         :udi_di "(01)09876543002002" ;
         rdfs:comment "Ceramic-on-ceramic total hip replacement system." ;
         rdfs:label "TRITON Total Hip System" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-011
:DEV-011 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :Active_Implant_Type ;
         :hasManufacturer :MAN-011 ;
         :hasRiskClass :Class_III ;
         :deviceName "Iluvien Intravitreal Implant" ;
         :intendedPurpose "Sustained-release fluocinolone acetonide ocular implant" ;
         :isActive "false"^^xsd:boolean ;
         :isIVD "false"^^xsd:boolean ;
         :isImplantable "true"^^xsd:boolean ;
         :isReusable "false"^^xsd:boolean ;
         :regulatoryFramework "MDR" ;
         :udi_di "(01)05391520001011" ;
         rdfs:comment "Sustained-release intravitreal implant for ocular therapy." ;
         rdfs:label "Iluvien Intravitreal Implant" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-012
:DEV-012 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :Active_Implant_Type ;
         :hasManufacturer :MAN-008 ;
         :hasRiskClass :Class_III ;
         :deviceName "Viva Cardiac Resynchronization Defibrillator" ;
         :intendedPurpose "Cardiac resynchronization therapy with defibrillation" ;
         :isActive "true"^^xsd:boolean ;
         :isIVD "false"^^xsd:boolean ;
         :isImplantable "true"^^xsd:boolean ;
         :isReusable "false"^^xsd:boolean ;
         :regulatoryFramework "MDR" ;
         :udi_di "(01)04012099001012" ;
         rdfs:comment "Cardiac resynchronization therapy device with defibrillation capacity." ;
         rdfs:label "Viva Cardiac Resynchronization Defibrillator" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-013
:DEV-013 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :Active_Device_Type ;
         :hasManufacturer :MAN-012 ;
         :hasRiskClass :Class_IIb ;
         :deviceName "ATERA Mechanical Ventilator" ;
         :intendedPurpose "ICU mechanical ventilator with pressure and volume modes" ;
         :isActive "true"^^xsd:boolean ;
         :isIVD "false"^^xsd:boolean ;
         :isImplantable "false"^^xsd:boolean ;
         :isReusable "true"^^xsd:boolean ;
         :regulatoryFramework "MDR" ;
         :udi_di "(01)04046539001013" ;
         rdfs:comment "ICU mechanical ventilator with advanced ventilation modes." ;
         rdfs:label "ATERA Mechanical Ventilator" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-014
:DEV-014 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :Active_Device_Type ;
         :hasManufacturer :MAN-004 ;
         :hasRiskClass :Class_IIa ;
         :deviceName "Lumify Portable Ultrasound" ;
         :intendedPurpose "Handheld point-of-care ultrasound probe" ;
         :isActive "true"^^xsd:boolean ;
         :isIVD "false"^^xsd:boolean ;
         :isImplantable "false"^^xsd:boolean ;
         :isReusable "true"^^xsd:boolean ;
         :regulatoryFramework "MDR" ;
         :udi_di "(01)08718998001014" ;
         rdfs:comment "Handheld point-of-care ultrasound diagnostic probe." ;
         rdfs:label "Lumify Portable Ultrasound" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-015
:DEV-015 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :Active_Device_Type ;
         :hasManufacturer :MAN-013 ;
         :hasRiskClass :Class_IIb ;
         :deviceName "Hemodialysis Machine 5008S" ;
         :intendedPurpose "High-volume online hemodiafiltration machine" ;
         :isActive "true"^^xsd:boolean ;
         :isIVD "false"^^xsd:boolean ;
         :isImplantable "false"^^xsd:boolean ;
         :isReusable "true"^^xsd:boolean ;
         :regulatoryFramework "MDR" ;
         :udi_di "(01)04547597001015" ;
         rdfs:comment "High-volume online hemodiafiltration machine for renal care." ;
         rdfs:label "Hemodialysis Machine 5008S" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-016
:DEV-016 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :In_Vitro_Diagnostic_Device_Type ;
         :hasManufacturer :MAN-005 ;
         :hasRiskClass :Class_C ;
         :deviceName "cobas e 801 Immunoassay Analyzer" ;
         :intendedPurpose "Automated immunoassay analyzer for clinical laboratory" ;
         :isActive "true"^^xsd:boolean ;
         :isIVD "true"^^xsd:boolean ;
         :isImplantable "false"^^xsd:boolean ;
         :isReusable "true"^^xsd:boolean ;
         :regulatoryFramework "IVDR" ;
         :udi_di "(01)04015630001016" ;
         rdfs:comment "Automated immunoassay analyzer for clinical laboratory use." ;
         rdfs:label "cobas e 801 Immunoassay Analyzer" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-017
:DEV-017 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :In_Vitro_Diagnostic_Device_Type ;
         :hasManufacturer :MAN-005 ;
         :hasRiskClass :Class_C ;
         :deviceName "cobas SARS-CoV-2 RT-PCR Test" ;
         :intendedPurpose "Molecular diagnostic test for SARS-CoV-2 detection" ;
         :isActive "false"^^xsd:boolean ;
         :isIVD "true"^^xsd:boolean ;
         :isImplantable "false"^^xsd:boolean ;
         :isReusable "false"^^xsd:boolean ;
         :regulatoryFramework "IVDR" ;
         :udi_di "(01)04015630001017" ;
         rdfs:comment "Molecular diagnostic test kit for SARS-CoV-2 detection." ;
         rdfs:label "cobas SARS-CoV-2 RT-PCR Test" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-018
:DEV-018 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :In_Vitro_Diagnostic_Device_Type ;
         :hasManufacturer :MAN-015 ;
         :hasRiskClass :Class_D ;
         :deviceName "VIDAS HIV DUO Ultra" ;
         :intendedPurpose "Combined HIV Ag/Ab detection assay" ;
         :isActive "false"^^xsd:boolean ;
         :isIVD "true"^^xsd:boolean ;
         :isImplantable "false"^^xsd:boolean ;
         :isReusable "false"^^xsd:boolean ;
         :regulatoryFramework "IVDR" ;
         :udi_di "(01)03760027001018" ;
         rdfs:comment "Combined HIV antigen and antibody detection assay." ;
         rdfs:label "VIDAS HIV DUO Ultra" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-019
:DEV-019 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :In_Vitro_Diagnostic_Device_Type ;
         :hasManufacturer :MAN-014 ;
         :hasRiskClass :Class_C ;
         :deviceName "PROGENSA PCA3 Assay" ;
         :intendedPurpose "Urine-based prostate cancer diagnosis assay" ;
         :isActive "false"^^xsd:boolean ;
         :isIVD "true"^^xsd:boolean ;
         :isImplantable "false"^^xsd:boolean ;
         :isReusable "false"^^xsd:boolean ;
         :regulatoryFramework "IVDR" ;
         :udi_di "(01)07000087001019" ;
         rdfs:comment "Urine-based assay for prostate cancer molecular diagnosis." ;
         rdfs:label "PROGENSA PCA3 Assay" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-020
:DEV-020 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :In_Vitro_Diagnostic_Device_Type ;
         :hasManufacturer :MAN-002 ;
         :hasRiskClass :Class_D ;
         :deviceName "Harmony Prenatal Test" ;
         :intendedPurpose "Non-invasive prenatal testing (NIPT) for aneuploidies" ;
         :isActive "false"^^xsd:boolean ;
         :isIVD "true"^^xsd:boolean ;
         :isImplantable "false"^^xsd:boolean ;
         :isReusable "false"^^xsd:boolean ;
         :regulatoryFramework "IVDR" ;
         :udi_di "(01)00800002001020" ;
         rdfs:comment "Non-invasive prenatal test for detecting genetic aneuploidies." ;
         rdfs:label "Harmony Prenatal Test" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-021
:DEV-021 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :Self_Test_Device_Type ;
         :hasManufacturer :MAN-009 ;
         :hasRiskClass :Class_C ;
         :deviceName "OPTIGA Glucose Monitoring System" ;
         :intendedPurpose "Continuous glucose monitor for patients with diabetes" ;
         :isActive "true"^^xsd:boolean ;
         :isIVD "true"^^xsd:boolean ;
         :isImplantable "false"^^xsd:boolean ;
         :isReusable "true"^^xsd:boolean ;
         :regulatoryFramework "IVDR" ;
         :udi_di "(01)07300000001021" ;
         rdfs:comment "Continuous glucose monitoring system for diabetic patients." ;
         rdfs:label "OPTIGA Glucose Monitoring System" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-022
:DEV-022 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :Active_Device_Type ;
         :hasManufacturer :MAN-009 ;
         :hasRiskClass :Class_IIa ;
         :deviceName "BeneVision N1 Patient Monitor" ;
         :intendedPurpose "Portable patient monitor for vital signs" ;
         :isActive "true"^^xsd:boolean ;
         :isIVD "false"^^xsd:boolean ;
         :isImplantable "false"^^xsd:boolean ;
         :isReusable "true"^^xsd:boolean ;
         :regulatoryFramework "MDR" ;
         :udi_di "(01)07300000001022" ;
         rdfs:comment "Portable patient monitor for real-time vital signs tracking." ;
         rdfs:label "BeneVision N1 Patient Monitor" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-023
:DEV-023 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :Active_Implant_Type ;
         :hasManufacturer :MAN-008 ;
         :hasRiskClass :Class_III ;
         :deviceName "Tivoli II Cochlear Implant" ;
         :intendedPurpose "Active cochlear implant for sensorineural hearing loss" ;
         :isActive "true"^^xsd:boolean ;
         :isIVD "false"^^xsd:boolean ;
         :isImplantable "true"^^xsd:boolean ;
         :isReusable "false"^^xsd:boolean ;
         :regulatoryFramework "MDR" ;
         :udi_di "(01)04012099001023" ;
         rdfs:comment "Active cochlear implant system for sensorineural hearing loss." ;
         rdfs:label "Tivoli II Cochlear Implant" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-024
:DEV-024 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :Active_Device_Type ;
         :hasManufacturer :MAN-002 ;
         :hasRiskClass :Class_IIb ;
         :deviceName "Infusion Pump Plum 360" ;
         :intendedPurpose "Large volume infusion pump with drug library" ;
         :isActive "true"^^xsd:boolean ;
         :isIVD "false"^^xsd:boolean ;
         :isImplantable "false"^^xsd:boolean ;
         :isReusable "true"^^xsd:boolean ;
         :regulatoryFramework "MDR" ;
         :udi_di "(01)00800002001024" ;
         rdfs:comment "Large volume infusion pump with integrated drug library." ;
         rdfs:label "Infusion Pump Plum 360" .


###  http://www.noel-garcia.org/ontologies/medical-devices#DEV-025
:DEV-025 rdf:type owl:NamedIndividual ,
                  :Device ;
         :hasDeviceType :Implantable_Type ;
         :hasManufacturer :MAN-011 ;
         :hasRiskClass :Class_III ;
         :deviceName "ValveXpert Transcatheter Mitral Valve" ;
         :intendedPurpose "Transcatheter mitral valve replacement system" ;
         :isActive "false"^^xsd:boolean ;
         :isIVD "false"^^xsd:boolean ;
         :isImplantable "true"^^xsd:boolean ;
         :isReusable "false"^^xsd:boolean ;
         :regulatoryFramework "MDR" ;
         :udi_di "(01)05391520001025" ;
         rdfs:comment "Transcatheter mitral valve replacement system." ;
         rdfs:label "ValveXpert Transcatheter Mitral Valve" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Device_Failure_Cat
:Device_Failure_Cat rdf:type owl:NamedIndividual ,
                             :DeviceFailure ;
                    rdfs:comment "Instance used to group risks by their area of impact."@en ;
                    rdfs:label "Device_Failure_Cat" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Device_Performance_Cat
:Device_Performance_Cat rdf:type owl:NamedIndividual ,
                                 :DevicePerformance ;
                        rdfs:comment "Instance used to group risks by their area of impact."@en ;
                        rdfs:label "Device_Performance_Cat" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Device_Safety_Cat
:Device_Safety_Cat rdf:type owl:NamedIndividual ,
                            :DeviceSafety ;
                   rdfs:comment "Instance used to group risks by their area of impact."@en ;
                   rdfs:label "Device_Safety_Cat" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Diagnostic_Error_Cat
:Diagnostic_Error_Cat rdf:type owl:NamedIndividual ,
                               :DiagnosticError ;
                      rdfs:comment "Instance used to group risks by their area of impact."@en ;
                      rdfs:label "Diagnostic_Error_Cat" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Diagnostic_Risk_Type
:Diagnostic_Risk_Type rdf:type owl:NamedIndividual ,
                               :DiagnosticRisk ;
                      rdfs:comment "Instance used to specify the hazard."@en ;
                      rdfs:label "Diagnostic_Risk_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#FSCA-001
:FSCA-001 rdf:type owl:NamedIndividual ,
                   :CorrectiveAction ;
          :hasActionType :Safety_Alert_Type ;
          :relatedToIncident :INC-001 ;
          :actionDate "2024-02-01"^^xsd:date ;
          :countriesAffected "EU-wide" ;
          :devicesAffected 850 ;
          :eudamedFSCARef "EU-FSCA-2024-000001" ;
          :scope "All HeartMate 3 LVAD units implanted since 2020" ;
          :status "Open" ;
          <http://purl.org/dc/terms/description> "Safety_Alert_Type issued to all implanting centres regarding anticoagulation protocol update for HeartMate 3 to reduce device thrombosis risk. INR target range revised to 2.0–3.0." ;
          rdfs:comment "Safety alert regarding anticoagulation protocol updates." ;
          rdfs:label "FSCA-001 (Safety Alert)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#FSCA-002
:FSCA-002 rdf:type owl:NamedIndividual ,
                   :CorrectiveAction ;
          :hasActionType :Recall_Type ;
          :relatedToIncident :INC-002 ;
          :actionDate "2024-02-28"^^xsd:date ;
          :closureDate "2024-05-31"^^xsd:date ;
          :countriesAffected "EU-wide + UK" ;
          :devicesAffected 1240 ;
          :eudamedFSCARef "EU-FSCA-2024-000002" ;
          :scope "Micra AV lots manufactured between 2022-09 and 2023-03" ;
          :status "Closed" ;
          <http://purl.org/dc/terms/description> "Voluntary Recall_Type of affected Micra AV lots due to premature battery depletion. Replacement units provided. 97% of affected devices successfully replaced." ;
          rdfs:comment "Voluntary recall of specific lots due to battery issues." ;
          rdfs:label "FSCA-002 (Recall)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#FSCA-003
:FSCA-003 rdf:type owl:NamedIndividual ,
                   :CorrectiveAction ;
          :hasActionType :In_Situ_Correction_Type ;
          :relatedToIncident :INC-003 ;
          :actionDate "2024-03-15"^^xsd:date ;
          :closureDate "2024-06-30"^^xsd:date ;
          :countriesAffected "EU-wide" ;
          :devicesAffected 320 ;
          :eudamedFSCARef "EU-FSCA-2024-000003" ;
          :scope "Portico THV sizes 23mm and 25mm from lots before 2023-11" ;
          :status "Closed" ;
          <http://purl.org/dc/terms/description> "Enhanced deployment training and updated IFU for Portico valve implantation technique. New implantation checklist mandatory for all TAVI centres." ;
          rdfs:comment "Field correction involving updated implantation techniques." ;
          rdfs:label "FSCA-003 (In Situ Correction)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#FSCA-004
:FSCA-004 rdf:type owl:NamedIndividual ,
                   :CorrectiveAction ;
          :hasActionType :Safety_Alert_Type ;
          :relatedToIncident :INC-005 ;
          :actionDate "2024-04-10"^^xsd:date ;
          :countriesAffected "EU-wide" ;
          :devicesAffected 2100 ;
          :eudamedFSCARef "EU-FSCA-2024-000004" ;
          :scope "All ACUITY X4 quadripolar LV leads" ;
          :status "Open" ;
          <http://purl.org/dc/terms/description> "Safety communication to implanting cardiologists regarding optimal fixation technique for ACUITY X4 lead. Enhanced fluoroscopy verification protocol at implantation." ;
          rdfs:comment "Communication on optimal fixation techniques for cardiac leads." ;
          rdfs:label "FSCA-004 (Safety Alert)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#FSCA-005
:FSCA-005 rdf:type owl:NamedIndividual ,
                   :CorrectiveAction ;
          :hasActionType :In_Situ_Correction_Type ;
          :relatedToIncident :INC-007 ;
          :actionDate "2024-05-20"^^xsd:date ;
          :closureDate "2024-09-30"^^xsd:date ;
          :countriesAffected "EU-wide + Switzerland" ;
          :devicesAffected 780 ;
          :eudamedFSCARef "EU-FSCA-2024-000005" ;
          :scope "Persona Knee tibial inserts with lot numbers PN-2019-* to PN-2021-*" ;
          :status "Closed" ;
          <http://purl.org/dc/terms/description> "Enhanced surveillance programme: annual DEXA scan and serum particle monitoring for patients with affected tibial inserts. Patients contacted individually." ;
          rdfs:comment "Enhanced surveillance programme for patients with joint implants." ;
          rdfs:label "FSCA-005 (In Situ Correction)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#FSCA-006
:FSCA-006 rdf:type owl:NamedIndividual ,
                   :CorrectiveAction ;
          :hasActionType :Recall_Type ;
          :relatedToIncident :INC-008 ;
          :actionDate "2024-05-30"^^xsd:date ;
          :countriesAffected "EU-wide" ;
          :devicesAffected 540 ;
          :eudamedFSCARef "EU-FSCA-2024-000006" ;
          :scope "TRITON Total Hip ceramic-on-ceramic 28mm heads from lots TH-2020-* and TH-2021-*" ;
          :status "Open" ;
          <http://purl.org/dc/terms/description> "Urgent safety Recall_Type due to elevated metal ion levels. Revision surgery recommended for patients with serum cobalt >7 ppb or symptomatic ALTR. Replacement implants provided." ;
          rdfs:comment "Urgent recall of hip implants due to metal ion release." ;
          rdfs:label "FSCA-006 (Recall)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#FSCA-007
:FSCA-007 rdf:type owl:NamedIndividual ,
                   :CorrectiveAction ;
          :hasActionType :User_Notice_Type ;
          :relatedToIncident :INC-009 ;
          :actionDate "2024-05-25"^^xsd:date ;
          :closureDate "2024-07-31"^^xsd:date ;
          :countriesAffected "EU-wide + UK" ;
          :devicesAffected 4300 ;
          :eudamedFSCARef "EU-FSCA-2024-000007" ;
          :scope "All Viva CRT-D devices" ;
          :status "Closed" ;
          <http://purl.org/dc/terms/description> "Urgent safety notice regarding MRI scanning protocol. Updated MRI-conditional guidelines issued. Mandatory reprogramming required before any MRI scan. Programmer software update v3.2 released." ;
          rdfs:comment "Safety notice regarding updated MRI-conditional guidelines." ;
          rdfs:label "FSCA-007 (User Notice)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#FSCA-008
:FSCA-008 rdf:type owl:NamedIndividual ,
                   :CorrectiveAction ;
          :hasActionType :Recall_Type ;
          :relatedToIncident :INC-010 ;
          :actionDate "2024-06-05"^^xsd:date ;
          :closureDate "2024-08-15"^^xsd:date ;
          :countriesAffected "EU-wide" ;
          :devicesAffected 180 ;
          :eudamedFSCARef "EU-FSCA-2024-000008" ;
          :scope "ATERA ventilators with software version 2.1.3" ;
          :status "Closed" ;
          <http://purl.org/dc/terms/description> "Software Recall_Type: mandatory update to version 2.2.0 resolving FiO2 calibration error. Biomedical engineers visited all affected units within 14 days. Field service documentation required." ;
          rdfs:comment "Mandatory software update to correct ventilator calibration." ;
          rdfs:label "FSCA-008 (Recall)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#FSCA-009
:FSCA-009 rdf:type owl:NamedIndividual ,
                   :CorrectiveAction ;
          :hasActionType :User_Notice_Type ;
          :relatedToIncident :INC-011 ;
          :actionDate "2024-06-20"^^xsd:date ;
          :closureDate "2024-09-30"^^xsd:date ;
          :countriesAffected "EU-wide" ;
          :devicesAffected 620 ;
          :eudamedFSCARef "EU-FSCA-2024-000009" ;
          :scope "All cobas e 801 immunoassay analysers" ;
          :status "Closed" ;
          <http://purl.org/dc/terms/description> "Customer field notification regarding biotin interference in TSH assay. Updated sample preparation protocol and interference screening algorithm released via software update 4.1.2." ;
          rdfs:comment "Field notification regarding interference screening in assays." ;
          rdfs:label "FSCA-009 (User Notice)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#FSCA-010
:FSCA-010 rdf:type owl:NamedIndividual ,
                   :CorrectiveAction ;
          :hasActionType :Recall_Type ;
          :relatedToIncident :INC-012 ;
          :actionDate "2024-06-30"^^xsd:date ;
          :closureDate "2024-08-31"^^xsd:date ;
          :countriesAffected "EU-wide + Norway + Iceland" ;
          :devicesAffected 12500 ;
          :eudamedFSCARef "EU-FSCA-2024-000010" ;
          :scope "cobas SARS-CoV-2 RT-PCR reagent lot numbers CV-2024-0312 to CV-2024-0318" ;
          :status "Closed" ;
          <http://purl.org/dc/terms/description> "Immediate quarantine and replacement of affected reagent lots. Reflex testing protocol issued. All positive results from affected lots to be re-confirmed. New primer design covering BA.2.86 released." ;
          rdfs:comment "Immediate quarantine and replacement of diagnostic reagent lots." ;
          rdfs:label "FSCA-010 (Recall)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#FSCA-011
:FSCA-011 rdf:type owl:NamedIndividual ,
                   :CorrectiveAction ;
          :hasActionType :In_Situ_Correction_Type ;
          :relatedToIncident :INC-014 ;
          :actionDate "2024-08-01"^^xsd:date ;
          :countriesAffected "EU-wide" ;
          :devicesAffected 3200 ;
          :eudamedFSCARef "EU-FSCA-2024-000011" ;
          :scope "All OPTIGA CGM sensors from manufacturing site GE-SGP-2" ;
          :status "Open" ;
          <http://purl.org/dc/terms/description> "Enhanced calibration protocol issued. Firmware update v1.8.5 mandatory improving temperature compensation algorithm. Patients instructed to perform confirmatory finger-stick at glucose readings <4.5 or >13.9 mmol/L." ;
          rdfs:comment "Mandatory firmware update to improve sensor compensation." ;
          rdfs:label "FSCA-011 (In Situ Correction)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#FSCA-012
:FSCA-012 rdf:type owl:NamedIndividual ,
                   :CorrectiveAction ;
          :hasActionType :Recall_Type ;
          :relatedToIncident :INC-015 ;
          :actionDate "2024-08-20"^^xsd:date ;
          :closureDate "2024-10-31"^^xsd:date ;
          :countriesAffected "EU-wide + UK + Norway" ;
          :devicesAffected 2870 ;
          :eudamedFSCARef "EU-FSCA-2024-000012" ;
          :scope "Plum 360 infusion pumps with drug library version 4.2.1" ;
          :status "Closed" ;
          <http://purl.org/dc/terms/description> "Urgent Recall_Type and remote software update. Drug library version 4.3.0 deployed correcting decimal point error. All units verified by biomedical engineering before return to clinical use." ;
          rdfs:comment "Urgent recall and software update for infusion pump drug library." ;
          rdfs:label "FSCA-012 (Recall)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#FSCA-013
:FSCA-013 rdf:type owl:NamedIndividual ,
                   :CorrectiveAction ;
          :hasActionType :Safety_Alert_Type ;
          :relatedToIncident :INC-016 ;
          :actionDate "2024-09-10"^^xsd:date ;
          :countriesAffected "EU-wide" ;
          :devicesAffected 420 ;
          :eudamedFSCARef "EU-FSCA-2024-000013" ;
          :scope "All HeartMate 3 LVAD units with outflow graft lot OG-2022-*" ;
          :status "Open" ;
          <http://purl.org/dc/terms/description> "Safety communication regarding outflow graft kinking risk. Updated surgical technique for graft routing issued. Mandatory follow-up CT at 6 months for patients with affected lot numbers." ;
          rdfs:comment "Communication regarding outflow graft routing techniques." ;
          rdfs:label "FSCA-013 (Safety Alert)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#FSCA-014
:FSCA-014 rdf:type owl:NamedIndividual ,
                   :CorrectiveAction ;
          :hasActionType :User_Notice_Type ;
          :relatedToIncident :INC-017 ;
          :actionDate "2024-09-25"^^xsd:date ;
          :closureDate "2024-12-31"^^xsd:date ;
          :countriesAffected "EU-wide" ;
          :devicesAffected 1100 ;
          :eudamedFSCARef "EU-FSCA-2024-000014" ;
          :scope "All Iluvien intravitreal implants" ;
          :status "Closed" ;
          <http://purl.org/dc/terms/description> "Updated IFU regarding post-operative infection prophylaxis protocol. Extended topical antibiotic course (14 days) mandatory post-insertion. Healthcare professionals notified via direct mail and implanting centre visits." ;
          rdfs:comment "Updated clinical protocol for infection prophylaxis." ;
          rdfs:label "FSCA-014 (User Notice)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#FSCA-015
:FSCA-015 rdf:type owl:NamedIndividual ,
                   :CorrectiveAction ;
          :hasActionType :In_Situ_Correction_Type ;
          :relatedToIncident :INC-018 ;
          :actionDate "2024-10-01"^^xsd:date ;
          :countriesAffected "EU-wide" ;
          :devicesAffected 890 ;
          :eudamedFSCARef "EU-FSCA-2024-000015" ;
          :scope "All 5008S hemodialysis machines with network connectivity module v2.x" ;
          :status "Open" ;
          <http://purl.org/dc/terms/description> "Security patch 3.0.1 mandatory deployment disabling unrestricted web interface access. Network segmentation guidance issued to hospital IT departments. Penetration test report provided to competent authorities." ;
          rdfs:comment "Deployment of security patch to disable unauthorized access." ;
          rdfs:label "FSCA-015 (In Situ Correction)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#High_Probability_Type
:High_Probability_Type rdf:type owl:NamedIndividual ,
                                :High ;
                       rdfs:comment "Value used to show likelihood."@en ;
                       rdfs:label "High_Probability_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#INC-001
:INC-001 rdf:type owl:NamedIndividual ,
                  :Incident ;
         :hasIncidentType :Serious_Incident_Type ;
         :hasRisk :RSK-003 ;
         :involvesDevice :DEV-001 ;
         :reportedBy :MAN-001 ;
         :correctiveActionTaken "true"^^xsd:boolean ;
         :countryReported "Germany" ;
         :detectionDate "2024-01-10"^^xsd:date ;
         :eudamedIncidentRef "EU-INC-2024-000001" ;
         :eventDate "2024-01-08"^^xsd:date ;
         :outcome "Serious_Sev patient injury - embolic stroke" ;
         :patientAge 58 ;
         :patientSex "Male" ;
         :reportDate "2024-01-15"^^xsd:date ;
         <http://purl.org/dc/terms/description> "Patient implanted with HeartMate 3 LVAD developed ischemic stroke 6 months post-implant. Device thrombus confirmed by echocardiography." ;
         rdfs:comment "Serious injury involving embolic stroke and device thrombus." ;
         rdfs:label "Incident INC-001 (Embolic stroke)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#INC-002
:INC-002 rdf:type owl:NamedIndividual ,
                  :Incident ;
         :hasIncidentType :Serious_Incident_Type ;
         :hasRisk :RSK-009 ;
         :involvesDevice :DEV-002 ;
         :reportedBy :MAN-001 ;
         :correctiveActionTaken "true"^^xsd:boolean ;
         :countryReported "France" ;
         :detectionDate "2024-02-01"^^xsd:date ;
         :eudamedIncidentRef "EU-INC-2024-000002" ;
         :eventDate "2024-01-29"^^xsd:date ;
         :outcome "Device malfunction - premature battery depletion" ;
         :patientAge 72 ;
         :patientSex "Female" ;
         :reportDate "2024-02-03"^^xsd:date ;
         <http://purl.org/dc/terms/description> "Micra AV pacemaker reached elective replacement indicator 14 months earlier than expected longevity specification." ;
         rdfs:comment "Malfunction report regarding premature battery depletion." ;
         rdfs:label "Incident INC-002 (Battery depletion)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#INC-003
:INC-003 rdf:type owl:NamedIndividual ,
                  :Incident ;
         :hasIncidentType :Serious_Incident_Type ;
         :hasRisk :RSK-005 ;
         :involvesDevice :DEV-003 ;
         :reportedBy :MAN-002 ;
         :correctiveActionTaken "true"^^xsd:boolean ;
         :countryReported "Italy" ;
         :detectionDate "2024-02-18"^^xsd:date ;
         :eudamedIncidentRef "EU-INC-2024-000003" ;
         :eventDate "2024-02-15"^^xsd:date ;
         :outcome "Surgical intervention required - valve re-anchoring" ;
         :patientAge 67 ;
         :patientSex "Male" ;
         :reportDate "2024-02-20"^^xsd:date ;
         <http://purl.org/dc/terms/description> "Portico valve showed paravalvular leak grade III due to partial migration 2 weeks post-TAVI procedure." ;
         rdfs:comment "Surgical intervention required due to valve migration." ;
         rdfs:label "Incident INC-003 (Valve migration)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#INC-004
:INC-004 rdf:type owl:NamedIndividual ,
                  :Incident ;
         :hasIncidentType :Serious_Incident_Type ;
         :hasRisk :RSK-002 ;
         :involvesDevice :DEV-004 ;
         :reportedBy :MAN-006 ;
         :correctiveActionTaken "false"^^xsd:boolean ;
         :countryReported "Spain" ;
         :detectionDate "2024-03-03"^^xsd:date ;
         :eudamedIncidentRef "EU-INC-2024-000004" ;
         :eventDate "2024-02-28"^^xsd:date ;
         :outcome "Device malfunction - stent fracture" ;
         :patientAge 55 ;
         :patientSex "Female" ;
         :reportDate "2024-03-05"^^xsd:date ;
         <http://purl.org/dc/terms/description> "SYNERGY stent fracture detected on angiography 18 months post-implant causing in-stent restenosis." ;
         rdfs:comment "Detection of stent fracture causing in-stent restenosis." ;
         rdfs:label "Incident INC-004 (Stent fracture)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#INC-005
:INC-005 rdf:type owl:NamedIndividual ,
                  :Incident ;
         :hasIncidentType :Serious_Incident_Type ;
         :hasRisk :RSK-006 ;
         :involvesDevice :DEV-005 ;
         :reportedBy :MAN-006 ;
         :correctiveActionTaken "true"^^xsd:boolean ;
         :countryReported "Netherlands" ;
         :detectionDate "2024-03-16"^^xsd:date ;
         :eudamedIncidentRef "EU-INC-2024-000005" ;
         :eventDate "2024-03-12"^^xsd:date ;
         :outcome "Surgical intervention required - lead extraction" ;
         :patientAge 63 ;
         :patientSex "Male" ;
         :reportDate "2024-03-18"^^xsd:date ;
         <http://purl.org/dc/terms/description> "ACUITY X4 lead dislodgement to right ventricle requiring fluoroscopy-guided repositioning." ;
         rdfs:comment "Incident involving lead dislodgement requiring repositioning." ;
         rdfs:label "Incident INC-005 (Lead dislodgement)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#INC-006
:INC-006 rdf:type owl:NamedIndividual ,
                  :Incident ;
         :hasIncidentType :Serious_Incident_Type ;
         :hasRisk :RSK-001 ;
         :involvesDevice :DEV-007 ;
         :reportedBy :MAN-003 ;
         :correctiveActionTaken "false"^^xsd:boolean ;
         :countryReported "Belgium" ;
         :detectionDate "2024-04-01"^^xsd:date ;
         :eudamedIncidentRef "EU-INC-2024-000006" ;
         :eventDate "2024-04-01"^^xsd:date ;
         :outcome "Device malfunction - complete system failure" ;
         :patientSex "N/A" ;
         :reportDate "2024-04-02"^^xsd:date ;
         <http://purl.org/dc/terms/description> "ACUSON Sequoia ultrasound system froze mid-examination. Emergency shutdown required; patient examination incomplete." ;
         rdfs:comment "Complete system failure during patient ultrasound examination." ;
         rdfs:label "Incident INC-006 (System failure)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#INC-007
:INC-007 rdf:type owl:NamedIndividual ,
                  :Incident ;
         :hasIncidentType :Serious_Incident_Type ;
         :hasRisk :RSK-019 ;
         :involvesDevice :DEV-009 ;
         :reportedBy :MAN-010 ;
         :correctiveActionTaken "true"^^xsd:boolean ;
         :countryReported "Sweden" ;
         :detectionDate "2024-04-10"^^xsd:date ;
         :eudamedIncidentRef "EU-INC-2024-000007" ;
         :eventDate "2024-03-01"^^xsd:date ;
         :outcome "Patient_Harm_Cat - adverse tissue reaction" ;
         :patientAge 70 ;
         :patientSex "Male" ;
         :reportDate "2024-04-14"^^xsd:date ;
         <http://purl.org/dc/terms/description> "Persona knee tibial insert showing accelerated polyethylene wear with metallosis confirmed at 3-year revision surgery." ;
         rdfs:comment "Adverse tissue reaction caused by accelerated component wear." ;
         rdfs:label "Incident INC-007 (Tissue reaction)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#INC-008
:INC-008 rdf:type owl:NamedIndividual ,
                  :Incident ;
         :hasIncidentType :Serious_Incident_Type ;
         :hasRisk :RSK-020 ;
         :involvesDevice :DEV-010 ;
         :reportedBy :MAN-007 ;
         :correctiveActionTaken "true"^^xsd:boolean ;
         :countryReported "Denmark" ;
         :detectionDate "2024-04-25"^^xsd:date ;
         :eudamedIncidentRef "EU-INC-2024-000008" ;
         :eventDate "2024-04-20"^^xsd:date ;
         :outcome "Patient_Harm_Cat - cobalt toxicity" ;
         :patientAge 65 ;
         :patientSex "Female" ;
         :reportDate "2024-04-28"^^xsd:date ;
         <http://purl.org/dc/terms/description> "TRITON hip patient presented with elevated serum cobalt (18 ppb). Adverse local tissue reaction (ALTR) confirmed by MRI." ;
         rdfs:comment "Report of cobalt toxicity and local tissue reaction." ;
         rdfs:label "Incident INC-008 (Cobalt toxicity)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#INC-009
:INC-009 rdf:type owl:NamedIndividual ,
                  :Incident ;
         :hasIncidentType :Serious_Incident_Type ;
         :hasRisk :RSK-013 ;
         :involvesDevice :DEV-012 ;
         :reportedBy :MAN-008 ;
         :correctiveActionTaken "true"^^xsd:boolean ;
         :countryReported "Poland" ;
         :detectionDate "2024-05-04"^^xsd:date ;
         :eudamedIncidentRef "EU-INC-2024-000009" ;
         :eventDate "2024-05-03"^^xsd:date ;
         :outcome "Inappropriate shock delivery" ;
         :patientAge 68 ;
         :patientSex "Male" ;
         :reportDate "2024-05-06"^^xsd:date ;
         <http://purl.org/dc/terms/description> "Viva CRT-D delivered inappropriate ICD therapy during MRI scan despite MRI-conditional programming. Patient experienced pain and syncope." ;
         rdfs:comment "Inappropriate ICD shock delivery during MRI procedure." ;
         rdfs:label "Incident INC-009 (Inappropriate shock)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#INC-010
:INC-010 rdf:type owl:NamedIndividual ,
                  :Incident ;
         :hasIncidentType :Serious_Incident_Type ;
         :hasRisk :RSK-010 ;
         :involvesDevice :DEV-013 ;
         :reportedBy :MAN-012 ;
         :correctiveActionTaken "true"^^xsd:boolean ;
         :countryReported "Germany" ;
         :detectionDate "2024-05-19"^^xsd:date ;
         :eudamedIncidentRef "EU-INC-2024-000010" ;
         :eventDate "2024-05-19"^^xsd:date ;
         :outcome "Device malfunction - incorrect FiO2 delivery" ;
         :patientSex "N/A" ;
         :reportDate "2024-05-20"^^xsd:date ;
         <http://purl.org/dc/terms/description> "ATERA ventilator software version 2.1.3 delivered FiO2 6% lower than set value for patients in ARDS protocol. 3 patients affected." ;
         rdfs:comment "Ventilator software error causing incorrect FiO2 delivery." ;
         rdfs:label "Incident INC-009 (Inappropriate shock)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#INC-011
:INC-011 rdf:type owl:NamedIndividual ,
                  :Incident ;
         :hasIncidentType :Serious_Incident_Type ;
         :hasRisk :RSK-014 ;
         :involvesDevice :DEV-016 ;
         :reportedBy :MAN-005 ;
         :correctiveActionTaken "true"^^xsd:boolean ;
         :countryReported "France" ;
         :detectionDate "2024-06-01"^^xsd:date ;
         :eudamedIncidentRef "EU-INC-2024-000011" ;
         :eventDate "2024-05-28"^^xsd:date ;
         :outcome "Diagnostic_Error_Cat - false positive TSH results" ;
         :patientSex "N/A" ;
         :reportDate "2024-06-03"^^xsd:date ;
         <http://purl.org/dc/terms/description> "cobas e 801 thyroid-stimulating hormone (TSH) assay reported false positive results (>10 mIU/L) in 12 euthyroid patients due to biotin interference." ;
         rdfs:comment "False positive results in TSH assay due to interference." ;
         rdfs:label "Incident INC-011 (False positive TSH)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#INC-012
:INC-012 rdf:type owl:NamedIndividual ,
                  :Incident ;
         :hasIncidentType :Serious_Incident_Type ;
         :hasRisk :RSK-015 ;
         :involvesDevice :DEV-017 ;
         :reportedBy :MAN-005 ;
         :correctiveActionTaken "true"^^xsd:boolean ;
         :countryReported "Spain" ;
         :detectionDate "2024-06-13"^^xsd:date ;
         :eudamedIncidentRef "EU-INC-2024-000012" ;
         :eventDate "2024-06-10"^^xsd:date ;
         :outcome "Diagnostic_Error_Cat - false negative SARS-CoV-2" ;
         :patientSex "N/A" ;
         :reportDate "2024-06-15"^^xsd:date ;
         <http://purl.org/dc/terms/description> "cobas SARS-CoV-2 assay failed to detect Omicron BA.2.86 subvariant in 7 samples confirmed positive by sequencing. Lot-specific issue." ;
         rdfs:comment "False negative results failing to detect SARS-CoV-2 subvariant." ;
         rdfs:label "Incident INC-012 (False negative SARS-CoV-2)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#INC-013
:INC-013 rdf:type owl:NamedIndividual ,
                  :Incident ;
         :hasIncidentType :Serious_Incident_Type ;
         :hasRisk :RSK-015 ;
         :involvesDevice :DEV-018 ;
         :reportedBy :MAN-015 ;
         :correctiveActionTaken "false"^^xsd:boolean ;
         :countryReported "Germany" ;
         :detectionDate "2024-06-29"^^xsd:date ;
         :eudamedIncidentRef "EU-INC-2024-000013" ;
         :eventDate "2024-06-25"^^xsd:date ;
         :outcome "Diagnostic_Error_Cat - false negative HIV" ;
         :patientSex "N/A" ;
         :reportDate "2024-07-01"^^xsd:date ;
         <http://purl.org/dc/terms/description> "VIDAS HIV DUO Ultra failed to detect HIV-1 group O infection in seroconversion panel. Patient missed early treatment window." ;
         rdfs:comment "Missed detection of HIV-1 group O during seroconversion." ;
         rdfs:label "Incident INC-013 (False negative HIV)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#INC-014
:INC-014 rdf:type owl:NamedIndividual ,
                  :Incident ;
         :hasIncidentType :Serious_Incident_Type ;
         :hasRisk :RSK-014 ;
         :involvesDevice :DEV-021 ;
         :reportedBy :MAN-009 ;
         :correctiveActionTaken "true"^^xsd:boolean ;
         :countryReported "Netherlands" ;
         :detectionDate "2024-07-15"^^xsd:date ;
         :eudamedIncidentRef "EU-INC-2024-000014" ;
         :eventDate "2024-07-10"^^xsd:date ;
         :outcome "Patient_Harm_Cat - hyperglycaemic event" ;
         :patientAge 45 ;
         :patientSex "Female" ;
         :reportDate "2024-07-18"^^xsd:date ;
         <http://purl.org/dc/terms/description> "OPTIGA CGM sensor reported glucose 3.8 mmol/L while laboratory reference showed 14.2 mmol/L. Patient delayed insulin administration." ;
         rdfs:comment "Hyperglycaemic event caused by incorrect CGM glucose reading." ;
         rdfs:label "Incident INC-014 (Hyperglycaemic event)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#INC-015
:INC-015 rdf:type owl:NamedIndividual ,
                  :Incident ;
         :hasIncidentType :Serious_Incident_Type ;
         :hasRisk :RSK-010 ;
         :involvesDevice :DEV-024 ;
         :reportedBy :MAN-002 ;
         :correctiveActionTaken "true"^^xsd:boolean ;
         :countryReported "Italy" ;
         :detectionDate "2024-08-04"^^xsd:date ;
         :eudamedIncidentRef "EU-INC-2024-000015" ;
         :eventDate "2024-08-04"^^xsd:date ;
         :outcome "Patient_Harm_Cat - drug overdose" ;
         :patientAge 81 ;
         :patientSex "Female" ;
         :reportDate "2024-08-05"^^xsd:date ;
         <http://purl.org/dc/terms/description> "Plum 360 infusion pump delivered 10x heparin dose due to software decimal point error in drug library version 4.2.1." ;
         rdfs:comment "Critical drug overdose due to software decimal point error." ;
         rdfs:label "Incident INC-015 (Drug overdose)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#INC-016
:INC-016 rdf:type owl:NamedIndividual ,
                  :Incident ;
         :hasIncidentType :Serious_Incident_Type ;
         :hasRisk :RSK-004 ;
         :involvesDevice :DEV-001 ;
         :reportedBy :MAN-001 ;
         :correctiveActionTaken "true"^^xsd:boolean ;
         :countryReported "United Kingdom" ;
         :detectionDate "2024-08-18"^^xsd:date ;
         :eudamedIncidentRef "EU-INC-2024-000016" ;
         :eventDate "2024-08-15"^^xsd:date ;
         :outcome "Patient_Harm_Cat - haemolytic anaemia" ;
         :patientAge 52 ;
         :patientSex "Male" ;
         :reportDate "2024-08-20"^^xsd:date ;
         <http://purl.org/dc/terms/description> "HeartMate 3 patient developed severe haemolysis (LDH >2000 U/L) associated with outflow graft kinking confirmed by CT." ;
         rdfs:comment "Severe haemolysis associated with device graft kinking." ;
         rdfs:label "Incident INC-016 (Haemolytic anaemia)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#INC-017
:INC-017 rdf:type owl:NamedIndividual ,
                  :Incident ;
         :hasIncidentType :Serious_Incident_Type ;
         :hasRisk :RSK-007 ;
         :involvesDevice :DEV-011 ;
         :reportedBy :MAN-011 ;
         :correctiveActionTaken "true"^^xsd:boolean ;
         :countryReported "France" ;
         :detectionDate "2024-08-30"^^xsd:date ;
         :eudamedIncidentRef "EU-INC-2024-000017" ;
         :eventDate "2024-08-25"^^xsd:date ;
         :outcome "Surgical intervention - implant removal" ;
         :patientAge 54 ;
         :patientSex "Female" ;
         :reportDate "2024-09-02"^^xsd:date ;
         <http://purl.org/dc/terms/description> "Iluvien implant required surgical removal due to device-related endophthalmitis confirmed by vitreous culture." ;
         rdfs:comment "Device-related endophthalmitis requiring implant removal." ;
         rdfs:label "Incident INC-017 (Endophthalmitis)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#INC-018
:INC-018 rdf:type owl:NamedIndividual ,
                  :Incident ;
         :hasIncidentType :Serious_Incident_Type ;
         :hasRisk :RSK-018 ;
         :involvesDevice :DEV-015 ;
         :reportedBy :MAN-013 ;
         :correctiveActionTaken "true"^^xsd:boolean ;
         :countryReported "Germany" ;
         :detectionDate "2024-09-14"^^xsd:date ;
         :eudamedIncidentRef "EU-INC-2024-000018" ;
         :eventDate "2024-09-12"^^xsd:date ;
         :outcome "Cybersecurity incident - unauthorised access" ;
         :patientSex "N/A" ;
         :reportDate "2024-09-15"^^xsd:date ;
         <http://purl.org/dc/terms/description> "5008S hemodialysis machine web interface exposed to hospital internal network. Unauthorised session accessed alarm configuration." ;
         rdfs:comment "Cybersecurity vulnerability exposing device network interface." ;
         rdfs:label "Incident INC-018 (Cybersecurity vulnerability)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#INC-019
:INC-019 rdf:type owl:NamedIndividual ,
                  :Incident ;
         :hasIncidentType :Near_Miss_Incident_Type ;
         :hasRisk :RSK-001 ;
         :involvesDevice :DEV-023 ;
         :reportedBy :MAN-008 ;
         :correctiveActionTaken "false"^^xsd:boolean ;
         :countryReported "Sweden" ;
         :detectionDate "2024-09-30"^^xsd:date ;
         :eudamedIncidentRef "EU-INC-2024-000019" ;
         :eventDate "2024-09-28"^^xsd:date ;
         :outcome "Near-miss - device not activated post-surgery" ;
         :patientAge 71 ;
         :patientSex "Male" ;
         :reportDate "2024-10-01"^^xsd:date ;
         <http://purl.org/dc/terms/description> "Tivoli II cochlear implant failed to respond to initial activation programming. Sound processor replacement resolved the issue." ;
         rdfs:comment "Near-miss incident involving cochlear implant activation failure." ;
         rdfs:label "Incident INC-019 (Activation failure)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#INC-020
:INC-020 rdf:type owl:NamedIndividual ,
                  :Incident ;
         :hasIncidentType :Serious_Incident_Type ;
         :hasRisk :RSK-011 ;
         :involvesDevice :DEV-008 ;
         :reportedBy :MAN-003 ;
         :correctiveActionTaken "false"^^xsd:boolean ;
         :countryReported "Belgium" ;
         :detectionDate "2024-10-12"^^xsd:date ;
         :eudamedIncidentRef "EU-INC-2024-000020" ;
         :eventDate "2024-10-10"^^xsd:date ;
         :outcome "Patient_Harm_Cat - SAR heating injury" ;
         :patientAge 38 ;
         :patientSex "Female" ;
         :reportDate "2024-10-14"^^xsd:date ;
         <http://purl.org/dc/terms/description> "MAGNETOM Vida MRI caused localised skin burn (1st degree) at anterior electrode lead in patient with DBS system not declared prior to scan." ;
         rdfs:comment "Localised skin burn during MRI scan due to SAR heating." ;
         rdfs:label "Incident INC-020 (SAR heating injury)" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Implantable_Active_Type
:Implantable_Active_Type rdf:type owl:NamedIndividual ,
                                  :ImplantableActiveDevice ;
                         rdfs:comment "Device category used to define its use."@en ;
                         rdfs:label "Implantable_Active_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Implantable_Type
:Implantable_Type rdf:type owl:NamedIndividual ,
                           :ImplantableDevice ;
                  rdfs:comment "Device category used to define its use."@en ;
                  rdfs:label "Implantable_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#In_Situ_Correction_Type
:In_Situ_Correction_Type rdf:type owl:NamedIndividual ,
                                  :InSituCorrection ;
                         rdfs:comment "Represents the specific action of performing repairs or adjustments at the device's location." ;
                         rdfs:label "In_Situ_Correction_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#In_Vitro_Diagnostic_Device_Type
:In_Vitro_Diagnostic_Device_Type rdf:type owl:NamedIndividual ,
                                          :InVitroDiagnosticDevice ;
                                 rdfs:comment "Device category used to define its use."@en ;
                                 rdfs:label "In_Vitro_Diagnostic_Device_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Infection_Risk_Type
:Infection_Risk_Type rdf:type owl:NamedIndividual ,
                              :InfectionRisk ;
                     rdfs:comment "Instance used to specify the hazard."@en ;
                     rdfs:label "Infection_Risk_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Injury_Risk_Type
:Injury_Risk_Type rdf:type owl:NamedIndividual ,
                           :InjuryRisk ;
                  rdfs:comment "Instance used to specify the hazard."@en ;
                  rdfs:label "Injury_Risk_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Interference_Risk_Type
:Interference_Risk_Type rdf:type owl:NamedIndividual ,
                                 :InterferenceRisk ;
                        rdfs:comment "Instance used to specify the hazard."@en ;
                        rdfs:label "Interference_Risk_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Low_Probability_Type
:Low_Probability_Type rdf:type owl:NamedIndividual ,
                               :Low ;
                      rdfs:comment "Value used to show likelihood."@en ;
                      rdfs:label "Low_Probability_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#MAN-001
:MAN-001 rdf:type owl:NamedIndividual ,
                  :Manufacturer ;
         :authorizationNumber "IE/2017/001234" ;
         :competentAuthority "Health Products Regulatory Authority (HPRA)" ;
         :country "Ireland" ;
         :eudamedSRN "SRN-IE-MED-0001" ;
         <https://schema.org/#email> "regulatory@medtronic.com" ;
         <https://schema.org/#name> "Medtronic plc" ;
         rdfs:comment "Global medical technology company based in Ireland." ;
         rdfs:label "Medtronic plc" .


###  http://www.noel-garcia.org/ontologies/medical-devices#MAN-002
:MAN-002 rdf:type owl:NamedIndividual ,
                  :Manufacturer ;
         :authorizationNumber "DE/2017/005678" ;
         :competentAuthority "Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)" ;
         :country "Germany" ;
         :eudamedSRN "SRN-DE-MED-0002" ;
         <https://schema.org/#email> "regulatory@abbott.com" ;
         <https://schema.org/#name> "Abbott Medical Devices" ;
         rdfs:comment "Major manufacturer of cardiovascular and diabetes care devices." ;
         rdfs:label "Abbott Medical Devices" .


###  http://www.noel-garcia.org/ontologies/medical-devices#MAN-003
:MAN-003 rdf:type owl:NamedIndividual ,
                  :Manufacturer ;
         :authorizationNumber "DE/2017/009012" ;
         :competentAuthority "Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)" ;
         :country "Germany" ;
         :eudamedSRN "SRN-DE-MED-0003" ;
         <https://schema.org/#email> "regulatory@siemens-healthineers.com" ;
         <https://schema.org/#name> "Siemens Healthineers AG" ;
         rdfs:comment "Leading provider of medical imaging and laboratory diagnostics." ;
         rdfs:label "Siemens Healthineers AG" .


###  http://www.noel-garcia.org/ontologies/medical-devices#MAN-004
:MAN-004 rdf:type owl:NamedIndividual ,
                  :Manufacturer ;
         :authorizationNumber "NL/2017/003456" ;
         :competentAuthority "Rijksinstituut voor Volksgezondheid en Milieu (RIVM)" ;
         :country "Netherlands" ;
         :eudamedSRN "SRN-NL-MED-0004" ;
         <https://schema.org/#email> "regulatory@philips.com" ;
         <https://schema.org/#name> "Philips Medical Systems" ;
         rdfs:comment "Healthcare technology company specializing in imaging and monitoring." ;
         rdfs:label "Philips Medical Systems" .


###  http://www.noel-garcia.org/ontologies/medical-devices#MAN-005
:MAN-005 rdf:type owl:NamedIndividual ,
                  :Manufacturer ;
         :authorizationNumber "DE/2017/007890" ;
         :competentAuthority "Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)" ;
         :country "Germany" ;
         :eudamedSRN "SRN-DE-MED-0005" ;
         <https://schema.org/#email> "regulatory@roche.com" ;
         <https://schema.org/#name> "Roche Diagnostics GmbH" ;
         rdfs:comment "Multinational healthcare company focused on pharmaceuticals and diagnostics." ;
         rdfs:label "Roche Diagnostics GmbH" .


###  http://www.noel-garcia.org/ontologies/medical-devices#MAN-006
:MAN-006 rdf:type owl:NamedIndividual ,
                  :Manufacturer ;
         :authorizationNumber "IE/2017/002345" ;
         :competentAuthority "Health Products Regulatory Authority (HPRA)" ;
         :country "Ireland" ;
         :eudamedSRN "SRN-IE-MED-0006" ;
         <https://schema.org/#email> "regulatory@bsci.com" ;
         <https://schema.org/#name> "Boston Scientific Corporation" ;
         rdfs:comment "Manufacturer of medical devices used in interventional specialties." ;
         rdfs:label "Boston Scientific Corporation" .


###  http://www.noel-garcia.org/ontologies/medical-devices#MAN-007
:MAN-007 rdf:type owl:NamedIndividual ,
                  :Manufacturer ;
         :authorizationNumber "NL/2017/006789" ;
         :competentAuthority "Rijksinstituut voor Volksgezondheid en Milieu (RIVM)" ;
         :country "Netherlands" ;
         :eudamedSRN "SRN-NL-MED-0007" ;
         <https://schema.org/#email> "regulatory@stryker.com" ;
         <https://schema.org/#name> "Stryker Corporation" ;
         rdfs:comment "Medical technology company focused on orthopaedics and spine surgery." ;
         rdfs:label "Stryker Corporation" .


###  http://www.noel-garcia.org/ontologies/medical-devices#MAN-008
:MAN-008 rdf:type owl:NamedIndividual ,
                  :Manufacturer ;
         :authorizationNumber "DE/2017/004567" ;
         :competentAuthority "Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)" ;
         :country "Germany" ;
         :eudamedSRN "SRN-DE-MED-0008" ;
         <https://schema.org/#email> "regulatory@biotronik.com" ;
         <https://schema.org/#name> "Biotronik SE & Co. KG" ;
         rdfs:comment "Specialist in cardio- and endovascular medical technology." ;
         rdfs:label "Biotronik SE & Co. KG" .


###  http://www.noel-garcia.org/ontologies/medical-devices#MAN-009
:MAN-009 rdf:type owl:NamedIndividual ,
                  :Manufacturer ;
         :authorizationNumber "SE/2017/008901" ;
         :competentAuthority "Läkemedelsverket (MPA)" ;
         :country "Sweden" ;
         :eudamedSRN "SRN-SE-MED-0009" ;
         <https://schema.org/#email> "regulatory@gehealthcare.com" ;
         <https://schema.org/#name> "GE HealthCare Technologies" ;
         rdfs:comment "Provider of medical imaging, monitoring, and digital solutions." ;
         rdfs:label "GE HealthCare Technologies" .


###  http://www.noel-garcia.org/ontologies/medical-devices#MAN-010
:MAN-010 rdf:type owl:NamedIndividual ,
                  :Manufacturer ;
         :authorizationNumber "CH/2017/001122" ;
         :competentAuthority "Swissmedic" ;
         :country "Switzerland" ;
         :eudamedSRN "SRN-CH-MED-0010" ;
         <https://schema.org/#email> "regulatory@zimmerbiomet.com" ;
         <https://schema.org/#name> "Zimmer Biomet Holdings" ;
         rdfs:comment "Global leader in musculoskeletal healthcare and joint replacement." ;
         rdfs:label "Zimmer Biomet Holdings" .


###  http://www.noel-garcia.org/ontologies/medical-devices#MAN-011
:MAN-011 rdf:type owl:NamedIndividual ,
                  :Manufacturer ;
         :authorizationNumber "UK/2017/003344" ;
         :competentAuthority "Medicines and Healthcare products Regulatory Agency (MHRA)" ;
         :country "United Kingdom" ;
         :eudamedSRN "SRN-UK-MED-0011" ;
         <https://schema.org/#email> "regulatory@livanova.com" ;
         <https://schema.org/#name> "LivaNova PLC" ;
         rdfs:comment "Medical device company focused on cardiac surgery and neuromodulation." ;
         rdfs:label "LivaNova PLC" .


###  http://www.noel-garcia.org/ontologies/medical-devices#MAN-012
:MAN-012 rdf:type owl:NamedIndividual ,
                  :Manufacturer ;
         :authorizationNumber "DE/2017/005566" ;
         :competentAuthority "Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)" ;
         :country "Germany" ;
         :eudamedSRN "SRN-DE-MED-0012" ;
         <https://schema.org/#email> "regulatory@draeger.com" ;
         <https://schema.org/#name> "Drägerwerk AG & Co. KGaA" ;
         rdfs:comment "International leader in medical and safety technology." ;
         rdfs:label "Drägerwerk AG & Co. KGaA" .


###  http://www.noel-garcia.org/ontologies/medical-devices#MAN-013
:MAN-013 rdf:type owl:NamedIndividual ,
                  :Manufacturer ;
         :authorizationNumber "FR/2017/007788" ;
         :competentAuthority "Agence nationale de sécurité du médicament (ANSM)" ;
         :country "France" ;
         :eudamedSRN "SRN-FR-MED-0013" ;
         <https://schema.org/#email> "regulatory@nipro.com" ;
         <https://schema.org/#name> "Nipro Corporation" ;
         rdfs:comment "Global manufacturer of renal and vascular products." ;
         rdfs:label "Nipro Corporation" .


###  http://www.noel-garcia.org/ontologies/medical-devices#MAN-014
:MAN-014 rdf:type owl:NamedIndividual ,
                  :Manufacturer ;
         :authorizationNumber "BE/2017/009900" ;
         :competentAuthority "Agence fédérale des médicaments et des produits de santé (AFMPS)" ;
         :country "Belgium" ;
         :eudamedSRN "SRN-BE-MED-0014" ;
         <https://schema.org/#email> "regulatory@hologic.com" ;
         <https://schema.org/#name> "Hologic Inc." ;
         rdfs:comment "Medical technology company primarily focused on women's health." ;
         rdfs:label "Hologic Inc." .


###  http://www.noel-garcia.org/ontologies/medical-devices#MAN-015
:MAN-015 rdf:type owl:NamedIndividual ,
                  :Manufacturer ;
         :authorizationNumber "FR/2017/002211" ;
         :competentAuthority "Agence nationale de sécurité du médicament (ANSM)" ;
         :country "France" ;
         :eudamedSRN "SRN-FR-MED-0015" ;
         <https://schema.org/#email> "regulatory@biomerieux.com" ;
         <https://schema.org/#name> "bioMérieux SA" ;
         rdfs:comment "World leader in the field of in vitro diagnostics." ;
         rdfs:label "bioMérieux SA" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Malfunction_Rick_Type
:Malfunction_Rick_Type rdf:type owl:NamedIndividual ,
                                :MalfunctionRisk ;
                       rdfs:comment "Instance used to specify the hazard."@en ;
                       rdfs:label "Malfunction_Rick_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Material_Risk_Type
:Material_Risk_Type rdf:type owl:NamedIndividual ,
                             :MaterialRisk ;
                    rdfs:comment "Instance used to specify the hazard."@en ;
                    rdfs:label "Material_Risk_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Medium_Probability_Type
:Medium_Probability_Type rdf:type owl:NamedIndividual ,
                                  :Medium ;
                         rdfs:comment "Value used to show likelihood."@en ;
                         rdfs:label "Medium_Probability_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Moderate_Sev
:Moderate_Sev rdf:type owl:NamedIndividual ,
                       :Moderate ;
              rdfs:comment "Value used to show severity."@en ;
              rdfs:label "Moderate_Sev" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Near_Miss_Incident_Type
:Near_Miss_Incident_Type rdf:type owl:NamedIndividual ,
                                  :NearMissIncident ;
                         rdfs:comment "Instance used to flag an event that did not cause harm but could have done."@en ;
                         rdfs:label "Near_Miss_Incident_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Patient_Harm_Cat
:Patient_Harm_Cat rdf:type owl:NamedIndividual ,
                           :PatientHarm ;
                  rdfs:comment "Instance used to group risks by their area of impact."@en ;
                  rdfs:label "Patient_Harm_Cat" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Product_Quality_Type
:Product_Quality_Type rdf:type owl:NamedIndividual ,
                               :ProductQuality ;
                      rdfs:comment "Instance used to group risks by their area of impact.en"@en ;
                      rdfs:label "Product_Quality_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#RSK-001
:RSK-001 rdf:type owl:NamedIndividual ,
                  :Risk ;
         :affectedDeviceType_ :Active_Device_Type ;
         :hasProbability :Low_Probability_Type ;
         :hasRiskCategory :Device_Failure_Cat ;
         :hasRiskType :Malfunction_Rick_Type ;
         :hasSeverity :Critical_Sev ;
         :imdrfCode "A0101" ;
         :riskName "Device_Failure_Cat - electrical" ;
         <http://purl.org/dc/terms/description> "Complete loss of electrical function leading to device shutdown" ;
         rdfs:comment "Risk of complete electrical shutdown of the device." ;
         rdfs:label "Electrical failure" .


###  http://www.noel-garcia.org/ontologies/medical-devices#RSK-002
:RSK-002 rdf:type owl:NamedIndividual ,
                  :Risk ;
         :affectedDeviceType_ :Implantable_Type ;
         :hasProbability :Medium_Probability_Type ;
         :hasRiskCategory :Device_Failure_Cat ;
         :hasRiskType :Malfunction_Rick_Type ;
         :hasSeverity :Critical_Sev ;
         :imdrfCode "A0102" ;
         :riskName "Device_Failure_Cat - mechanical" ;
         <http://purl.org/dc/terms/description> "Structural failure of mechanical components under physiological load" ;
         rdfs:comment "Risk of structural mechanical failure under physiological load." ;
         rdfs:label "Mechanical failure" .


###  http://www.noel-garcia.org/ontologies/medical-devices#RSK-003
:RSK-003 rdf:type owl:NamedIndividual ,
                  :Risk ;
         :affectedDeviceType_ :Implantable_Active_Type ;
         :hasProbability :Low_Probability_Type ;
         :hasRiskCategory :Patient_Harm_Cat ;
         :hasRiskType :Injury_Risk_Type ;
         :hasSeverity :Critical_Sev ;
         :imdrfCode "A0201" ;
         :riskName "Thrombosis - device-related" ;
         <http://purl.org/dc/terms/description> "Thrombus formation on device surface causing embolic events" ;
         rdfs:comment "Potential for thrombus formation on blood-contacting surfaces." ;
         rdfs:label "Device thrombosis" .


###  http://www.noel-garcia.org/ontologies/medical-devices#RSK-004
:RSK-004 rdf:type owl:NamedIndividual ,
                  :Risk ;
         :affectedDeviceType_ :Active_Implant_Type ;
         :hasProbability :Low_Probability_Type ;
         :hasRiskCategory :Patient_Harm_Cat ;
         :hasRiskType :Injury_Risk_Type ;
         :hasSeverity :Serious_Sev ;
         :imdrfCode "A0202" ;
         :riskName "Hemolysis - pump-induced" ;
         <http://purl.org/dc/terms/description> "Mechanical destruction of red blood cells by pump mechanism" ;
         rdfs:comment "Risk of red blood cell destruction by mechanical pump action." ;
         rdfs:label "Pump-induced hemolysis" .


###  http://www.noel-garcia.org/ontologies/medical-devices#RSK-005
:RSK-005 rdf:type owl:NamedIndividual ,
                  :Risk ;
         :affectedDeviceType_ :Implantable_Type ;
         :hasProbability :Low_Probability_Type ;
         :hasRiskCategory :Device_Performance_Cat ;
         :hasRiskType :Malfunction_Rick_Type ;
         :hasSeverity :Serious_Sev ;
         :imdrfCode "A0301" ;
         :riskName "Device migration - implant" ;
         <http://purl.org/dc/terms/description> "Unintended displacement of implant from intended anatomical position" ;
         rdfs:comment "Unintended migration of an implant from its original site." ;
         rdfs:label "Implant migration" .


###  http://www.noel-garcia.org/ontologies/medical-devices#RSK-006
:RSK-006 rdf:type owl:NamedIndividual ,
                  :Risk ;
         :affectedDeviceType_ :Active_Implant_Type ;
         :hasProbability :Medium_Probability_Type ;
         :hasRiskCategory :Device_Performance_Cat ;
         :hasRiskType :Malfunction_Rick_Type ;
         :hasSeverity :Serious_Sev ;
         :imdrfCode "A0302" ;
         :riskName "Lead dislodgement" ;
         <http://purl.org/dc/terms/description> "Cardiac lead displacement requiring repositioning or replacement" ;
         rdfs:comment "Potential for cardiac lead displacement post-implantation." ;
         rdfs:label "Lead dislodgement" .


###  http://www.noel-garcia.org/ontologies/medical-devices#RSK-007
:RSK-007 rdf:type owl:NamedIndividual ,
                  :Risk ;
         :affectedDeviceType_ :Implantable_Type ;
         :hasProbability :Medium_Probability_Type ;
         :hasRiskCategory :Patient_Harm_Cat ;
         :hasRiskType :Infection_Risk_Type ;
         :hasSeverity :Serious_Sev ;
         :imdrfCode "A0401" ;
         :riskName "Infection - device-related" ;
         <http://purl.org/dc/terms/description> "Device-related infection at implantation site or systemic sepsis" ;
         rdfs:comment "Risk of infection or sepsis related to the medical device." ;
         rdfs:label "Device-related infection" .


###  http://www.noel-garcia.org/ontologies/medical-devices#RSK-008
:RSK-008 rdf:type owl:NamedIndividual ,
                  :Risk ;
         :affectedDeviceType_ :Implantable_Type ;
         :hasProbability :High_Probability_Type ;
         :hasRiskCategory :Patient_Harm_Cat ;
         :hasRiskType :Infection_Risk_Type ;
         :hasSeverity :Moderate_Sev ;
         :imdrfCode "A0402" ;
         :riskName "Biofilm formation" ;
         <http://purl.org/dc/terms/description> "Bacterial biofilm accumulation on implant surface resistant to antibiotics" ;
         rdfs:comment "Accumulation of bacterial biofilm on the implant surface." ;
         rdfs:label "Biofilm formation" .


###  http://www.noel-garcia.org/ontologies/medical-devices#RSK-009
:RSK-009 rdf:type owl:NamedIndividual ,
                  :Risk ;
         :affectedDeviceType_ :Active_Implant_Type ;
         :hasProbability :Low_Probability_Type ;
         :hasRiskCategory :Device_Failure_Cat ;
         :hasRiskType :Malfunction_Rick_Type ;
         :hasSeverity :Critical_Sev ;
         :imdrfCode "A0501" ;
         :riskName "Battery depletion - premature" ;
         <http://purl.org/dc/terms/description> "Battery end-of-life earlier than specified, risking therapy interruption" ;
         rdfs:comment "Unexpected battery failure prior to calculated end-of-life." ;
         rdfs:label "Premature battery depletion" .


###  http://www.noel-garcia.org/ontologies/medical-devices#RSK-010
:RSK-010 rdf:type owl:NamedIndividual ,
                  :Risk ;
         :affectedDeviceType_ :Active_Device_Type ;
         :hasProbability :Low_Probability_Type ;
         :hasRiskCategory :Device_Failure_Cat ;
         :hasRiskType :Software_Risk_Type ;
         :hasSeverity :Critical_Sev ;
         :imdrfCode "A0502" ;
         :riskName "Software malfunction" ;
         <http://purl.org/dc/terms/description> "Software bug causing incorrect dosing, alarming, or therapy delivery" ;
         rdfs:comment "Critical software bug affecting therapy or dosing delivery." ;
         rdfs:label "Software malfunction" .


###  http://www.noel-garcia.org/ontologies/medical-devices#RSK-011
:RSK-011 rdf:type owl:NamedIndividual ,
                  :Risk ;
         :affectedDeviceType_ :Active_Device_Type ;
         :hasProbability :Low_Probability_Type ;
         :hasRiskCategory :Patient_Harm_Cat ;
         :hasRiskType :Radiaton_Risk_Type ;
         :hasSeverity :Critical_Sev ;
         :imdrfCode "A0601" ;
         :riskName "Radiation overdose" ;
         <http://purl.org/dc/terms/description> "Unintended ionising radiation exposure exceeding therapeutic dose" ;
         rdfs:comment "Risk of unintended ionising radiation exposure to patients." ;
         rdfs:label "Radiation overdose" .


###  http://www.noel-garcia.org/ontologies/medical-devices#RSK-012
:RSK-012 rdf:type owl:NamedIndividual ,
                  :Risk ;
         :affectedDeviceType_ :Implantable_Type ;
         :hasProbability :High_Probability_Type ;
         :hasRiskCategory :Device_Performance_Cat ;
         :hasRiskType :Interference_Risk_Type ;
         :hasSeverity :Moderate_Sev ;
         :imdrfCode "A0701" ;
         :riskName "Metallic artifact - MRI" ;
         <http://purl.org/dc/terms/description> "Metallic implant causing MRI image artifacts compromising diagnostics" ;
         rdfs:comment "Formation of MRI artifacts compromising diagnostic quality." ;
         rdfs:label "MRI metallic artifact" .


###  http://www.noel-garcia.org/ontologies/medical-devices#RSK-013
:RSK-013 rdf:type owl:NamedIndividual ,
                  :Risk ;
         :affectedDeviceType_ :Active_Implant_Type ;
         :hasProbability :Low_Probability_Type ;
         :hasRiskCategory :Device_Performance_Cat ;
         :hasRiskType :Interference_Risk_Type ;
         :hasSeverity :Serious_Sev ;
         :imdrfCode "A0702" ;
         :riskName "Electromagnetic interference" ;
         <http://purl.org/dc/terms/description> "External EMI affecting pacemaker/ICD sensing and pacing functions" ;
         rdfs:comment "External EMI interference affecting active implant functions." ;
         rdfs:label "Electromagnetic interference" .


###  http://www.noel-garcia.org/ontologies/medical-devices#RSK-014
:RSK-014 rdf:type owl:NamedIndividual ,
                  :Risk ;
         :affectedDeviceType_ :In_Vitro_Diagnostic_Device_Type ;
         :hasProbability :Medium_Probability_Type ;
         :hasRiskCategory :Diagnostic_Error_Cat ;
         :hasRiskType :Diagnostic_Risk_Type ;
         :hasSeverity :Serious_Sev ;
         :imdrfCode "B0101" ;
         :riskName "False positive result" ;
         <http://purl.org/dc/terms/description> "IVD test returns positive result in absence of target condition" ;
         rdfs:comment "Diagnostic risk of reporting a condition when none is present." ;
         rdfs:label "False positive diagnostic" .


###  http://www.noel-garcia.org/ontologies/medical-devices#RSK-015
:RSK-015 rdf:type owl:NamedIndividual ,
                  :Risk ;
         :affectedDeviceType_ :In_Vitro_Diagnostic_Device_Type ;
         :hasProbability :Low_Probability_Type ;
         :hasRiskCategory :Diagnostic_Error_Cat ;
         :hasRiskType :Diagnostic_Risk_Type ;
         :hasSeverity :Critical_Sev ;
         :imdrfCode "B0102" ;
         :riskName "False negative result" ;
         <http://purl.org/dc/terms/description> "IVD test fails to detect target condition in affected individual" ;
         rdfs:comment "Diagnostic risk of failing to detect a target condition." ;
         rdfs:label "False negative diagnostic" .


###  http://www.noel-garcia.org/ontologies/medical-devices#RSK-016
:RSK-016 rdf:type owl:NamedIndividual ,
                  :Risk ;
         :affectedDeviceType_ :In_Vitro_Diagnostic_Device_Type ;
         :hasProbability :Medium_Probability_Type ;
         :hasRiskCategory :Diagnostic_Error_Cat ;
         :hasRiskType :Diagnostic_Risk_Type ;
         :hasSeverity :Serious_Sev ;
         :imdrfCode "B0201" ;
         :riskName "Cross-reactivity" ;
         <http://purl.org/dc/terms/description> "Reagent reacts with non-target analyte producing incorrect result" ;
         rdfs:comment "Reagent cross-reactivity leading to incorrect test results." ;
         rdfs:label "Reagent cross-reactivity" .


###  http://www.noel-garcia.org/ontologies/medical-devices#RSK-017
:RSK-017 rdf:type owl:NamedIndividual ,
                  :Risk ;
         :affectedDeviceType_ :In_Vitro_Diagnostic_Device_Type ;
         :hasProbability :Low_Probability_Type ;
         :hasRiskCategory :Product_Quality_Type ;
         :hasRiskType :Contamination_Risk_Type ;
         :hasSeverity :Critical_Sev ;
         :imdrfCode "B0301" ;
         :riskName "Contamination - reagent" ;
         <http://purl.org/dc/terms/description> "Reagent lot contamination leading to systematic Diagnostic_Error_Cats" ;
         rdfs:comment "Reagent contamination causing systematic diagnostic errors." ;
         rdfs:label "Reagent contamination" .


###  http://www.noel-garcia.org/ontologies/medical-devices#RSK-018
:RSK-018 rdf:type owl:NamedIndividual ,
                  :Risk ;
         :affectedDeviceType_ :Active_Device_Type ;
         :hasProbability :Low_Probability_Type ;
         :hasRiskCategory :Device_Safety_Cat ;
         :hasRiskType :Cybersecurity_Risk_Type ;
         :hasSeverity :Critical_Sev ;
         :imdrfCode "B0401" ;
         :riskName "Cybersecurity vulnerability" ;
         <http://purl.org/dc/terms/description> "Exploitable software vulnerability enabling unauthorized device access" ;
         rdfs:comment "Software vulnerability allowing unauthorized device access." ;
         rdfs:label "Cybersecurity vulnerability" .


###  http://www.noel-garcia.org/ontologies/medical-devices#RSK-019
:RSK-019 rdf:type owl:NamedIndividual ,
                  :Risk ;
         :affectedDeviceType_ :Implantable_Type ;
         :hasProbability :Medium_Probability_Type ;
         :hasRiskCategory :Patient_Harm_Cat ;
         :hasRiskType :Material_Risk_Type ;
         :hasSeverity :Serious_Sev ;
         :imdrfCode "C0101" ;
         :riskName "Wear debris - joint implant" ;
         <http://purl.org/dc/terms/description> "Particulate debris from bearing surfaces causing adverse tissue reaction" ;
         rdfs:comment "Tissue reaction caused by particulate debris from implants." ;
         rdfs:label "Joint wear debris" .


###  http://www.noel-garcia.org/ontologies/medical-devices#RSK-020
:RSK-020 rdf:type owl:NamedIndividual ,
                  :Risk ;
         :affectedDeviceType_ :Implantable_Type ;
         :hasProbability :Low_Probability_Type ;
         :hasRiskCategory :Patient_Harm_Cat ;
         :hasRiskType :Material_Risk_Type ;
         :hasSeverity :Serious_Sev ;
         :imdrfCode "C0201" ;
         :riskName "Corrosion - metallic implant" ;
         <http://purl.org/dc/terms/description> "Metallic ion release from corrosion causing local or systemic toxicity" ;
         rdfs:comment "Local or systemic toxicity due to metallic ion corrosion." ;
         rdfs:label "Metallic corrosion" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Radiaton_Risk_Type
:Radiaton_Risk_Type rdf:type owl:NamedIndividual ,
                             :RadiationRisk ;
                    rdfs:comment "Instance used to specify the hazard."@en ;
                    rdfs:label "Radiaton_Risk_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Recall_Type
:Recall_Type rdf:type owl:NamedIndividual ,
                      :Recall ;
             rdfs:comment "Instance representing the removal of a device from the market."@en ;
             rdfs:label "Recall_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Safety_Alert_Type
:Safety_Alert_Type rdf:type owl:NamedIndividual ,
                            :SafetyAlert ;
                   rdfs:comment "Value used to categorize notifications regarding critical safety updates to users." ;
                   rdfs:label "Safety_Alert_Type"@en .


###  http://www.noel-garcia.org/ontologies/medical-devices#Self_Test_Device_Type
:Self_Test_Device_Type rdf:type owl:NamedIndividual ,
                                :SelfTestDevice ;
                       rdfs:comment "Device category used to define its use."@en ;
                       rdfs:label "Self_Test_Device_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Serious_Incident_Type
:Serious_Incident_Type rdf:type owl:NamedIndividual ,
                                :SeriousIncident ;
                       rdfs:comment "Instance used to flag events resulting in death or serious problems."@en ;
                       rdfs:label "Serious_Incident_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Serious_Sev
:Serious_Sev rdf:type owl:NamedIndividual ,
                      :Serious ;
             rdfs:comment "Value used to show severity."@en ;
             rdfs:label "Serious_Sev" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Single_Use_Device_Type
:Single_Use_Device_Type rdf:type owl:NamedIndividual ,
                                 :SingleUseDevice ;
                        rdfs:comment "Device category used to define its use."@en ;
                        rdfs:label "Single_Use_Device_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#Software_Risk_Type
:Software_Risk_Type rdf:type owl:NamedIndividual ,
                             :SoftwareRisk ;
                    rdfs:comment "Instance used to specify the hazard."@en ;
                    rdfs:label "Software_Risk_Type" .


###  http://www.noel-garcia.org/ontologies/medical-devices#User_Notice_Type
:User_Notice_Type rdf:type owl:NamedIndividual ,
                           :UserNotice ;
                  rdfs:comment "Represents the specific notice sent to the user."@en ;
                  rdfs:label "User_Notice_Type" .


#################################################################
#    Annotations
#################################################################

<http://purl.org/dc/terms/description> rdfs:comment "A textual description providing details about the incident or risk."@en ;
                                       rdfs:label "description" .


#################################################################
#    General axioms
#################################################################

[ rdf:type owl:AllDisjointClasses ;
  owl:members ( :ActiveDevice
                :ActiveImplant
                :InVitroDiagnosticDevice
                :SelfTestDevice
                :SingleUseDevice
              )
] .


[ rdf:type owl:AllDisjointClasses ;
  owl:members ( :ActiveImplant
                :ImplantableDevice
                :InVitroDiagnosticDevice
                :SelfTestDevice
                :SingleUseDevice
              )
] .


[ rdf:type owl:AllDisjointClasses ;
  owl:members ( :ClassA
                :ClassB
                :ClassC
                :ClassD
                :ClassI
                :ClassIII
                :ClassIIa
                :ClassIIb
              )
] .


[ rdf:type owl:AllDisjointClasses ;
  owl:members ( :ContaminationRisk
                :CybersecurityRisk
                :DiagnosticRisk
                :InfectionRisk
                :InjuryRisk
                :InterferenceRisk
                :MalfunctionRisk
                :MaterialRisk
                :RadiationRisk
                :SoftwareRisk
              )
] .


[ rdf:type owl:AllDisjointClasses ;
  owl:members ( :CorrectiveAction
                :Device
                :Incident
                :Manufacturer
                :Risk
              )
] .


[ rdf:type owl:AllDisjointClasses ;
  owl:members ( :Critical
                :Moderate
                :Serious
              )
] .


[ rdf:type owl:AllDisjointClasses ;
  owl:members ( :DeviceFailure
                :DevicePerformance
                :DeviceSafety
                :DiagnosticError
                :PatientHarm
                :ProductQuality
              )
] .


[ rdf:type owl:AllDisjointClasses ;
  owl:members ( :High
                :Low
                :Medium
              )
] .


[ rdf:type owl:AllDisjointClasses ;
  owl:members ( :InSituCorrection
                :Recall
                :SafetyAlert
                :UserNotice
              )
] .


#################################################################
#    Rules
#################################################################

:a rdf:type <http://www.w3.org/2003/11/swrl#Variable> .

:d rdf:type <http://www.w3.org/2003/11/swrl#Variable> .

:i rdf:type <http://www.w3.org/2003/11/swrl#Variable> .

:r rdf:type <http://www.w3.org/2003/11/swrl#Variable> .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "CorrectiveAction - In Situ" ;
   rdfs:label "In situ" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :CorrectiveAction ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :a
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasActionType ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :a ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :In_Situ_Correction_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :InSituCorrection ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :a
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "CorrectiveAction - Recall" ;
   rdfs:label "Recall" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :CorrectiveAction ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :a
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasActionType ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :a ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Recall_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Recall ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :a
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "CorrectiveAction - Safety Alert" ;
   rdfs:label "Safety Alert" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :CorrectiveAction ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :a
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasActionType ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :a ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Safety_Alert_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :SafetyAlert ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :a
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "CorrectiveAction - User Notice" ;
   rdfs:label "User Notice" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :CorrectiveAction ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :a
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasActionType ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :a ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :User_Notice_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :UserNotice ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :a
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Active Device" ;
   rdfs:label "Device type Active Device" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Device ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasDeviceType ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :d ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Active_Device_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :ActiveDevice ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Active Implant" ;
   rdfs:label "Device type Active Implant" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Device ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasDeviceType ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :d ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Active_Implant_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :ActiveImplant ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Class A risk" ;
   rdfs:label "Device risk Class A" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Device ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskClass ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :d ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Class_A
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :ClassA ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Class B risk" ;
   rdfs:label "Device risk Class B" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Device ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskClass ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :d ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Class_B
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :ClassB ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Class C risk" ;
   rdfs:label "Device risk Class C" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Device ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskClass ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :d ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Class_C
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :ClassC ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Class D risk" ;
   rdfs:label "Device risk Class D" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Device ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskClass ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :d ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Class_D
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :ClassD ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Class I risk" ;
   rdfs:label "Device risk Class I" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Device ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskClass ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :d ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Class_I
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :ClassI ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Class III risk" ;
   rdfs:label "Device risk Class III" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Device ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskClass ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :d ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Class_III
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :ClassIII ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Class IIa risk" ;
   rdfs:label "Device risk Class IIa" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Device ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskClass ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :d ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Class_IIa
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :ClassIIa ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Class IIb risk" ;
   rdfs:label "Device risk Class IIb" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Device ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskClass ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :d ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Class_IIb
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :ClassIIb ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Implantable Active Device" ;
   rdfs:label "Device type Implantable Active Device" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Device ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasDeviceType ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :d ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Implantable_Active_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :ImplantableActiveDevice ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Implantable Device" ;
   rdfs:label "Device type Implantable Device" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Device ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasDeviceType ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :d ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Implantable_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :ImplantableDevice ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "In Vitro" ;
   rdfs:label "Device type In Vitro" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Device ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasDeviceType ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :d ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :In_Vitro_Diagnostic_Device_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :InVitroDiagnosticDevice ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Self Test" ;
   rdfs:label "Device type Self Test" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Device ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasDeviceType ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :d ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Self_Test_Device_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :SelfTestDevice ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Single Use" ;
   rdfs:label "Device type Single Use" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Device ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasDeviceType ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :d ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Single_Use_Device_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :SingleUseDevice ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :d
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Incident - Type" ;
   rdfs:label "Near Miss Incident" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Incident ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :i
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasIncidentType ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :i ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Near_Miss_Incident_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :NearMissIncident ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :i
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Incident - Type" ;
   rdfs:label "Serious Incident" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Incident ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :i
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasIncidentType ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :i ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Serious_Incident_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Serious ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :i
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Contamination Risk" ;
   rdfs:label "Risk type Contia" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Risk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskType ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :r ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Contamination_Risk_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :ContaminationRisk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Critical Sev Level" ;
   rdfs:label "Severity Critical" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Risk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasSeverity ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :r ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Critical_Sev
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Critical ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Cybersecurity Risk" ;
   rdfs:label "Risk type Cyber" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Risk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskType ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :r ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Cybersecurity_Risk_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :CybersecurityRisk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Device Failure" ;
   rdfs:label "Risk cat Failure" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Risk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskCategory ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :r ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Device_Failure_Cat
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :DeviceFailure ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Device Performance" ;
   rdfs:label "Risk cat Performance" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Risk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskCategory ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :r ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Device_Performance_Cat
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :DevicePerformance ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Device Safety" ;
   rdfs:label "Risk cat Safety" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Risk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskCategory ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :r ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Device_Safety_Cat
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :DeviceSafety ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Diagnostic error" ;
   rdfs:label "Risk cat Diag" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Risk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskCategory ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :r ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Diagnostic_Error_Cat
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :DiagnosticError ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Diagnostic Risk" ;
   rdfs:label "Risk type Diag" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Risk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskType ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :r ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Diagnostic_Risk_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :DiagnosticRisk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "High Probability Level" ;
   rdfs:label "Probability High" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Risk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasProbability ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :r ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :High_Probability_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :High ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Infection Risk" ;
   rdfs:label "Risk type Infe" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Risk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskType ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :r ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Infection_Risk_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :InfectionRisk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Injury Risk" ;
   rdfs:label "Risk type Injury" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Risk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskType ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :r ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Injury_Risk_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :InjuryRisk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Interference Risk" ;
   rdfs:label "Risk type Interf" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Risk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskType ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :r ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Interference_Risk_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :InterferenceRisk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Low Probability Level" ;
   rdfs:label "Probability Low" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Risk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasProbability ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :r ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Low_Probability_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Low ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Malfunction Risk" ;
   rdfs:label "Risk type Malf" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Risk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskType ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :r ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Malfunction_Rick_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :MalfunctionRisk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Material Risk" ;
   rdfs:label "Risk type Mat" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Risk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskType ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :r ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Material_Risk_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :MaterialRisk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Medium Probability Level" ;
   rdfs:label "Probability Medium" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Risk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasProbability ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :r ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Medium_Probability_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Medium ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Moderate Sev Level" ;
   rdfs:label "Severity Moderate" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Risk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasSeverity ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :r ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Moderate_Sev
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Moderate ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Patient Harm" ;
   rdfs:label "Risk cat Patient" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Risk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskCategory ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :r ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Patient_Harm_Cat
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :PatientHarm ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Product quality" ;
   rdfs:label "Risk cat prod" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Risk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskCategory ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :r ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Product_Quality_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :ProductQuality ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Radiation Risk" ;
   rdfs:label "Risk type Rad" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Risk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskType ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :r ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Radiaton_Risk_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :RadiationRisk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Serious Sev Level" ;
   rdfs:label "Severity Serious" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Risk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasSeverity ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :r ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Serious_Sev
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Serious ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

[ <http://swrl.stanford.edu/ontologies/3.3/swrla.owl#isRuleEnabled> "true"^^xsd:boolean ;
   rdfs:comment "Software Risk" ;
   rdfs:label "Risk type Soft" ;
   rdf:type <http://www.w3.org/2003/11/swrl#Imp> ;
   <http://www.w3.org/2003/11/swrl#body> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :Risk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                                      rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#IndividualPropertyAtom> ;
                                                                  <http://www.w3.org/2003/11/swrl#propertyPredicate> :hasRiskType ;
                                                                  <http://www.w3.org/2003/11/swrl#argument1> :r ;
                                                                  <http://www.w3.org/2003/11/swrl#argument2> :Software_Risk_Type
                                                                ] ;
                                                      rdf:rest rdf:nil
                                                    ]
                                         ] ;
   <http://www.w3.org/2003/11/swrl#head> [ rdf:type <http://www.w3.org/2003/11/swrl#AtomList> ;
                                           rdf:first [ rdf:type <http://www.w3.org/2003/11/swrl#ClassAtom> ;
                                                       <http://www.w3.org/2003/11/swrl#classPredicate> :SoftwareRisk ;
                                                       <http://www.w3.org/2003/11/swrl#argument1> :r
                                                     ] ;
                                           rdf:rest rdf:nil
                                         ]
 ] .

###  Generated by the OWL API (version 5.1.18) https://github.com/owlcs/owlapi/