@prefix : . @prefix dc: . @prefix dcterms: . @prefix ns: . @prefix owl: . @prefix rdf: . @prefix xml: . @prefix xsd: . @prefix rdfs: . @prefix schema: . @prefix vann: . @base . rdf:type owl:Ontology ; owl:versionIRI ; dcterms:description "The Riskman Ontology defines various notions related to risk management for medical devices." ; dcterms:abstract "The Riskman Ontology defines various notions related to risk management for medical devices. It builds on terms from ISO 14971. The central notion of the Riskman ontology is that of a Safe Design Argument (SDA), a reusable artifact that aims to demonstrate how a specific hazard occurring with a device has been mitigated (possibly using further context information and assumptions)." ; schema:funder "(Add funder info)" ; schema:funding "(Add funding info)" ; dcterms:license ; dcterms:title "Digital Risk Management Ontology" ; dcterms:created "2023-09-12"^^xsd:date ; dcterms:issued "2025-07-15"^^xsd:date ; ns:status "Published" ; dcterms:source ; schema:citation "Gorczyca, P., Arndt, D., Diller, M., Hampe, J., Heidenreich, G., Kettmann, P., Krötzsch, M., Mennicke, S., Rudolph, S., & Strass, H. (2025). Supporting Risk Management for Medical Devices via the RISKMAN Ontology and Shapes. To appear in Proceedings of the 21st International Conference on Semantic Systems (SEMANTiCS 2025), Vienna, Austria, September 03–05, 2025." ; schema:logo ; owl:versionInfo "1.0.0" ; rdfs:label "The Riskman Ontology" ; rdfs:seeAlso ; schema:dateModified "2024-04-13"^^xsd:date ; vann:preferredNamespacePrefix "riskman" ; vann:preferredNamespaceURI ; dcterms:creator _:person_arndt, _:person_diller, _:person_gorczyca, _:person_kettmann, _:person_mennicke, _:person_strass ; dcterms:author _:person_arndt, _:person_diller, _:person_gorczyca, _:person_kettmann, _:person_mennicke, _:person_strass ; dcterms:contributor _:person_hartig, _:person_tsurkan, _:person_heidenreich . # Named blank nodes for creators/authors _:person_arndt a schema:Person ; schema:name "Dörthe Arndt" ; schema:url ; schema:affiliation _:iccl_tud . _:person_diller a schema:Person ; schema:name "Martin Diller" ; schema:url ; schema:affiliation _:iccl_tud . _:person_gorczyca a schema:Person ; schema:name "Piotr Gorczyca" ; schema:url ; schema:affiliation _:iccl_tud . _:person_kettmann a schema:Person ; schema:name "Pascal Kettmann" ; schema:url ; schema:affiliation _:iccl_tud . _:person_mennicke a schema:Person ; schema:name "Stephan Mennicke" ; schema:url ; schema:affiliation _:iccl_tud . _:person_strass a schema:Person ; schema:name "Hannes Straß" ; schema:url ; schema:affiliation _:iccl_tud . _:person_hartig a schema:Person ; schema:name "Evi Hartig" ; schema:affiliation _:ekfz . _:person_tsurkan a schema:Person ; schema:name "Sarah Tsurkan" ; schema:affiliation _:ekfz . _:person_heidenreich a schema:Person ; schema:name "Georg Heidenreich" ; schema:affiliation _:siemens_healthineers . # Organizations _:iccl_tud a schema:Organization ; schema:name "ICCL, TU Dresden" ; schema:url . _:ekfz a schema:Organization ; schema:name "EKFZ, TU Dresden" . _:siemens_healthineers a schema:Organization ; schema:name "Siemens Healthineers" . ################################################################# # Object Properties ################################################################# ### https://w3id.org/riskman/ontology#causesHarm :causesHarm rdf:type owl:ObjectProperty ; rdfs:domain :DomainSpecificHazard ; rdfs:range :Harm ; rdfs:comment "Links a domain specific hazard to the harm it may cause." ; rdfs:label "causes harm" . ### https://w3id.org/riskman/ontology#hasAnalyzedRisk :hasAnalyzedRisk rdf:type owl:ObjectProperty ; rdfs:domain :ControlledRisk ; rdfs:range :AnalyzedRisk ; rdfs:comment "Links a controlled risk to its underlying analyzed risk." ; rdfs:label "has analyzed risk" . ### https://w3id.org/riskman/ontology#hasDeviceContext :hasDeviceContext rdf:type owl:ObjectProperty ; rdfs:domain :AnalyzedRisk ; rdfs:range :DeviceContext ; rdfs:comment "Links an analyzed risk with its relevant device context." ; rdfs:label "has device context" . ### https://w3id.org/riskman/ontology#hasDeviceComponent :hasDeviceComponent rdf:type owl:ObjectProperty ; rdfs:domain :DomainSpecificHazard ; rdfs:range :DeviceComponent ; rdfs:comment "Links a domain specific hazard with the device component involved." ; rdfs:label "has device component" . ### https://w3id.org/riskman/ontology#hasDeviceProblem :hasDeviceProblem rdf:type owl:ObjectProperty ; rdfs:domain :DomainSpecificHazard ; rdfs:range :DeviceProblem ; rdfs:comment "Links a domain specific hazard to the corresponding device problem, usually represented by an IMDRF code, in risk reports." ; rdfs:label "has device problem" . ### https://w3id.org/riskman/ontology#hasDomainSpecificHazard :hasDomainSpecificHazard rdf:type owl:ObjectProperty ; rdfs:domain :AnalyzedRisk ; rdfs:range :DomainSpecificHazard ; rdfs:comment "Links an analyzed risk to a domain-specific hazard." ; rdfs:label "has domain specific hazard" . ### https://w3id.org/riskman/ontology#hasEvent :hasEvent rdf:type owl:ObjectProperty ; rdfs:domain :HazardousSituation ; rdfs:range :Event ; rdfs:comment "Links a hazardous situation to an event that may cause it." ; rdfs:label "has event" . ### https://w3id.org/riskman/ontology#hasDeviceFunction :hasDeviceFunction rdf:type owl:ObjectProperty ; rdfs:domain :DomainSpecificHazard ; rdfs:range :DeviceFunction ; rdfs:comment "Links a domain specific hazard to a related device function." ; rdfs:label "has device function" . ### https://w3id.org/riskman/ontology#hasHarm :hasHarm rdf:type owl:ObjectProperty ; owl:propertyChainAxiom ( :hasAnalyzedRisk :hasHarm ) ; rdfs:range :Harm ; rdfs:domain :Risk ; rdfs:comment "Links a risk to the harm it involves." ; rdfs:label "has harm" . ### https://w3id.org/riskman/ontology#hasHazard :hasHazard rdf:type owl:ObjectProperty ; rdfs:domain :DomainSpecificHazard ; rdfs:range :Hazard ; rdfs:comment "Links a domain specific hazard to its underlying hazard." ; rdfs:label "has hazard" . ### https://w3id.org/riskman/ontology#hasHazardousSituation :hasHazardousSituation rdf:type owl:ObjectProperty ; rdfs:domain :AnalyzedRisk ; rdfs:range :HazardousSituation ; rdfs:comment "Links an analyzed risk to a hazardous situation." ; rdfs:label "has hazardous situation" . ### https://w3id.org/riskman/ontology#hasImplementationManifest :hasImplementationManifest rdf:type owl:ObjectProperty ; rdfs:domain :SDA ; rdfs:range :ImplementationManifest ; rdfs:comment "Links an SDA to its supporting implementation manifest." ; rdfs:label "has implementation manifest" . ### https://w3id.org/riskman/ontology#hasPatientProblem :hasPatientProblem rdf:type owl:ObjectProperty ; rdfs:domain :AnalyzedRisk ; rdfs:range :PatientProblem ; rdfs:comment "Links an analyzed risk to the corresponding patient problem, usually represented by an IMDRF code, in risk reports." ; rdfs:label "has patient problem" . ### https://w3id.org/riskman/ontology#hasParentHazard :hasParentHazard rdf:type owl:ObjectProperty, owl:TransitiveProperty ; rdfs:domain :Hazard ; rdfs:range :Hazard ; rdfs:comment "Links a hazard to its parent hazard in a hierarchical relationship." ; rdfs:label "has parent hazard" . ### https://w3id.org/riskman/ontology#hasParentSituation :hasParentSituation rdf:type owl:ObjectProperty, owl:TransitiveProperty ; rdfs:domain :HazardousSituation ; rdfs:range :HazardousSituation ; rdfs:label "has parent situation" ; rdfs:comment "Links a hazardous situation to its parent situation in a hierarchical relationship." . ### https://w3id.org/riskman/ontology#hasResidualRiskLevel :hasResidualRiskLevel rdf:type owl:ObjectProperty ; rdfs:domain :ControlledRisk ; rdfs:range :RiskLevel ; rdfs:subPropertyOf :hasRiskLevel ; rdfs:comment "Links a controlled risk to its residual risk level after mitigation." ; rdfs:label "has residual risk level" . ### https://w3id.org/riskman/ontology#hasInitialRiskLevel :hasInitialRiskLevel rdf:type owl:ObjectProperty ; rdfs:domain :AnalyzedRisk ; rdfs:range :RiskLevel ; rdfs:subPropertyOf :hasRiskLevel ; rdfs:comment "Links an analyzed risk to its initial risk level before mitigation." ; rdfs:label "has initial risk level" . ### https://w3id.org/riskman/ontology#hasRiskLevel :hasRiskLevel rdf:type owl:ObjectProperty ; rdfs:range :RiskLevel ; rdfs:domain :Risk ; rdfs:comment "Links a risk to its risk level, combining probability and severity." ; rdfs:label "has risk level" . ### https://w3id.org/riskman/ontology#hasPrecedingEvent :hasPrecedingEvent rdf:type owl:ObjectProperty, owl:TransitiveProperty ; rdfs:domain :Event ; rdfs:range :Event ; rdfs:comment "Links an event to a preceding event that may lead to it." ; rdfs:label "has preceding event" . ### https://w3id.org/riskman/ontology#hasSafetyAssurance :hasSafetyAssurance rdf:type owl:ObjectProperty ; rdfs:domain :AssuranceSDA ; rdfs:range :SafetyAssurance ; rdfs:comment "Links an SDA to its related safety assurance." ; rdfs:label "has safety assurance" . ### https://w3id.org/riskman/ontology#hasSubSDA :hasSubSDA rdf:type owl:ObjectProperty ; rdfs:domain :SDA ; rdfs:range :SDA ; rdfs:comment "Links an SDA to a related subordinate SDA." ; rdfs:label "has sub SDA" . ### https://w3id.org/riskman/ontology#isMitigatedBy :isMitigatedBy rdf:type owl:ObjectProperty ; rdfs:domain :ControlledRisk ; rdfs:range :SDA ; rdfs:comment "Links a controlled risk to the SDA that mitigates it." ; rdfs:label "is mitigated by" . ### https://w3id.org/riskman/ontology#isPartOfDeviceComponent :isPartOfDeviceComponent rdf:type owl:ObjectProperty, owl:TransitiveProperty ; rdfs:domain :DeviceComponent ; rdfs:range :DeviceComponent ; rdfs:comment "Links a device component to another device component it is part of." ; rdfs:label "is part of device component" . ### https://w3id.org/riskman/ontology#hasProbability :hasProbability rdf:type owl:ObjectProperty ; rdfs:domain :RiskLevel ; rdfs:range :Probability ; rdfs:comment "Probability of occurrence of harm, can additionally be expressed as a combination of separate probabilities via respective object properties hasProbability1 and hasProbability2. A decomposition into P1 and P2 is not mandatory." ; rdfs:label "has Probability" . ### https://w3id.org/riskman/ontology#hasProbability1 :hasProbability1 rdf:type owl:ObjectProperty ; rdfs:domain :RiskLevel ; rdfs:range :Probability ; rdfs:comment "Probability of a hazardous situation occurring." ; rdfs:label "has Probability1" . ### https://w3id.org/riskman/ontology#hasProbability2 :hasProbability2 rdf:type owl:ObjectProperty ; rdfs:domain :RiskLevel ; rdfs:range :Probability ; rdfs:comment "Probability of a hazardous situation leading to harm." ; rdfs:label "has Probability2" . ### https://w3id.org/riskman/ontology#hasSeverity :hasSeverity rdf:type owl:ObjectProperty ; rdfs:domain :RiskLevel ; rdfs:range :Severity ; rdfs:comment "Measure of the possible consequences of a hazard." ; rdfs:label "has Severity" . ################################################################# # Classes ################################################################# ### https://w3id.org/riskman/ontology#AnalyzedRisk :AnalyzedRisk rdf:type owl:Class ; rdfs:label "Analyzed risk" ; rdfs:comment "Combination of one or more domain-specific hazard(s) with one hazardous situation and one harm with reference to a device context and a specification of an initial risk level." . [ owl:intersectionOf ( [ rdf:type owl:Restriction ; owl:onProperty :hasDomainSpecificHazard ; owl:someValuesFrom owl:Thing ] [ rdf:type owl:Restriction ; owl:onProperty :hasHarm ; owl:someValuesFrom owl:Thing ] [ rdf:type owl:Restriction ; owl:onProperty :hasDeviceContext ; owl:someValuesFrom owl:Thing ] [ rdf:type owl:Restriction ; owl:onProperty :hasHazardousSituation ; owl:someValuesFrom owl:Thing ] [ rdf:type owl:Restriction ; owl:onProperty :hasInitialRiskLevel ; owl:someValuesFrom owl:Thing ] ) ; ] rdfs:subClassOf :AnalyzedRisk. ### https://w3id.org/riskman/ontology#AssuranceSDA :AssuranceSDA rdf:type owl:Class ; rdfs:subClassOf :SDA ; owl:disjointWith :RiskSDA ; rdfs:label "Assurance SDA" ; rdfs:comment "A safe design argument (SDA), where the purpose is to make a safety assurance" . [ owl:intersectionOf ( :SDA [ rdf:type owl:Restriction ; owl:onProperty :hasSafetyAssurance ; owl:someValuesFrom owl:Thing ] ); ] rdfs:subClassOf :AssuranceSDA . ### https://w3id.org/riskman/ontology#AssuranceSDAI :AssuranceSDAI rdf:type owl:Class ; rdfs:comment "A safe design argument (SDA), where the purpose is to make a safety assurance" ; rdfs:label "Assurance SDAI" . [ owl:intersectionOf ( :AssuranceSDA :SDAI ) ; ] rdfs:subClassOf :AssuranceSDAI . ### https://w3id.org/riskman/ontology#DeviceComponent :DeviceComponent rdf:type owl:Class ; rdfs:comment "A (physical or logical) part of a device." ; rdfs:label "Device component" . ### https://w3id.org/riskman/ontology#DeviceContext :DeviceContext rdf:type owl:Class ; rdfs:comment "Information about possible environments the device can be used in that may affect probability or severity of some risk." ; rdfs:label "Device context" . ### https://w3id.org/riskman/ontology#DomainSpecificHazard :DomainSpecificHazard rdf:type owl:Class ; rdfs:comment "Structured artifact that centers around one hazard having the potential to cause one or more harm(s) in the context of a domain-specific function and component. Caution: strictly speaking a Domain Specific Hazard is not actually a Hazard, but a combination containing a Hazard." ; rdfs:label "Domain specific hazard" . [ rdf:type owl:Restriction ; owl:onProperty :causesHarm ; owl:someValuesFrom owl:Thing ] rdfs:subClassOf :DomainSpecificHazard . [ owl:intersectionOf ( [ rdf:type owl:Restriction ; owl:onProperty :hasDeviceComponent ; owl:someValuesFrom owl:Thing ] [ rdf:type owl:Restriction ; owl:onProperty :hasDeviceFunction ; owl:someValuesFrom owl:Thing ] [ rdf:type owl:Restriction ; owl:onProperty :hasHazard ; owl:someValuesFrom owl:Thing ] ) ; ] rdfs:subClassOf :DomainSpecificHazard . ### https://w3id.org/riskman/ontology#Event :Event rdf:type owl:Class ; rdfs:comment "An incidence or occurrence leading to another event and/or (eventually) a hazardous situation." ; rdfs:label "Event" . ### https://w3id.org/riskman/ontology#DeviceFunction :DeviceFunction rdf:type owl:Class ; rdfs:comment "A specific functionality of a device related with the domain specific hazard." ; rdfs:label "Device function" . ### https://w3id.org/riskman/ontology#DeviceProblem :DeviceProblem rdf:type owl:Class ; rdfs:comment "Information allowing to link the Domain Specific Hazard to risk reports' notion of a device problem, e.g. an IMDRF term. " ; rdfs:label "Device problem" . ### https://w3id.org/riskman/ontology#Harm :Harm rdf:type owl:Class ; rdfs:comment "Injury or damage to the health of people, or damage to property or the environment." ; rdfs:label "Harm" . ### https://w3id.org/riskman/ontology#Hazard :Hazard rdf:type owl:Class ; rdfs:comment "Potential source of harm" ; rdfs:label "Hazard" . ### https://w3id.org/riskman/ontology#HazardousSituation :HazardousSituation rdf:type owl:Class ; rdfs:comment "Circumstance in which people, property or the environment is/are exposed to one or more hazards." ; rdfs:label "Hazardous situation" . [ rdf:type owl:Restriction ; owl:onProperty :hasEvent ; owl:someValuesFrom owl:Thing ] rdfs:subClassOf :HazardousSituation . ### https://w3id.org/riskman/ontology#ImplementationManifest :ImplementationManifest rdf:type owl:Class ; rdfs:comment "A concrete piece of objective evidence (or a reference to such) that an SDA has been implemented, e.g. reference to a line of code or a particular section in the device manual." ; rdfs:label "Implementation manifest" . ### https://w3id.org/riskman/ontology#ControlledRisk :ControlledRisk rdf:type owl:Class ; rdfs:label "Controlled risk" ; rdfs:comment "Structured artifact that relates one analyzed risk with one or more SDA(s) and specifies a resulting residual risk." . [ owl:intersectionOf ( [ rdf:type owl:Restriction ; owl:onProperty :isMitigatedBy ; owl:someValuesFrom owl:Thing ] [ rdf:type owl:Restriction ; owl:onProperty :hasAnalyzedRisk ; owl:someValuesFrom owl:Thing ] [ rdf:type owl:Restriction ; owl:onProperty :hasResidualRiskLevel ; owl:someValuesFrom owl:Thing ] ) ; ] rdfs:subClassOf :ControlledRisk . ### https://w3id.org/riskman/ontology#PatientProblem :PatientProblem rdf:type owl:Class ; rdfs:comment "Information allowing to link an Analyzed Risk to risk reports' notion of a patient problem, e.g. an IMDRF term. " ; rdfs:label "Patient problem" . ### https://w3id.org/riskman/ontology#Probability :Probability rdf:type owl:Class ; rdfs:label "Probability" ; rdfs:comment "Probability of occurence of a harm." . ### https://w3id.org/riskman/ontology#Risk :Risk rdf:type owl:Class ; rdfs:label "Risk" ; rdfs:comment "Combination of the probability of occurrence of harm and the severity of that harm." . [ owl:intersectionOf ( [ rdf:type owl:Restriction ; owl:onProperty :hasHarm ; owl:someValuesFrom owl:Thing ] [ rdf:type owl:Restriction ; owl:onProperty :hasRiskLevel ; owl:someValuesFrom owl:Thing ] ) ; ] rdfs:subClassOf :Risk . ### https://w3id.org/riskman/ontology#RiskLevel :RiskLevel rdf:type owl:Class ; rdfs:comment "Combination of probability and severity." ; rdfs:label "Risk level" . [ owl:intersectionOf ( [ rdf:type owl:Restriction ; owl:onProperty :hasProbability ; owl:someValuesFrom owl:Thing ] [ rdf:type owl:Restriction ; owl:onProperty :hasSeverity ; owl:someValuesFrom owl:Thing ] ) ; ] rdfs:subClassOf :RiskLevel . ### https://w3id.org/riskman/ontology#RiskSDA :RiskSDA rdf:type owl:Class ; rdfs:subClassOf :SDA ; rdfs:comment "SDA where the purpose is to mitigate an analyzed risk." ; rdfs:label "Risk SDA" . ### https://w3id.org/riskman/ontology#RiskSDAI :RiskSDAI rdf:type owl:Class ; rdfs:comment "Structured artifact specifying a concrete implementation or realization of a specific Risk SDA." ; rdfs:label "Risk SDAI" . [ owl:intersectionOf ( :RiskSDA :SDAI ) ] rdfs:subClassOf :RiskSDAI . ### https://w3id.org/riskman/ontology#SDA :SDA rdf:type owl:Class ; rdfs:comment "Reusable artifact embodying or expressing one possible method or approach to risk control." ; rdfs:label "SDA" . ### https://w3id.org/riskman/ontology#SDAI :SDAI rdf:type owl:Class ; rdfs:comment "Reusable artifact embodying or expressing one possible method or approach to risk control." ; rdfs:label "SDAI" . [ owl:intersectionOf ( :SDA [ rdf:type owl:Restriction ; owl:onProperty :hasImplementationManifest ; owl:someValuesFrom owl:Thing ] ) ] rdfs:subClassOf :SDAI . ### https://w3id.org/riskman/ontology#Severity :Severity rdf:type owl:Class ; rdfs:label "Severity" ; rdfs:comment "Measure of the possible consequences of a harm." . ### https://w3id.org/riskman/ontology#SafetyAssurance :SafetyAssurance rdf:type owl:Class ; rdfs:comment "A credible reference (or list of such) to the state of the art of achieving safety with respect to a certain class of hazards, e.g. referring to an international norm such as ISO 60601." ; rdfs:label "Safety assurance" . ################################################################# # General axioms ################################################################# # disjointness [ rdf:type owl:AllDisjointClasses ; owl:members ( :AnalyzedRisk :DeviceComponent :DeviceContext :DeviceProblem :DomainSpecificHazard :Event :DeviceFunction :Harm :Hazard :HazardousSituation :ImplementationManifest :ControlledRisk :PatientProblem :Probability :Severity :SafetyAssurance :RiskLevel :SDA ) ] .