RuleML ( Prefix(: ) Prefix(math: ) Prefix(phys: ) Prefix(mdcode: ) Import() Import() Assert ( % Exoskeletons European Regulations % Version: 2019-08-13 % Author: Sofia Almpani % Affiliation: School of Electrical and Computer Engineering, National Technical University of Athens, Greece % Reordering and subgrouping rules from REGULATION (EU) 2017/745 - Annex IX Chapter III (page 141) % Link: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=DE % Manufacturers of medical devices will need to declare the classification of their products. There are four classes: % Class I - Generally regarded as low risk such as stethoscopes, bandages, etc. The devices are non-invasive. % The manufacturer must complete a technical file with a declaration of conformity. % (Class Im - Class I with measuring function & Class Is - Class I sterile) % Class IIa - Generally regarded as low-to-medium risk devices such as a hearing-aid. % This class also warrants technical files as well as having a European Notified Body perform a Quality Assurance. % Class IIb - Generally regarded as are medium-to-high risk such as ventilators and intensive-care monitoring equipment. % Compliance workflow is the same as Class IIa with an additional step of type examination of the device by the European % Notified Body. % Class III - Generally regarded as high risk such as balloon catheters and prosthetic heart valves. % The steps to approval are audit of the full quality assurance system and examination of the design by the European % Notified Body examination and testing of the device. % Rules for Non-Invasive Devices % Rule 1 % Devices that either do not touch the patient or contact intact skin only. Forall ?m ( :CategoryOfMedicalDevice(?m :N1) :- ?m#:MedicalDevice(:kind->:NonInvasive :use->:None :specificCase->:None) ) % Rule 2 % Channeling or storing for eventual administration. Forall ?m ( :CategoryOfMedicalDevice(?m :N2) :- ?m#:MedicalDevice(:kind->:NonInvasive :use->:ChannelingOrStoring :specificCase->:None) ) Forall ?m ( :CategoryOfMedicalDevice(?m :N2a) :- ?m#:MedicalDevice(:kind->:NonInvasive :use->:ChannelingOrStoring :specificCase->:ConnectWithAD) ) Forall ?m ( :CategoryOfMedicalDevice(?m :N2b) :- ?m#:MedicalDevice(:kind->:NonInvasive :use->:ChannelingOrStoring :specificCase->:ForStoringOrgans) ) Forall ?m ( :CategoryOfMedicalDevice(?m :N2c) :- ?m#:MedicalDevice(:kind->:NonInvasive :use->:ChannelingOrStoring :specificCase->:BloodBags) ) % Rule 3 % Devices that modify biological or chemical composition of blood, body liquids or other liquids. Forall ?m ( :CategoryOfMedicalDevice(?m :N3a) :- ?m#:MedicalDevice(:kind->:NonInvasive :use->:ModifyingComposition :specificCase->:Implantation) ) Forall ?m ( :CategoryOfMedicalDevice(?m :N3b) :- ?m#:MedicalDevice(:kind->:NonInvasive :use->:ModifyingComposition :specificCase->:Filtration) ) Forall ?m ( :CategoryOfMedicalDevice(?m :N3c) :- ?m#:MedicalDevice(:kind->:NonInvasive :use->:ModifyingComposition :specificCase->:InVitro) ) % Rule 4 % Devices in contact with injured skin. Forall ?m ( :CategoryOfMedicalDevice(?m :N4a) :- ?m#:MedicalDevice(:kind->:NonInvasive :use->:ContactInjuredSkin :specificCase->:MechanicalBarrier) ) Forall ?m ( :CategoryOfMedicalDevice(?m :N4b) :- ?m#:MedicalDevice(:kind->:NonInvasive :use->:ContactInjuredSkin :specificCase->:UsedPrincipally) ) Forall ?m ( :CategoryOfMedicalDevice(?m :N4c) :- ?m#:MedicalDevice(:kind->:NonInvasive :use->:ContactInjuredSkin :specificCase->:ManageMicroenvironment) ) % Rules for Invasive Devices % Rule 5 % Devices invasive in body orifices. Forall ?m ( :CategoryOfMedicalDevice(?m :I5a) :- ?m#:MedicalDevice(:kind->:Invasive :use->:NonSurgically :specificCase->:Transient) ) Forall ?m ( :CategoryOfMedicalDevice(?m :I5b) :- ?m#:MedicalDevice(:kind->:Invasive :use->:NonSurgically :specificCase->:ShortTerm) ) Forall ?m ( :CategoryOfMedicalDevice(?m :I5c) :- ?m#:MedicalDevice(:kind->:Invasive :use->:NonSurgically :specificCase->:LongTerm) ) % Time Period of usage of Medical Devices in Rule 5 Forall ?m ?d ( ?m#:MedicalDevice(:specificCase ->:Transient) :- And(?m#:MedicalDevice(:duration->?d) math:lessThan(?d 0.02)) ) Forall ?m ?d ( ?m#:MedicalDevice(:specificCase ->:ShortTerm) :- And(?m#:MedicalDevice(:duration->?d) math:lessEq(?d 30) math:greaterEq(?d 0.02)) ) Forall ?m ?d ( ?m#:MedicalDevice(:specificCase->:LongTerm) :- And(?m#:MedicalDevice(:duration->?d) math:greaterThan(?d 30)) ) % Rule 6 % Surgically invasive devices for transient use except if there are reusable surgical instruments. Forall ?m ( :CategoryOfMedicalDevice(?m :I6) :- ?m#:MedicalDevice(:kind->:Invasive :use->:SurgicallyTransient :specificCase->:None) ) Forall ?m ( :CategoryOfMedicalDevice(?m :I6a) :- ?m#:MedicalDevice(:kind->:Invasive :use->:SurgicallyTransient :specificCase->:CirculatorySystem) ) Forall ?m ( :CategoryOfMedicalDevice(?m :I6b) :- ?m#:MedicalDevice(:kind->:Invasive :use->:SurgicallyTransient :specificCase->:ReusableInstruments) ) % Here and later, polyadic Xor (not yet available in PSOA) is simplified to polyadic Or (more efficient), % where all disjuncts but one are understood to be false. Forall ?m ( :CategoryOfMedicalDevice(?m :I6c) :- Or (?m#:MedicalDevice(:kind->:Invasive :use->:SurgicallyTransient :specificCase->:Ionization) ?m#:MedicalDevice(:kind->:Invasive :use->:SurgicallyTransient :specificCase->:DeliverySystem) ?m#:MedicalDevice(:kind->:Invasive :use->:SurgicallyTransient :specificCase->:BiologicalEffect)) ) % Rule 7 % Surgically invasive devices for short term use. Forall ?m ( :CategoryOfMedicalDevice(?m :I7) :- ?m#:MedicalDevice(:kind->:Invasive :use->:SurgicallyShortTerm :specificCase->:None) ) Forall ?m ( :CategoryOfMedicalDevice(?m :I7a) :- Or(?m#:MedicalDevice(:kind->:Invasive :use->:SurgicallyShortTerm :specificCase->:CirculatorySystem) ?m#:MedicalDevice(:kind->:Invasive :use->:SurgicallyShortTerm :specificCase->:BiologicalEffect)) ) Forall ?m ( :CategoryOfMedicalDevice(?m :I7b) :- Or(?m#:MedicalDevice(:kind->:Invasive :use->:SurgicallyShortTerm :specificCase->:Ionization) ?m#:MedicalDevice(:kind->:Invasive :use->:SurgicallyShortTerm :specificCase->:ChemicalChanges) ?m#:MedicalDevice(:kind->:Invasive :use->:SurgicallyShortTerm :specificCase->:Medicines)) ) % Rule 8 % Surgically invasive devices for long term use and implantable devices. Forall ?m ( :CategoryOfMedicalDevice(?m :I8) :- ?m#:MedicalDevice(:kind->:Invasive :use->:SurgicallyLongTerm :specificCase->:None) ) Forall ?m ( :CategoryOfMedicalDevice(?m :I8a) :- ?m#:MedicalDevice(:kind->:Invasive :use->:SurgicallyLongTerm :specificCase->:Dental) ) Forall ?m ( :CategoryOfMedicalDevice(?m :I8b) :- Or(?m#:MedicalDevice(:kind->:Invasive :use->:SurgicallyLongTerm :specificCase->:CentralSystems) ?m#:MedicalDevice(:kind->:Invasive :use->:SurgicallyLongTerm :specificCase->:Implants) ?m#:MedicalDevice(:kind->:Invasive :use->:SurgicallyLongTerm :specificCase->:BiologicalOrMedicalChange)) ) % Rules for Active Devices % Rule 9 % Active therapeutic devices intended to exchange or administer energy. Forall ?m ( :CategoryOfMedicalDevice(?m :A9a) :- ?m#:MedicalDevice(:kind->:Active :use->:Therapeutic :specificCase->:Energy) ) Forall ?m ( :CategoryOfMedicalDevice(?m :A9b) :- ?m#:MedicalDevice(:kind->:Active :use->:Therapeutic :specificCase->:Ionizing) ) %@@@ Forall ?m ( :CategoryOfMedicalDevice(?m :A9c) :- ?m#:MedicalDevice(:kind->:Active :use->:Therapeutic :specificCase->:ConnectingWithImplantable) ) % Rule 10 % Active devices for diagnosis. Forall ?m ( :CategoryOfMedicalDevice(?m :A10) :- ?m#:MedicalDevice(:kind->:Active :use->:DiagnosisMonitoring :specificCase->:None) ) Forall ?m ( :CategoryOfMedicalDevice(?m :A10a) :- ?m#:MedicalDevice(:kind->:Active :use->:DiagnosisMonitoring :specificCase->:VisibleSpectrum) ) Forall ?m ( :CategoryOfMedicalDevice(?m :A10b) :- Or(?m#:MedicalDevice(:kind->:Active :use->:DiagnosisMonitoring :specificCase->:Radiology) ?m#:MedicalDevice(:kind->:Active :use->:DiagnosisMonitoring :specificCase->:CentralSystems)) ) % Rule 11 % Softwares Forall ?m ( :CategoryOfMedicalDevice(?m :A11) :- ?m#:MedicalDevice(:kind->:Active :use->:SoftwareTherapeutic :specificCase->:None) ) Forall ?m ( :CategoryOfMedicalDevice(?m :A11a) :- ?m#:MedicalDevice(:kind->:Active :use->:SoftwareTherapeutic :specificCase->:PossibleIrreversibleHealthDeterioration) ) Forall ?m ( :CategoryOfMedicalDevice(?m :A11b) :- ?m#:MedicalDevice(:kind->:Active :use->:SoftwareTherapeutic :specificCase->:PossibleSeriousHealthDeterioration) ) Forall ?m ( :CategoryOfMedicalDevice(?m :A11c) :- ?m#:MedicalDevice(:kind->:Active :use->:SoftwareTherapeutic :specificCase->:OtherSoftwares) ) % Rule 12 % Active devices to administer, remove medicines and other substances to or from the body. Forall ?m ( :CategoryOfMedicalDevice(?m :A12) :- ?m#:MedicalDevice(:kind->:Active :use->:MoveSubstances :specificCase->:None) ) Forall ?m ( :CategoryOfMedicalDevice(?m :A12a) :- ?m#:MedicalDevice(:kind->:Active :use->:MoveSubstances :specificCase->:PotentiallyHazardous) ) % Rule 13 % All other active devices. Forall ?m ( :CategoryOfMedicalDevice(?m :A13) :- ?m#:MedicalDevice(:kind->:Active :use->:AllOtherAD :specificCase->:None) ) % Special Rules % Rule 14 % Devices incorporating a medicinal substance Forall ?m ( :CategoryOfMedicalDevice(?m :S14) :- ?m#:MedicalDevice(:kind->:Special :use->:MedicalSubstance :specificCase->:None) ) % Rule 15 % Devices used for contraception or prevention of sexually transmitted diseases. Forall ?m ( :CategoryOfMedicalDevice(?m :S15) :- ?m#:MedicalDevice(:kind->:Special :use->:SexualTransmitted :specificCase->:None) ) Forall ?m ( :CategoryOfMedicalDevice(?m :S15a) :- ?m#:MedicalDevice(:kind->:Special :use->:SexualTransmitted :specificCase->:Implantable) ) Forall ?m ( :CategoryOfMedicalDevice(?m :S15a) :- ?m#:MedicalDevice(:kind->:Special :use->:SexualTransmitted :specificCase->:LongTerm) ) % Rule 16 % Specific disinfecting, cleaning and rinsing devices. Forall ?m ( :CategoryOfMedicalDevice(?m :S16a) :- ?m#:MedicalDevice(:kind->:Special :use->:Disinfecting :specificCase->:ContactLenses) ) Forall ?m ( :CategoryOfMedicalDevice(?m :S16a) :- ?m#:MedicalDevice(:kind->:Special :use->:Disinfecting :specificCase->:InvasiveDevices) ) Forall ?m ( :CategoryOfMedicalDevice(?m :S16b) :- ?m#:MedicalDevice(:kind->:Special :use->:Disinfecting :specificCase->:MedicalDevices) ) % Rule 17 % Non-active devices to record X-ray diagnostic images. Forall ?m ( :CategoryOfMedicalDevice(?m :S17) :- ?m#:MedicalDevice(:kind->:Special :use->:Xray :specificCase->:None) ) % Rule 18 % Devices utilizing animal tissues or derivatives. Forall ?m ( :CategoryOfMedicalDevice(?m :S18) :- ?m#:MedicalDevice(:kind->:Special :use->:Derivatives :specificCase->:None) ) % Rule 19 % Nanomaterial. Forall ?m ( :CategoryOfMedicalDevice(?m :S19a) :- ?m#:MedicalDevice(:kind->:Special :use->:Nanomaterial :specificCase->:HighExposure) ) Forall ?m ( :CategoryOfMedicalDevice(?m :S19b) :- ?m#:MedicalDevice(:kind->:Special :use->:Nanomaterial :specificCase->:LowExposure) ) Forall ?m ( :CategoryOfMedicalDevice(?m :S19c) :- ?m#:MedicalDevice(:kind->:Special :use->:Nanomaterial :specificCase->:NegligibleExposure) ) % Rule 20 % Devices with respect to body orifices for inhalation. Forall ?m ( :CategoryOfMedicalDevice(?m :S20) :- ?m#:MedicalDevice(:kind->:Special :use->:Inhalation :specificCase->:None) ) Forall ?m ( :CategoryOfMedicalDevice(?m :S20a) :- ?m#:MedicalDevice(:kind->:Special :use->:Inhalation :specificCase->:LifeThreatening) ) % Rule 21 % Devices that are intended to be introduced into the human body via a body orifice. Forall ?m ( :CategoryOfMedicalDevice(?m :S21a) :- ?m#:MedicalDevice(:kind->:Special :use->:ViaBodyOrifice :specificCase->:Metabolism) ) Forall ?m ( :CategoryOfMedicalDevice(?m :S21a) :- ?m#:MedicalDevice(:kind->:Special :use->:ViaBodyOrifice :specificCase->:Stomach) ) Forall ?m ( :CategoryOfMedicalDevice(?m :S21b) :- ?m#:MedicalDevice(:kind->:Special :use->:ViaBodyOrifice :specificCase->:OnCavities) ) Forall ?m ( :CategoryOfMedicalDevice(?m :S21c) :- ?m#:MedicalDevice(:kind->:Special :use->:ViaBodyOrifice :specificCase->:AllOtherCases) ) % Rule 22 % Active therapeutic devices with an integrated or incorporated diagnostic function. Forall ?m ( :CategoryOfMedicalDevice(?m :S2s) :- ?m#:MedicalDevice(:kind->:Special :use->:IntegratedDiagnostic :specificCase->:None) ) %Extra Classification groupings for Class I (Different requirements for CE marking) %Devices in Class I in sterile condition. Forall ?m ( :CategoryOfMedicalDevice(?m :Ss) :- ?m#:MedicalDevice(:kind->:Special :use->:Sterile :specificCase->:None) ) %Devices in Class I with a measuring function. Forall ?m ( :CategoryOfMedicalDevice(?m :Sm) :- ?m#:MedicalDevice(:kind->:Special :use->:Measuring :specificCase->:None) ) %Classification Grouping %Class I Forall ?m ( :IsClassifiedIn(?m :I) :- Or(:CategoryOfMedicalDevice(?m :N1) :CategoryOfMedicalDevice(?m :N2) :CategoryOfMedicalDevice(?m :N4a) :CategoryOfMedicalDevice(?m :I5a) :CategoryOfMedicalDevice(?m :I6b) :CategoryOfMedicalDevice(?m :A10a) :CategoryOfMedicalDevice(?m :A11c) :CategoryOfMedicalDevice(?m :A13)) ) %Class Is :IsClassifiedIn(?m :Is) :- :CategoryOfMedicalDevice(?m :Ss) %Class Im :IsClassifiedIn(?m :Im) :- :CategoryOfMedicalDevice(?m :Sm) %Class IIa Forall ?m ( :IsClassifiedIn(?m :IIa) :- Or(:CategoryOfMedicalDevice(?m :N2a) :CategoryOfMedicalDevice(?m :N2b) :CategoryOfMedicalDevice(?m :N3b) :CategoryOfMedicalDevice(?m :N4c) :CategoryOfMedicalDevice(?m :I5b) :CategoryOfMedicalDevice(?m :I6) :CategoryOfMedicalDevice(?m :I7) :CategoryOfMedicalDevice(?m :I8a) :CategoryOfMedicalDevice(?m :A9a) :CategoryOfMedicalDevice(?m :A10) :CategoryOfMedicalDevice(?m :A11) :CategoryOfMedicalDevice(?m :A12) :CategoryOfMedicalDevice(?m :S16b) :CategoryOfMedicalDevice(?m :S17) :CategoryOfMedicalDevice(?m :S19a) :CategoryOfMedicalDevice(?m :S20) :CategoryOfMedicalDevice(?m :S21b)) ) %Class IIb Forall ?m ( :IsClassifiedIn(?m :IIb) :- Or(:CategoryOfMedicalDevice(?m :N2c) :CategoryOfMedicalDevice(?m :N3a) :CategoryOfMedicalDevice(?m :N4b) :CategoryOfMedicalDevice(?m :I5c) :CategoryOfMedicalDevice(?m :I6c) :CategoryOfMedicalDevice(?m :I7a) :CategoryOfMedicalDevice(?m :I8) :CategoryOfMedicalDevice(?m :A9b) :CategoryOfMedicalDevice(?m :A10b) :CategoryOfMedicalDevice(?m :A11b) :CategoryOfMedicalDevice(?m :A12a) :CategoryOfMedicalDevice(?m :S15) :CategoryOfMedicalDevice(?m :S16a) :CategoryOfMedicalDevice(?m :S19b) :CategoryOfMedicalDevice(?m :S20a) :CategoryOfMedicalDevice(?m :S21c)) ) %Class III Forall ?m ( :IsClassifiedIn(?m :III) :- Or(:CategoryOfMedicalDevice(?m :I6a) :CategoryOfMedicalDevice(?m :I7b) :CategoryOfMedicalDevice(?m :I8b) :CategoryOfMedicalDevice(?m :N3c) :CategoryOfMedicalDevice(?m :A9c) :CategoryOfMedicalDevice(?m :A11a) :CategoryOfMedicalDevice(?m :S14) :CategoryOfMedicalDevice(?m :S15a) :CategoryOfMedicalDevice(?m :S18) :CategoryOfMedicalDevice(?m :S19a) :CategoryOfMedicalDevice(?m :S21a) :CategoryOfMedicalDevice(?m :S22)) ) % Workflow to CE marking for Medical Devices with Notified Body Number (NBN) for Manufacturers % For Manufacturer's Declaration of Conformity the following five requirements must be fulfilled: % 1. Conformity Assessment & Technical File of the Medical Device - Annex VII % 2. Manufacturer appointing an European Authorized Representative (EAR) as in 93/42/EEC, Article 1 parag.2 % 3a. European Competent Authorities (ECA) as in 93/42/EEC, Article 14 for Class I % 3b. Quality Assurance for Classes IIa,IIb,III % 4a. Notified body Involvement only for Classes Im, Is - Annex V, Article 3 parag.1. % 4b. Type examination for Classes IIb,III - Annex III % 5. Design Dossier Certificate in Full Quality Assurance for Class III %Requirements for all Classes Forall ?m ( :MarketableMedicalDevice(?m) :- :HasCEwithNBN(?m) ) Forall ?m (:HasCEwithNBN(?m) :- :DeclarationOfConformity(?m) ) Forall ?m (:DeclarationOfConformity(?m) :- Or( And(:IsClassifiedIn(?m :I) :RegisterWithTheECA(?m) :AppointingAnEAR(?m) :ConformityAssessment(:device->?m :technicalFile->:Yes :vigilanceSystem->:Yes :harmonizedStandards->:No) :ManufacturingRequirements(?m)) And(:IsClassifiedIn(?m :Is) :RegisterWithTheECA(?m) :AppointingAnEAR(?m) :ConformityAssessment(:device->?m :technicalFile->:Yes :vigilanceSystem->:Yes :harmonizedStandards->:No) :NBforSterileConditions(?m) :ManufacturingRequirements(?m)) And(:IsClassifiedIn(?m :Im) :RegisterWithTheECA(?m) :AppointingAnEAR(?m) :ConformityAssessment(:device->?m :technicalFile->:Yes :vigilanceSystem->:Yes :harmonizedStandards->:No) :NBforMetrologicalRequirements(?m) :ManufacturingRequirements(?m)) And(:IsClassifiedIn(?m :IIa) :AppointingAnEAR(?m) :ConformityAssessment(:device->?m :technicalFile->:Yes :vigilanceSystem->:Yes :harmonizedStandards->:No) :QualityAssurance(?m) :ManufacturingRequirements(?m)) And(:IsClassifiedIn(?m :IIb) :AppointingAnEAR(?m) :ConformityAssessment(:device->?m :technicalFile->:Yes :vigilanceSystem->:Yes :harmonizedStandards->:Yes) :QualityAssurance(?m) :TypeExamination(?m) :ManufacturingRequirements(?m)) And(:IsClassifiedIn(?m :III) :AppointingAnEAR(?m) :ConformityAssessment(:device->?m :technicalFile->:Yes :vigilanceSystem->:Yes :harmonizedStandards->:Yes) :QualityAssurance(?m) :TypeExamination(?m) :ManufacturingRequirements(?m)) ) ) %Various routes for Quality Assurance Forall ?m (:QualityAssurance(?m) :- Or(:QualityType(?m :FullQuality) :QualityType(?m :ProductionTesting) :QualityType(?m :ProductionQuality) :QualityType(?m :InspectionQuality)) ) Forall ?m (:QualityType(?m :FullQuality) :- Or( And(:RequirementsOfQualityType(:device->?m :design->:Yes :manufacture->:Yes) %Annex II, EN ISO 13485:2003 :IsClassifiedIn(?m :IIa)) And(:RequirementsOfQualityType(:device->?m :design->:Yes :manufacture->:Yes) :IsClassifiedIn(?m :IIb)) And(:RequirementsOfQualityType(:device->?m :design->:Yes :manufacture->:Yes) %Annex II,parag.4 EN ISO 13485:2003 :IsClassifiedIn(?m :III) :DesignDossierCertificate(?m)) ) ) Forall ?m (:QualityType(?m :ProductionTesting) :- :RequirementsOfQualityType(:device->?m :design->:Verification :manufacture->:Verification)) %Annex IV Forall ?m (:QualityType(?m :ProductionQuality) :- :RequirementsOfQualityType(:device->?m :design->:No :manufacture->:Yes)) %Annex V, EN ISO 13485:2003 Forall ?m (:QualityType(?m :InspectionQuality) :- :RequirementsOfQualityType(:device->?m :design->:No :manufacture->:No)) %Annex VI, EN ISO 46003:1999 Forall ?m (:ManufacturingRequirements(?m) :- And (:MDDManufacturingRequirements(?m) :MDManufacturingRequirements (?m) )) % REGULATION (EU) 2017/745 - Annex I Chapter II (page 95) % Link: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=DE Forall ?m (:MDDManufacturingRequirements(?m) :- And( :ChemicalPhysicalBiologicalProperties(?m) % p.10 % :InfectionMicrobialContamination (?m) % p.11 % :SubstancesMedicalProductOrAbsorbed(?m) % p.12 % :IncorporatingMaterialsOfBiologicalOrigin(?m) % p.13 % :InteractionWithTheirEnvironment(?m) % p.14 % :DiagnosticOrMeasuringFunction(?m) % p.15 % :ProtectionAgainstRadiation(?m) % p.16 % :ElectronicProgrammableSystems (?m) % p.17 % :ActiveDevices(?m) % p.18 % :ActiveImplantableDevices(?m) % p.19 % :ProtectionAgainstMechanicalAndThermalRisks(?m) % p.20 % :RisksByDevicesSupplyingEnergyOrSubstances(?m) % p.21 % :DevicesForUseByLayPersons(?m) % p.22 % )) Forall ?m (:ChemicalPhysicalBiologicalProperties(?m) :- % p.10 % And( :Design(?m :Checked) % p.10.1 % :ContaminantsResidues(?m :Checked) % p.10.2 % :MedicinalProducts(?m :Checked) % p.10.3 % :Substances(?m :Checked) % p.10.4 % :IngressOfSubstances(?m :Checked) % p.10.5 % :SizePropertiesOfParticles (?m :Checked) % p.10.6 % )) Forall ?m (:Substances(?m :Checked) :- And( :SubstancesDesignManufacture(?m :Checked) % p.10.4.1 % :EndocrineDisruptingCMPSubstances(?m :Checked) % p.10.4.2 % :GuidelinesOnPhthalates(?m :Checked) % p.10.4.3 % :GuidelinesOnOtherEndocrineDisruptingCMRSubstances(?m :Checked) % p.10.4.4 % :Labelling(?m :Checked) % p.10.4.5 % )) Forall ?m (:InfectionMicrobialContamination (?m) :- % p.11 % And( :ReduceRiskOfInfection(?m :Checked) % p.11.1 % :SafeCleaning(?m :Checked) % p.11.2 % :SecureMicrobialState(?m :Checked) % p.11.3 % :DeliveredInSterileState(?m :Checked) % p.11.4 % :DevicesLabelledSterile(?m :Checked) % p.11.5 % :IntendedToBeSterilised(?m :Checked) % p.11.6 % :PackagingSystemsForNonSterileDevices(?m :Checked) % p.11.7 % :DistinguishableLabelling(?m :Checked) % p.11.8 % )) Forall ?m (:SubstancesMedicalProductOrAbsorbed(?m) :- % p.12 % And( :SubstancesMedicalProduct(?m :Checked) % p.12.1 % :SubstancesAbsorbed(?m :Checked) % p.12.2 % )) Forall ?m (:IncorporatingMaterialsOfBiologicalOrigin(?m) :- % p.13 % And( :DerivativesOfHumanOriginRequirements(?m :Checked) % p.13.1 % :DerivativesOfAnimalOriginRequirements(?m :Checked) % p.13.2 % :OtherBiologicalSubstancesOriginRequirements(?m :Checked) % p.13.3 % )) Forall ?m (:InteractionWithTheirEnvironment(?m) :- % p.14 % And( :SafeCombinationOfDevices(?m :Checked) % p.14.1 % :RemoveReduceRisks(?m :Checked) % p.14.2 % :MinimiseRisksOfFireExplosion(?m :Checked) % p.14.3 % :AdjustmentCalibrationMaintenance(?m :Checked) % p.14.4 % :SafeInteroperabilityCompatibility(?m :Checked) % p.14.5 % :MeasurementMonitoringDisplayScale(?m :Checked) % p.14.6 % :SafeDisposal(?m :Checked) % p.14.7 % )) Forall ?m (:DiagnosticOrMeasuringFunction(?m) :- % p.15 % And( :SufficientAccuracyPrecisionStability(?m :Checked) % p.15.1 % :MeasurementsExpressedInLegalUnits(?m :Checked) % p.15.2 % )) Forall ?m (:ProtectionAgainstRadiation(?m) :- % p.16 % And( :ReduceExposureToRadiationAndIncludeOperatingInstructions(?m :Checked) % p.16.1 % :IntendedRadiation(?m :Checked) % p.16.2 % :ReduceExposureToRadiationAndIncludeOperatingInstructions(?m :Checked) % p.16.3 % :IonisingRadiation(?m :Checked) % p.16.4 % )) Forall ?m (:ElectronicProgrammableSystems (?m) :- % p.17 % And( :RepeatabilityReliabilityPerformanceOfSoftwares(?m :Checked) % p.17.1 % :IncorporateSoftware(?m :Checked) % p.17.2 % :SoftwareInCombinationWithMobileComputingPlatforms(?m :Checked) % p.17.3 % :SecurityMinimumRequirements(?m :Checked) % p.17.4 % )) Forall ?m (:ActiveDevices(?m) :- % p.18 % And( :NonImplantableActive(?m :Checked) % p.18.1 % :InternalPowerSupply(?m :Checked) % p.18.2 % :ExternalPowerSupply(?m :Checked) % p.18.3 % :AlarmSystemsForClinicalParameters(?m :Checked) % p.18.4 % :ReduceRisksOfElectromagneticInterference(?m :Checked) % p.18.5 % :IntrinsicImmunityToElectromagneticInterference(?m :Checked) % p.18.6 % :RiskOfAccidentalElectricShocks(?m :Checked) % p.18.7 % :ProtectAgainstUnauthorisedAccess(?m :Checked) % p.18.8 % )) Forall ?m (:ActiveImplantableDevices(?m) :- % p.19 % And( :RemoveOrMinimizeRisks(?m :Checked) % p.19.1 % :CompatibilityReliability(?m :Checked) % p.19.2 % :IdentifiableDeviceAndComponentsParts(?m :Checked) % p.19.3 % :UnequivocallyIdentifiedByCode(?m :Checked) % p.19.4 % )) Forall ?m (:ProtectionAgainstMechanicalAndThermalRisks(?m) :- % p.20 % And( :MechanicalRisks(?m :Checked) % p.20.1 % :Vibration(?m :Checked) % p.20.2 % :ReduceNoise(?m :Checked) % p.20.3 % :ElectricityAndEnergySupplies(?m :Checked) % p.20.4 % :ErrorsWhenFittingParts (?m :Checked) % p.20.5 % :DangerousTemperatures (?m :Checked) % p.20.6 % )) Forall ?m (:RisksByDevicesSupplyingEnergyOrSubstances(?m) :- % p.21 % And( :ΜaintenanceOfTheAmountDelivered(?m :Checked) % p.21.1 % :InadequaciesInTheAmountOfEnergy(?m :Checked) % p.21.2 % :ControlsIndicatorsFunction(?m :Checked) % p.21.3 % )) Forall ?m (:DevicesForUseByLayPersons(?m) :- % p.22 % And( :AppropriateForSkillsAndAvailableMeansToLayPersons(?m :Checked) % p.22.1 % :SafeUseReduceRisks(?m :Checked) % p.22.2 % :VerificationAndFailure(?m :Checked) % p.22.3 % )) % Guidance on the applicability of EHSR of the Machinery Directive (2006/42/EC) to Medical Devices % Link: % Machinery Directive 2006/42 Forall ?m (:MDManufacturingRequirements(?m) :- And( :DefineGeneralTermsOfMD(?m :Checked) % p.1.1.1 % :Lighting(?m :Checked) % p.1.1.4 % :SeatingAsIntegralPart(?m :Checked) % p.1.1.8 % :ControlDevices(?m :Checked) % p.1.2.2 % :ErrorsOfFitting(?m :Checked) % p.1.5.4 % :MachineryMaintenance(?m :Checked) % p.1.6.1 % :AccessToOperatingPositionsAndServicingPoints(?m :Checked) % p.1.6.2 % :IsolationOfEnergySources(?m :Checked) % p.1.6.3 % :DefineMobilityTermsOfMD(?m :Checked) % p.3.1.1 % :MeansOfAccess(?m :Checked) % p.3.4.5 % :MarkingsForDevicesIn311(?m :Checked) % p.3.6.2 % :DefineTermsOfMDForLiftingOperations(?m :Checked) % p.4.1.1 % )) %Exoskeletons Facts (1st) %Requirements of Ekso Legs: Class IIa :EksoLegs#:MedicalDevice(:kind->:Active :use->:Therapeutic :specificCase->:Energy) :AppointingAnEAR(:EksoLegs) :ConformityAssessment(:device->:EksoLegs :technicalFile->:Yes :vigilanceSystem->:Yes :harmonizedStandards->:No) :RequirementsOfQualityType(:device->:EksoLegs :design->:No :manufacture->:No) :Design(:EksoLegs :Checked) % p.10.1 % :ContaminantsResidues(:EksoLegs :Checked) % p.10.2 % :MedicinalProducts(:EksoLegs :Checked) % p.10.3 % :IngressOfSubstances(:EksoLegs :Checked) % p.10.5 % :SizePropertiesOfParticles (:EksoLegs :Checked) % p.10.6 % :SubstancesDesignManufacture(:EksoLegs :Checked) % p.10.4.1 % :EndocrineDisruptingCMPSubstances(:EksoLegs :Checked) % p.10.4.2 % :GuidelinesOnPhthalates(:EksoLegs :Checked) % p.10.4.3 % :GuidelinesOnOtherEndocrineDisruptingCMRSubstances(:EksoLegs :Checked) % p.10.4.4 % :Labelling(:EksoLegs :Checked) % p.10.4.5 % :ReduceRiskOfInfection(:EksoLegs :Checked) % p.11.1 % :SafeCleaning(:EksoLegs :Checked) % p.11.2 % :SecureMicrobialState(:EksoLegs :Checked) % p.11.3 % :DeliveredInSterileState(:EksoLegs :Checked) % p.11.4 % :DevicesLabelledSterile(:EksoLegs :Checked) % p.11.5 % :IntendedToBeSterilised(:EksoLegs :Checked) % p.11.6 % :PackagingSystemsForNonSterileDevices(:EksoLegs :Checked) % p.11.7 % :DistinguishableLabelling(:EksoLegs :Checked) % p.11.8 % :SubstancesMedicalProduct(:EksoLegs :Checked) % p.12.1 % :SubstancesAbsorbed(:EksoLegs :Checked) % p.12.2 % :DerivativesOfHumanOriginRequirements(:EksoLegs :Checked) % p.13.1 % :DerivativesOfAnimalOriginRequirements(:EksoLegs :Checked) % p.13.2 % :OtherBiologicalSubstancesOriginRequirements(:EksoLegs :Checked) % p.13.3 % :SafeCombinationOfDevices(:EksoLegs :Checked) % p.14.1 % :RemoveReduceRisks(:EksoLegs :Checked) % p.14.2 % :MinimiseRisksOfFireExplosion(:EksoLegs :Checked) % p.14.3 % :AdjustmentCalibrationMaintenance(:EksoLegs :Checked) % p.14.4 % :SafeInteroperabilityCompatibility(:EksoLegs :Checked) % p.14.5 % :MeasurementMonitoringDisplayScale(:EksoLegs :Checked) % p.14.6 % :SafeDisposal(:EksoLegs :Checked) % p.14.7 % :SufficientAccuracyPrecisionStability(:EksoLegs :Checked) % p.15.1 % :MeasurementsExpressedInLegalUnits(:EksoLegs :Checked) % p.15.2 % :ReduceExposureToRadiationAndIncludeOperatingInstructions(:EksoLegs :Checked) % p.16.1 % :IntendedRadiation(:EksoLegs :Checked) % p.16.2 % :ReduceExposureToRadiationAndIncludeOperatingInstructions(:EksoLegs :Checked) % p.16.3 % :IonisingRadiation(:EksoLegs :Checked) % p.16.4 % :RepeatabilityReliabilityPerformanceOfSoftwares(:EksoLegs :Checked) % p.17.1 % :IncorporateSoftware(:EksoLegs :Checked) % p.17.2 % :SoftwareInCombinationWithMobileComputingPlatforms(:EksoLegs :Checked) % p.17.3 % :SecurityMinimumRequirements(:EksoLegs :Checked) % p.17.4 % :NonImplantableActive(:EksoLegs :Checked) % p.18.1 % :InternalPowerSupply(:EksoLegs :Checked) % p.18.2 % :ExternalPowerSupply(:EksoLegs :Checked) % p.18.3 % :AlarmSystemsForClinicalParameters(:EksoLegs :Checked) % p.18.4 % :ReduceRisksOfElectromagneticInterference(:EksoLegs :Checked) % p.18.5 % :IntrinsicImmunityToElectromagneticInterference(:EksoLegs :Checked) % p.18.6 % :RiskOfAccidentalElectricShocks(:EksoLegs :Checked) % p.18.7 % :ProtectAgainstUnauthorisedAccess(:EksoLegs :Checked) % p.18.8 % :RemoveOrMinimizeRisks(:EksoLegs :Checked) % p.19.1 % :CompatibilityReliability(:EksoLegs :Checked) % p.19.2 % :IdentifiableDeviceAndComponentsParts(:EksoLegs :Checked) % p.19.3 % :UnequivocallyIdentifiedByCode(:EksoLegs :Checked) % p.19.4 % :MechanicalRisks(:EksoLegs :Checked) % p.20.1 % :Vibration(:EksoLegs :Checked) % p.20.2 % :ReduceNoise(:EksoLegs :Checked) % p.20.3 % :ElectricityAndEnergySupplies(:EksoLegs :Checked) % p.20.4 % :ErrorsWhenFittingParts (:EksoLegs :Checked) % p.20.5 % :DangerousTemperatures (:EksoLegs :Checked) % p.20.6 % :ΜaintenanceOfTheAmountDelivered(:EksoLegs :Checked) % p.21.1 % :InadequaciesInTheAmountOfEnergy(:EksoLegs :Checked) % p.21.2 % :ControlsIndicatorsFunction(:EksoLegs :Checked) % p.21.3 % :AppropriateForSkillsAndAvailableMeansToLayPersons(:EksoLegs :Checked) % p.22.1 % :SafeUseReduceRisks(:EksoLegs :Checked) % p.22.2 % :VerificationAndFailure(:EksoLegs :Checked) % p.22.3 % :DefineGeneralTermsOfMD(:EksoLegs :Checked) % p.1.1.1 % :Lighting(:EksoLegs :Checked) % p.1.1.4 % :SeatingAsIntegralPart(:EksoLegs :Checked) % p.1.1.8 % :ControlDevices(:EksoLegs :Checked) % p.1.2.2 % :ErrorsOfFitting(:EksoLegs :Checked) % p.1.5.4 % :MachineryMaintenance(:EksoLegs :Checked) % p.1.6.1 % :AccessToOperatingPositionsAndServicingPoints(:EksoLegs :Checked) % p.1.6.2 % :IsolationOfEnergySources(:EksoLegs :Checked) % p.1.6.3 % :DefineMobilityTermsOfMD(:EksoLegs :Checked) % p.3.1.1 % :MeansOfAccess(:EksoLegs :Checked) % p.3.4.5 % :MarkingsForDevicesIn311(:EksoLegs :Checked) % p.3.6.2 % :DefineTermsOfMDForLiftingOperations(:EksoLegs :Checked) % p.4.1.1 % %Exoskeletons Facts (2nd) %Requirements of Rex Bionics:Class I :RexBionics#:MedicalDevice(:kind->:Active :use->:AllOtherAD :specificCase->:None) :RegisterWithTheECA(:RexBionics) :AppointingAnEAR(:RexBionics) :ConformityAssessment(:device->:RexBionics :technicalFile->:Yes :vigilanceSystem->:Yes :harmonizedStandards->:No) :Design(:RexBionics :Checked) % p.10.1 % :ContaminantsResidues(:RexBionics :Checked) % p.10.2 % :MedicinalProducts(:RexBionics :Checked) % p.10.3 % :IngressOfSubstances(:RexBionics :Checked) % p.10.5 % :SizePropertiesOfParticles (:RexBionics :Checked) % p.10.6 % :SubstancesDesignManufacture(:RexBionics :Checked) % p.10.4.1 % :EndocrineDisruptingCMPSubstances(:RexBionics :Checked) % p.10.4.2 % :GuidelinesOnPhthalates(:RexBionics :Checked) % p.10.4.3 % :GuidelinesOnOtherEndocrineDisruptingCMRSubstances(:RexBionics :Checked) % p.10.4.4 % :Labelling(:RexBionics :Checked) % p.10.4.5 % :ReduceRiskOfInfection(:RexBionics :Checked) % p.11.1 % :SafeCleaning(:RexBionics :Checked) % p.11.2 % :SecureMicrobialState(:RexBionics :Checked) % p.11.3 % :DeliveredInSterileState(:RexBionics :Checked) % p.11.4 % :DevicesLabelledSterile(:RexBionics :Checked) % p.11.5 % :IntendedToBeSterilised(:RexBionics :Checked) % p.11.6 % :PackagingSystemsForNonSterileDevices(:RexBionics :Checked) % p.11.7 % :DistinguishableLabelling(:RexBionics :Checked) % p.11.8 % :SubstancesMedicalProduct(:RexBionics :Checked) % p.12.1 % :SubstancesAbsorbed(:RexBionics :Checked) % p.12.2 % :DerivativesOfHumanOriginRequirements(:RexBionics :Checked) % p.13.1 % :DerivativesOfAnimalOriginRequirements(:RexBionics :Checked) % p.13.2 % :OtherBiologicalSubstancesOriginRequirements(:RexBionics :Checked) % p.13.3 % :SafeCombinationOfDevices(:RexBionics :Checked) % p.14.1 % :RemoveReduceRisks(:RexBionics :Checked) % p.14.2 % :MinimiseRisksOfFireExplosion(:RexBionics :Checked) % p.14.3 % :AdjustmentCalibrationMaintenance(:RexBionics :Checked) % p.14.4 % :SafeInteroperabilityCompatibility(:RexBionics :Checked) % p.14.5 % :MeasurementMonitoringDisplayScale(:RexBionics :Checked) % p.14.6 % :SafeDisposal(:RexBionics :Checked) % p.14.7 % :SufficientAccuracyPrecisionStability(:RexBionics :Checked) % p.15.1 % :MeasurementsExpressedInLegalUnits(:RexBionics :Checked) % p.15.2 % :ReduceExposureToRadiationAndIncludeOperatingInstructions(:RexBionics :Checked) % p.16.1 % :IntendedRadiation(:RexBionics :Checked) % p.16.2 % :ReduceExposureToRadiationAndIncludeOperatingInstructions(:RexBionics :Checked) % p.16.3 % :IonisingRadiation(:RexBionics :Checked) % p.16.4 % :RepeatabilityReliabilityPerformanceOfSoftwares(:RexBionics :Checked) % p.17.1 % :IncorporateSoftware(:RexBionics :Checked) % p.17.2 % :SoftwareInCombinationWithMobileComputingPlatforms(:RexBionics :Checked) % p.17.3 % :SecurityMinimumRequirements(:RexBionics :Checked) % p.17.4 % :NonImplantableActive(:RexBionics :Checked) % p.18.1 % :InternalPowerSupply(:RexBionics :Checked) % p.18.2 % :ExternalPowerSupply(:RexBionics :Checked) % p.18.3 % :AlarmSystemsForClinicalParameters(:RexBionics :Checked) % p.18.4 % :ReduceRisksOfElectromagneticInterference(:RexBionics :Checked) % p.18.5 % :IntrinsicImmunityToElectromagneticInterference(:RexBionics :Checked) % p.18.6 % :RiskOfAccidentalElectricShocks(:RexBionics :Checked) % p.18.7 % :ProtectAgainstUnauthorisedAccess(:RexBionics :Checked) % p.18.8 % :RemoveOrMinimizeRisks(:RexBionics :Checked) % p.19.1 % :CompatibilityReliability(:RexBionics :Checked) % p.19.2 % :IdentifiableDeviceAndComponentsParts(:RexBionics :Checked) % p.19.3 % :UnequivocallyIdentifiedByCode(:RexBionics :Checked) % p.19.4 % :MechanicalRisks(:RexBionics :Checked) % p.20.1 % :Vibration(:RexBionics :Checked) % p.20.2 % :ReduceNoise(:RexBionics :Checked) % p.20.3 % :ElectricityAndEnergySupplies(:RexBionics :Checked) % p.20.4 % :ErrorsWhenFittingParts (:RexBionics :Checked) % p.20.5 % :DangerousTemperatures (:RexBionics :Checked) % p.20.6 % :ΜaintenanceOfTheAmountDelivered(:RexBionics :Checked) % p.21.1 % :InadequaciesInTheAmountOfEnergy(:RexBionics :Checked) % p.21.2 % :ControlsIndicatorsFunction(:RexBionics :Checked) % p.21.3 % :AppropriateForSkillsAndAvailableMeansToLayPersons(:RexBionics :Checked) % p.22.1 % :SafeUseReduceRisks(:RexBionics :Checked) % p.22.2 % :VerificationAndFailure(:RexBionics :Checked) % p.22.3 % :DefineGeneralTermsOfMD(:RexBionics :Checked) % p.1.1.1 % :Lighting(:RexBionics :Checked) % p.1.1.4 % :SeatingAsIntegralPart(:RexBionics :Checked) % p.1.1.8 % :ControlDevices(:RexBionics :Checked) % p.1.2.2 % :ErrorsOfFitting(:RexBionics :Checked) % p.1.5.4 % :MachineryMaintenance(:RexBionics :Checked) % p.1.6.1 % :AccessToOperatingPositionsAndServicingPoints(:RexBionics :Checked) % p.1.6.2 % :IsolationOfEnergySources(:RexBionics :Checked) % p.1.6.3 % :DefineMobilityTermsOfMD(:RexBionics :Checked) % p.3.1.1 % :MeansOfAccess(:RexBionics :Checked) % p.3.4.5 % :MarkingsForDevicesIn311(:RexBionics :Checked) % p.3.6.2 % :DefineTermsOfMDForLiftingOperations(:RexBionics :Checked) % p.4.1.1 % ) )