关于EN-ISO-14971：2012标准及附录Z的解释

1NotifiedBodiesRecommendationGroupConsensusPaperfortheInterpretationandApplicationofAnnexesZinENISO14971:2012DraftV1.1fromtheNBRGWGRMJune,25th,2014!!NotyetadoptedfromNBRG!!2Content1.)Introduction......................................................................................322.)Terminology.......................................................................................33.)GeneralConsiderations.....................................................................44.)RecommendationsforIndustry..........................................................55.)RecommendationsfortheNBauditprocess......................................9Annex1:RecommendationsforStandardizationBodies.......................11Membersoftheworkgroup:MichaelBothe,MBA,VDETesting&CertificationInstitute,ChairMarinaBelonogova,St.JudeMedical(Eucomed)OliverBisazza,(COCIR)GertBos,BSICaterinaBrusasco,IBA(COCIR)UweHerrmann,RocheDiagnostics(EDMA)Hans-HeinerJunker,TÜVSüdPeterLinders,PhilipsHealthcare(COCIR)KatalinMate,(EDMA)PeterMeeremans,Alcon(Eucomed)GerdNeumann,SiemensHealthcare(COCIR)MartinPenver,LRQARydin,Carrie,TerumoBCTTheclaSterk,(Eucomed)MartinSchraag,PhilipsHealthcare,(ZVEI)AndreSchmitz,TÜVRheinlandLGAProductsGmbHSueSpencer,BSIJosvanVroonhoven,PhilipsHealthcare(COCIR)31.)IntroductionInOctober2010,theregularreviewofISO14971:2007whichisthebasisofENISO14971:2009wasclosedbyabroadmajorityofvotesconfirmingtheexistingstatusandthewide-spreadacceptanceofthisstandardinthemedicaldevicescommunity,includingcompetentauthorities.InNovember2010,theEuropeanCommissionraisedaformalobjectionagainsttheuseofseveralharmonizedstandards,includingENISO14971,followedbyanin-depthassessmentofthecoverageoftheEssentialRequirementsoftheMedicalDeviceDirectives(90/385/EEC,93/42/EECand98/79/EC)bythesestandards.Asaresultoftheseobjections,theAnnexesZtoENISO14971weremodified,resultinginENISO14971:2012.ThisamendmentoftheENISO14971standarddidnotmodifythenormativepartsofISO14971:20071.TheAnnexesZdescribetheextentofpresumptionofconformitythatcanbebasedonapplicationofthenormativerequirementsofISO14971alone.The“contentdeviations”,expressedintherevisedAnnexesZ,betweenISO14971:2007andtheMedicalDeviceDirectiveshavebeencommentedbymanyexpertsinthefieldofriskmanagementandresultedindiverginginterpretationsfromdifferentstakeholders(e.g.manufacturers,notifiedbodies,competentauthorities).ThisdocumenthasbeenpreparedasaNotifiedBodyConsensusPaperbyaworkinggroupheadedbytheNBRGViceChair,withrepresentativesfromseveralEuropeanNotifiedBodiesandindustryassociationsCOCIR,Eucomed,EDMAandZVEI.Thepaperaimstoprovideapracticalinterpretationofthese“contentdeviations”totheMedicalDeviceDirectivesandgiveguidanceastohowtoimplementtheriskmanagementrequirements.TheworkconsolidatespriorpublicationsofvarioussourcesandisintendedtofacilitatecommonunderstandingbetweenindustryandNotifiedBodies.2.)TerminologyThethreemedicaldevicesdirectives(93/42/EEC,90/385/EECand98/79/EC)referto“risk”and“safety”inageneralsense.Sincethetimeofwritingthesedirectivesabout20yearsago,theknowledgeofandexperienceinriskmanagementhaveevolvedconsiderably.ThisisreflectedbythesuccessivepublicationofEN1441in1994andISO14971-1in1998aswellasfirst(2000)andsecond(2007)editionsofISO14971whichallhavebeenrecognizedgloballyasthestateoftheartforriskmanagementatthemomentoftheirpublication.ThewordingoftheriskmanagementaspectsintheessentialrequirementsoftheMedicalDevicesDirectiveshasnotbeenmodifiedovertime,however.TheinternationalstandardISO14971:2007anditsEuropeanequivalentENISO14971:2012containspecificdefinedtermswithaclearandpreciselydescribed1ENISO14971:2012AnnexesZapplytomanufacturersplacingdevicesonthemarketintheEuropeanUnion;fortherestoftheworld,ISO14971:2007remainstheapplicablestandard.4meaning.SeeTable1foranoverviewofthemostrelevanttermsusedinthisdocument.NotethatthesedefinedtermsaremoreprecisethanthegeneraltermsasusedintheMedicalDeviceDirective.Forexample,“risk”inthemedicaldevicesdirectivescanbearthemeaningof“risk”,“hazard”or“hazardoussituation”dependingonthecontext.Thisdocumentiscompiledontheassumptionthat“risk”intheMedicalDeviceDirectivesisequivalentto“unacceptablerisk”inISO14971:2007.TermDefinitionClauseHarmPhysicalinjuryordamagetothehealthofpeople,ordamagetopropertyortheenvironment(a)2.2HazardPotentialsourceofharm(a)2.3HazardoussituationCircumstanceinwhichpeople,property,ortheenvironmentareexposedtooneormorehazard(s)(a)2.4RiskCombinationoftheprobabilityofoccurrenceofharmandtheseverityofthatharm(a)2.16Riskcontrolprocessinwhichdecisionsaremadeandmeasuresimplementedbywhichrisksarereducedto,ormaintainedwithinspecifiedlevels(a)2.19SafetyFreedomfromunacceptablerisk(a)2.24DisclosureofresidualrisksInformationintheaccompanyingdocumentsonrisksremainingafterallriskcontrolmeasureshavebeentaken(b)5.1InformationforsafetyInstructionsofwhatactionstotakeortoavoidinordertopreventahazardoussituationfromoccurring(b)5.2Table1:Relevanttermsfrom(a)ISO14971:2007and(b)ISO/TR24971:20133.)GeneralConsiderationsThisConsensusPaperintendstobridgethegapbetweentheinterpreta