ISO 5910-2018.docx

ISO 5910-2018.docx

《ISO 5910-2018.docx》由会员分享，可在线阅读，更多相关《ISO 5910-2018.docx（129页珍藏版）》请在冰点文库上搜索。

INTERNATIONAL

STANDARD

ISO

5910

Firstedition

2018-06

Cardiovascularimplantsandextracorporealsystems—Cardiacvalverepairdevices

Implantscardiovasculairesetcircuitsextra-corporels—Dispositifsdereparationdevalvescardiaques

ReferencenumberISO5910:

2018（E）

COPYRIGHTPROTECTEDDOCUMENT

©ISO2018

Allrightsreserved.Unlessotherwisespecified,orrequiredinthecontextofitsimplementation,nopartofthispublicationmaybereproducedorutilizedotherwiseinanyformorbyanymeans,electronicormechanical,includingphotocopying,orpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbeloworISO’smemberbodyinthecountryoftherequester.

ISOcopyrightoffice

CP401•Ch.deBlandonnet8

CH-1214Vernier,Geneva

Phone:

+41227490111

Fax:

+41227490947

Email:

copyright@iso.org

Website:

www.iso.org

PublishedinSwitzerland

Contents Page

Foreword v

Introduction vi

1 Scope . 1

2 Normativereferences 1

3 Termsanddefinitions 2

4 Abbreviations 11

5 Fundamentalrequirements 12

5.1 General 12

5.2 Riskmanagement 12

6 Devicedescription 13

6.1 Intendeduse/Indicationforuse 13

6.2 Designinputs 13

6.2.1 General 13

6.2.2 Operationalspecifications 13

6.2.3 Functional,performanceandsafetyrequirements 14

6.2.4 Usability 15

6.2.5 Packaging,labelling,andsterilization 16

6.3 Designoutputs 16

6.4 Designtransfer（manufacturingverification/validation） 16

7 Designverificationtestingandanalysis/Designvalidation 16

7.1 Generalrequirements 16

7.2 Invitroassessment 16

7.2.1 General 16

7.2.2 Testarticles,sampleselection,testconditionsandreportingrequirements.. 17

7.2.3 Devicematerialpropertyassessment 18

7.2.4 Functionalperformanceassessment 19

7.2.5 Devicestructuralperformanceassessment 19

7.2.6 Devicecorrosionassessment 20

7.2.7 Deliverysystemdesignevaluationrequirements 20

7.2.8 Visibility 20

7.2.9 Simulateduseassessment 20

7.2.10 Humanfactors/Usabilityassessment 21

7.2.11 DeviceMRIsafety 21

7.2.12 Designspecifictesting 21

7.3 Preclinicalinvivoevaluation 21

7.3.1 General 21

7.3.2 Overallrequirements... .... .... 21

7.3.3 Methods 23

7.3.4 Testreport 24

7.4 Clinical Investigations 24

7.4.1 General 24

7.4.2 Studyconsiderations 25

7.4.3 Studyendpoints 28

7.4.4 Ethicalconsiderations. 28

7.4.5 Distributionofsubjectsandinvestigators 28

7.4.6 Statisticalconsiderationsincludingsample sizeandduration 29

7.4.7 Patientselectioncriteria .... ... 31

7.4.8 Clinicaldatarequirements 31

7.4.9 Clinicalinvestigationanalysisandreporting 34

7.4.10 Post-marketclinicalfollow-up 34

AnnexA（informative）Rationalefortheprovisionsofthisdocument 36

AnnexB（informative）Examplesofheartvalverepairdevicesanddeliverysystems 39

AnnexC（normative）Packaging 45

AnnexD（normative）Productlabels,instructionsforuse,andtraining 46

AnnexE（normative）Sterilization, 49

AnnexF（informative）Heartvalverepairsystemcharacteristics 50

AnnexG（informative）Heartvalverepairsystemhazards,associatedfailuremodesandevaluationmethods 52

AnnexH（informative）Invitrotestguidelinesforpaediatricdevices 63

AnnexI（informative）Examplesanddefinitionsofsomephysicalandmaterialpropertiesofheartvalverepairdevicecomponents 65

AnnexJ（informative）Examplesofstandardsapplicabletotestingofmaterialsandcomponentsofheartvalverepairdevices 79

AnnexK（informative）Considerationsfordevicematerialpropertiesundergoingalterationspostimplantation 85

AnnexL（informative）Corrosionassessment 86

AnnexM（informative）Guidelinesforinvitroevaluationoffunctionalperformanceoftherepair 89

AnnexN（informative）Durabilitytesting 95

Annex0（informative）Fatigueassessment 97

AnnexP（informative）Preclinicalinvivoevaluation 103

AnnexQ（normative）Adverseeventclassificationduringclinicalinvestigation. 106

AnnexR（informative）Imagingprotocol 112

AnnexS（informative）Clinicalinvestigationendpointsforvalverepairdevices:

Suggestionsforendpointsandtheirtiming 116

AnnexT（informative）Additionaldevicedesignevaluationrequirements 120

AnnexU（informative）Guidelinesfordeliverysystemdesignevaluation 122

Bibliography 124

Foreword

ISO（theInternationalOrganizationforStandardization）isaworldwidefederationofnationalstandardsbodies（ISOmemberbodies）.TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission（IEC）onallmattersofelectrotechnicalstandardization.

TheproceduresusedtodevelopthisdocumentandthoseintendedforitsfurthermaintenancearedescribedintheISO/IECDirectives,Part1.InparticularthedifferentapprovalcriterianeededforthedifferenttypesofISOdocumentsshouldbenoted.ThisdocumentwasdraftedinaccordancewiththeeditorialrulesoftheISO/IECDirectives,Part2（seewww.iso.org/directives）.

Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.DetailsofanypatentrightsidentifiedduringthedevelopmentofthedocumentwillbeintheIntroductionand/orontheISOlistofpatentdeclarationsreceived（seewww.iso.org/patents）.

Anytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddoesnotconstituteanendorsement.

Foranexplanationonthevoluntarynatureofstandards,themeaningofISOspecifictermsandexpressionsrelatedtoconformityassessment,aswellasinformationaboutISO'sadherencetotheWorldTradeOrganization（WTO）principlesintheTechnicalBarrierstoTrade（TBT）seethefollowingURL:

www.iso.org/iso/foreword.html.

ThisdocumentwaspreparedbyISO/TC150,Implantsforsurgery,SubcommitteeSC2,Cardiovascularimplantsandextracorporealsystems.

Introduction

Noheartvalverepairdeviceisideal.Therefore,agroupofengineers,scientists,andclinicians,expertswellawareoftheproblemsassociatedwithheartvalverepairdevicesandtheirdevelopment,haspreparedthisdocument.Thisdocumentspecifiestypesoftests,testmethods,andrequirementsfortestapparatus.Itrequiresdocumentationoftestmethodsandresults.Thisdocumentdealswiththoseareasthatwillensureadequatemitigationofdevice-associatedrisksforpatientsandotherusersofthedevice,facilitatequalityassurance,aidtheheartteaminchoosingaheartvalverepairdevice,andensurethatthedevicewillbeprovidedinaconvenientandusableform.Thisdocumentemphasizestheneedtospecifyandreporttypesofinvitrotesting,preclinicalinvivoandclinicalevaluations.Itdescribesthelabelsandpackagingofthedevice.Suchaprocessinvolvinginvitro,preclinicalinvivoandclinicalevaluationsisintendedtoclarifytherequirementspriortomarketreleaseandtoenablepromptidentificationandmanagementofanysubsequentproblems.

Withregardtoinvitrotestingandreporting,apartfrombasicmaterialtestingformechanical,physical,chemicalandbiocompatibilitycharacteristics,thisdocumentalsocoversimportantfunctionalanddurabilitycharacteristicsofheartvalverepairdevicesandtheiraccessories.Thisdocumentdoesnotspecifyexacttestmethodsforfunctionalanddurabilitytestingbutitoffersguidelinesforthetestapparatus.

Thisdocumentshouldberevised,updated,andamendedasknowledgeandtechniquesinheartvalverepairdevicetechnologyimprove.

Cardiovascularimplantsandextracorporealsystems—Cardiacvalverepairdevices

1 Scope

1.1 Thisdocumentappliestoallheartvalverepairsystemsthathaveanintendedusetorepairand/orimprovethefunctionofnativehumanheartvalvesbyactingeitheronthevalveapparatusorontheadjacentanatomy（e.g.ventricle,coronarysinus）.

1.2 Thisdocumentoutlinesanapproachforverifying/validatingthedesignandmanufactureofaheartvalverepairsystemthroughriskmanagement.Theselectionofappropriateverification/validationtestsandmethodsarederivedfromtheriskassessment.Thetestsincludeassessmentsofthephysical,chemical,biological,andmechanicalpropertiesofcomponentsandmaterialsofheartvalverepairsystems.Thetestsalsoincludepreclinicalinvivoevaluationandclinicalinvestigationofthefinishedheartvalverepairsystemtoassessthesafetyandeffectivenessoftheheartvalverepairsystem.

NOTEForthepurposesofthisdocument,effectivenessendpointincludesclinicalperformanceandbenefits.

1.3 Thisdocumentdefinesoperationalconditionsandperformancerequirementsforheartvalverepairsystemswhereadequatescientificand/orclinicalevidenceexistsfortheirjustification.

1.4 ThisdocumentexcludesCardiacResynchronizationTherapy（CRT）devices,paravalvularleakageclosuredevices,systemsthatdonotleaveanimplantinplace（e.g.ablation,radiofrequencyannuloplasty）,apicalconduitsanddeviceswithcomponentscontainingviablecells.ThisStandardalsoexcludesmaterialsnotintendedforrepairingand/orimprovingthefunctionofhumanheartvalvesaccordingtoitsintendeduse（e.g.patchmaterialandsuturesusedingeneralsurgicalpractice）.

NOTEArationalefortheprovisionsofthisdocumentis