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)》请在冰豆网上搜索。
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,inliaisonwithI