ISO116072201407

©ISO2014Packagingforterminallysterilizedmedicaldevices—Part2:Validationrequirementsforforming,sealingandassemblyprocessesAMENDMENT1Emballagesdesdispositifsmédicauxstérilisésaustadeterminal—Partie2:Exigencesdevalidationpourlesprocédésdeformage,scellageetassemblageAMENDEMENT1INTERNATIONALSTANDARDISO11607-2Firstedition2006-04-15ReferencenumberISO11607-2:2006/Amd.1:2014(E)AMENDMENT12014-07-15CopyrightInternationalOrganizationforStandardizationProvidedbyIHSunderlicensewithISOLicensee=UniversityofAlberta/5966844001,User=ahmadi,rozitaNotforResale,01/26/201509:54:30MSTNoreproductionornetworkingpermittedwithoutlicensefromIHS--```,`,`,,``,,````,,,,,``,`,,-`-`,,`,,`,`,,`---ISO11607-2:2006/Amd.1:2014(E)ii©ISO2014–AllrightsreservedCOPYRIGHTPROTECTEDDOCUMENT©ISO2014Allrightsreserved.Unlessotherwisespecified,nopartofthispublicationmaybereproducedorutilizedotherwiseinanyformorbyanymeans,electronicormechanical,includingphotocopying,orpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbeloworISO’smemberbodyinthecountryoftherequester.ISOcopyrightofficeCasepostale56•[e-mail]=UniversityofAlberta/5966844001,User=ahmadi,rozitaNotforResale,01/26/201509:54:30MSTNoreproductionornetworkingpermittedwithoutlicensefromIHS--```,`,`,,``,,````,,,,,``,`,,-`-`,,`,,`,`,,`---ISO11607-2:2006/Amd.1:2014(E)ForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.TheproceduresusedtodevelopthisdocumentandthoseintendedforitsfurthermaintenancearedescribedintheISO/IECDirectives,Part1.InparticularthedifferentapprovalcriterianeededforthedifferenttypesofISOdocumentsshouldbenoted.ThisdocumentwasdraftedinaccordancewiththeeditorialrulesoftheISO/IECDirectives,Part2(see).Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.DetailsofanypatentrightsidentifiedduringthedevelopmentofthedocumentwillbeintheIntroductionand/orontheISOlistofpatentdeclarationsreceived(see).Anytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddoesnotconstituteanendorsement.ForanexplanationonthemeaningofISOspecifictermsandexpressionsrelatedtoconformityassessment,aswellasinformationaboutISO’sadherencetotheWTOprinciplesintheTechnicalBarrierstoTrade(TBT)seethefollowingURL:Foreword-Supplementaryinformation.ThecommitteeresponsibleforthisdocumentisISO/TC198,Sterilizationofhealthcareproducts.ISO11607consistsofthefollowingparts,underthegeneraltitlePackagingforterminallysterilizedmedicaldevices:—Part1:Requirementsformaterials,sterilebarriersystemsandpackagingsystems—Part2:Validationrequirementsforforming,sealingandassemblyprocesses©ISO2014–AllrightsreservediiiCopyrightInternationalOrganizationforStandardizationProvidedbyIHSunderlicensewithISOLicensee=UniversityofAlberta/5966844001,User=ahmadi,rozitaNotforResale,01/26/201509:54:30MSTNoreproductionornetworkingpermittedwithoutlicensefromIHS--```,`,`,,``,,````,,,,,``,`,,-`-`,,`,,`,`,,`---CopyrightInternationalOrganizationforStandardizationProvidedbyIHSunderlicensewithISOLicensee=UniversityofAlberta/5966844001,User=ahmadi,rozitaNotforResale,01/26/201509:54:30MSTNoreproductionornetworkingpermittedwithoutlicensefromIHS--```,`,`,,``,,````,,,,,``,`,,-`-`,,`,,`,`,,`---Packagingforterminallysterilizedmedicaldevices—Part2:Validationrequirementsforforming,sealingandassemblyprocessesAMENDMENT1Page2,definition3.9Updatethedateofpublicationofthereferencetoread‘[ISO9000:2005]’.Page4,4.1.2Replace‘Itisnotnecessary’with‘Itshallnotbenecessary’.Page4,4.1.3Replace‘Healthcarefacilitiesmayuse’with‘Healthcarefacilitiesshallconsiderusing’.Page7,5.3.2b),NoteReplace‘SeeEN868-5:1999,4.3.2’with‘SeeEN868-5:2009,4.3.2’Page11,BibliographyReplacereference[2]withISO2859-1:1999(includingCorrigendum1:2001+Amendment1:2011),Samplingproceduresforinspectionbyattributes—Part1:Samplingschemesindexedbyacceptancequalitylimit(AQL)forlot-by-lotinspectionReplacereference[3]withISO9001:2008(includingCorrigendum1:2009),Qualitymanagementsystems—RequirementsReplacereference[5]withISO13485:2003(includingCorrigendum1:2009),Medicaldevices—Qualitymanagementsystems—RequirementsforregulatorypurposesReplacereference[6]withISO9000:2005,Qualitymanagementsystems—FundamentalsandvocabularyReplacereference[7]wit