【英文标准名称】:Biologicalevaluationofmedicaldevices-Part2:Animalwelfarerequirements(ISO10993-2:2006);EnglishversionofDINENISO10993-2:2006-10
【原文标准名称】:医疗器械的生物评定.第2部分:动物饲养照料要求(ISO10993-2-2006)
【标准号】:DINENISO10993-2-2006
【标准状态】:现行
【国别】:德国
【发布日期】:2006-10
【实施或试行日期】:
【发布单位】:德国标准化学会(DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:畜牧业;动物保护;生物测定;生物试验;兼容性试验;定义;文献工作;试验动物;精密机械;人用的药物;外科植入物;实验室动物;医疗设备;医疗产品;医学科学;人员;药剂学;产品试验;研究;规范(验收);外科设备;试验;证实
【英文主题词】:
【摘要】:ThispartofISO10993isaimedatthosewhocommission,designandperformtestsorevaluatedatafromanimaltestsundertakentoassessthebiocompatibilityofmaterialsintendedforuseinmedicaldevices,orthatofthemedicaldevicesthemselves.Itspecifiestheminimumrequirementstobesatisfiedtoensureanddemonstratethatproperprovisionhasbeenmadeforthewelfareofanimalsusedinanimalteststoassessthebiocompatibilityofmaterialsusedinmedicaldevices.Italsomakesrecommendationsandoffersguidanceintendedtofacilitatefuturefurtherreductionsintheoverallnumberofanimalsused,refinementoftestmethodstoreduceoreliminatepainordistressinanimals,andthereplacementofanimaltestsbyotherscientificallyvalidmeansnotrequiringanimaltests.Itappliestotestsperformedonlivingvertebrateanimals,otherthanman,toestablishthebiocompatibilityofmaterialsormedicaldevices.Itdoesnotapplytotestsperformedoninvertebrateanimalsandotherlowerforms;nor(otherthanwithrespecttoprovisionsrelatingtospecies,source,healthstatus,andcareandaccommodation)doesitapplytotestingperformedonisolatedtissuesandorganstakenfromvertebrateanimalsthathavebeeneuthanized.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:18P.;A4
【正文语种】:英语