ISO 10993-2-2006 医疗器械的生物学评价.第2部分:动物保护要求
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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part2:Animalwelfarerequirements
【原文标准名称】:医疗器械的生物学评价.第2部分:动物保护要求
【标准号】:ISO10993-2-2006
【标准状态】:现行
【国别】:国际
【发布日期】:2006-07
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC194
【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;实验动物;精密机械;人用的药物;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;外科植入物;试验;证实
【英文主题词】:Animalhusbandry;Animalprotection;Bioassay;Biologicaltests;Compatibilitytests;Definitions;Documentations;Experimentalanimals;Finemechanics;Humanmedicine;Implants(surgical);Laboratoryanimals;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Personnel;Pharmacy;Producttests;Research;Specification(approval);Surgicalequipment;Surgicalimplants;Validation
【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】:13P;A4
【正文语种】:英语
【原文标准名称】:医疗器械的生物学评价.第2部分:动物保护要求
【标准号】:ISO10993-2-2006
【标准状态】:现行
【国别】:国际
【发布日期】:2006-07
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC194
【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;实验动物;精密机械;人用的药物;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;外科植入物;试验;证实
【英文主题词】:Animalhusbandry;Animalprotection;Bioassay;Biologicaltests;Compatibilitytests;Definitions;Documentations;Experimentalanimals;Finemechanics;Humanmedicine;Implants(surgical);Laboratoryanimals;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Personnel;Pharmacy;Producttests;Research;Specification(approval);Surgicalequipment;Surgicalimplants;Validation
【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】:13P;A4
【正文语种】:英语
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