ISO 12891-1-1998 外科植入物的分析和取出.第1部分:取出和处理
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【英文标准名称】:Retrievalandanalysisofsurgicalimplants-Part1:Retrievalandhandling
【原文标准名称】:外科植入物的分析和取出.第1部分:取出和处理
【标准号】:ISO12891-1-1998
【标准状态】:作废
【国别】:国际
【发布日期】:1998-11
【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/TC150
【标准类型】:()
【标准水平】:()
【中文主题词】:定义;生物测定;取出;处理;医疗产品;外科植入物;医疗技术学
【英文主题词】:definitions;bioassay;taking-out;handling;medicalproducts;surgicalimplants;medicaltechnology
【摘要】:ThisInternationalStandard,withitsseveralparts,givesrecommendationsfortheretrieval,handlingandanalysisofsurgicalimplants,medicalimplantsandassociatedspecimenswhichareremovedfrompatientsroutinely,duringrevisionsurgery,orpostmortem.Theaimistoprovideguidanceinpreventingdamagetotheassociatedspecimenswhichcouldobscureinvestigationresults,andingatheringdataatthepropertimeandcircumstancetovalidatethestudy.ISO12891-1isintendedtobetheoverallguidancedocumentfortheretrievalandhandlingofsurgicalimplants,ensuringtheirsafeandproperretrieval,sterilizationandhandling.IntheassociatedpartsofthisInternationalStandard,protocolsforthecollectionofdataandexaminationsareprovidedforspecifictypesofmaterialinrelationtotheirtypicalapplications.Forparticularinvestigationpro-grammes,additional,morespecific,protocolsmayberequired.Ifspecialanalyticaltechniquesareemployed,theappropriatehandlingproceduresneedtobespecified.ThispartofISO12891shouldbeappliedinaccordancewithnationalregulationsorlegalrequirementsregardingthehandlingandanalysisofretrievedimplantsandtissues.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:27P.;A4
【正文语种】:英语
【原文标准名称】:外科植入物的分析和取出.第1部分:取出和处理
【标准号】:ISO12891-1-1998
【标准状态】:作废
【国别】:国际
【发布日期】:1998-11
【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/TC150
【标准类型】:()
【标准水平】:()
【中文主题词】:定义;生物测定;取出;处理;医疗产品;外科植入物;医疗技术学
【英文主题词】:definitions;bioassay;taking-out;handling;medicalproducts;surgicalimplants;medicaltechnology
【摘要】:ThisInternationalStandard,withitsseveralparts,givesrecommendationsfortheretrieval,handlingandanalysisofsurgicalimplants,medicalimplantsandassociatedspecimenswhichareremovedfrompatientsroutinely,duringrevisionsurgery,orpostmortem.Theaimistoprovideguidanceinpreventingdamagetotheassociatedspecimenswhichcouldobscureinvestigationresults,andingatheringdataatthepropertimeandcircumstancetovalidatethestudy.ISO12891-1isintendedtobetheoverallguidancedocumentfortheretrievalandhandlingofsurgicalimplants,ensuringtheirsafeandproperretrieval,sterilizationandhandling.IntheassociatedpartsofthisInternationalStandard,protocolsforthecollectionofdataandexaminationsareprovidedforspecifictypesofmaterialinrelationtotheirtypicalapplications.Forparticularinvestigationpro-grammes,additional,morespecific,protocolsmayberequired.Ifspecialanalyticaltechniquesareemployed,theappropriatehandlingproceduresneedtobespecified.ThispartofISO12891shouldbeappliedinaccordancewithnationalregulationsorlegalrequirementsregardingthehandlingandanalysisofretrievedimplantsandtissues.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:27P.;A4
【正文语种】:英语
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