【英文标准名称】:Springleavesfasteningbolts.
【原文标准名称】:弹簧片固定螺栓
【标准号】:NFR47-203-1952
【标准状态】:作废
【国别】:法国
【发布日期】:1952-04-01
【实施或试行日期】:
【发布单位】:法国标准化协会(AFNOR)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:
【摘要】:
【中国标准分类号】:T70
【国际标准分类号】:21_160;43_040_60;43_040_50
【页数】:1P;A4
【正文语种】:其他


【英文标准名称】:Medicaldevicesutilizinganimaltissuesandtheirderivatives-Part2:Controlsonsourcing,collectionandhandling(ISO22442-2:2007);EnglishversionofDINENISO22442-2:2008-03
【原文标准名称】:医疗设备用动物组织及其衍生物.第2部分:来源、采集和处理控制(ISO22442-2-2007)
【标准号】:DINENISO22442-2-2008
【标准状态】:现行
【国别】:德国
【发布日期】:2008-03
【实施或试行日期】:
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:分析;动物产品;动物;应用;检验;收集;定义;衍生物;搬运;杂质;医疗产品;医学科学;方法;病原细菌;规程;生产;危险;危险分析;选择;规范(验收);储存;组织;运输;使用;回采(煤)
【英文主题词】:Analysis;Animalproducts;Animals;Applications;Checks;Collections;Definition;Definitions;Derivatives;Handling;Impurities;Medicalproducts;Medicalsciences;Methods;Pathogenicbacteria;Procedures;Production;Risk;Riskanalysis;Selection;Specification(approval);Storage;Tissue;Transport;Use;Winning
【摘要】:ThispartofISO22442specifiesrequirementsforcontrolsonthesourcing,collectionandhandling(whichincludesstorageandtransport)ofanimalsandtissuesforthemanufactureofmedicaldevicesutilizingmaterialsofanimalorigin,otherthaninvitrodiagnosticmedicaldevices.ItapplieswhererequiredbytheriskmanagementprocessasdescribedinISO22442-1.NOTE1Selectivesourcingisconsideredtobeespeciallyimportantfortransmissiblespongiformencephalopathy(TSE)riskmanagement.NOTE2ManufacturersshouldrefertoISO22442-3forinformationonthevalidationoftheeliminationand/orinactivationofvirusesandTSEagents.ThispartofISO22442doesnotcovertheutilizationofhumantissuesinmedicaldevices.ThispartofISO22442doesnotspecifyaqualitymanagementsystemforthecontrolofallstagesofproductionofmedicaldevices.NOTE3ItisnotarequirementofthispartofISO22442tohaveafullqualitymanagementsystemduringmanufacture,butitdoesspecifyrequirementsforsomeoftheelementsofaqualitymanagementsystem.Attentionisdrawntothestandardsforqualitymanagementsystems(seeISO13485)thatcontrolallstagesofproductionorreprocessingofmedicaldevices.ThequalitymanagementsystemelementsthatarerequiredbythispartofISO22442canformapartofaqualitymanagementsystemconformingtoISO13485.NOTE4AgeneralprinciplefortheapplicationofISO22442isthatitisadvisabletogivedueconsiderationtotherequirementsandrecommendationscontainedinallthreepartsofthestandard.
【中国标准分类号】:C37
【国际标准分类号】:11_100_99
【页数】:23P.;A4
【正文语种】:英语