【英文标准名称】:Medicaldevicesutilizinganimaltissuesandtheirderivatives-Controlsonsourcing,collectionandhandling
【原文标准名称】:医疗设备用动物组织及其衍生物.来源控制,采集和处理
【标准号】:BSENISO22442-2-2008
【标准状态】:现行
【国别】:英国
【发布日期】:2008-02-29
【实施或试行日期】:2008-02-29
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【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;处理;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;开采
【英文主题词】:Analysis;Animalproducts;Animals;Applications;Checks;Collections;Definition;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_20
【页数】:28P.;A4
【正文语种】:英语


Product Code:SAE AS5969
Title:Fitting Assembly, Union, Axially Swaged, Hydraulic, 5080 psi
Issuing Committee:G-3, Aerospace Couplings, Fittings, Hose, Tubing Assemblies
Scope:Scope unavailable.