基本信息
标准名称: | 冲模零件及其技术条件 冲模导向装置 B 型小导柱 |
中标分类: |
机械 >>
工艺装备 >>
模具 |
替代情况: | 替代原标准号GB 2861.5-1981;被JB/T 7645.2-2008代替 |
发布部门: | 模具标委会 |
发布日期: | 1994-12-09 |
实施日期: | 1995-06-01 |
首发日期: | 1900-01-01 |
作废日期: | 2008-07-01 |
归口单位: | 模具标委会 |
出版日期: | 1900-01-01 |
页数: | 2页 |
适用范围
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前言
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引用标准
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所属分类: 机械 工艺装备 模具
【英文标准名称】:Medicaldevicesutilizinganimaltissuesandtheirderivatives-Part1:Applicationofriskmanagement(ISO22442-1:2007);EnglishversionofDINENISO22442-1:2008-03
【原文标准名称】:医疗设备用动物组织及其衍生物.第1部分:风险管理的应用
【标准号】:DINENISO22442-1-2008
【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;定义;衍生物;保健;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;保险业管理;安全;规范(验收);组织;使用
【英文主题词】:Analysis;Animalproducts;Animals;Applications;Definition;Definitions;Derivatives;Healthprotection;Impurities;Medicalproducts;Medicalsciences;Methods;Pathogenicbacteria;Procedures;Production;Risk;Riskanalysis;Riskmanagement;Safety;Specification(approval);Tissue;Use
【摘要】:ThispartofISO22442appliestomedicaldevicesotherthaninvitrodiagnosticmedicaldevicesmanufacturedutilizingmaterialsofanimalorigin,whicharenon-viableorhavebeenrenderednon-viable.Itspecifies,inconjunctionwithISO14971,aproceduretoidentifythehazardsandhazardoussituationsassociatedwithsuchdevices,toestimateandevaluatetheresultingrisks,tocontroltheserisks,andtomonitortheeffectivenessofthatcontrol.Furthermore,itoutlinesthedecisionprocessfortheresidualriskacceptability,takingintoaccountthebalanceofresidualrisk,asdefinedinISO14971,andexpectedmedicalbenefitascomparedtoavailablealternatives.ThispartofISO22442isintendedtoproviderequirementsandguidanceonriskmanagementrelatedtothehazardstypicalofmedicaldevicesmanufacturedutilizinganimaltissuesorderivativessuchas:a)contaminationbybacteria,mouldsoryeasts;b)contaminationbyviruses;c)contaminationbyagentscausingTransmissibleSpongiformEncephalopathies(TSE);d)materialresponsibleforundesiredpyrogenic,immunologicalortoxicologicalreactions.Forparasitesandotherunclassifiedpathogenicentities,similarprinciplescanapply.ThispartofISO22442doesnotstipulatelevelsofacceptabilitywhich,becausetheyaredeterminedbyamultiplicityoffactors,cannotbesetdowninsuchanInternationalStandardexceptforsomeparticularderivativesmentionedinAnnexC.AnnexCstipulateslevelsofTSEriskacceptabilityfortallowderivatives,animalcharcoal,milkandmilkderivatives,woolderivativesandaminoacids.ThispartofISO22442doesnotspecifyaqualitymanagementsystemforthecontrolofallstagesofproductionofmedicaldevices.ThispartofISO22442doesnotcovertheutilizationofhumantissuesinmedicaldevices.NOTE1ItisnotarequirementofthispartofISO22442tohaveafullqualitymanagementsystemduringmanufacture.However,attentionisdrawntoInternationalStandardsforqualitymanagementsystems(seeISO13485)thatcontrolallstagesofproductionorreprocessingofmedicaldevices.NOTE2ForguidanceontheapplicationofthispartofISO22442seeAnnexA.
【中国标准分类号】:C37
【国际标准分类号】:11_100_99
【页数】:35P.;A4
【正文语种】:英语