【英文标准名称】:Medicaldevicesutilizinganimaltissuesandtheirderivatives-Part1:Applicationofriskmanagement
【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】:ISO22442-1-2007
【标准状态】:现行
【国别】:国际
【发布日期】:2007-12-01
【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】: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;风险管理;安全;规范(验收);组织;使用
【英文主题词】:Acceptance;Accessories;Analysis;Animal;Animalproducts;Animals;Applications;Biologicalhazards;Calibration;Cloth;Computersoftware;Consumption;Contact;Contexts;Definitions;Derivatives;Disposables;Energy;Environment;Environmentaleffects;Establishment;Examination(qualityassurance);Fabrics;Handling;Healthprotection;Impurities;Information;Interaction;Life(durability);Loss;Maintenance;Materials;Measurement;Medicaldevices;Medicalproducts;Medicalsciences;Medicaments;Methods;Organisms;Pathogenicbacteria;People;Procedures;Production;Products;Properties;Qualitative;Quantitative;Reuse;Risk;Riskanalysis;Riskmanagement;Safety;Specification(approval);Sterile;Sterilization(birthcontrol);Storagetime;Tissue;Use;Viruses
【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_20
【页数】:34P.;A4
【正文语种】:英语