【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
基本信息
标准名称: | 塔式起重机钢结构制造与检验 |
英文名称: | Steel structure manufacturing and testing for tower cranes |
中标分类: |
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ICS分类: |
材料储运设备 >>
起重设备 >>
起重机
|
发布部门: | 中华人民共和国建设部 |
发布日期: | 1999-05-10 |
实施日期: | 1999-12-01 |
首发日期: | 1900-01-01 |
作废日期: | 1900-01-01 |
提出单位: | 建设部标准定额研究所 |
归口单位: | 建设部机械设备与车辆标准技术归口单位建设部北京建筑机械综合研究所 |
起草单位: | 四川建筑机械厂 |
起草人: | 杨春媛、孙德忻、程昌永 |
出版社: | 中国标准出版社 |
出版日期: | 2004-04-22 |
页数: | 22页 |
书号: | 155066.2-12779 |
适用范围
本标准规定了塔式起重机钢结构件在制造过程中的技术要求。本标准适用于塔机钢结构件的制造与检验。其他建筑机械的钢结构件也可参照执行。
前言
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引用标准
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所属分类: 材料储运设备 起重设备 起重机