EN ISO 15792-3-2011 焊接消耗品.试验方法.第3部分:角焊中焊接消耗品的填位能力和根部焊透层的分类试验(ISO15792-3-2011).德文版本ENISO15792-3-2011
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【英文标准名称】:Weldingconsumables-Testmethods-Part3:Classificationtestingofpositionalcapacityandrootpenetrationofweldingconsumablesinafilletweld(ISO15792-3:2011);GermanversionENISO15792-3:2011
【原文标准名称】:焊接消耗品.试验方法.第3部分:角焊中焊接消耗品的填位能力和根部焊透层的分类试验(ISO15792-3-2011).德文版本ENISO15792-3-2011
【标准号】:ENISO15792-3-2011
【标准状态】:现行
【国别】:
【发布日期】:2011-08
【实施或试行日期】:
【发布单位】:欧洲标准学会(EN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:全焊金属;电弧焊接;电极;焊接填料;角焊;机械测试;性能试验;生产;试样;抽样方法;试样制备;钢;样品;试验;焊缝金属样品;焊接接头;焊接;焊接工程;焊接填充金属;钢丝
【英文主题词】:All-weldmetals;Arcwelding;Electrodes;Filletwelding;Filletwelds;Mechanicaltesting;Performancetests;Production;Samples;Samplingmethods;Specimenpreparation;Steels;Testspecimens;Testing;Weldmetalsample;Weldedjoints;Welding;Weldingengineering;Weldingfillermetals;Wires
【摘要】:
【中国标准分类号】:J33
【国际标准分类号】:25_160_20
【页数】:11P.;A4
【正文语种】:英语
【英文标准名称】:Medicaldevicesutilizinganimaltissuesandtheirderivatives-Applicationofriskmanagement
【原文标准名称】:医疗设备用动物组织及其衍生物.风险管理的应用
【标准号】:BSENISO22442-1-2008
【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;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;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_20
【页数】:38P.;A4
【正文语种】:英语
