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【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


【英文标准名称】:StandardGuideforApplicationofBasicStatisticalMethodstoWeatheringTests
【原文标准名称】:自然老化试验基本统计方法应用的标准指南
【标准号】:ASTMG169-2001(2008)e1
【标准状态】:现行
【国别】:美国
【发布日期】:2001
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:G03.93
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:experimentaldesign;statistics;weathering;Application;Statisticalmethods;Weathering
【摘要】:Thecorrectuseofstatisticsaspartofaweatheringprogramcangreatlyincreasetheusefulnessofresults.Abasicunderstandingofstatisticsisrequiredforthestudyofweatheringperformancedata.Properexperimentaldesignandstatisticalanalysisstronglyenhancesdecision-makingability.Inweathering,therearemanyuncertaintiesbroughtaboutbyexposurevariability,methodprecisionandbias,measurementerror,andmaterialvariability.Statisticalanalysisisusedtohelpdecidewhichproductsarebetter,whichtestmethodsaremostappropriatetogaugeenduseperformance,andhowreliabletheresultsare.Resultsfromweatheringexposurescanshowdifferencesbetweenproductsorbetweenrepeatedtesting.Theseresultsmayshowdifferenceswhicharenotstatisticallysignificant.Thecorrectuseofstatisticsonweatheringdatacanincreasetheprobabilitythatvalidconclusionsarederived.1.1Thisguidecoverselementarystatisticalmethodsfortheanalysisofdatacommontoweatheringexperiments.Themethodsarefordecisionmaking,inwhichtheexperimentsaredesignedtotestahypothesisonasingleresponsevariable.Themethodsworkforeithernaturalorlaboratoryweathering.1.2Onlybasicstatisticalmethodsarepresented.Therearemanyadditionalmethodswhichmayormaynotbeapplicabletoweatheringteststhatarenotcoveredinthisguide.1.3Thisguideisnotintendedtobeamanualonstatistics,andthereforesomegeneralknowledgeofbasicandintermediatestatisticsisnecessary.Thetextbooksreferencedattheendofthisguideareusefulforbasictraining.1.4Thisguidedoesnotprovidearigoroustreatmentofthematerial.Itisintendedtobeareferencetoolfortheapplicationofpracticalstatisticalmethodstoreal-worldproblemsthatariseinthefieldofdurabilityandweathering.Thefocusisontheinterpretationofresults.Manybookshavebeenwrittenonintroductorystatisticalconceptsandstatisticalformulasandtables.Thereaderisreferredtotheseformoredetailedinformation.Examplesofthevariousmethodsareincluded.Theexamplesshowtypicalweatheringdataforillustrativepurposes,andarenotintendedtoberepresentativeofspecificmaterialsorexposures.^REFERENCE:ASTMStandards:E41TerminologyRelatingToConditioningG113TerminologyRelatingtoNaturalandArtificialWeatheringTestsofNonmetallicMaterialsG141GuideforAddressingVariabilityinExposureTestingofNonmetallicMaterialsISODocuments:ISO3534/1VocabularyandSymbolsx2013;Part1:ProbabilityandGeneralStatisticalTermsISO3534/3VocabularyandSymbolsx2013;Part3:DesignofExperiments^KEYWORDS:experimentaldesign;statistics;weathering^INDEXTERMS:Application;Statisticalmethods;Weathering^STATUS:DnCnSnNnMn^APPROVAL:20080601^PAGES:11^COMMITTEE:G03^SUBCOMMITTEE:9300^BOS:14.04^ORGINFO:none^ACTION:REAPPR_EDITS^MISCPUB:^PDESIG:G0169^PYEAR:2001R2008E01^CLASS:Guide
【中国标准分类号】:A41
【国际标准分类号】:19_040
【页数】:11P.;A4
【正文语种】:英语