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ANSI/AAMI/ISO 10993-12-2002 医疗器械的生物评价.第12部分:样品制备和标样

作者:标准资料网 时间:2024-05-12 23:11:32  浏览:9547   来源:标准资料网
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【英文标准名称】:BiologicalEvaluationofMedicalDevices-Part12:SamplePreparationandReferenceMaterials
【原文标准名称】:医疗器械的生物评价.第12部分:样品制备和标样
【标准号】:ANSI/AAMI/ISO10993-12-2002
【标准状态】:作废
【国别】:美国
【发布日期】:2002
【实施或试行日期】:
【发布单位】:美国国家标准学会(ANSI)
【起草单位】:ANSI
【标准类型】:()
【标准水平】:()
【中文主题词】:试验;医疗产品;试样制备
【英文主题词】:Biologicaltests;Definition;Definitions;Dentalequipment;Dentalinstruments;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Referencematerials;Specification(approval);Specimenpreparation;Surgicalequipment;Surgicalimplants;Surgicalinstruments;Testing
【摘要】:
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:
【正文语种】:英语


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【英文标准名称】:Clinicalthermometers-Performanceofcompactelectricalthermometers(non-predictiveandpredictive)withmaximumdevice
【原文标准名称】:临床体温计.最大装置的压缩式电气体温计(非预测式和预测式)的性能
【标准号】:BSEN12470-3-2000
【标准状态】:作废
【国别】:英国
【发布日期】:2000-05-15
【实施或试行日期】:2000-05-15
【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】:作标记;性能试验;使用说明;机械试验;环境试验;热试验;储存;医用电气设备;医疗器械;试验条件;性能;外观检查(试验);误差;临床检查器械;电气试验;温度计;温度测量仪表;体温计;体温计
【英文主题词】:Definition;Definitions;Electricalappliances;Electricalengineering;Extrapolation;Feverthermometers;Finemechanics;Fitnessforpurpose;Measurementduration;Medicalequipment;Medicalsciences;Specification(approval);Testing;Thermometers;Units
【摘要】:Doesnotapplytoclinicalelectricalthermometersforcontinuousmeasurementortothermometersintendedtomeasureskintemperature.
【中国标准分类号】:C31
【国际标准分类号】:17_200_20
【页数】:12P.;A4
【正文语种】:英语


【英文标准名称】:StandardPracticeforSamplingofGaseousUraniumHexafluoride
【原文标准名称】:气态六氟化铀采样的标准方法
【标准号】:ASTMC1703-2008
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【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】:C26.02
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:
【英文主题词】:bulksampling;nuclearmaterial;uraniumhexafluoride
【摘要】:Uraniumhexafluorideisnormallyproducedandhandledinlarge(typically1to14-ton)quantitiesandmust,therefore,becharacterizedbyreferencetorepresentativesamples(seeISO/DIS7195).ThesamplesareusedtodeterminecompliancewiththeapplicablecommercialspecificationsC996andC787.Thequantitiesinvolved,physicalproperties,chemicalreactivity,andhazardousnatureofUF6aresuchthatforrepresentativesampling,speciallydesignedequipmentmustbeusedandoperatedinaccordancewiththemostcarefullycontrolledandstringentprocedures.ThispracticecanbeusedbyUF6converters,enrichers,andfuelfabricatorstoreviewtheeffectivenessofexistingproceduresorasaguidetothedesignofequipmentandproceduresforfutureuse.TheintentionofthispracticeistoavoidliquidUF6samplingoncethecylinderhasbeenfilled.Forsafetyreasons,manipulationoflargequantitiesofliquidUF6shouldbeavoidedwhenpossible.Itisemphasizedthatthispracticeisnotmeanttoaddressconventionalornuclearcriticalitysafetyissues.1.1Thispracticecoversmethodsforwithdrawingrepresentativesample(s)ofuraniumhexafluoride(UF6)duringatransferoccurringinthegasphase.Suchtransferinthegasphasecantakeplacefromamothercylinder,forexampleinanautoclavetoareceivingcylinder.Itcanalsooccurduringthefillinginthegasphaseofacylinderduringacontinuousproductionprocess,forexamplecentrifugeenrichmentfacilityorthedistillationcolumninaconversionfacility.Suchsample(s)maybeusedfordeterminingcompliancewiththeapplicablecommercialspecification,forexampleSpecificationC996orSpecificationC787.1.2SinceUF6samplingistakenduringthefillingprocess,thispracticedoesnotaddressanyspecialadditionalarrangementsthatmaybeagreeduponbetweenthebuyerandthesellerwhenthesampledbulkmaterialisbeingaddedtoresiduesalreadypresentinacontainer(x201C;heelsrecyclex201D;).SucharrangementswillbebasedonQAproceduressuchastraceabilityofcylinderorigin(topreventforexamplecontaminationwithirradiatedmaterial).1.3Ifthereceivingcylinderispurgedafterfillingandsampling,specialverificationsmustbeperformedbytheusertoverifytherepresentativityofthesample(s).Itisthenexpectedthattheresultsfoundonvolatileimpuritieswithgasphasesamplingmaybeconservative.1.4Thispracticeisonlyapplicablewhenthetransferoccursinthegasphase.Whenthetransferisperformedintheliquidphase,PracticeC1052shouldapply.Thispracticedoesnotapplytogassamplingafterthecylinderhasbeenfilledsincethesampletakenwillnotberepresentativeofthecylinder.1.5Thescopeofthispracticedoesnotincludeprovisionsforpreventingcriticalityincidents.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:F46
【国际标准分类号】:27_120_30
【页数】:5P.;A4
【正文语种】:英语



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