NF S97-601-1-2008 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
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来源:标准资料网
【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】:NFS97-601-1-2008
【标准状态】:现行
【国别】:法国
【发布日期】:2008-03-01
【实施或试行日期】:2008-03-06
【发布单位】:法国标准化协会(AFNOR)
【起草单位】:
【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;诱导生成物;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;危险管理;安全;规范(验收);组织;使用
【英文主题词】:
【摘要】:
【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】:其他
【英文标准名称】:StandardPracticeforEvaluationofMetallicWeaponsDetectorsforControlledAccessSearchandScreening
【原文标准名称】:受控通道处搜查用金属武器检测器的评价用标准实施规程
【标准号】:ASTMF1468-2004a(2010)
【标准状态】:现行
【国别】:美国
【发布日期】:2004
【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】:F12.60
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:
【英文主题词】:controlledaccessscreening;controlledaccesssearch;metaldetector;metaldetectorevaluation;metalobjectdetector;metallicweaponsdetector;walk-throughmetaldetector;weaponsdetector;weaponsdetectorevaluation;Controlledaccesssearc
【摘要】:Thesignificantattributesofthispracticearethemethodsfordeterminingthedetectioncapabilitiesofmetaldetectors,themethodsfordeterminingtheeffectsofoutsideinfluencesondetectors,andcertainsafetyrequirementsfordetectors.Whilethispracticewasoriginatedforwalk-throughmetalweaponsdetectors,itisequallyapplicabletodetectorsofothermetalobjects.Theinnocentobjectsset(15.1.2)wouldrequiremodificationcommensuratewiththesizeoftheotherobjecttobetested;sometestsmaynotbeapplicableandotherspecificanddifferenttestsmaybenecessary.Thispracticeincludestestingsiterequirements(Section6)tominimizedatavariations.Thesemethodsmaybeusedatnonconformingsitesifsite-relateddisturbancesareconsideredandaccountedfor.Thispracticeisnotmeanttoconstraindesignsbutitisapplicableonlytodetectorswhicharedesignedforindividualwalk-through.Theportalstructureshallbedeemedtomeetthiscriterionifitprovidesaminimumverticalclearanceof1.96m(77in.)andaminimumhorizontalwidthclearanceof0.66m(26in.).Thispracticerecognizesthatthecomplexmovementsofatestobjectwhencarriedbyapersonwalkingthroughadetectorlimitstheprecisionandrepeatabilityoftheresultantobservedsignals.Averagedresultsfromrepeatedtestsunderidenticalcontrolledconditionsarerecommendedtoobtainabetterapproximationoftheunderlyinghypotheticaltruevalueforthatsetofconditions.Wherethetermx201C;significantx201D;isused,itreferstophenomenawhich,inaccordancewithacceptedengineeringpractices,exceedthenormalvariationofdata.1.1Thispracticecoversmethodsfortheevaluationofwalk-throughmetalweaponsdetectorsandcriteriafortestingmetaldetectionperformance.1.2Thispracticespecifiescertainhealth,safety,andhumanfactorscriteriapertainingtotheusageofthedetectionequipment.1.3Thispracticerequirestheuseofnon-standardized(user-supplied)testobjectsandtestequipment.Evaluationsmadeusingtheproceduresoutlinedinthispracticecanbeusedforcomparativeevaluationsonlyifthetestsaremadewiththesameequipmentandtestobjects.1.4Thispracticeisintendedforusebymanufacturersandevaluatorsofelectromagneticfielddevicesusedforscreeningpersonsenteringintocontrolledaccessareas.Itisnotintendedtosetperformancenorlimitorconstrainoperatingtechnologies,norisitadocumentforusebyindividualoperatorsorusersofsuchequipmentatspecificaccesscontrolpoints.1.5ThevaluesstatedinSIunitsaretoberegardedasthestandard.Otherunitsgiveninparenthesesareforinformationonly.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.Foraspecifichazardsstatement,seewarningnotein12.2.5.
【中国标准分类号】:A91
【国际标准分类号】:
【页数】:12P.;A4
【正文语种】:英语
【英文标准名称】:Medicalelectricalequipment-Part2-26:Particularrequirementsforthesafetyofelectroencephalographs
【原文标准名称】:医用电气设备.第2-26部分:脑电图机安全的特殊要求
【标准号】:IEC60601-2-26-2003
【标准状态】:作废
【国别】:国际
【发布日期】:2003-12
【实施或试行日期】:
【发布单位】:国际电工委员会(IX-IEC)
【起草单位】:IEC/SC62D
【标准类型】:()
【标准水平】:()
【中文主题词】:脑照相术;医学科学;安全要求;安全;环境试验;安全工程;规范(验收);试验;电医学;电气器具;防电击;电气工程;定义;保护装置;安全元件;辐射防护;诊断;医疗技术学;脑电描记器;医疗设备;医用电气设备
【英文主题词】:Definitions;Diagnosis;Electricappliances;Electricalengineering;Electricalmedicalequipment;Electroencephalographs;Electromedicine;Encephalography;Environmentaltesting;Medicalequipment;Medicalsciences;Medicaltechnology;Protectionagainstelectricshocks;Protectivedevices;Radiationprotection;Safety;Safetycomponents;Safetyengineering;Safetyrequirements;Specification(approval);Testing
【摘要】:Specifiestheparticularsafetyrequirementsforelectroencephalographs,i.e.devicestoproduceanelectroencephalogram.ThisParticularStandardamendsandsupplementsIEC60601-1(1988):Medicalelectricalequipment-Part1:Generalrequirementsfor
【中国标准分类号】:C39
【国际标准分类号】:11_040_55
【页数】:52P;A4
【正文语种】:英语
