ASTM ANSI/ISO21647-2004 医疗电气设备.8212呼吸监测器的基本安全和基本性能的特殊要求

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【英文标准名称】:MedicalElectricalEquipment8212ParticularRequirementsfortheBasicSafetyandEssentialPerformanceofRespiratoryGasMonitors
【原文标准名称】:医疗电气设备.8212呼吸监测器的基本安全和基本性能的特殊要求
【标准号】:ASTMANSI/ISO21647-2004
【标准状态】:现行
【国别】:
【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】:
【标准类型】:(ISO)
【标准水平】:()
【中文主题词】:
【英文主题词】:
【摘要】:IEC60601-1:1998,Clause1,applies,exceptasfollows.Amendment(assattheendof1.1):ThisInternationalStandardspecifiedparticularrequirementsforthebasicsafetyandessentialperformanceofrespiratorygasmonitors(RGM)(asdefinedin3.15)intendedforcontinuousoperationforusewithhumans.ThisInternationalStandardspecifiesrequirementsforaa)anaestheticgasmonitoring,bb)carbondioxidemonitoring,cc)oxygenmonitoring,ThisInternationalStandardisnotapplicabletomonitorsintendedforusewithflammableanestheticagents.TherequirementsofthisInternationalStandardwhichreplaceormodifytherequirementsofIEC60601-1:1998anditsAmendments1(1991)and2(1995)areintendedtotakeprecedenceoverthecorrespondinggeneralrequirements.EnvironmentalaspectsareaddressedinAnnexCC.NOTEAdditionalaspectsofenvironmentalimpactareaddressedinISO14971.
【中国标准分类号】:C37
【国际标准分类号】:11_040
【页数】:54P.;A4
【正文语种】: