【英文标准名称】:MedicalDevicesandMedicalSystems-Essentialsafetyrequirementsforequipmentcomprisingthepatient-centricintegratedclinicalenvironment(ICE)-Part1:Generalrequirementsandconceptualmodel
【原文标准名称】:医疗器械和医疗系统.包含病人的设备用基础安全要求.中心综合临床环境(ICE).第1部分:一般要求和概念模型
【标准号】:ASTMF2761-2009
【标准状态】:现行
【国别】:
【发布日期】:2009
【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】:F29.21
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:
【摘要】:Thisstandardspecifiesgeneralrequirements,amodelandframeworkforintegratingequipmenttocreateaINTEGRATEDCLINICALENVIRONMENT(ICE),asdefinedin3.6.ThisstandardspecifiesthecharacteristicsnecessaryforthesafeintegrationofMEDICALDEVICESandotherequipment,viaanelectronicinterface,fromdifferentMANUFACTURERSintoasinglemedicalsystemforthecareofasinglehighacuityPATIENT.ThisstandardestablishesrequirementsforamedicalsystemthatisintendedtohavegreatererrorresistanceandimprovedPATIENTsafety,treatmentefficacyandworkflowefficiencythancanbeachievedwithindependentlyusedMEDICALDEVICES.Thisseriesofstandardsestablishesrequirementsfordesign,verification,andvalidationprocessesofamodelbasedintegrationsystemforanINTEGRATEDCLINICALENVIRONMENT.Thisseriesofstandardsisintendedtodefinetherequirementsessentialforsafetyandtherebyfacilitateregulatoryacceptance.NOTETheserequirementswerederivedtosupporttheclinicalscenariosorclinicalconceptsofoperationsdescribedinAnnexB.
【中国标准分类号】:C37
【国际标准分类号】:35_240_80
【页数】:39P.;A4
【正文语种】: