【英文标准名称】:Healthinformatics—Measuresforensuringthepatientsafetyofhealthsoftware
【原文标准名称】:医疗信息学.确保病人安全的医疗软件的测量
【标准号】:BSPDCEN/TR15640-2007
【标准状态】:现行
【国别】:英国
【发布日期】:2007-09-28
【实施或试行日期】:2007-09-28
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:
【摘要】:Thisdocumentconsidersthecontrolmeasuresrequiredtoensurepatientsafetyinrespecttohealthsoftwareproducts.Itdoesnotapplytosoftwarewhichis:?necessaryfortheproperapplicationofamedicaldeviceor?whichisanaccessorytoamedicaldeviceor?whichisamedicaldeviceinitsownright.Thedocumentisaimedatidentifyingwhatstandardsmightbestbeusedorcreated,andtheirnature,ifhealthsoftwareproductsweretoberegulatedorcontrolledinsomeotherformalorinformalorvoluntarymannerwhethernational,regionalorlocal.Howeveritisnotthepurposeofthisdocumenttorecommendwhetherornothealthsoftwareproductsshouldberegulated.Thisdocumentappliestoanyhealthsoftwareproductwhetherornotitisplacedonthemarketandwhetherornotitisforsaleorfreeofcharge.Itisaddressedtomanufacturersofhealthsoftwareproducts.NOTEThescopeisintendedtocoverhealthsoftwareproductswhicharenot,inpractice,coveredbymedicaldeviceregulations.AnnexAconsidersthismatterindetail.ThisTRacknowledgesthat,ontheboundary,therearehealthsoftwareproductswhichareencompassedbymedicaldeviceregulationsinsomecountriesbutnotinothersandthatsomedefinitionsofmedicaldevicesmayappeartocoverhealthsoftwareproductsingeneralbutinpracticedonot.
【中国标准分类号】:C07
【国际标准分类号】:35_240_80
【页数】:48P.;A4
【正文语种】:英语