ISO/TR 27809-2007 健康信息学.健康软件确保病人安全用措施
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【英文标准名称】:Healthinformatics-Measuresforensuringpatientsafetyofhealthsoftware
【原文标准名称】:健康信息学.健康软件确保病人安全用措施
【标准号】:ISO/TR27809-2007
【标准状态】:现行
【国别】:国际
【发布日期】:2007-07
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC215
【标准类型】:()
【标准水平】:()
【中文主题词】:管理;检验;门诊部;计算机科学;数据交换;数据管理;数据处理;数据保护;数据安全;定义;医院;信息技术;医学科学;病患者保护;病人;保护措施;公共卫生;质量保证;风险管理;软件
【英文主题词】:Administration;Checks;Clinics;Computersciences;Dataexchange;Datamanagement;Dataprocessing;Dataprotection;Datasecurity;Definitions;Hospitals;Informationtechnology;Medicalsciences;Patientprotection;Patients;Protectivemeasures;Publichealth;Qualityassurance;Riskmanagement;Software
【摘要】:ThisTechnicalReportconsidersthecontrolmeasuresrequiredtoensurepatientsafetyinrespecttohealthsoftwareproducts.Itdoesnotapplytosoftwarewhichis:necessaryfortheproperapplicationofamedicaldeviceoranaccessorytoamedicaldeviceoramedicaldeviceinitsownright.ThisTechnicalReportisaimedatidentifyingwhatstandardsmightbestbeusedorcreated,andtheirnature,ifhealthsoftwareproductsweretoberegulatedorcontrolledinsomeotherformalorinformalorvoluntarymannerwhethernational,regionalorlocal.However,itisnotthepurposeofthisTechnicalReporttorecommendwhetherornothealthsoftwareproductsshouldberegulated.ThisTechnicalReportappliestoanyhealthsoftwareproductwhetherornotitisplacedonthemarketandwhetherornotitisforsaleorfreeofcharge.Itisaddressedtomanufacturersofhealthsoftwareproducts.NOTEThescopeisintendedtocoverhealthsoftwareproductswhicharenot,inpractice,coveredbymedicaldeviceregulations.AnnexAconsidersthismatterindetail.ThisTechnicalReportacknowledgesthat,ontheboundary,therearehealthsoftwareproductswhichareencompassedbymedicaldeviceregulationsinsomecountriesbutnotinothersandthatsomedefinitionsofmedicaldevicesmayappeartocoverhealthsoftwareproductsingeneralbutinpracticedonot.
【中国标准分类号】:C07
【国际标准分类号】:35_240_80
【页数】:45P.;A4
【正文语种】:英语
【原文标准名称】:健康信息学.健康软件确保病人安全用措施
【标准号】:ISO/TR27809-2007
【标准状态】:现行
【国别】:国际
【发布日期】:2007-07
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC215
【标准类型】:()
【标准水平】:()
【中文主题词】:管理;检验;门诊部;计算机科学;数据交换;数据管理;数据处理;数据保护;数据安全;定义;医院;信息技术;医学科学;病患者保护;病人;保护措施;公共卫生;质量保证;风险管理;软件
【英文主题词】:Administration;Checks;Clinics;Computersciences;Dataexchange;Datamanagement;Dataprocessing;Dataprotection;Datasecurity;Definitions;Hospitals;Informationtechnology;Medicalsciences;Patientprotection;Patients;Protectivemeasures;Publichealth;Qualityassurance;Riskmanagement;Software
【摘要】:ThisTechnicalReportconsidersthecontrolmeasuresrequiredtoensurepatientsafetyinrespecttohealthsoftwareproducts.Itdoesnotapplytosoftwarewhichis:necessaryfortheproperapplicationofamedicaldeviceoranaccessorytoamedicaldeviceoramedicaldeviceinitsownright.ThisTechnicalReportisaimedatidentifyingwhatstandardsmightbestbeusedorcreated,andtheirnature,ifhealthsoftwareproductsweretoberegulatedorcontrolledinsomeotherformalorinformalorvoluntarymannerwhethernational,regionalorlocal.However,itisnotthepurposeofthisTechnicalReporttorecommendwhetherornothealthsoftwareproductsshouldberegulated.ThisTechnicalReportappliestoanyhealthsoftwareproductwhetherornotitisplacedonthemarketandwhetherornotitisforsaleorfreeofcharge.Itisaddressedtomanufacturersofhealthsoftwareproducts.NOTEThescopeisintendedtocoverhealthsoftwareproductswhicharenot,inpractice,coveredbymedicaldeviceregulations.AnnexAconsidersthismatterindetail.ThisTechnicalReportacknowledgesthat,ontheboundary,therearehealthsoftwareproductswhichareencompassedbymedicaldeviceregulationsinsomecountriesbutnotinothersandthatsomedefinitionsofmedicaldevicesmayappeartocoverhealthsoftwareproductsingeneralbutinpracticedonot.
【中国标准分类号】:C07
【国际标准分类号】:35_240_80
【页数】:45P.;A4
【正文语种】:英语
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