ISO/TS 25238-2007 健康信息学.健康软件防范风险分类

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【英文标准名称】:Healthinformatics-Classificationofsafetyrisksfromhealthsoftware
【原文标准名称】:健康信息学.健康软件防范风险分类
【标准号】:ISO/TS25238-2007
【标准状态】:现行
【国别】:国际
【发布日期】:2007-06
【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】:分析;类别;分类;分类系统;计算机科学;损伤;定义;危害分析;危害等级;危害;保健;医疗信息学;医疗产品;医学科学;病患者保护;病人;公共卫生;危险;危险分析;安全;软件
【英文主题词】:Analysis;Categories;Classification;Classificationsystems;Computersciences;Damage;Definitions;Hazardanalysis;Hazardclasses;Hazards;Healthprotection;Medicaldevices;Medicalinformatics;Medicalproducts;Medicalsciences;Patientprotection;Patients;Publichealth;Risk;Riskanalysis;Safety;Software
【摘要】:ThisTechnicalSpecificationisconcernedwiththesafetyofpatientsandgivesguidanceontheanalysisandcategorizationofhazardsandriskstopatientsfromhealthsoftwareproducts,inordertoallowanyproducttobeassignedtooneoffiveriskclasses.Itappliestohazardsandriskswhichcouldcauseharmtoapatient.Otherrisks,suchasfinancialororganizationalrisks,areoutsidethescopeofthisTechnicalSpecificationunlesstheyhavethepotentialtoharmapatient.ThisTechnicalSpecificationappliestoanyhealthsoftwareproduct,whetherornotitisplacedonthemarketandwhetheritisforsaleorfreeofcharge.Examplesoftheapplicationoftheclassificationschemearegiven.ThisTechnicalSpecificationdoesnotapplytoanysoftwarewhichisnecessaryfortheproperapplicationorfunctioningofamedicaldevice.NOTEThisTechnicalSpecificationisintendedfortheassignmentofhealthsoftwaretobroadriskclasses,soastoaiddecisionssuchaswhatcontrolsshouldbeappliedtoensuresafety.Itisnotintendedfortheapplicationofriskanalysisandriskmanagementtothedesignofhealthsoftwareproductsandthemitigationofanyidentifiedriskstoacceptablelevels(seeAnnexA).
【中国标准分类号】:C07
【国际标准分类号】:35_240_80
【页数】:24P.;A4
【正文语种】:英语