【英文标准名称】: Biological evaluation of medical devices - Guidance on a risk-management process 【原文标准名称】: 医用设备的生物评价.风险管理处理导则 【标准号】: ISO/TS 20993-2006 【标准状态】: 现行 【国别】: 国际 【发布日期】: 2006-08 【实施或试行日期】: 【发布单位】: 国际标准化组织(ISO)【起草单位】: ISO/TC 194【标准类型】: ()【标准水平】: ()【中文主题词】: 生物的;生物危害;检验;消费者保护;危险;企业;评定;危害;医疗产品;医用的;药剂学;危险分析;保险业管理;安全【英文主题词】: Biological;Biological hazards;Checks;Consumer protection;Danger;Enterprises;Evaluations;Hazards;Medical products;Medicamentsharmacy;Risk analysis;Risk management;Safety【摘要】: This Technical Specification describes a process by which a manufacturer can identify the biological hazardsassociated with medical devices, estimate and evaluate the risks, control these risks and monitor theeffectiveness of the control.【中国标准分类号】: C30【国际标准分类号】: 11_100_20【页数】: 4P;A4【正文语种】: 英语