标准编号:ISO/TS 20993:2006

中文名称:医用设备的生物评价.风险管理处理导则

英文名称:Biological evaluation of medical devices — Guidance on a risk-management process

发布日期:2006-08

标准范围

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.

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