
Biological Evaluation Of Medical Devices - Part 17: Establishment Of Allowable Limits For Leachable Substances
出版:Association for Advancement of Medical Instrumentation

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基本信息
標準編號: AAMI ISO 10993-17:2002 (R2012)
發布時間:2002/11/15 0:00:00
標準類別:Standard
出版單位:Association for Advancement of Medical Instrumentation
標準頁數:33
標準簡介
Describes a method for determining allowable limits for leachable substances from medical devices and describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.
等同采用的國際標準
ISO 10993-17:2002 - Identical