DR 03508 CP被替代
Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
出版：Standards Australia
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基本信息
標準編號： DR 03508 CP
標準類別：Draft
出版單位：Standards Australia
標準頁數：0
標準簡介
Proposes adoption of ISO 10993-17:2002 to provide a method for the determination of allowable limits for substances leachable from medical devices. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.
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