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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
标准编号: DR 03508 CP
标准类别:Draft
出版单位:Standards Australia
标准页数:0
标准简介

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.

替代本标准的新标准

AS ISO 10993.17-2004