AS ISO 10993.17-2004废止
Biological evaluation of medical devices Establishment of allowable limits for leachable substances
出版：Standards Australia
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基本信息
标准编号： AS ISO 10993.17-2004
发布时间：2004/9/15 0:00:00
标准类别：Standard
出版单位：Standards Australia
标准页数：25
标准简介
Specifies 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. Not applicable to devices that have no patient contact, e.g. in vitro diagnostic devices. The Standard is identical to, and has been reproduced from, ISO 10993-17:2002.
本标准替代的旧标准
等同采用的国际标准
ISO 10993-17:2002 - Identical
