DR 03177 CP被替代
Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys
出版：Standards Australia
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基本信息
标准编号： DR 03177 CP
标准类别：Draft
出版单位：Standards Australia
标准页数：0
标准简介
Proposes guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding material samples finished as ready for clinical use. It is only applicable to those degradation products generated by chemical alteration of the finished metallic device in an in vitro accelerated degradation test.
替代本标准的新标准
