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AS ISO 10993.15-2003废止

Biological evaluation of medical devices 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: AS ISO 10993.15-2003
发布时间:2003/6/30 0:00:00
标准类别:Standard
出版单位:Standards Australia
标准页数:12
标准简介

Specifies 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. This Standard is only applicable to those degradation products generated by chemical alteration of the finished metallic device in an in-vitro accelerated degradation test.

本标准替代的旧标准

DR 03177 CP

DR 03172-03177 CP

等同采用的国际标准

ISO 10993-15:2000 - Identical