AS ISO 10993.15-2003
给水用1/2 In.(12 mm)到2 In.(50 mm)聚乙烯-铝-聚乙烯和交联聚乙烯-铝-交联聚乙烯复合压力管

Biological evaluation of medical devices - Identification and quantification of degradation products from metals and alloys

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标准号

AS ISO 10993.15-2003

发布日期

2003年

实施日期

废止日期

无

国际标准分类号

11.100.20

发布单位

AU-SA

适用范围

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.

AS ISO 10993.15-2003系列标准