CNS 14393-15-2006 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (English Version)
Taiwan Provincial Standard of the People's Republic of China
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CNS 14393-15-2006
Scope
This standard provides guidance on the general requirements for designing test methods to identify and quantify degradation products in finished metallic medical devices or material samples intended for clinical use. It is only applicable to degradation products produced by chemical changes in finished metal equipment during accelerated degradation tests in vitro. Because these tests are accelerated, the test results do not reflect the behavior of the implant or material in the body. The described
CNS 14393-15-2006 history
2006CNS 14393-15-2006 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys