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EVS-EN ISO 10993-15:2009

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys

General information
Valid from 07.08.2009
Base Documents
ISO 10993-15:2000; EN ISO 10993-15:2009
Directives or regulations
93/42/EEC Medical devices (MDD)
Standard history
Status
Date
Type
Name
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prEN ISO 10993-15
07.08.2009
Main
This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying andquantifying degradation products from finished metallic medical devices or corresponding material samples finishedas ready for clinical use. It is applicable only to those degradation products generated by chemical alteration of thefinished metallic device in an in vitro accelerated degradation test. Because of the accelerated nature of thesetests, the test results may not reflect the implant or material behavior in the body. The described chemicalmethodologies are a means to generate degradation products for further assessments.This part of ISO 10993 is not applicable to degradation products induced by applied mechanical stress.
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