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ISO 10993-15:2019
M00002829
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ISO 10993-15:2019 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
standard by International Organization for Standardization, 12/01/2019
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Full Description
ISO 10993-15:2019 specifies general requirements for the design of tests for identifying and quantifying degradation products from final metallic medical devices or corresponding material samples finished as ready for clinical use.This document is applicable only to those degradation products generated by chemical alteration of the final metallic device in an in vitro degradation test. Because of the nature of in vitro tests, the test results approximate the in vivo behaviour of the implant or material. The described chemical methodologies are a means to generate degradation products for further assessments.
This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade.
This document is not applicable to evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available.