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About This Item
Full Description
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.
Document History
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ISO 10993-15:2019
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Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys- Most Recent
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ISO 10993-15:2000
Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys- Historical Version