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Norm
ÖNORM EN ISO 10993-15
Issue date: 2023 08 15
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
This document specifies general requirements for the design of tests for identifying and quantifying degradation products from final metallic medical devices or correspon...
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§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 27 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
This document 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.
Because of the wide range of metallic materials used in medical devices, no specific analytical techniques are identified for quantifying the degradation products. The identification of trace elements (<10^(-6) w/w) contained in the specific metal or alloy is not addressed in this document, nor are specific requirements for acceptable levels of degradation products provided in this document.
This document excludes the biological activity of the degradation products. (See instead the applicable clauses of ISO 10993-1 and ISO 10993-17).
ÖNORM EN ISO 10993-15
2023 08 15
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation...
Norm
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ÖNORM EN ISO 10993-15
2009 12 01
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation...
Norm
ÖNORM EN ISO 10993-15
2001 05 01
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation...
Norm
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Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys