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Norm
ÖNORM EN ISO 10993-15
Issue date: 2009 12 01
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medic...
Withdrawn: 2023 08 15
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 18 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding material samples finished as ready for clinical use. It is applicable only to those degradation products generated by chemical alteration of the finished metallic device in an in vitro accelerated degradation test. Because of the accelerated nature of these tests, the test results may not reflect the implant or material behavior in the body. The described chemical methodologies are a means to generate degradation products for further assessments.
ÖNORM EN ISO 10993-15
2023 08 15
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation...
Norm
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
Norm
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)
Norm
Issue date :
2000 11 30
Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (Corrected version 2001-03)
