DS/EN ISO 10993-15
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
inactive
| Organization: | DS |
| Publication Date: | 21 February 2001 |
| Status: | inactive |
| Page Count: | 26 |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
This part of the standard provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding materials samples finished as ready for clinical use. It considers only those degradation products generated by an electrochemical alteration of the finished metallic device, coated or uncoated, in an accelerated in-vitro test. No degradation induced by applied mechanical stress is covered by this standard.
Document History
May 30, 2023
Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
This document provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from final metallic medical devices or corresponding material...
July 14, 2009
Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys
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...
DS/EN ISO 10993-15
February 21, 2001
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
This part of the standard provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or...
Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys (ISO/FDIS 10993-15:2019)
This document provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from final metallic medical devices or corresponding material...
Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys (ISO/DIS 10993-15:2018)
This document provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from final metallic medical devices or corresponding material...
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 medical devices or corresponding...
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