NEN-EN-ISO 10993-15
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
inactive
| Organization: | NEN |
| Publication Date: | 1 November 1997 |
| Status: | inactive |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
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
June 1, 2023
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
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...
July 1, 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...
January 1, 2001
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
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...
January 1, 1999
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
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...
NEN-EN-ISO 10993-15
November 1, 1997
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
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...