CEN - EN ISO 10993-17
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
inactive
| Organization: | CEN |
| Publication Date: | 1 December 2002 |
| Status: | inactive |
| Page Count: | 36 |
| ICS Code (Laboratory medicine): | 11.100 |
Document History
November 1, 2023
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
This document specifies the process and requirements for the toxicological risk assessment of medical device constituents. The methods and criteria used to assess whether exposure to a constituent is...
April 1, 2009
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
This part of ISO 10993 specifies a method for the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating...
EN ISO 10993-17
December 1, 2002
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
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