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 April 2009 |
| Status: | inactive |
| Page Count: | 36 |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
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 appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.
This part of ISO 10993 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices).
Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. This part of ISO 10993 does not address the potential for exposure from such sources.
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...
EN ISO 10993-17
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...
December 1, 2002
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
A description is not available for this item.