DS/EN ISO 10993-17
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
inactive
| Organization: | DS |
| Publication Date: | 24 March 2003 |
| Status: | inactive |
| Page Count: | 38 |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
This standard 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 standard is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices).
Document History
November 29, 2023
Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
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...
June 15, 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...
DS/EN ISO 10993-17
March 24, 2003
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
This standard 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...
Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents (ISO/DIS 10993-17:2021)
A description is not available for this item.
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
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...
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