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Norm
ÖNORM EN ISO 10993-17
Issue date: 2003 06 01
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 sta...
Withdrawn: 2010 01 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 31 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
ICS
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.
ÖNORM EN ISO 10993-17
2024 02 15
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device ...
Norm
ÖNORM EN ISO 10993-17
2009 09 15
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable ...
Norm
ÖNORM EN ISO 10993-17
2003 06 01
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable ...
Norm
↖
Norm
Issue date :
2009 10 13
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
Norm
Issue date :
2018 08 17
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)
Norm
Issue date :
2002 11 27
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
Norm
Issue date :
2009 09 15
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
