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Norm

ISO 10993-17:2002

Ausgabedatum: 2002 11 27

Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances

ISO 10993-17:2002 specifies the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimati...
ZURÜCKGEZOGEN: 2023 09 13
Herausgeber:
International Organization for Standardization
Format:
Digital | 25 Seiten
Sprache:
Englisch

ISO 10993-17:2002 specifies 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.

ISO 10993-17:2002 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. ISO 10993-17:2002 does not address the potential for exposure from such sources.

ISO 10993-17:2023
2023 09 13
Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device ...
Norm
ISO 10993-17:2002
2002 11 27
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable ...
Norm
Norm
ISO 10993-17:2023
Ausgabedatum : 2023 09 13
Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents