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ISO 10993-17:2002

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

Nov 27, 2002

General information

90.92     Jan 19, 2018

ISO

ISO/TC 194

International Standard

11.100.20  

English   French  

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Scope

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.

Life cycle

NOW

PUBLISHED
ISO 10993-17:2002
90.92 Standard to be revised
Jan 19, 2018

REVISED BY

ABANDON
ISO/PWI 10993-17

IN_DEVELOPMENT
ISO/FDIS 10993-17

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