ISO-10993-17 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances

ISO-10993-17 - 1ST EDITION - CURRENT


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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.

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To find similar documents by classification:

11.100 (Laboratory medicine)

11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)

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Document Number

ISO 10993-17:2002

Revision Level

1ST EDITION

Status

Current

Publication Date

Dec. 1, 2002

Committee Number

ISO/TC 194