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ISO 10993-17:2002

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

standard by International Organization for Standardization , 12/01/2002

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Full Description

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.

 

Product Details

Published:
12/01/2002
Number of Pages:
25
File Size:
1 file , 580 KB
Same As:
BS EN ISO 10993-17:2009, DIN EN ISO 10993-17, BS EN ISO 10993-17:2009
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This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 10993-17:2023


    Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents

    • Most Recent

  2. ISO 10993-17:2002

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

    • Historical Version