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BS EN ISO 10993-17:2009

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

standard by British Standard / European Standard / International Organization for Standardization , 06/30/2009

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Full Description

BS EN ISO 10993-17:2009 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.

BS EN ISO 10993-17:2009 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. BS EN ISO 10993-17:2009 does not address the potential for exposure from such sources.

Cross References:
ISO 10993-1
ISO 10993-7
ISO 14971
93/42/EEC
90/385/EEC


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Product Details

Published:
06/30/2009
ISBN(s):
9780580658235
Number of Pages:
36
File Size:
1 file , 1 MB
Same As:
ISO 10993-17:2002, ISO 10993-17:2002
Product Code(s):
30195362, 30195362, 30195362
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. BS EN ISO 10993-17:2023


    Biological evaluation of medical devices-Toxicological risk assessment of medical device constituents

    • Most Recent

  2. BS EN ISO 10993-17:2009

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

    • Historical Version

  3. BS EN ISO 10993-17:2002


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

    • Historical Version