BS EN ISO 10993-16:2017 ✓ Most Recent

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Biological evaluation of medical devices-Toxicokinetic study design for degradation products and leachables

standard by British Standard / European Standard / International Organization for Standardization , 03/30/2020

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Full Description

BS EN ISO 10993-16:2017 provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.


Cross References:
ISO 10993-1:2009
ISO/TR 10993-22:2017
ISO 10993-17:2002
ISO 10993-18:2005
ISO 10993-2:2006
ISO 10993-12:2012
ISO 14971:2007


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Document History

  1. BS EN ISO 10993-16:2017

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    Biological evaluation of medical devices-Toxicokinetic study design for degradation products and leachables

    • Most Recent

  2. BS EN ISO 10993-16:2010


    Biological evaluation of medical devices-Toxicokinetic study design for degradation products and leachables

    • Historical Version

  3. BS EN ISO 10993-16:2009


    Biological evaluation of medical devices-Toxicokinetic study design for degradation products and leachables

    • Historical Version

  4. BS 08/30187781 DC


    BS EN ISO 10993-16. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables

    • Historical Version

  5. BS EN ISO 10993-16:1997


    Biological evaluation of medical devices-Toxicokinetic study design for degradation products and leachables

    • Historical Version

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Price: $279.40
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Product Details

Published:

03/30/2020

ISBN(s):

9780539134605, 9780580929106

Number of Pages:

26

File Size:

1 file

Same As:

ISO 10993-16:2017

Product Code(s):

30415927, 30415927, 30335532

Note:

This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus