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BS EN ISO 10993-16:2010

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

standard by British Standard / European Standard / International Organization for Standardization , 03/31/2010

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Full Description

BS EN ISO 10993-16:2010 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices

Cross References:
ISO 10993-1
ISO 10993-2
ISO 10993-12
ISO 10993-17
ISO 10993-18
ISO 14971
93/42/EEC
90/385/EEC


All current amendments available at time of purchase are included with the purchase of this document.
 

Product Details

Published:
03/31/2010
ISBN(s):
9780580642432
Number of Pages:
22
File Size:
1 file , 430 KB
Same As:
ISO 10993-16:2010
Product Code(s):
30187782, 30187782, 30187782
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. BS EN ISO 10993-16:2017


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

    • Most Recent

  2. BS EN ISO 10993-16:2010

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    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