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BS EN ISO 10993-16:2017

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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Identical Versions Available

ISO 10993-16:2017

May 2017
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
- This is the most recent version of this document.

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

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

Product Details

Published:: 03/30/2020
ISBN(s):: 9780539134605, 9780580929106
Number of Pages:: 26
File Size:: 1 file , 1000 KB
Same As:: ISO 10993-16:2017
Product Code(s):: 30415927, 30415927, 30335532
Note:: This product is unavailable in Ukraine, Russia, Belarus

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