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BS EN ISO 10993-16:1997 Biological evaluation of medical devices - Part 16. Toxicokinetic study design for degradation products and leachables

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This part of ISO 10993 gives principle on how toxicokinetic studies relevat 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.
Primary Item Type:
British Standard
Identifiers:
ISBN 0 580 28099 3
ICS 11.100.20 Biological evaluation of medical devices
Language:
English
Subject Keywords:
Design; Absorption; Biological analysis and testing; Degradation; Toxicity; Metabolism; Toxicology; Decomposition reactions; Medical equipment;
First presented to the public:
3/4/2026
Original Publication Date:
11/15/1997
Previously Published By:
British Standards Institution
Place Of Publication:
London, United Kingdom
Citation:
Extents:
Number of Pages - 9
License Grantor / Date Granted:
  / ( View License )
Date Deposited
2026-03-04 17:14:46.111
Submitter:
Engku Shahidil Engku Ab Rahman

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BS EN ISO 10993-16:1997 Biological evaluation of medical devices - Part 16. Toxicokinetic study design for degradation products and leachables1 2026-03-04 17:14:46.111
Engineering Library USM @ 2017