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ISO 10993-16:2010

Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables

Feb 9, 2010
95.99   Withdrawal of Standard   May 16, 2017

General information

95.99     May 16, 2017

ISO

ISO/TC 194

International Standard

11.100.20  

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 10993-16:1997

NOW

WITHDRAWN
ISO 10993-16:2010
95.99 Withdrawal of Standard
May 16, 2017

REVISED BY

PUBLISHED
ISO 10993-16:2017

National adoptions

SRPS EN ISO 10993-16:2011  
ISS

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)

95.99   Withdrawal of Standard

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