ISO 10993-16:2010

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

Publication date: 9 shk 2010

95.99 Withdrawal of Standard 16 maj 2017

General information

Current stage: 95.99 Effective date: 16 maj 2017

Originator: ISO

Owner: ISO/TC 194

Type: International Standard

ICS: 11.100.20

Gjuha: anglisht frëngjisht

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Statusi: Shfuqizuar

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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WITHDRAWN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WITHDRAWN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
16 maj 2017

REVISED BY

PUBLISHED
ISO 10993-16:2017