ISO 10993-16:2010

Name: ISO 10993-16:2010
Brand: ISO
SKU: ISO 10993-16:2010
Price: 76.23 EUR
Availability: InStock
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Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables

Publication date: Feb 9, 2010

95.99 Withdrawal of Standard May 16, 2017

General information

Current stage: 95.99 Withdrawal of Standard May 16, 2017

Originator: ISO

Owner: ISO/TC 194 Biological and clinical evaluation of medical devices

Type: International Standard

ICS: 11.100.20 Biological evaluation of medical devices

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Status: Withdrawn

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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WITHDRAWN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WITHDRAWN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