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EN ISO 10993-16:1997

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

Publication date:   Oct 23, 2003

General information

99.60 Withdrawal effective   Apr 29, 2009

CEN

CEN/TC 206 Biological and clinical evaluation of medical devices

European Norm

11.020   Medical sciences and health care facilities in general

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Scope

This part of ISO 10993 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.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting
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93/42/EEC

Medical devices

Harmonized/Supporting
more

Life cycle

NOW

WITHDRAWN
EN ISO 10993-16:1997
99.60 Withdrawal effective
Apr 29, 2009

REVISED BY

WITHDRAWN
EN ISO 10993-16:2009