0

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

Buying

Withdrawn

Language in which you want to receive the document.

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
Legislation 90/385/EEC
93/42/EEC

Medical devices

Harmonized/Supporting
Legislation 93/42/EEC

Life cycle

NOW

WITHDRAWN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

REVISED BY

WITHDRAWN
EN ISO 10993-16:2009