CAN/CSA-ISO 10993-16-00

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

This National Standard of Canada is equivalent to International Standard ISO 10993-16:1997. 1 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.

SDO:

CSA

Language:

English

ICS Codes:

11.040.01; 11.100

Status:

Withdrawn

Publish date:

2000-02-28

Standard Number:

CAN/CSA-ISO 10993-16-00