SANS 10993-3:2004
Biological evaluation of medical devices Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity

Standard No.

SANS 10993-3:2004

Release Date

2004

Published By

ZA-SANS

Latest

SANS 10993-3:2004

Scope

Specifies strategies for hazard identification and tests on medical devices for the following biological aspects: genotoxicity, carcinogenicity, and reproductive and developmental toxicity. This part of SANS 10993 is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified.

SANS 10993-3:2004 history

• 2004 SANS 10993-3:2004 Biological evaluation of medical devices Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity