ANSI/AAMI/ISO 10993-3:2014
Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

Standard No.

ANSI/AAMI/ISO 10993-3:2014

Release Date

2014

Published By

US-AAMI

Latest

ANSI/AAMI/ISO 10993-3:2014

Scope

specifies strategies for hazard identification and tests on medical devices for genotoxicity, carcinogenicity, and reproductive and developmental toxicity. Applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established

ANSI/AAMI/ISO 10993-3:2014 history

• 2014 ANSI/AAMI/ISO 10993-3:2014 Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity