BS EN ISO 10993-3:2003

Biological evaluation of medical devices - Tests for genotoxicity, carcinogenicity and reproductive toxicity

Published:

31 Oct 2003

•

Withdrawn:

30 Jun 2009

BS EN ISO 10993-3 specifies strategies for hazard identification and tests on medical devices for the biological aspects of genotoxicity, carcinogenicity, and reproductive and developmental toxicity. It is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified. Guidance on selection of tests is provided in BS EN ISO 10993-1.

Product Details

Descriptors

Reproductive system

Biological hazards

Toxicity

Biological analysis and testing

Implants (surgical)

Medical equipment

Toxic materials

Dental equipment

Genotoxicity tests

Cytotoxicity tests

Medical instruments

ICS Codes

11.100.20 Biological evaluation of medical devices

Committee

CH/194

International relationships

Identical to:

EN ISO 10993-3:2003

ISO 10993-3:2003

ISBN

0 580 42881 8

Publisher

BSI