SR EN ISO 10993-3:2009

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)

ISO 10993-3:2003 specifies strategies for hazard identification and tests on medical devices for the following biological aspects: genotoxicity, carcinogenicity, and reproductive and developmental toxicity. ISO 10993-3:2003 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 ISO 10993-1.

Add to cart

General information

Status : Withdrawn
Approval date : 10/30/2009
Publish date : 11/1/2009
Withdrawal date : 3/31/2015
Number of pages : 28
ICS : 11.100.20 Biological evaluation of medical devices
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN ISO 10993-3:2004
Replaced by SR EN ISO 10993-3:2015