NF S99-501-3*NF EN ISO 10993-3:2014
Biological evaluation of medical devices - Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity

Standard No.

NF S99-501-3*NF EN ISO 10993-3:2014

Release Date

2014

Published By

Association Francaise de Normalisation

Latest

NF S99-501-3*NF EN ISO 10993-3:2014

Replace

NF S99-501-3:2009

Scope

This part of is 10993 specifies strategies for ris estimation, selection of ris identification tests and ris management, based on the ris of occurrence of the following potentially irreversible biological effects resulting from the exposure to medical devices: 　——genotoxicity; 　——carcinogenicity; 　——toxicity on reproduction and development.

NF S99-501-3*NF EN ISO 10993-3:2014 Referenced Document

• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
• ISO 10993-2 Biological evaluation of medical devices — Part 2: Animal welfare requirements*， 2022-11-03 Update
• ISO 10993-6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation*， 2016-12-01 Update

NF S99-501-3*NF EN ISO 10993-3:2014 history

• 0000 NF S99-501-3:2014
• 2009 NF S99-501-3:2009 Biological evaluation of medical devices - Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity.
• 0000 NF S99-503:2004
• 1994 NF S99-503:1994 Biological evaluation of medical devices. Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity.