Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
This standard has been revised by: ISO 10993-3:2014
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.
Document published on: 2003-10 Edition: 2 (Monolingual) ICS: 11.100.20 Status: Withdrawn Stage: 95.99 (2014-09-24) TC/SC: ISO/TC 194 Number of Pages:
Revised by: ISO 10993-3:2014
Revises: ISO 10993-3:1992
No corrigenda or amendments available