EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
This part of ISO 10993 specifies specific strategies for risk assessment, selection of hazard detection test methods and risk management, taking into account the possibility of the following potential irreversible biological effects that may occur as a result of exposure to medical devices: genotoxicity; carcinogenicity; Reproductive and developmental toxicity. This part of ISO 10993 is applicable once the need to test a medical device for potential genotoxicity, carcinogenicity or reproductive toxicity has been determined. NOTE Guidance on the selection of tests is provided in ISO 10993-1.
EN ISO 10993-3:2014 Referenced Document
ASTM F1439-03 Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials*， 2024-04-20 Update
ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements
ISO 10993-6:2007 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
EN ISO 10993-3:2014 history
2014EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
2009EN ISO 10993-3:2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity@ carcinogenicity and reproductive toxicity
2003EN ISO 10993-3:2003 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity Supersedes EN 30993-3: 1999; ISO 10993-3: 2003