ISO 10993-3:2014 — Biological evaluation — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

Specifies strategies, tests, and test methods for assessing the genotoxicity, carcinogenicity, and reproductive/developmental toxicity potential of medical device materials. Applies primarily to devices with prolonged or permanent contact, implantable devices, and devices with potential for systemic exposure.

Standard Details

• Standard Number: ISO 10993-3:2014
• Type: ISO 10993 Series
• Published by: ISO
• Official Link: https://www.iso.org/standard/55614.html

This standard is referenced in the harmonized standards lists for the EU Medical Device Regulation (MDR) 2017/745, EU In Vitro Diagnostic Regulation (IVDR) 2017/746, and is recognized by regulatory authorities worldwide including the FDA, Health Canada, and TGA.