ISO 10993-5:2009 — Biological evaluation — Part 5: Tests for in vitro cytotoxicity

Describes test methods for the assessment of in vitro cytotoxicity of medical devices, materials, and their extracts. Covers direct contact, indirect contact, and extract testing methods. In vitro cytotoxicity testing is one of the most commonly performed biocompatibility tests and typically the first biological evaluation endpoint assessed.

Standard Details

• Standard Number: ISO 10993-5:2009
• Type: ISO 10993 Series
• Published by: ISO
• Official Link: https://www.iso.org/standard/36519.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.