ISO 10993-10:2021 — Biological evaluation — Part 10: Tests for skin sensitization

Specifies procedures for the assessment of medical devices and their constituent materials for their potential to produce skin sensitization (delayed-type hypersensitivity). Includes both in vivo and in vitro test methods including the guinea pig maximization test, local lymph node assay, and in chemico/in vitro alternatives.

Standard Details

• Standard Number: ISO 10993-10:2021
• Type: ISO 10993 Series
• Published by: ISO
• Official Link: https://www.iso.org/standard/75279.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.