ISO 10993-18:2020 — Biological evaluation — Part 18: Chemical characterization of medical device materials

Provides a framework for identifying and quantifying the chemical constituents of medical device materials and their potential leachables. Covers qualitative and quantitative analytical methods, analytical evaluation thresholds (AET), and integration with the toxicological risk assessment per ISO 10993-17.

Standard Details

• Standard Number: ISO 10993-18:2020
• Type: ISO 10993 Series
• Published by: ISO
• Official Link: https://www.iso.org/standard/64750.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.