Summary

Provides a framework for the chemical characterization of medical device materials and their potential leachables and extractables. Covers qualitative and quantitative chemical analysis methods, analytical evaluation thresholds, and reporting of chemical characterization data.

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.

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

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