ISO 10993-7:2008 — Biological evaluation — Part 7: Ethylene oxide sterilization residuals

Specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, and procedures for measurement of residual EO and ECH. Critical for devices sterilized with ethylene oxide.

Standard Details

• Standard Number: ISO 10993-7:2008
• Type: ISO 10993 Series
• Published by: ISO
• Official Link: https://www.iso.org/standard/41276.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.