ISO 11137-2:2013/AMD1:2023 — Sterilization — Radiation — Part 2: Establishing the sterilization dose

Specifies methods for establishing the minimum dose needed to achieve a specified sterilization assurance level (SAL) and for substantiation of an established sterilization dose. Includes Methods 1, 2, and VDmax dose setting approaches.

Standard Details

• Standard Number: ISO 11137-2:2013+AMD1:2023
• Type: Sterilization Standard
• Published by: ISO
• Official Link: https://www.iso.org/standard/62442.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.