ISO 11137-1:2006/AMD2:2023 — Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control
Summary
Specifies requirements for the development, validation, and routine control of a radiation sterilization process for medical devices. Covers gamma irradiation, electron beam, and X-ray sterilization methods. Applicable to single-use and reusable medical devices.
Standard Details
- Standard Number: ISO 11137-1:2006+AMD2:2023
- Type: Sterilization Standard
- Published by: ISO
- Official Link: https://www.iso.org/standard/33952.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.
Document Details
Document IDISO 11137-1:2006+AMD2:2023
TypeSterilization Standard
AuthorityISO
Publication Date2023-02-01