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About This Item

 

Full Description

This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope of this part of ISO 11137 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.
 

Amendments, rulings, supplements, and errata

  1. CAN/CSA Z11137-1-07/A2:22


    Amendment 2:2022 to Sterilization of Health Care Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices (Adopted ISO 11137-1:2006, First Edition, 2006-04-15)

  2. CAN/CSA Z11137-1A-07 (R2021)


    Amendment 1:2016 to Sterilization of Health Care Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices (Adopted ISO 11137-1:2006, First Edition, 2006-04-15)