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ISO 11137-1

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2

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Organization: ISO
Publication Date: 1 November 2018
Status: active
Page Count: 6
ICS Code (Sterilization and disinfection in general): 11.080.01

Document History

April 14, 2023
Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope of this document is limited...
ISO 11137-1
November 1, 2018
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2
A description is not available for this item.
July 15, 2013
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 1
A description is not available for this item.
April 15, 2006
Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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...
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