DS/EN ISO 11137-1:2006
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

Standard No.

DS/EN ISO 11137-1:2006

Release Date

2006

Published By

Danish Standards Foundation

Status

Be replaced 2013-08

Replace By

DS/EN ISO 11137-1/A1:2013

Latest

DS/EN ISO 11137-1/A1:2013

Replace

DS/EN 552:1994 DS/EN 552/A2:2001 DS/EN 552/A1:1999

Scope

This part of ISO 11137 specifies requirements for the development, validation and routine control of aradiation 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.This part of ISO 11137 covers radiation processes employing irradiators using,a) the radionuclide 60Co or 137Cs,b) a beam from an electron generatororc) a beam from an X-ray generator.

DS/EN ISO 11137-1:2006 history

• 2013 DS/EN ISO 11137-1/A1:2013 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• 2006 DS/EN ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• 0000 DS/EN 552/A2:2001
• 0000 DS/EN 552/A1:1999
• 0000 DS/EN 552:1994