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

Standard No.

DS/EN ISO 11137-1/A1:2013

Release Date

2013

Published By

Danish Standards Foundation

Latest

DS/EN ISO 11137-1/A1:2013

Scope

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 requir

DS/EN ISO 11137-1/A1:2013 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