DS/EN ISO 11135-1:2007
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

Standard No.

DS/EN ISO 11135-1:2007

Release Date

2007

Published By

Danish Standards Foundation

Latest

DS/EN ISO 11135-1:2007

Replace

DS/EN 550:1994

Scope

This standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.

DS/EN ISO 11135-1:2007 history

• 2007 DS/EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• 0000 DS/EN 550:1994