SANS 11135-1:2008
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.

SANS 11135-1:2008

Release Date

2008

Published By

ZA-SANS

Latest

SANS 11135-1:2008

Scope

Specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices. It does not: - detail a specified requirement for designating a medical device as sterile; - specify a quality mana

SANS 11135-1:2008 history

• 2008 SANS 11135-1:2008 Sterilization of health care products - Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices