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CEN ISO/TS 11135-2:2008

Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008)

Publication date:   Dec 17, 2010

General information

99.60 Withdrawal effective   Jul 16, 2014

CEN

CEN/TC 204 Sterilization of medical devices

Technical Specification

11.080.01   Sterilization and disinfection in general

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Scope

ISO/TS 11135-2:2008 provides guidance for the requirements in ISO 11135-1:2007. It does not repeat the requirements and is not intended to be used in isolation. The exclusions in ISO 11135-1 apply also to this Technical Specification.
This guidance document is intended for people who have a basic knowledge of the principles of EO sterilization but may need help in determining how to best meet the requirements contained in ISO 11135-1. This document is not intended for people lacking a basic knowledge of the principles of EO sterilization.

Life cycle

NOW

WITHDRAWN
CEN ISO/TS 11135-2:2008
99.60 Withdrawal effective
Jul 16, 2014

CORRIGENDA / AMENDMENTS

WITHDRAWN
CEN ISO/TS 11135-2:2008/AC:2009

REVISED BY

PUBLISHED
EN ISO 11135:2014