Standard

NS-EN ISO 11135:2014

Oct 2014 Published

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Standard

NS-EN ISO 11135:2014
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)

Oct 2014 Published
Standard

SN-CEN ISO/TS 11135-2:2008/AC:2009
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008/Cor 1:2009)

Apr 2009 Withdrawn
Standard

SN-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)

Aug 2008 Withdrawn
Standard

NS-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 (ISO 11135-1:2007)

Sept 2007 Withdrawn

Abstract

ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

Document information

Standard from SN
Published: 1 October 2014
Edition: 2014-07
Version: 1
Document type: NAT
ISBN:

ICS 11.080.01
National Committee CEN/TC 204

Legal references

EU law: 2017/745, 2017/746, 90/385/EEC, 93/42/EEC

Product Relations

Replaces: SN-CEN ISO/TS 11135-2:2008
Replaces: NS-EN ISO 11135-1:2007
Adopted from: EN ISO 11135:2014 , 0

NS-EN ISO 11135:2014

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