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Norm
ÖNORM CEN ISO/TS 11135-2
Issue date: 2011 01 15
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) (consolidated version)
This Technical Specification 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....
Withdrawn: 2014 10 15
Publisher:
Austrian Standards International
Format:
Digital | 47 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
This Technical Specification 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.
For ease of reference, the clause numbering in this Technical Specification corresponds to that in
ISO 11135-1:2007. Further guidance for the requirements given in ISO 11135-1 is also included in Annex C of
ISO 11135-1:2007 and should be used in conjunction with 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.
ÖNORM EN ISO 11135
2020 04 01
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validatio...
Norm
ÖNORM EN ISO 11135
2015 03 15
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validatio...
Norm
ÖNORM EN ISO 11135
2014 10 15
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validatio...
Norm
ÖNORM CEN ISO/TS 11135-2
2011 01 15
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO ...
Norm
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ÖNORM CEN ISO/TS 11135-2
2008 11 01
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO ...
Vornorm
ÖNORM CEN ISO/TS 11135-2
2008 04 01
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO ...
Vornorm Entwurf
Norm
Issue date :
2006 03 20
Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (Corrected version 2006-03)
Norm
Issue date :
2004 02 25
Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices
Norm
Issue date :
2007 04 27
Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (Corrected version 2007-10)
Norm
Issue date :
2006 06 26
Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
Norm
Issue date :
2005 07 20
Sterilization of health care products — Chemical indicators — Part 1: General requirements
Norm
Issue date :
2018 01 12
Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
Norm
Issue date :
2003 07 03
Medical devices — Quality management systems — Requirements for regulatory purposes
Norm
Issue date :
2017 10 25
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
Norm
Issue date :
2014 10 15
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)
