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Technische Regel

ISO/TS 11135-2:2008

Issue date: 2008 07 17

Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1

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 exclu...
Withdrawn: 2014 07 07
Publisher:
International Organization for Standardization
Format:
Digital | 39 Pages
Language:
English
Currently valid:

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.

ISO 11135:2014
2014 07 07
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validatio...
Norm
ISO/TS 11135-2:2008
2008 07 17
Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO ...
Technische Regel
ISO 11135:1994/Cor 1:1994
1994 10 27
Medical devices — Validation and routine control of ethylene oxide sterilization — Technical Corrige...
Norm
ISO 11135:1994
1994 01 27
Medical devices — Validation and routine control of ethylene oxide sterilization
Norm
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Norm
ISO 11135:2014
Issue date : 2014 07 07
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
Technische Regel
ISO/TS 11135-2:2008/Cor 1:2009
Issue date : 2009 02 09
Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1 — Technical Corrigendum 1