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ISO/TS 11135-2:2008 [ Withdrawn ]

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

standard by International Organization for Standardization (Technical Standard) , 08/01/2008

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Full Description

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.

 

Product Details

Published:
08/01/2008
File Size:
1 file , 320 KB
Note:
This product is unavailable in Russia, Ukraine, Belarus
 

Document History

  1. 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

    • Most Recent

  2. ISO/TS 11135-2:2008

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

    • Historical Version

  3. 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

    • Historical Version

  4. ISO 11135:1994


    Medical devices -- Validation and routine control of ethylene oxide sterilization

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. ISO/TS 11135-2/Cor1:2009

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    Corrigendum