AAMI/ISO 11135-1 / 11135-2 SET Historical

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Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (11135-1:2007) and Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1 (TIR11135-2:2008)

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 09/23/2008

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About AAMI/ISO 11135-1:2007
Specifies requirements for the development, validation, and routine control of an ethylene oxide sterilization process for medical devices.

About AAMI/ISO TIR11135-2:2008
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.
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Document History

  1. AAMI/ISO 11135:2014


    Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices

    • Most Recent

  2. AAMI/ISO TIR11135-2:2008


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

    • Historical Version

  3. AAMI/ISO 11135-1 / 11135-2 SET

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    Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (11135-1:2007) and Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1 (TIR11135-2:2008)

    • Historical Version

  4. AAMI/ISO 11135-1:2007


    Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

    • Historical Version

  5. AAMI 11135:1994


    Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization - Includes Errata

    • Historical Version

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Product Details

Published:

09/23/2008

ANSI:

ANSI Approved

Number of Pages:

122

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