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About This Item

 

Full Description

Establishes requirements and guidance for validation and routine control of ethylene oxide sterilization processes for medical devices. Identical with ISO 11135:1ed. Revision of ANSI/AAMI ST27-1988.
 

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


    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

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

    • Historical Version