• Available Formats
    • Availability
    • Priced From ( in USD )
    • Printed Edition
    • Ships in 1-2 business days
    • $127.00
    • Add to Cart

Customers Who Bought This Also Bought


About This Item


Full Description

This technical information report provides additional guidance to augment the ANSI/AAMI/IS0 11135 series both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations. It addresses how ANSI/AAMI/ISO 11135:2014 applies to ethylene oxide sterilization operations for devices marketed in the United States. Ethylene oxide sterilization guidance for health care facilities is not specifically covered.

Document History

  1. AAMI TIR14:2016


    Contract sterilization using ethylene oxide

    • Most Recent
  2. AAMI TIR14:2009

    Contract sterilization using ethylene oxide

    • Historical Version
  3. AAMI TIR14:1997/A1:2004

    Contract Sterilization for Ethylene Oxide, Includes Amendment 1

    • Historical Version
  4. AAMI TIR14:1997

    Guidance for the Validation and Routine Control of Industrial Ethylene Oxide Sterilization - Contract Sterilization

    • Historical Version