Language:
    • Available Formats
    •  
    • Availability
    • Priced From ( in USD )
    • Printed Edition
    • Ships in 1-2 business days
    • $163.00
    • Add to Cart

Customers Who Bought This Also Bought

 

About This Item

 

Full Description

Addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. Does not address the various factors that can have an effect on the bioburden of the product and on the sterilization process. Provides additional guidance to ANSI/AAMI/ISO 11135-1:2007 and ANSI/AAMI/ISO TIR11135-2:2008 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations.
 

Document History

  1. AAMI TIR16:2023


    Microbiological aspects of ethylene oxide sterilization

    • Most Recent
  2. AAMI TIR16:2017 (R2020)


    Microbiological aspects of ethylene oxide sterilization [HISTORICAL]

    • Historical Version
  3. AAMI TIR16:2009/(R)2013

    👀currently
    viewing


    Microbiological aspects of ethylene oxide sterilization

    • Historical Version
  4. AAMI TIR16:2000


    Process development and performance qualification for ethylene oxide sterilization-Microbiological aspects

    • Historical Version