Wednesday, April 19, 2017

New Sterilization and Disinfection Standards for the 1st Quarter 2017

Document Center, Inc. is pleased to announce that the following Standards on Sterilization and Disinfection in General are now available;

  • AAMI TIR40, 2009 Edition Reapproved in 2016, Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2
  • AAMI TIR56, 2013 Edition Reapproved in 2016, Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
  • ISO 11138-1, 3rd Edition, Sterilization of health care products - Biological indicators - Part 1: General requirements
  • ISO 11138-2, 3rd Edition, Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
  • ISO 11138-3, 3rd Edition, Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
  • ISO 11138-4, 3rd Edition, Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
  • ISO 11138-5, 2nd Edition, Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes


For more standards like these, please refer to our Document Center List of Standards on Sterilization and Disinfection in General.