Wednesday, March 4, 2015

New Sterilization and Disinfection Standards for the 4th Quarter 2014

Document Center Inc. is pleased to announce that the following New Standards on Sterilization and Disinfection are now available:


  • ANSI/AAMI/ISO 11607-1, Amendment 1 for 2006 Edition, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging
  • ANSI/AAMI/ISO 11607-2, Amendment 1 for 2006 Edition, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
  • ASTM D6646, 2003 Edition Reaffirmed in 2014, Standard Test Method for Determination of the Accelerated Hydrogen Sulfide Breakthrough Capacity of Granular and Pelletized Activated Carbon
  • ASTM E1837, 1996 Edition Reaffirmed in 2014, Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test)
  • ASTM E2314, 2003 Edition Reaffirmed in 2014, Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)
  • BS EN ISO 11140-1, 2014 Edition, Sterilization of health care products. Chemical indicators. General requirements
  • DIN EN 14180, 2014 Edition, Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
  • DIN EN ISO 11607-1, 2014 Edition, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
  • DIN EN ISO 11607-2, 2014 Edition, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
  • DIN EN ISO 15883-1, 2014 Edition, Washer-disinfectors - Part 1: General requirements, terms and definitions and tests
  • ISO 11140-1, 3rd Edition, Sterilization of health care products - Chemical indicators - Part 1: General requirements


For more standards like these, please see our Document Center List of Standards on Sterilization and Disinfection.

You can also review my previous postings: