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New Sterilization and Disinfection Standards for the 3rd Quarter 2014

Kyle Bach

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


  • AAMI TIR37, 2013 Edition, Sterilization of health care products – Radiation – Guidance on sterilization of biologics and tissue-based products
  • AAMI TIR56, 2013 Edition, Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
  • BS EN ISO 11135, 2014 Edition, Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices (replaces BS EN ISO 11135-1)
  • BS EN ISO 11607-1, 2009 Edition with Amendment 1, Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems
  • BS EN ISO 11607-2, 2006 Edition with Amendment 1, Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
  • BS EN ISO 15883-1, 2009 Edition with Amendment 1, Washer-disinfectors. General requirements, terms and definitions and tests
  • DIN EN 1422, 2014 Edition, Sterilizers for medical purposes – Ethylene oxide sterilizers – Requirements and test methods (English Language Edition)
  • ISO 11135, 2nd Edition , Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices (replaces ISO 11135-1 and ISO 11135-2)
  • ISO 11607-1 Amendment 1, Amendment 1 for the 1st Edition, Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems
  • ISO 11607-2 Amendment 1, Amendment 1 for the 1st Edition, Packaging for Terminally Sterilized Medical Devices – Part 2: Validation Requirements for Forming, Sealing and Assembly Processes
  • ISO 15883-1 Amendment 1, Amendment 1 for the 1st Edition, Washer-disinfectors – Part 1: General requirements, terms and definitions and tests
  • SIS EN ISO 11607-1 Amendment 1, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2009/Amd 1:2014) Swedish Standard, English language edition
  • SIS EN ISO 11607-2 Amendment 1, Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006/Amd 1:2014) Swedish Standard, English language edition


Would you like to see more standards like these?  Please go to our Document Center List of Standards on Sterilization and Disinfection and follow the links to the sub-topics you’re interested in.

And don’t forget to review my previous blogs: