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New Sterilization and Disinfection Standards for the 2nd Quarter 2014

Kyle Bach

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


  • 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
  • AAMI/ISO 11137-1, Amendment 1 for 2006 Edition, Sterilization of health care products – Radiation – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
  • ASTM E1153, 2014 Edition, Standard Test Method for Efficacy of Sanitizers Recommended for Inanimate, Hard, Nonporous Non-Food Contact Surfaces
  • BS EN 1422, 2014 Edition, Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods
  • BS EN 14180, 2014 Edition, Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing
  • 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
  • ISO 11135-1, Withdrawn and replaced by ISO 11135, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • ISO 11135-2, Withdrawn and replaced by ISO 11135, Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1
  • ISO 11607-1, Amendment 1 for 1st Edition, Amendment 1 – Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems
  • ISO 11607-2, Amendment 1 for 1st Edition, Amendment 1 – Packaging for Terminally Sterilized Medical Devices – Part 2: Validation Requirements for Forming, Sealing and Assembly Processes
  • ISO 16775, 1st Edition, Packaging for terminally sterilized medical devices – Guidance on the application of ISO 11607-1 and ISO 11607-2


For more standards on this topic, please see our Document Center List of Standards on Sterilization and Disinfection.  The links will take you to the areas you’re interested in.

You’ll also want to review my previous blogs: