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New Sterilization and Disinfection Standards for the 2nd Quarter 2013

Kyle Bach

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


  • BS EN ISO 11137-2, 2013 Edition, Sterilization of health care products. Radiation. Establishing the sterilization dose
  • BS EN ISO 13408-1, Amendment A1 for 2011 Edition, Aseptic processing of health care products. General requirements
  • BS EN ISO 13408-6, Amendment A1 for 2011 Edition, Aseptic processing of health care products. Isolator systems
  • BS EN ISO 20857, 2013 Edition, Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
  • ISO 11137-2, 3rd Edition, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose
  • ISO 13004, 1st Edition, Sterilization of health care products – Radiation – Substantiation of selected sterilization dose: Method VDmaxSD
  • ISO 13408-1, Amendment 1 for 2nd Edition, Amendment 1, Part 1: General Requirements, Aseptic Processing of health care products
  • ISO 17665-3, 1st Edition, Sterilization of health care products – Moist heat – Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization


Sterilization standards are of particular importance to our Medical Device customers.  Use of these standards can provide assurance of sterile product for medical applications.  And these standards are also used in health care settings, where tools and other products may be sterilized prior to re-use.

As you can see, there are a variety of changes that have occurred in the last three months.   Some documents have been issued for the first time, some updated by amendment, and some revised entirely.

If you’d like to see more about the changes in the BS EN ISO 11137-2 2013 Edition, my StandardsForum.com blog today has the complete details.

Remember, Document Center is here to help you identify the standards you need.  Rely on us to be Your Standards Experts!