Berkshire follows EN1174 and EN552 European Standards for our Sterilization Validation Process.

CEN - European Committee for Standardization ( http://www.cenorm.be/ )

"CEN promotes voluntary technical harmonization in Europe in conjunction with worldwide bodies and its partners in Europe and the conformity assessment of products and their certification."

EN1174-1     Sterilization of medical devices - Estimation of the population of     microorganisms on product - Part 1: Requirements.     EN1174-2     Sterilization of medical devices - Estimation of the population of     microorganisms on product - Part 2: Guidance.     EN1174-3      Sterilization of medical devices - Estimation of the population of      microorganisms on product - Part 3: Guide to the methods for      validation of microbiological techniques.