Euro Standards

BERKSHIRE COMPLIES with EN1174 and EN552 European Standards for its Sterilization Validation Process. These standards include:

CEN — The European Committee for Standardization (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 — This standard pertains to the Sterilization of Medical Devices and the Estimation of the Population of Microorganisms on Product (Part 1: Requirements).

EN1174-2 — This sets the standard for the Estimation of the Population of Microorganisms on Product (Part 2: Guidance).

EN1174-3 — For the Sterilization of Medical Devices and the Estimation of the Population of Microorganisms on Product (Part 3: Guide to the Methods for Validation of Microbiological Techniques).