European Standards

Berkshire adheres to EN1174 and EN552 European Standards for its Sterilization Validation Process.

These 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).

Privacy Preference Center

Necessary Cookies

Necessary cookies enable core functionality. The website cannot function properly without these cookies, and can only be disabled by changing your browser preferences.

cerber_groove, gdpr, wp-settings-1, wp-settings-time-1, muxData, __distillery

Analytical Cookies

Analytical cookies help us to improve our website by collecting and reporting information on its usage.

_ga, _gid, __mauuid