IVD Directive - Sterilin Products Hit the Mark!

Bibby Sterilin, highly respected manufacturers of the Sterilin range of single use laboratory plastic products, always prides itself on meeting the most stringent quality standards.

Many of the containers in the extensive Sterilin range, including Universals, have been designed specifically for in vitro diagnostic use, and these all meet the recent IVD Directive and bear the requisite CE mark.

Under the EU legislation (IVD-Directive 98/79/EU), all "In-vitro-Diagnostic Medical Devices" used in vitro for the examination of specimens derived from the human body (including blood and tissue donations) must meet specific requirements. This became effective from June 2000 and will be mandatory from December 2003.

A pioneering approach to sterility standards continues to give Bibby Sterilin a strong advantage over many other manufacturers. All their main line products are manufactured according to stringent aseptic procedures, with production and packaging carried out in clean-room conditions.