A pioneering approach by Bibby Sterilin meets the increasingly stringent requirements of EU legislation for in-vitro diagnostic medical devices
Meeting the most stringent quality standards, many of the containers in Bibby Sterilin's extensive Sterilin range, including Universals, have been designed specifically for in vitro diagnostic use.
These all meet the recent IVD Directive and bear the requisite CE mark.
Several of Bibby Sterilin's main line products are manufactured aseptically by an innovative, pioneering technique developed in-house.
An appropriate and validated method of manufacture, this involves heating and injecting virgin grade polystyrene into the mould at high temperature and pressure - exacting conditions which ensure a germ-free product.
With assembly and packaging then carried out in 10,000 standard clean-room conditions, extremely high sterility assurance levels are guaranteed.
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.
Effective since June 2000, this will be mandatory from December 2003.
