In selecting materials for sterile barrier systems for medical devices many aspects need to be considered. Along with physical and chemical properties of the materials involved it is important to understand the sterilisation process that they will be subjected to and its limitations. Read more….
During the past 25 years, the medical technology industry has developed an amazing number of life- saving and life enhancing products. Government policies translated into national regulations that are enforced by legislation form a necessary part of a country’s overall national health system. Regulatory controls for medical devices play a vital role in the fight against health care-associated infections. The manufacture of medical devices and their sterile barrier systems in a highly regulated environment can be extremely challenging and traceability throughout the whole life cycle is essential. Read more…
Presentation to Healthpack in 2007 including information about the SBA, the European Union legislative process, an outline of key legislation and standards, European demographics forecast, opportunities and challenges presented by China’s growing market – read more
Position Paper on CE marking of Sterile Barrier Systems