Medical device manufacturers must comply with the safety requirements contained in the Medical Devices Directive to minimise the risks to users and patients. It is important that manufacturers have their products evaluated using appropriate tests that satisfy the requirements for all countries in which they are to be marketed.
The biological safety of medical devices is assessed using the international standard,BS ENISO10993. Part 5 of this standard describes the test methods which are to be used to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells either directly or through diffusion with extracts produced from a device or in contact with the device.
With over 15 years experience in testing medical devices to ENISO10993 - Part 5. During this time a large number of different types of products have been examined, including catheters, gloves, dressings and wheelchair material.
BS ENISO10993-5:1999 Biological Evaluation of Medical Devices - Part 5: Tests for in vitro cytotoxicity