With regard to the "basic requirements for medical devices", a mutual compatibility between the materials being used, the tissue, the biological cells, and the bodily fluids of the patient must be taken into account by the manufacturer (Medical Device Directive 93/42/EEC).
The requirements and test methods for the biological safety of medical devices are more precisely specified in EN ISO 10993 "Biological evaluation of medical devices". The testing of the biological properties begins with the determination of the scope of testing (EN ISO 10993-1). Various tests are required depending on the type and duration of contact with the body.
Test for in-vitro cytotoxicity (EN ISO 10993-5)
Multiple test methods are used to test cytotoxicity. These test methods are all carried out in vitro, i.e. not on live animals. Normally either the medical device or representative parts of it are extracted in a suitable medium. Our experience shows that the in-vitro cytotoxicity test (EN ISO 10993-5) is of primary importance.
Test for irritation and skin sensitization (EN ISO 10993-10)
The test for sensitivity as well as irritation is carried out using test methods in which the reactivity and induction of irritations directly on the skin, mucous membranes, or subcutaneously (under the skin) of medical devices are studied directly or as extracts. This is normally done after determining cytotoxicity because cytotoxicity is a good indicator of cellular destruction/irritation. The skin irritation test on human subjects will only begin once the medical device has passed the cytotoxicity test.
In addition, we carry out tests for sterility (EN ISO 11737), determination of the bioburden (EN ISO 11737), residue analyses of medical devices, and determination of the residual protein content, among other things.