With regard to the "basic requirements for medical devices" a mutual compatibility between the materials used, the tissue, the biological cells and the body fluids of the patient must be taken into account by the manufacturer (MDD 93/42/EEC).
Requirements and test methods for the biological safety of medical devices are specified more precisely in EN ISO standard 10993 "Biological Evaluation of Medical Devices".
The test on the biological characteristics starts with the definition of the extent of the test (EN ISO 10993-1). Depending on the type of body contact and the contact time different tests are required.
These are for example:
- Determination of bioburden
- Sterility Testing
- Residue analyzes of medical devices
- Determination of residual protein count