Manufacturing process and Quality control

Biocompatibily tests

Tests were executed in an Accredited Laboratory under OECD principles of Good Laboratory Practice in January 1998. The test on these needles was executed according to EN 30993-5.

Test was executed in cell metabolism of fibroblasts. (see Test realization).

All test materials were sterilised before use in the test.
An agreed weight of needles is put in the medium for a period of three (3) hours at 37˚C.