Medical Technology

For use of materials in medical applications, Directive 93/42/EEC applies in the European Union; this was transposed into German law as the Medical Devices Act in August 1994. The approval procedure is regulated in detail by the corresponding international and national standards such as ISO 10993 and DIN EN 30993-1. In individual cases, the regulations in the current German Pharmacopoeia (DAB) and the European Pharmacopoeia can also be used to aid in the assessment. In cases of doubt, the moldings or semi-finished products must be investigated by the manufacturer or user under actual usage conditions.

Processors of S1-stabilized VESTAMID^® E molding compounds have approvals for medical technology applications such as catheter production.