Quality and Approvals
Evonik has established a product portfolio that is build on the specific quality, process and performance requirements demanded by the medical industry.
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 10993-1 and DIN EN 10993-1. 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.
The following products passed the tests according to USP, Class VI, the highest classification of the United States Pharmacopeia (requirements in conformity with ISO 10993). They are therefore suitable for the manufacture of medical products. Furthermore please find more test results in the table below: cytotoxicity according to ISO 10993-5, irritation and delayed-type hypersensitivity according to ISO 10993-10, systemic toxicity according to ISO 10993-11, and hemo-compatibility according to ASTM F756-08.
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| Polymer | USP Class VI | ASTM F756-08 | ISO 10993-5 | ISO 10993-10 | ISO 10993-11 |
|---|---|---|---|---|---|
| VESTAMID® Care ML 16 | X | X | X | X | X |
| VESTAMID® Care ML 17 | X | X | X | X | X |
| VESTAMID® Care ML 18 | X | X | X | X | X |
| VESTAMID® Care ML 19 | X | X | X | X | X |
| VESTAMID® Care ML 21 | X | X | X | X | X |
| VESTAMID® Care ML 67 | X | X | X | X | X |
| VESTAMID® Care ML 94 | X | X | X | X | X |
| VESTAMID® Care ML 24 | X | X | X | X | X |
| VESTAMID® Care ML GB30 | X | X | X | X | X |
| VESTAMID® Care ME 26 | X | X | X | ||
| VESTAMID® Care ME 40 | X | X | X | X | X |
| VESTAMID® Care ME 47 | X | X | X | X | X |
| VESTAMID® Care ME 55 | X | X | X | X | X |
| VESTAMID® Care ME 62 | X | X | X | X | X |
| VESTAMID® Care ME 71 | X | X | X | X | X |