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Regulatory Compliance

The basis for a successful outcome in medical tests is raw material selection, only allowing raw materials that, from a medical point of view, are highly qualified. The raw materials are then compounded together under clean conditions, with high consistency.

To further assure the customer, representative grades from the Mediprene standard series (500200M and 520620M, respectively) have been tested by NAMSA in the USA for cytotoxicity according to USP <87>/ISO 10993-5 and for biocompatibility according to ISO 10993-4 (Hemolysis), ISO 10993-10 (Intracutaneous Reactivity and Sensitization), ISO 10993-11 (Acute Systemic Toxicity) and USP Class VI. All materials that were tested successfully passed (copies of the certificates are available on request).

The other compounds in the Mediprene standard series with hardness values between 20 ShA (500200M) and 62 ShD (520620M) consist of the same raw materials and would therfore probably pass if tested. Note that there is an overlap between some tests in USP Class VI and tests described in parts of ISO 10993, meaning that the material is highly likely to pass parts of ISO 10993 when having passed USP Class VI. However, be aware that it is always the responsibility of the supplier of the finished product to perform relevant tests to ensure that the complete device fulfils the compliance criteria that have been set up for the product.

Further details regarding regulatory information including Cytotoxicity test - USP <87> and ISO 10993-5, Biocompatibility tests according to USP Class VI, Systemic injection test, Intracutaneous test, Implantation test and European Pharmacopoeia (EP) are available in the Mediprene 500M Product Guide