Kraiburg Thermolast M TPEs Approved for Blood and Drug Contact Under ISO 10993-4

German manufacturer of specialist TPEs Kraiburg has announced it has tested its Thermoplast M brand of medical grades to ISO10993-4. This signifies that they are approved for the processing up to the direct contact with blood or medicine. According to the company, this and the first-time possibility of compliant colouring to medical standards result in completely new applications for the Thermolast brand.

The press release announcing the news states that Thermolast M compounds are already certified according to DIN ISO 10993-5, -10, -11, USP Class VI, USP 661. With ISO 10993-4, the compounds can be used for seals of infusion systems, medical tubes, and functional parts of for example dialysis machines and in surgical areas.

In terms of colouring, Kraiburg offers a special service whereby compounds are certified to ISO 10993-5 cytotox after colouring.