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PVC-free meliflex XT medical tubing materials achieve ISO 10993-4 certification

Article-PVC-free meliflex XT medical tubing materials achieve ISO 10993-4 certification

Danish supplier of PVC-free materials to medical OEMs, Melitek (Alslev) has announced that its meliflex XT tubing grades have been tested to ISO 10993-4, the international standard that provides general requirements for evaluating the interaction of medical devices with blood.

"We have had strong interest in our newest meliflex XT grades not only from Europe, but also from USA and Asia", says Jesper Laursen, Business Director. "Materials are now also explored for various blood-contact applications with good results and, therefore, we have decided to certify these to ISO 10993-4 to support our customers in their qualification work."

Meliflex XT grades are available in hardnesses ranging from Shore 50A to 95A, withstand 121°C sterilization and are compatible with EtO, gamma and E-beam sterilization methods. The phthalate-, BPA- and latex-free materials are described as an environmentally sound replacement for flexible PVC and TPU.

In addition to ISO 10993-4 hemolysis testing, meliflex XT tubing grades have also passed ISO 10993-5/USP <87> in vitro testing, USP <88> in vivo testing and meet the USP <661> standard for containers and closures.

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