XT now ISO 10993-4 compliant
We are pleased to announce that our meliflex XT tubing grades have passed the requirements of the ISO 10993-4 hemolysis testing.
meliflex XT tubing grades have for years set the standard in non-PVC medical tubing and has been used in numerous applications.
Recently, we introduced our latest XT generation that has been well-received in the market for their enhanced properties and improved costs. Now, we are pleased to announce that these has been tested and proven to pass ISO 10993-4 hemolysis testing.
"We have had a strong interest in our newest meliflex XT grades not only from Europe, but also from USA and Asia", says Jesper Laursen, Business Director at MELITEK.
"Materials are now also explored for various blood contact applications with good results and therefore, we decided to certify these to ISO 10993-4 to support our customers in their qualification work", he adds.
meliflex XT grades are available in a wide range of shore durometer hardness ranging from Shore 50A-95A and withstand sterilization at 121°C, EtO, gamma and E-beam. meliflex XT tubing grades offer an environmentally sound replacement for materials such as flexible PVC and TPU and are phthalate-free, BPA-free and latex-free. In addition to ISO 10993-4 hemolysis testing, meliflex XT tubing grades have already successfully passed the requirements of ISO 10993-5 / USP <87> in vitro testing, USP <88> in vivo testing and the USP <661> standard.