Medical devices designed for use in the treatment of humans are subject to very stringent requirements in terms of their safety. This means that everyone involved in the production and the distribution of such devices usually has to first spend considerable money and time acquiring marketing authorisation for these products.
Fleima-Plastic, one of the two medical device specialists of the Masterflex Group, will be presenting at this year's Compamed fair novel medical device components made of ABS with a glass fibre content of 16%. These have a biocompatibility that meets the requirements of ISO 10993. This means that subsequent approval of any finished products made using these components will be facilitated.
"This new form of ABS has been developed after several years close collaboration with a leading manufacturer of plastics," explains Ismail Dogru, Technical Sales Consultant at Fleima-Plastic. "Thanks to the presence of the glass fibres, this ABS has an excellent elastic modulus and significantly enhanced compressive, flexural, tensile and impact strength." In addition to housings, Fleima-Plastic is also producing spikes and caps made of the innovative material. As it conforms to ISO 10993, manufacturers of medical devices who use these components will find it far easier to obtain marketing authorisation of their finished products.
This is because, despite the use of glass fibre-reinforcement, the ABS material complies with the requirements of the FDA, EU, ISO 10993 and USP Class VI. Dogru adds: "The composition of the material had to be fully specified in a Drug Master File (DMF)."
Customers are already exhibiting considerable interest. "As there is currently no other glass fibre-reinforced ABS material available that has similar official approval and the regulatory stipulations for medical devices and the materials used in them are growing ever more rigorous, we assume that this new material will become a gold standard for use in medical technical applications and particularly in spikes," concludes Dogru. The good impact resistance coupled with superb surface quality and outstanding processing characteristics mean that the material can be employed to make items with more complex geometries for medical use.
At present, items made of this material are available only from Fleima-Plastic, a member of the Masterflex Group.
