A glass fibre filled medical polymer grade, Novodur HD M203FC G3, is going to be a first choice material for healthcare applications such as medical spikes, as well as for medical applications requiring structural stability and high flowability.
In addition to its regulatory compliance for selected applications, the product’s characteristics such as good impact strength, surface quality and processability mean that it can even be used to produce complex geometrics.
Alexander Silvestre, Global Director for Healthcare at Styrolution, said:
This is the first glass fibre filled polymer grade to be offered with the full complement of healthcare compliance documents worldwide.
Most importantly, the material was designed to meet strict regulatory requirements. The glass fibre reinforcement and the ABS material comply with the requirements of USP Class VI, selected ISO 10993 biocompatibility standards and various food contact regulation.
The regulatory compliance makes certification of the end product much easier for device manufacturers, no matter where in the world they want to launch products. Due to its unique properties and regulatory compliance, Novodur HD M203FC G3 has the potential to become a global standard material for healthcare applications.
In addition to housings, Fleima Plastic (Masterflex Group) will also manufacture spikes and caps made with Novodur HD M203FC G3. This makes Fleima Plastic the first manufacturer releasing products that exploit the properties of this new medical polymer grade.
Thanks to these special glass fibres, this ABS material has significantly improved compression, bending, tensile and impact strength.
The challenge was to create a material with the required stiffness. Products must not bend, so they are reinforced with glass fibre to achieve the required stiffness, while still being regulatory compliant.
“Thanks to these special glass fibres, this ABS material has an exceptionally high E-modulus and a significantly improved compression, bending, tensile and impact strength,” says Ismail Dogru, Key Account Manager at Fleima Plastic.
