Certified: New biocompatible ball bearing material for medical technology

The plastics manufacturer igus is expanding its range for medical technology with Xirodur MT180, a material for lightweight, lubrication-free and hygienic xiros deep groove ball bearings - certified according to USP Class VI and DIN EN ISO 10993.

Thanks to the certified biocompatibility of the material, medical technology manufacturers are now on the safe side and save time and costs in the approval of their products.

More and more frequently, OEMs are replacing metal components such as deep groove ball bearings with counterparts made of high-performance plastic. The advantage: these run without lubrication, are maintenance-free and yet have low friction and are hygienic. 

"We invest a lot of energy in R&D to bring materials to market that are already certified to the strictest standards in the world. Materials that medical technology manufacturers can use without hesitation," says Marcus Semsroth, Head of Business Unit xiros Polymer Ball Bearings at igus. "One of our latest developments is xirodur MT180, a biocompatible material from which lightweight, hygienic and non-magnetic xiros deep groove ball bearings can be manufactured."

Even approved for contact with bloodstream

The new ball bearings made of xirodur MT180 are suitable, for example, for bioreactors that cultivate microorganisms in a nutrient medium. Such reactors played a crucial role in the production of RNA vaccines during the Covid 19 pandemic. The ball bearings can be used here in the agitator, for example. 

The fact that they do not become a contamination hazard at this point is proven by a classification according to USP 88 Class VI of the so-called United States Pharmacopeia (USP). "Our new material xirodur MT180 has thus reached the highest biocompatibility class," says Semsroth. In this class, the high-performance plastic is even approved for contact with the bloodstream and is thus as biocompatible as implant materials. The material also complies with DIN EN ISO 10993 for medical products.

Suitable for prostheses, laboratory equipment and hospital beds

The single-row xiros deep groove ball bearings consist of four components: an inner and outer race, a cage and the race balls. The cage and races are injection moulded from xirodur MT180. The balls are made of either stainless steel or glass. When using glass balls, the bearings are completely non-magnetic and electrically insulating. This makes them suitable for magnetic resonance imaging (MRI). These ball bearings are not only suitable for biorectors and MRI, but also for prostheses and orthoses, X-ray robots, laboratory equipment and hospital beds.