DSM Biomedical has announced that its medical-grade Dyneema Purity fibres fully meet the requirements of ASTM International’s revised standard F2848-16 for medical-grade ultra-high-molecular-weight polyethylene (UHMWPE) yarns. The standard establishes clear requirements for medical-grade UHMWPE yarns.
Recognised by the US Food and Drug Administration (FDA), ASTM International standards are critical to improving product quality, enhancing health and safety, and building consumer confidence, according to a company release. This revised standard, recently published, includes the addition of coloured yarns, updated requirements for biocompatibility and biosafety risk assessment, as well as the adherence to the ISO 13485 Quality Management System. Both Dyneema Purity coloured and non-coloured yarns meet all the requirements as stated in this revised standard, according to a the release.
“The ASTM committee recognises that UHMWPE yarn is an important component in the design of medical devices which needed more clearly defined requirements for biocompatibility and biosafety risk assessment,” says Carola Hansen, director of Biomedical Polyethylenes, DSM Biomedical.
The US Food and Drug Administration (FDA) has previously cleared DSM Biomedical’s Dyneema Purity radiopaque cerclage cable for use in orthopaedic trauma treatments, such as the treatment of spine fractures. This cable is made using the company’s UHMWPE medical fibre.