Exton PA, US, 11 Apr 2016 16:00 CEST
DSM Biomedical, a global leader in biomedical materials science and regenerative medicine, today announced that its medical-grade Dyneema Purity® fibers 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, which are an important component to the safety and effectiveness of medical devices.
Recognized by the U.S. Food and Drug Administration (FDA), ASTM International standards are critical to improving product quality, enhancing health and safety, and building consumer confidence. This revised standard, recently published, includes the addition of colored yarns, updated requirements for biocompatibility and biosafety risk assessment, as well as the adherence to the ISO 13485 Quality Management System. Both Dyneema Purity colored and non-colored yarns meet all the requirements as stated in this revised standard.
"The ASTM committee recognizes 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,” said Carola Hansen, Director of Biomedical Polyethylenes, DSM Biomedical. “We agree with the ASTM’s assessment and are committed to helping our customers to make high-end medical devices that meet industry standards, without compromising quality or strength.”
Dyneema Purity medical-grade UHMWPE fiber is significantly stronger than steel while maintaining high pliability and increased flexibility. The innovative UHMWPE fiber technology designed for use in medical devices, has the potential to improve therapeutic repairs that require longer lasting and stronger mechanical performance, while increasing comfort. In this way, the fibers contribute to improving quality of life for patients.
More information about DSM’s Dyneema Purity fiber can be found here.