Royal DSM’s Dyneema Purity Fibers Meet Revised ASTM F2848-16 Material Specifications For Medical-Grade UHMWPE Yarns

EXTON, Pa.--(BUSINESS WIRE)--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.

“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”

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.

DSM – Bright Science. Brighter Living.™

Royal DSM is a global science-based company active in health, nutrition and materials. By connecting its unique competences in life sciences and materials sciences DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders simultaneously. DSM delivers innovative solutions that nourish, protect and improve performance in global markets such as food and dietary supplements, personal care, feed, medical devices, automotive, paints, electrical and electronics, life protection, alternative energy and bio-based materials. DSM and its associated companies deliver annual net sales of about €10 billion with approximately 25,000 employees. The company is listed on NYSE Euronext. More information can be found at www.dsm.com/medical or www.dsm.com.

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Dyneema Purity^® is a registered trademark of DSM.

Forward-looking statements

This press release may contain forward-looking statements with respect to DSM’s future (financial) performance and position. Such statements are based on current expectations, estimates and projections of DSM and information currently available to the company. DSM cautions readers that such statements involve certain risks and uncertainties that are difficult to predict and therefore it should be understood that many factors can cause actual performance and position to differ materially from these statements. DSM has no obligation to update the statements contained in this press release, unless required by law. The English language version of the press release is leading.