DSM’s Dyneema Purity® Fibers Meet Revised ASTM F2848-16 Material Specifications for Medical-Grade UHMWPE Yarns
April 11 2016 - 10:00AM
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.
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.
Or find us on: Facebook, Twitter, LinkedIn, and YouTube
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.
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Chandler Chicco AgencySherri
Jaffe312-861-0033Sherri.Jaffe@inventivhealth.com