DSM Dyneema Achieves ISO 13485 Certification for Dyneema® Purity Fiber Operations

Urmond (NL), January 31 – DSM Dyneema, the inventor and manufacturer of Dyneema®, the world’s strongest fiber, today announced its Dyneema® Purity operations have been certified under the international ISO 13485:2003 standard. Dyneema® Purity, an ultra-high-molecularweight polyethylene fiber that is, weight for weight, 15 times stronger than steel, is used in high-performance medical applications such as orthopedic surgery sutures. Supplementing the ISO 9001 standard, ISO 13485 provides certification of a quality management system dedicated to medical devices.

The assessment of Dyneema® Purity operations for conformity with the ISO 13485 standard was conducted by Bureau Veritas (BVQI). According to Eric de Boer, director BVQI the Netherlands, "DSM Dyneema is one of the very first raw material suppliers to undergo this level of certification. There is no obligation for raw material suppliers to undergo any such certification but DSM Dyneema has voluntarily solicited the same. It is clear that the company is fully committed to producing the highest quality materials for use in medical applications. Proactive adoption of this international standard demonstrates substantial professionalism on the part of DSM Dyneema."

Christophe Dardel, president of DSM Dyneema, said, “We aim to be the leading supplier of high performance fiber to the medical device industry. Therefore we want to show our commitment and focus on the high quality that the industry typically depends upon. This certification is an important milestone in reaching our goals, and confirms that we want to be a serious player in this field. We believe that suppliers that want to operate in this segment need to go above and beyond the basics in achieving the highest standards for their products.”

The ISO 13485:2003 standard, the structure of which is identical to the well-known ISO 9001:2000 standard, primarily addresses medical device manufacturers and is specifically designed to enhance the consistent manufacturing of high-quality medical devices that meet customer and regulatory requirements. Compared to the ISO 9001:2000 standard, compliance with ISO 13485 requires additional documentation such as product and process risk management, post-market evaluation, implementation of a large number of procedures, and registration of all records.

Dyneema® Purity offers exceptional strength combined with the softness of silk, plus a high level of resistance to abrasion and flex fatigue. This combination of properties makes the fiber an excellent candidate for use in high-performance medical textiles. Applications for the fiber include orthopaedic sutures which are used in arthroscopic and open repairs of ligaments and tendons.

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