ASTM Standards & Med Device Development

ASTM International standards are widely recognized for industry-leading work on creating consistency and supporting traceability for medical device development. The tagline “Helping Our World Work Better” is an excellent description of purpose. In reality, ASTM International is a volunteer organization where industry and academic collaborators develop standards to guide users in the selection, use, and analysis of materials, including critical evaluation parameters for products in development. The FDA medical device regulatory process also references the use of ASTM standards in guidance documents to support new product applications.

At Poly-Med, we apply ASTM standards on a daily basis, both to create consistency in our work but also to educate our employees and companies we work with. Making sure we are all “speaking the same language” is crucial to our success. Some key ASTM standards that guide the use of our materials include:

• ASTM F1925-09: Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants

• ASTM F2313-10: Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide

• ASTM F2579-11: Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants

• • F2902-16e1: Standard Guide for Assessment of Absorbable Polymeric Implants

It is also important to note that ASTM is continuously evaluating standards for improvement and to adapt to new technologies. This is a reason that we are involved with ASTM, in particular the F04: Medical and Surgical Materials and Devices and F42: Additive Manufacturing committees, and we uphold active status through the maintenance of existing and development of new standards.

In a recent example, we are working in the F04.11 group to develop a new standard for Polydioxanone resin. Over the past several years, we have seen interest in polydioxanone increase as it has an intermediate degradation life (6 – 8 week strength retention typical), excellent flexibility, and processing through fiber extrusion and injection molding, for example.

To support the broader adoption of this polymer, this standard compiles and addresses specific keys for identifying quality resin to give products the best chance for success. Through these efforts we expect this new standard to become approved in 2018. By working with ASTM International, we all work together towards improving products and helping those that use them.

M. Scott Taylor, Ph.D.
CTO, Poly-Med, Inc.

Contact Us if you would like more information about Poly-Med and our work with ASTM.