Introduction to Polymer Materials in Medical Devices – from a Biocompatibility Risk Perspective

The course provides a fundamental understanding of polymer materials, with an emphasis on commonly used plastics in medical devices, focusing on their chemical composition, properties, and potential safety implications from a polymer-chemists point of view.

Course objective and outcome

This course provides a foundational understanding of polymer materials, with an emphasis on commonly used plastics in medical devices, focusing on their chemical composition (including additives, stabilizers, monomers, etc.), properties, and potential safety implications from a polymer-chemists point of view.

Participants will gain insights into polymer chemistry, both as plastics and adhesives, their degradation processes, common additives, with a focus on the impact of these factors on biocompatibility and regulatory compliance. Throughout the course, there will be a strong emphasis on the relationship between the chemical composition of polymer materials and their inherited risks of providing small molecular/low boiling point chemicals, from either production phase, user phase, or degradation such as thermal, UV or similar instances.

Through fundamental understanding of the materials, the course will equip attendees with the knowledge to make informed decisions regarding material selection and risk assessment for medical device applications, and just maybe a new viewpoint for evaluating material risks.

Content

General Introduction to Polymer Materials

Participants will get a comprehensive overview of polymer science, including the distinction between thermoplastics and thermosets, common polymer structures, and the role of additives and stabilizers. Special attention will be given to small molecules, such as additives, stabilizers, monomers, and potential degradation products as they are the core attention when evaluating material risks in medical devices.

Adhesives

Participants will get an in-depth look at the chemistry and applications of various adhesive types, including UV-curable adhesives, solvent-based adhesives, and cyanoacrylate adhesives. Curing mechanisms, risks, and potential degradation products will be presented.

Plastics in Medical Devices

Selected materials commonly used in the sector will be described independently, such as PC, PET, PVC, Polyurethane, and rubbers

This is an onsite course, however, it is possible to participate online. During the course there will be material samples that online participants will not have the opportunity to touch. The instructor will try to show the samples to the camera.

Who should attend

This course is designed for professionals in the medical device industry, including biocompatibility specialists, quality control professionals, design engineers, and anyone involved in material selection and risk assessment for medical devices.

Trainer

Andreas Sommerfeldt, Specialist, ph.d. Teknologisk Institut

What previous participants said

Contact

Morten Petersen

Uddannelseskonsulent

49 18 47 03
mp@medicoindustrien.dk