Radiation Effect on Polymer Materials Commonly Used in Medical Devices

The overall objective of this CRP is to expand our understanding of radiation effects on polymer materials common for medical devices by comparing gamma, e-beam, and x-ray irradiation. The research outputs covering material and mechanical studies, dosimetry, process control and technology will include peer-reviewed journal articles, book chapters, reports, user cases, technical presentations, etc.
We propose the studies to focus on the polymers commonly used in medical industry, including low density polyethylene (LDPE), polypropylene (PP), poly (ether-block-amide) thermoplastic elastomers (PEBA), polytetrafluoroethylene (PTFE), and others. However, biopolymers (e.g., biodegradable polyesters like polylactic acid, polyglycolic acid, polysaccharides, and collagen) can also be of interest. Bioresorbable implants sterilization or crosslinking applications such as for ultra-high molecular weight polyethylene (UHMWPE) are of particular interest, where differences in irradiation conditions are expected to introduce a significant difference in critical attributes of products. Such effects are believed less likely to occur for the majority of product currently sterilized using ionizing radiation. For example, it has been reported by a patent of IMEDEX Biomateriaux [2] that collagen presents significantly different biodegradation resistances, depending on the radiation mode (e-beam versus gamma-ray). The effect of additives (e.g., anti-oxidants, stabilizers, friction lubricant, plasticizers), mainly present in dominant polymers, should also be considered (investigation of radiation-induced by-products and/or leachables).