Biomaterial Database

Radiation sterilization of polymeric implant materials. 1988

S D Bruck, and E P Mueller

Biomedical Materials and Medical Devices Consulting Group, Stephen D. Bruck Associates, Inc., Rockville, Maryland 20851.

High-energy irradiation sterilization of medical devices and implants composed of polymeric biomaterials that are in contact with tissue and/or blood, may adversely affect their long-term mechanical and/or biological performance (tissue and/or blood compatibility). Since many polymeric implants may contain trace quantities of catalysts and/or other additives, the effect of high-energy radiation on these additives, and possible synergistic effects with the polymer chains under the influence of high-energy radiation, must be considered. It is essential to indicate whether polymeric implants are used in short-term (acute) or long-term (chronic) applications. Relatively small changes in their physicochemical, mechanical, and biological properties may be tolerable in the short term, whereas similar changes may lead to catastrophic failures in long-term applications. Therefore, polymeric implants which are to be sterilized by high-energy irradiation should be carefully evaluated for long-term property changes which may be induced by the radiation.

UI	MeSH Term	Description	Entries
D011108	Polymers	Compounds formed by the joining of smaller, usually repeating, units linked by covalent bonds. These compounds often form large macromolecules (e.g., BIOPOLYMERS; PLASTICS).	Polymer
D011839	Radiation, Ionizing	ELECTROMAGNETIC RADIATION or particle radiation (high energy ELEMENTARY PARTICLES) capable of directly or indirectly producing IONS in its passage through matter. The wavelengths of ionizing electromagnetic radiation are equal to or smaller than those of short (far) ultraviolet radiation and include gamma and X-rays.	Ionizing Radiation,Ionizing Radiations,Radiations, Ionizing
D001672	Biocompatible Materials	Synthetic or natural materials, other than DRUGS, that are used to replace or repair any body TISSUES or bodily function.	Biomaterials,Bioartificial Materials,Hemocompatible Materials,Bioartificial Material,Biocompatible Material,Biomaterial,Hemocompatible Material,Material, Bioartificial,Material, Biocompatible,Material, Hemocompatible
D013242	Sterilization	The destroying of all forms of life, especially microorganisms, by heat, chemical, or other means.
D019736	Prostheses and Implants	Artificial substitutes for body parts, and materials inserted into tissue for functional, cosmetic, or therapeutic purposes. Prostheses can be functional, as in the case of artificial arms and legs, or cosmetic, as in the case of an artificial eye. Implants, all surgically inserted or grafted into the body, tend to be used therapeutically. IMPLANTS, EXPERIMENTAL is available for those used experimentally.	Implants, Artificial,Prostheses and Implant,Prosthesis,Prosthetic Implant,Endoprostheses,Endoprosthesis,Prostheses,Prosthetic Implants,Artificial Implant,Artificial Implants,Implant and Prostheses,Implant, Artificial,Implant, Prosthetic,Implants and Prostheses,Implants, Prosthetic