Materials for Medical Devices
Abstract
This article discusses several aspects of biocompatibility of polymers, including the selection of a suitable polymer, specific use of a material, contact of polymer on body site, and duration of the contact. It describes the factors influencing the biological response of the polymer from a biocompatibility perspective. These include raw materials, the manufacturing process, cleaning and sterilization processes, and biodegradation and biostability. The article reviews the general testing methods of polymers, such as chemical, mechanical and thermal. It concludes with a section on the guidance, provided by the regulatory authorities, on the biocompatibility testing of polymers and polymer-containing devices that can aid in selecting the right analysis.
Marcus Jarman-Smith, Biocompatibility of Polymers, Materials for Medical Devices, Vol 23, ASM Handbook, Edited By Roger J. Narayan, ASM International, 2012, p 135–143, https://doi.org/10.31399/asm.hb.v23.a0005667
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