This article discusses the several aspects of biocompatibility of polymers, including selection of a suitable polymer, specific use of a material, contact of polymer on body site, and duration of the contact. It describes factors influencing the biological response to the polymer in a biocompatibility perspective. These include raw materials, manufacturing process, cleaning and sterilization, and biodegradation and biostability. The article reviews the general testing of polymer, such as chemical, mechanical and thermal tests, to ensure that the polymer is stable and has not been adversely altered due to sterilization or processing. It concludes with a description of 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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