Guidance on transferring health care products between radiation sterilization sources
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For further reading:
AAMI TIR40, Sterilization of Health Care Products - Radiation - Guidance on Dose Setting Utilizing a Modified Method 2
Croonenborghs, B, Smith, MA, and Strain, P. (2007). X-ray versus gamma effects on polymers, Radiation Physics and Chemistry, 76:1676-1678
Dawes, K, Glover, LC, and Vroom, DA. (2007). “The Effects of Electron Beam and G-Irradiation on Polymeric Materials.” Physical Properties of Polymers Handbook, 867-87
Device and Diagnostic Industry News, posted in Medical Plastics, 2/1/2000
Fairand, BP. (2002). Radiation Sterilization for Health Care Products, CRC Press
Fifield, L, Pharr, M, Staack, D, Pillai, S, Nichols, L, McCoy, J, Faucette, T, Bisel, T, Huang, M, Hasan, K, Perkins, L, Cooley, S, Murphy, M. (2021). Direct Comparison of Gamma, Electron Beam and X-ray Irradiation Doses on Characteristics of Low-density Polyethylene, Polypropylene Homopolymer, Polyolefin Elastomer and Chlorobutyl Rubber Medical Device Polymers. Radiation Physics and Chemistry. 186, 109505
Gunay, S, Mine & Ozer, Yekta. (2009). Sterilization methods and the comparison of E-Beam sterilization with gamma radiation sterilization. FABAD J Pharm Sci. 34. 43-53
Hansen, JM, and Shafer, HL. (2001). Chapter 37, Sterilization and Preservation by Radiation Sterilization in Seymour Stanton Block, Disinfection, Sterilization, and Preservation (Lippincott Williams & Wilkins), 2001
Hemmerich, KJ. Polymer Materials Selection for Radiation-Sterilized Products, MDDI Medical
Hinkelmann, K, Kempthorne, O. (2007) Design and Analysis of Experiments, Volume 1: Introduction to Experimental Design, 2nd Edition, Wiley Press
Izdebska, J and Thomas, S. (2016) “Aging and Degradation of Printed Materials” in Printing on Polymers: Fundamentals and Applications, Pages 353-370, Elsevier
Jonah, C. (1995). A Short History of the Radiation Chemistry of Water. Radiation Research, 144(2), 141-147.
Kroc - PI, TK, Thangaraj, JCT, Penning, RT, Kephart, RD. (2017) Accelerator-driven Medical Sterilization to Replace Co-60 Sources. A study submitted to NNSA performed by Fermi National Accelerator Laboratory, August 11, 2017
Logar JR and Daniell E. (2020) “Sterilization and Preservation by Radiation” Chapter 29 in Block’s Disinfection, Sterilization, and Preservation, sixth edition, Gerald McDonnell and Joyce Hansen, editors, Wolters-Kluwer, Philadelphia
Loo, SCJ, Tan, HT, Ooi, CP, Boey, YCF. (2006). “Hydrolytic degradation of electron beam irradiated high molecular weight and non-irradiated moderate molecular weight PLLA.” Acta Biomaterialia 2.3: 287-296
Meissner, J, et. al. (2000). X-ray treatment at 5 MeV and above, Radiation Physics and Chemistry. 57: 647-651
Montgomery, DC. (2019). Design and Analysis of Experiments, Wiley Press
Odelius, K, Plikk, P, and Albertsson, AC. (2008). “The influence of composition of porous copolyester scaffolds on reactions induced by irradiation sterilization.” Biomaterials, 29.2: 129-140
Pribil, W, Gehringer, P, Eschweiler, H, Cabaj, A, Haider, T, Sommer, R. (2007). Assessment of Bacillus subtilis spores as a possible bioindicator for evaluation of the microbicidal efficacy of radiation processing of water. Water Environment Research, 79(7):720-4
Sargin, I and Beckman, SP. (2020). “Modeling the effect of dose rate and time on crosslinking and scission in irradiated polyethylene,” in IEEE Transactions on Dielectrics and Electrical Insulation, vol. 27, no. 3, pp. 731-738, June 2020
Smith, M, Lundahl, B, and Strain, P. (2005). Effects of X-ray irradiation on material properties. Medical Device Technology, 16:16-18
Tohfafarosh, M, et. al. (2016). Effects of gamma and e-beam on the chemical, mechanical and tribological properties of a novel hydrogel. Journal of the Mechanical Behavior of Biomedical Materials, 53, 250-256
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