Abstract
Aim of this study was to evaluate the biocompatibility properties of a coronary artery stent following radiation sterilization (19.3 KGy). sensitisation, genotoxicity and properties of the packaging materials were tested. The results show that after the irradiation and accelerated ageing test, the sample products and the package remained effective. The device remained sterile, and no adverse responses were detected in sensitisation and genotoxicity tests. Radiation, as a sterilization method for these kind of materials, is worth generalising and applying more widely.
This is a preview of subscription content, log in via an institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsPreview
Unable to display preview. Download preview PDF.
References
Wu, L.R.: Follow the guidelines,Appropriate intervention for the treatment of coronary heart disease med and Philosophy. Clinical Decision Making Forum Edition 30(7), 14–21 (2009)
Fang, J.Y., Liu, Q.: Systematic evaluation on biocompatibility of Coronary Stents. Laboratory Animal and Comparative Med. 27, 19–122 (2007)
Zhang, T.C., Zhong, H.L., Liu, Q.: Research on dose setting for radiation sterilization of medical device. Radiat. Res. Radiat. Process 20, 103–107 (2002)
ISO11137-2 .Sterilization of health care products, Part 2: Establishing the sterilization dose, 5–16 (2006)
Hao, H.P.: Companion of biological evaluation criterion of medical devices. Standards Press, Beijing (2000)
ISO 10993-10: Biological evaluation of medical devices-part10: Tests for irritation and sensitization. 2002/Amd.1, 05–15 (2006)
ISO10993-5: Biological evaluation of medical devices-part5:Tests for in vitrocytotoxicity,1–30 (2009)
Demirel, C., Kilçiksiz, S., Ay, O.I., Gürgül, S., Ay, M.E., Erdal, N.: Effect of N-acetylcysteine on Radiation-induced Genotoxicityand Cytotoxicity in Rat Bone Marrow. J. Radiat. Res. 50, 43–50 (2009)
Hong, C.E., Lyu, S.: Genotoxicity detection of five medicinal plants in Nigeria. J. Toxicol. Sci. 36, 87–93 (2011)
Gahyva, S.M., Siqueira Jr., J.: Direct genotoxicity and mutagenicity of endodontic substances and materials as evaluated by two prokaryotic test systems. J. Appl. Oral Sci. 13, 387–392 (2005)
ISO10993-3. Biological evaluation of medical devices-part3: Tests for genotoxicity, carcinogenicity and reproductive toxicity, 1–15 (2003)
ISO11607-1.Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems, and packaging systems, 1–12 (2006)
Bunnak, J., Takigami, M., Ito, H., Shinozawa, T.: Gamma irradiation effects on cultured cells: investigated by the MTT method. J. Radiat. Res. 35, 205–212 (1994)
Holst, C.M., Oredsson, S.: Comparison of three cytotoxicity tests in the evaluation of the cytotoxicity of a spermine analogue on human breast cancer cell lines. Toxicol in Vitro 19, 379–387 (2005)
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2011 Springer-Verlag Berlin Heidelberg
About this paper
Cite this paper
Liu, W., Liu, Q., Chen, G. (2011). Evaluation of the Effects of Sterilization by Irradiation on Biocompatibility and Adaption of a Coronary Artery Stent. In: Liu, C., Chang, J., Yang, A. (eds) Information Computing and Applications. ICICA 2011. Communications in Computer and Information Science, vol 244. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-27452-7_19
Download citation
DOI: https://doi.org/10.1007/978-3-642-27452-7_19
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-642-27451-0
Online ISBN: 978-3-642-27452-7
eBook Packages: Computer ScienceComputer Science (R0)