Abstract
The aim of this study was to evaluate the the biocompatibility properties of central vein catheter following radiation sterilisation (8.8kGy).we conducted a series of tests including cytotoxicity, sensitisation, intracutaneous irritation test, local reaction test after implantation and tests of properties of the packaging materials. The results show that after the irradiation and accelerated ageing tests, the sample products and the package remained effective. No toxic or sensitising substances or particles were released from the central vein catheter after radiation sterilisation. After simulated storage and radiation sterilisation with the setting dose, neither physicochemical properties nor packaging capability of sample products were significantly changed, indicating that the product material is relatively stable for radiation. Therefore, radiation sterilisation is a useful method to these kind of materials, and is worth generalising and applying more widely.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Nam, K.W., Yoo, J.J., Koo, K.H., Yoon, K.S., Kim, H.J.: Optimal sterilisation method for the zirconia/alumina composites used for total hip replacements. J. Biomed. Mater. Res. B Appl. Biomater. 90, 962–966 (2009)
Brinston, R., Miller, A., Deeley, C.: Developments in radiation sterilisation. J. Med. Device Technol. 19, 36–37 (2008)
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)
ISO11137-2 .Sterilisation of health care products, Part 2: Establishing the sterilisation dose, 5–16 (2006)
Hao, H.P.: Companion of biological evaluation criterion of medical devices. Standards Press of China, Beijing (2000)
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)
ISO 10993-10: Biological evaluation of medical devices-part10: Tests for irritation and sensitization. 2002/Amd.1, 05–s15 (2006)
ISO11607-1.Packaging for terminally sterilised 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 Histocompatibility and Adaption of a Central Vein Catheter. 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_20
Download citation
DOI: https://doi.org/10.1007/978-3-642-27452-7_20
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)