Abstract
The variability associated with most of the biological evaluation studies is relatively large and hence experimental controls are frequently employed to ensure that the results are reliable. These experimental controls, either positive or negative controls, could be considered as reference materials in the context of biological evaluation. Currently, reference biomaterial needs across the world are not addressed satisfactorily. Affordability and lack of availability of certified reference materials necessitates the development and the use of laboratory developed RMs. A well defined characterization strategy is essential for the successful development of in house reference materials. This article provides an overview of the current international status in the area of reference biomaterials and enumerates the steps involved in the development of an in house reference material. The production and characterization of commercially pure titanium pins for use as negative controls during muscle implantation studies is presented as a case study.
Similar content being viewed by others
References
International Organisation for Standardization, ISO Guide 30: Terms and Definitions Used in Connection with Reference Materials (1992)
International Organization for Standardization, ISO Vim : International Vocabulary of Basic and General Terms in Metrology (2004, Draft)
A.E. Mayer, in Reference Materials, ed. by A.F. Von Recum. Handbook of Biomaterials Evaluations. Scientific, Technical, and Clinical Testing of Implant Materials (Taylor & Francis, Philadelphia, 1999), p. 195
A.F. Von Recum, M.E. Jenkins, H.A. Von Recum, in Introduction: Biomaterials and Biocompatibility, ed. by A.F. Von Recum. Handbook of Biomaterials Evaluations. Scientific, Technical, and Clinical Testing of Implant Materials (Taylor & Francis, Philadelphia, 1999), p. 1
National Heart, Lung and Blood Institute, in Guidelines for Blood-Material Interactions, NIH Publication No: 80-2185 (NIH, Washington DC, 1980)
M.-C. Belanger, Y. Marois, J. Biomed. Mater. Res. Appl. Biomater. 58, 467 (2001)
H. Pelzer, N. Heimburger, J. Biomed. Mater. Res. 20, 1401 (1986)
B.P., Muller, E. Silke, D. Wolfgang, H. Juliane, J. Biomed. Mater. Res. 61, 83 (2002)
T. Tsuchiya, J. Biomed. Mater. Res. 9, 138 (1994)
T. Tsuchiya, T. Arai, J. Ohhashi, K. Imai, H. Kojima, S. Miyamoto, H. Hata, Y. Ikarashi, K. Toyoda, M. Takahashi, A. Nakamura, J. Biomed. Mater. Res. 27, 885 (1993)
M.V. Sefton, W.F. IP, J. Biomed. Mater. Res. 25, 1321 (1991)
J.A.Tesk, J. Biomed. Mater. Res. 51, 155 (2000)
J.A. Tesk, J. Biomed. Mater. Res. Appl. Biomater. 58, 466 (2001)
International Organisation for Standardization, ISO Guide 34: General Requirements for the Competence of Reference Material Producers (2000)
International Organisation for Standardization, ISO 10993-6: Biological Evaluation of Medical Devices-Part 6: Tests for Local Effects after Implantation (2007)
American Society for Testing and Materials, ASTM F-67: Unalloyed Titanium for Surgical Implant Applications (2006)
International Organisation for Standardization, ISO 5832-2: Implants for Surgery––Metallic Materials––Unalloyed Titanium (1999)
C. Olin, in Titanium in Cardiac and Cardiovascular Applications, ed. by D.M. Brunette, P. Tengvallet, M. Textor, P. Thomsen. Titanium in Medicine (Springer-Verlag Heidelberg, New York, 2001), p. 890
S.H. Hsu, B.-S. Lau, W.-H. Lin, H.-C. Chiang, C.-C. Huang, S.-S. Cheng, Bio. Med. Mater. Eng. 17, 53 (2007)
M. Therin, A. Meunier, P. Christel, J. Mater. Sci. Mater. Med. 2, 1–8 (1991)
B.D. Ratner, in A perspective on Titanium Biocompatibility, ed. by D.M. Brunette, P. Tengvallet, M. Textor, P. Thomsen. Titanium in Medicine (Springer-Verlag Heidelberg, New York, 2001), p. 1
P.H. Pennekamp, J. Gessmann, O. Deidrich, B. Burian, M.A. Wimmer, V.M. Frauchiger, C.N. Kraft, J. Orthop. Res. 24(3), 531–40 (2006)
C.V. Muraleedharan, G.S. Bhuvaneshwar, Metals Mater. Process. 18(3/4), 441 (2006)
International Organisation for Standardization, ISO Guide 35: Certification of Reference Materials-General and Statistical Principles for Certification (1989)
International Organisation for Standardization, ISO 10993-8: Biological Evaluation of Medical Devices-Part 8: Selection and Qualification of Reference Materials for Biological Tests (2000)
International Organisation for Standardization, ISO 10993-5: Biological Evaluation of Medical Devices-Part 5: Tests for In Vitro Cytotoxicity (1999)
International Organisation for Standardization, ISO 10993-4: Biological Evaluation of Medical Devices- Part 4: Selection of Test for Interactions with Blood (2002)
L.K. Krishnan, N. Varghese, C.V. Muraleedharan, G.S. Bhuvaneshwar, F. Derange, Y. Sampeur, R. Suryanarayanan, Bimol. Eng. 19, 251 (2002)
International Organisation for Standardization, ISO Guide 35: Reference Materials-General and Statistical Principles For Certification (2006)
United Kingdom Accreditation Service (UKAS), M 3003, The Expression of Uncertainty and Confidence in Measurement, 2nd edn. (2007)
International Organisation for Standardization, ISO 10993-12: Biological Evaluation of Medical Devices. Part 12: Sample Preparation and Reference Materials (2007)
Acknowledgements
The authors wish to acknowledge the support of the divisions of Precision Fabrication Facility, Scanning Electron Microscope, Tissue Culture, Thrombosis Research Unit and Toxicology of the Institute for their invaluable contributions in the characterization of the materials.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Joseph, L., Velayudhan, A., Charuvila, M.V. et al. Reference biomaterials for biological evaluation. J Mater Sci: Mater Med 20 (Suppl 1), 9–17 (2009). https://doi.org/10.1007/s10856-008-3522-2
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10856-008-3522-2