Skip to main content
Article
Licensed
Unlicensed Requires Authentication

Biocompatibility of biomaterials and test methods: a review

  • Altun Buse Karakullukcu, born in 1996, received her BS in Mechanical Engineering, Kocaeli University in 2022. She worked as an undergraduate research assistant between 2017 and 2019 in Kocaeli University Mechanical Engineering Department. She worked on material testing and material characterization. She is working as a visitor researcher in Trinity College Dublin.

         ,

    Prof. Dr. Emel TABAN, born in 1980, received her BS, MSc, and Ph.D. in Mechanical Engineering in 2002, 2004, and 2007, respectively. She has been working as a Professor in the Department of Mechanical Eng. of Kocaeli University and is the Vice Director of the Welding Research Center. She has over 100 publications and books on welding technologies, weldability and the welding metallurgy of stainless steel, high alloyed steel, and aluminum alloys using conventional and advanced welding processes.

     EMAIL logo     and

    Dr. Olatunji Oladimeji Ojo was born in 1983, in Akure, Nigeria. He worked as a Research Assistant from 2010 to 2012 and presently holds the position of Senior Lecturer at The Federal University of Technology Akure, Ondo State, Nigeria. He obtained his BEng in Mechanical Engineering and MEng. in Production Engineering from the School of Engineering and Engineering Technology, The Federal University of Technology, Akure, Nigeria in 2008 and 2012, respectively. He completed his Ph.D. in 2016 at Kocaeli University. His current research interests cover welding engineering technologies and material characterizations.
Published/Copyright: April 27, 2023
Become an author with De Gruyter Brill
Submit Manuscript Author Information
Materials Testing
From the journal Materials Testing Volume 65 Issue 4

Abstract

Biomaterials research has gained considerable momentum recently. The development of technology and the changing human lifestyles have also changed human health needs. The developed materials for use in different areas like in medical products and living bodies have necessitated adding biocompatibility to the mechanical, physical, and chemical properties of these materials. This article is a review of the concept and evaluation of biocompatibility. It explains how biomaterials change with the development of technology, human changing lifestyles, and needs, and how these materials are developed with the same technology. It contains what biocompatibility is, the factors that affect biocompatibility, what can happen in case of low biocompatibility, and the standards and work plans required for tests such as hemocompatibility, genotoxicity, toxicokinetic, and immunotoxicology for biocompatibility..

Keywords: biocompatibility; biomaterials; biotechnology; implants; toxicology
Corresponding author: Emel Taban, Department of Mechanical Engineering, and Welding Research Center, Kocaeli University, Kocaeli, 41001, Türkiye, E-mail:

About the authors

Altun Buse Karakullukcu

Altun Buse Karakullukcu, born in 1996, received her BS in Mechanical Engineering, Kocaeli University in 2022. She worked as an undergraduate research assistant between 2017 and 2019 in Kocaeli University Mechanical Engineering Department. She worked on material testing and material characterization. She is working as a visitor researcher in Trinity College Dublin.

Emel Taban

Prof. Dr. Emel TABAN, born in 1980, received her BS, MSc, and Ph.D. in Mechanical Engineering in 2002, 2004, and 2007, respectively. She has been working as a Professor in the Department of Mechanical Eng. of Kocaeli University and is the Vice Director of the Welding Research Center. She has over 100 publications and books on welding technologies, weldability and the welding metallurgy of stainless steel, high alloyed steel, and aluminum alloys using conventional and advanced welding processes.

Olatunji Oladimeji Ojo

Dr. Olatunji Oladimeji Ojo was born in 1983, in Akure, Nigeria. He worked as a Research Assistant from 2010 to 2012 and presently holds the position of Senior Lecturer at The Federal University of Technology Akure, Ondo State, Nigeria. He obtained his BEng in Mechanical Engineering and MEng. in Production Engineering from the School of Engineering and Engineering Technology, The Federal University of Technology, Akure, Nigeria in 2008 and 2012, respectively. He completed his Ph.D. in 2016 at Kocaeli University. His current research interests cover welding engineering technologies and material characterizations.

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: None declared.

  3. Conflict of interest statement: The authors declare no conflicts of interest regarding this article.

References

[1] S. Sharma, T. T. Aiswarya, I. Mirza, and S. Saha, “Biocompatible polymers and their applications,” in Encyclopedia of Materials: Plastics and Polymers, Sawston, UK, Woodhead Publishing, 2022, pp. 796–819.10.1016/B978-0-12-820352-1.00044-4Search in Google Scholar

[2] W. Du, Z. Li, Y. Zhao, et al.., “Biocompatible and breathable all-fiber-based piezoresistive sensor with high sensitivity for human physiological movements monitoring,” Chem. Eng. J., vol. 446, 2022, p. 137268, https://doi.org/10.1016/j.cej.2022.137268.Search in Google Scholar

[3] Y. Wang, H. Ouyang, Y. Xie, et al.., “Mechanically robust, biocompatible, and durable PHEMA-based hydrogels enabled by the synergic effect of strong intermolecular interaction and suppressed phase separation,” Polymer, vol. 254, p. 125083, 2022, https://doi.org/10.1016/j.polymer.2022.125083.Search in Google Scholar

[4] K. Bashandeh, A. Amiri, A. Rafieerad, et al.., “MXene-aromatic thermosetting copolyester nanocomposite as an extremely wear-resistant biocompatible implant material for osteoarthritis applications,” Appl. Surf. Sci., vol. 600, p. 154124, 2022, https://doi.org/10.1016/j.apsusc.2022.154124.Search in Google Scholar

[5] T. Xiang, W. Bao, M. Zhao, P. Du, Z. Cai, and G. Xie, “Ultra-high strength TiZrNbTa high entropy alloy substrate coated by coral-like metal oxide nanotubes to enhance biocompatibility,” J. Alloys Compd., vol. 923, p. 166408, 2022, https://doi.org/10.1016/j.jallcom.2022.166408.Search in Google Scholar

[6] C. M. Franca, G. de Souza Balbinot, D. Cunha, V. de Paulo Aragão Saboia, J. Ferracane, and L. E. Bertassoni, “In-vitro models of biocompatibility testing for restorative dental materials: from 2D cultures to organs on-a-chip,” Acta Biomater., vol. 150, pp. 58–66, 2022, https://doi.org/10.1016/j.actbio.2022.07.060.Search in Google Scholar PubMed PubMed Central

[7] S. U. Zaman, S. Rafiq, A. Ali, et al.., “Recent advancement challenges with synthesis of biocompatible hemodialysis membranes,” Chemosphere, vol. 307, p. 135626, 2022, https://doi.org/10.1016/j.chemosphere.2022.135626.Search in Google Scholar PubMed

[8] C. Guttridge, A. Shannon, A. O’Sullivan, K. J. O’Sullivan, and L. W. O’Sullivan, “Biocompatible 3D printing resins for medical applications: a review of marketed intended use, biocompatibility certification, and post-processing guidance,” Annal. 3D Print. Med., vol. 5, p. 100044, 2022, https://doi.org/10.1016/j.stlm.2021.100044.Search in Google Scholar

[9] S. Shankar, R. Nithyaprakash, and B. R. Santhosh, “Short term tribological behavior of ceramic and polyethylene biomaterials for hip prosthesis,” Mater. Test., vol. 63, no. 5, pp. 470–473, 2021. https://doi.org/10.1515/mt-2020-0080.Search in Google Scholar

[10] Z. Yu, M. Duan, J. Hu, and H. Yang, “Preparation of graphene oxide coatings on textured Ti6Al4V by laser micromachining and electrophoretic deposition for improved biocompatibility,” Opt Laser. Technol., vol. 154, p. 108342, 2022, https://doi.org/10.1016/j.optlastec.2022.108342.Search in Google Scholar

[11] X. Bao, T. Juma, X. Li, et al.., “β duplex phase Ti-Zr-Nb-Ag alloys with impressive mechanical properties, excellent antibacterial and good biocompatibility,” J. Mater. Res. Technol., vol. 19, pp. 5008–5016, 2022, https://doi.org/10.1016/j.jmrt.2022.07.007.Search in Google Scholar

[12] C. Zhang, X. Zhang, S. Chen, et al.., “In situ decoration of TiO2 nanowire microspheres with silk fibroin for enhanced biocompatibility,” Mater. Lett., vol. 324, p. 132688, 2022, https://doi.org/10.1016/j.matlet.2022.132688.Search in Google Scholar

[13] M. Singh, R. Singh, and M. K. Dhami, “Biocompatible thermoplastics as implants/scaffold,” in Encyclopedia of Materials: Plastics and Polymers, Oxford, UK, Elsevier, 2022, pp. 47–55.10.1016/B978-0-12-820352-1.00012-2Search in Google Scholar

[14] M. Ge, D. Xie, C. Jiao, et al.., “Mechanical properties and biocompatibility of MgO/Ca3(PO4)2 composite ceramic scaffold with high MgO content based on digital light processing,” Ceram. Int., vol. 48, pp. 21175–21186, 2022, https://doi.org/10.1016/j.ceramint.2022.04.010.Search in Google Scholar

[15] P. Sengar, K. Chauhan, and G. A. Hirata, “Progress on carbon dots and hydroxyapatite based biocompatible luminescent nanomaterials for cancer theranostics,” Trans. Oncol., vol. 24, p. 101482, 2022, https://doi.org/10.1016/j.tranon.2022.101482.Search in Google Scholar PubMed PubMed Central

[16] S. A. Graham, H. Patnam, P. Manchi, M. Paranjapi, A. Kurakula, and J. S. Yu, “Biocompatible electrospun fibers-based triboelectric nanogenerators for energy harvesting and healthcare monitoring,” Nano Energy, vol. 100, p. 107455, 2022, https://doi.org/10.1016/j.nanoen.2022.107455.Search in Google Scholar

[17] R. Guo, S. Li, S. Chen, et al.., “Synthesis of hydroxyapatite whisker membranes for use as biocompatible and recyclable filters for bacterial removal,” J. Phys. Chem. Solids, vol. 170, p. 110901, 2022, https://doi.org/10.1016/j.jpcs.2022.110901.Search in Google Scholar

[18] M. E. Çetin, G. Polat, M. Tekin, A. B. Batibay, and H. Kotan, “Effect of Y addition on the structural transformation and thermal stability of Ti-22Al-25Nb alloy produced by mechanical alloying,” Mater. Test., vol. 63, no. 7, pp. 599–605, 2021. https://doi.org/10.1515/mt-2020-0099.Search in Google Scholar

[19] A. Jain, S. Wadhawan, and S. K. Mehta, “Biogenic synthesis of biocompatible L-lysine coated hematite NPs for seed germination,” Inorg. Chem. Commun., vol. 136, pp. 109169, 2022, https://doi.org/10.1016/j.inoche.2021.109169.Search in Google Scholar

[20] T. Hwang, H. J. Lee, S. Hwang, et al.., “Self-adhesive polyurethane via selective photo-polymerization for biocompatible epidermal soft sensor and thermal heater,” Appl. Mater. Today, vol. 27, p. 101479, 2022, https://doi.org/10.1016/j.apmt.2022.101479.Search in Google Scholar

[21] X. Wei, J. Ma, S. Ma, P. Liu, H. Qing, and Q. Zhao, “Enhanced anti-corrosion and biocompatibility of a functionalized layer formed on ZK60 Mg alloy via hydroxyl (OH-) ion implantation,” Colloids. Surf. B: Biointerfaces, vol. 216, p. 112533, 2022, https://doi.org/10.1016/j.colsurfb.2022.112533.Search in Google Scholar PubMed

[22] T. Wang, S. Jia, Y. Xu, et al.., “Improving the corrosion resistance and biocompatibility of magnesium alloy via composite coatings of calcium phosphate/carbonate induced by silane,” Prog. Org. Coat., vol. 163, p. 106653, 2022, https://doi.org/10.1016/j.porgcoat.2021.106653.Search in Google Scholar

[23] L. Bai, Y. Wang, L. Chen, et al.., “Preparation of functional coating on magnesium alloy with hydrophilic polymers and bioactive peptides for improved corrosion resistance and biocompatibility,” J. Magnes. Alloy., vol. 10, pp. 1975–1971, 2022 https://doi.org/10.1016/j.jma.2022.05.023.Search in Google Scholar

[24] D. Zhang, J. Tan, H. Du, S. Qian, and X. Liu, “Comparison study of Mg(OH)2, Mg-Fe LDH, and FeOOH coatings on PEO-treated Mg alloy in anticorrosion and biocompatibility,” Appl. Clay Sci., vol. 225, p. 106535, 2022, https://doi.org/10.1016/j.clay.2022.106535.Search in Google Scholar

[25] B. D. Ratner and G. Zhang, “A history of biomaterials,” Biomater. Sci., vol. 4, pp. 21–34, 2020, https://doi.org/10.1016/B978-0-12-816137-1.00002-7.Search in Google Scholar

[26] K. D. Jandt, “Evolutions, revolutions and trends in biomaterials science – a perspective,” Adv. Eng. Mater., vol. 9, pp. 1035–1050, 2007, https://doi.org/10.1002/adem.200700284.Search in Google Scholar

[27] Ş. Y. Güven, “Biocompatibility and selection of biomaterials,” SDU J. Eng. Sci. Design, vol. 2, pp. 303–311, 2014.Search in Google Scholar

[28] B. D. Ratner, A. S. Hoffman, F. J. Schoen, et al.., “Introduction to biomaterials science,” Biomater. Sci., vol. 4, pp. 3–19, 2020, https://doi.org/10.1016/B978-0-12-816137-1.00001-5.Search in Google Scholar

[29] M. Gudeppu, J. Balasubramanian, P. Bakthavachalam, L. Chokkalingam, and P.S.T. Shanmugam, “Biocompatibility and toxicology,” in Trends in Development of Medical Devices, Cambridge, MA, Academic Press, 2020, pp. 99–133.10.1016/B978-0-12-820960-8.00007-1Search in Google Scholar

[30] Y. Ozalp and N. Ozdemır, “Biomaterials and biocompatibility,” J. Ankara Univ. Faculty Pharmacy, vol. 25, no. 2, pp. 57–72, 1996, https://doi.org/10.1501/Eczfak_0000000307.Search in Google Scholar

[31] D. Kamal, N. Helmy, and Y. Sayed, “Hazards and biocompatibility of nano-bio materials: strategies to improve the biocompatibility of dental materials and operative techniques,” Nanotechnol. Conser. Dent., pp. 187–238, 2021.10.1016/B978-0-323-90282-3.00005-7Search in Google Scholar

[32] A. Khalifa, K. Chapin, O. Abdelgawad, J. Anderson, O. Akkus, and A. Hijaz, “PD36-11 biocompatibility of woven collagen mesh as A novel biomaterial for future slings,” J. Urol., vol. 195, 2016, https://doi.org/10.1016/j.juro.2016.02.1116.Search in Google Scholar

[33] S. Wang, L. Zhou, Y. Zheng, et al.., “Synthesis and biocompatibility of two-dimensional biomaterials,” Colloid Surf. A, vol. 583, p. 124004, 2019, https://doi.org/10.1016/j.colsurfa.2019.124004.Search in Google Scholar

[34] 10993-4: Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood, ISO 10993-4, 2017, Available at: https://www.iso.org/standard/63448.html.Search in Google Scholar

[35] 10993-16: Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables, ISO10993–16, 2017, Available at: https://www.iso.org/standard/64582.html.Search in Google Scholar

[36] M. Mozafarı, Chapter 1, Handbook of Biomaterials Biocompatibility, 1st ed., United Kingdom, Elsevier, 2020.Search in Google Scholar

[37] M. Mozafari, M. Yamato, and S. Ramakrishna, “Editorial overview: biomaterials: on the biocompatibility of biomaterials,” Curr. Opin. Biomed. Eng., vol. 10, pp. A1–A3, 2019, https://doi.org/10.1016/j.cobme.2019.10.008.Search in Google Scholar

[38] J. Zhou, K. Ning, Y. Yang, et al.., “1 H-NMR -based metabolic analysis on biocompatibility of dental biomaterials,” Proc. Biochem., vol. 114, pp. 163–173, 2022, https://doi.org/10.1016/j.procbio.2020.01.020.Search in Google Scholar

[39] S. Ozturk, F. B. Ayanoglu, M. Parmaksız, A. E. Elçin, and Y. M. Elçin, Chapter 11, Handbook of Biomaterials Biocompatibility, 1st ed., United Kingdom, Elsevier, 2020.Search in Google Scholar

[40] N. Huebsch and D. J. Mooney, “Inspiration and Application in the evolution of biomaterials,” Nature, vol. 462, no. 7272, pp. 426–432, 2009, https://doi.org/10.1038/nature08601.Search in Google Scholar PubMed PubMed Central

[41] E. Marin, F. Boschetto, and G. Pezzottı, “Biomaterials and biocompatibility: an historical overview,” J. Biomed. Mater. Res., vol. 108, no. 8, pp. 1617–1633, 2020, https://doi.org/10.1002/jbm.a.36930.Search in Google Scholar PubMed

[42] S. C. Gad and S. Gad-McDonald, Biomaterials, Medical Devices, and Combination Products, Biocompatibility Testing and Safety Assessment, 1st ed. Boca Raton, Florida, USA, CRC Press, 2015.10.1201/b19086Search in Google Scholar

[43] J. M. Anderson, “Biocompatibility and the relationship to standards: meaning and scope of biomaterials testing,” in Comprehensive Biomaterials, Oxford, UK, Elsevier, 2011, pp. 7–26.10.1016/B978-0-08-055294-1.00002-7Search in Google Scholar

[44] J. M. Anderson, “Biocompatibility and bioresponse to biomaterials,” in Principles of Regenerative Medicine, Cambridge, MA, Academic Press, 2011, pp. 693–716.10.1016/B978-0-12-381422-7.10038-0Search in Google Scholar

[45] M. Assad and N. Jackson, “Biocompatibility evaluation of orthopedic biomaterials and medical devices: A review of safety and efficacy models,” in Encyclopedia of Biomedical Engineering, Oxford, UK, Woodhead Publishing, 2019, pp. 281–309.10.1016/B978-0-12-801238-3.11104-3Search in Google Scholar

[46] P. Murray, “Biocompatibility of biomaterials for dental tissue repair,” in Biocompatibility of Dental Biomaterials, Sawston, UK, Woodhead Publishing, 2017, pp. 41–62.10.1016/B978-0-08-100884-3.00004-7Search in Google Scholar

[47] S. H. Hassan, I. M. R. Najjar, N. Fouda, F. W. Al-Thobiani, and H. A. Timraz, “Effect of material and dimensions on the mechanical behavior of a dental implant,” Mater. Test., vol. 62, no. 8, pp. 775–782, 2020. https://doi.org/10.3139/120.111553.Search in Google Scholar

[48] Z. D. Çırak and D. B. Yakıncı, “Biocompatible biomaterials used in medical applications,” J. İnönü Univ. Vocat. School Health Serv., vol. 8, pp. 515–526, 2020, https://doi.org/10.33715/inonusaglik.745301.Search in Google Scholar

[49] B. Massoumi, M. Abbasian, R. Jahanban-Esfahlan, et al.., “A novel bio-inspired conductive, biocompatible, and adhesive terpolymer based on polyaniline, polydopamine, and polylactide as scaffolding biomaterial for tissue engineering application,” Int. J. Biol. Macromol., vol. 147, pp. 1174–1184, 2020, https://doi.org/10.1016/j.ijbiomac.2019.10.086.Search in Google Scholar PubMed

[50] Y. Xiang, Y. Wang, Y. Luo, B. Zhang, J. Xin, and D. Zheng, “Molecular biocompatibility evaluation of poly(d,l-lactic acid)-modified biomaterials based on long serial analysis of gene expression,” Colloids Surf. B: Biointerfaces, vol. 85, pp. 248–261, 2011, https://doi.org/10.1016/j.colsurfb.2011.02.036.Search in Google Scholar PubMed

[51] M. A. Tolli, M. P. A. Ferreira, S. M. Kinnunen, et al.., “In vivo biocompatibility of porous silicon biomaterials for drug delivery to the heart,” Biomaterials, vol. 35, pp. 8394–8405, 2014, https://doi.org/10.1016/j.biomaterials.2014.05.078.Search in Google Scholar PubMed

[52] F. Campos, A. B. Bonhome-Espinos, R. Carmona, et al.., “In vivo time-course biocompatibility assessment of biomagnetic nanoparticles-based biomaterials for tissue engineering applications,” Mater. Sci. Eng. C, vol. 118, p. 111476, 2021, https://doi.org/10.1016/j.msec.2020.111476.Search in Google Scholar PubMed

[53] A. Impergre, B. Ter-Ovanessian, C. D. Loughian, and B. Normand, “Systemic strategy for biocompatibility assessments of metallic biomaterials: representativeness of cell culture medium,” Electrochim. Acta, vol. 283, pp. 1017–1027, 2018, https://doi.org/10.1016/j.electacta.2018.06.196.Search in Google Scholar

[54] Biocompatibility and tissue reaction to biomaterials,” in Craig’s Restorative Dental Materials, Mosby, Missouri/USA, Maryland Heights, Mosby, 2019, pp. 91–111.10.1016/B978-0-323-47821-2.00006-8Search in Google Scholar

[55] L. Ghasemi-Mobarakeh, D. Kolahreez, S. Ramakrishna, and D. Williams, “Key terminology in biomaterials and biocompatibility,” Curr. Opt. Biomed. Eng., vol. 10, pp. 45–50, 2019, https://doi.org/10.1016/j.cobme.2019.02.004.Search in Google Scholar

[56] D. Zou, X. Luo, C.-z. Han, et al.., “Preparation of a biomimetic ECM surface on cardiovascular biomaterials via a novel layer-by-layer decellularization for better biocompatibility,” Mater. Sci. Eng. C., vol. 96, pp. 509–521, 2019, https://doi.org/10.1016/j.msec.2018.11.078.Search in Google Scholar PubMed

[57] A. A. Zadpoor, “The evolution of biomaterials research,” Mater. Today, vol. 16, no. 11, pp. 408–409, 2013, https://doi.org/10.1016/j.mattod.2013.10.015.Search in Google Scholar

[58] B. D. Ratner and F. J. Schoen, “The concept and assessment of biocompatibility,” Biomater. Sci., vol. 4, pp. 843–849, 2020, https://doi.org/10.1016/B978-0-12-816137-1.00056-8.Search in Google Scholar

[59] D. Taylor, “Through-life engineering: inspirations from nature,” Procedia Manuf., vol. 16, pp. 163–170, 2018, https://doi.org/10.1016/j.promfg.2018.10.164.Search in Google Scholar

[60] N. Hassanein, H. Bougherara, and A. Amleh, “In-vitro evaluation of the bioactivity and the biocompatibility of a novel coated UHMWPE biomaterial for biomedical applications,” J. Mech. Behav. Biomed. Mater., vol. 101, p. 103409, 2020, https://doi.org/10.1016/j.jmbbm.2019.103409.Search in Google Scholar PubMed

[61] L. Vijayalakshmi and J. D. Baek, “Conversion of UV light to dazzling reddish-orange light with robust color purity for plant growth in biocompatible glasses,” J. Non-Cryst. Solids, vol. 589, p. 121662, 2022, https://doi.org/10.1016/j.jnoncrysol.2022.121662.Search in Google Scholar

[62] J. M. Morais, F. Papadimitrakopoulas, and D. J. Burgess, “Biomaterials/tissue interactions: possible solutions to overcome foreign body response,” AAPS J., vol. 12, no. 2, pp. 188–196, 2010, https://doi.org/10.1208/s12248-010-9175-3.Search in Google Scholar PubMed PubMed Central

[63] S. Sahoo, A. Sinha, and M. Das, “Synthesis, characterization and in vitro biocompatibility study of strontium titanate ceramic: a potential biomaterial,” J. Mech. Behav. Biomed. Mater., vol. 102, p. 103494, 2020, https://doi.org/10.1016/j.jmbbm.2019.103494.Search in Google Scholar PubMed

[64] J.-E. Park, Y.-S. Jang, S.-Y. Kim, et al.., “Corrosion properties and biocompatibility of strontium doped calcium phosphate coated magnesium prepared by electrodeposition,” Mater. Today Commun., vol. 31, p. 2022, https://doi.org/10.1016/j.mtcomm.2022.103759.Search in Google Scholar

[65] B. A. Fiedler, “Role of biocompatibility,” in Managing Medical Devices Within a Regulatory Framework, Oxford, UK, Elsevier, 2017, pp. 91–108.10.1016/B978-0-12-804179-6.00006-XSearch in Google Scholar

[66] S. Liu, Q. Guo, X. Wang, G. Li, X. Ma, and Z. Xu, “Fabrication of liquid metal loaded polycaprolactone conductive film for biocompatible and flexible electronics,” Biosens. Bioelect. X, vol. 11, p. 100182, 2022, https://doi.org/10.1016/j.biosx.2022.100182.Search in Google Scholar

[67] N. S. Goud, “Biocompatibility evaluation of medical devices,” in A Comprehensive Guide to Toxicology in Nonclinical Drug Development, vol. 2, Cambridge, MA, Academic Press, 2017, pp. 825–840.10.1016/B978-0-12-803620-4.00031-1Search in Google Scholar

[68] J.-A. Li, L. Chen, X.-Q. Zhang, and S.-K. Guan, “Enhancing biocompatibility and corrosion resistance of biodegradable Mg-Zn-Y-Nd alloy by preparing PDA/HA coating for potential application of cardiovascular biomaterials,” Mater. Sci. Eng. C, vol. 109, p. 110607, 2020, https://doi.org/10.1016/j.msec.2019.110607.Search in Google Scholar PubMed

[69] D. Williams, “Concepts in biocompatibility: new biomaterials, new paradigms, and new testing regimes,” in Biocompatibility and Performance of Medical Devices, Sawston, UK, Woodhead Publishing, 2012, pp. 3–17.10.1533/9780857096456.1.1Search in Google Scholar

[70] J. P. Boutrand, Medical Device Biocompatibility Evaluation: An Industry Perspective, Biocompatibility and Performance of Medical Devices, Cambridge, UK, Woodhead Publishing, 2012.10.1533/9780857096456Search in Google Scholar

[71] 10993-1: Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process, ISO 10993-1, 2018, Available at: https://www.iso.org/standard/68936.html.Search in Google Scholar

[72] 10993-5: Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity, ISO 10993-5, 2017, Available at: https://www.iso.org/standard/36406.html.Search in Google Scholar

[73] 10993-20: Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices, ISO 10993-20, 2014, Available at: https://www.iso.org/standard/35979.html.Search in Google Scholar

[74] 10993-11: Biological evaluation of medical devices — Part 11: Tests for systemic toxicity, ISO 10993-11, 2017, Available at: https://www.iso.org/standard/68426.html.Search in Google Scholar

[75] 10993-10: Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization, ISO 10993-10, 2016, Available at: https://www.iso.org/standard/75279.html.Search in Google Scholar

[76] M. Dhanka, V. Pawar, D. S. Chauhan, et al.., “Synthesis and characterization of an injectable microparticles integrated hydrogel composite biomaterial: in-vivo biocompatibility and inflammatory arthritis treatment,” Colloids Surf. B: Biointerfaces, vol. 201, p. 111597, 2021, https://doi.org/10.1016/j.colsurfb.2021.111597.Search in Google Scholar PubMed

[77] X. Luo, C. Han, P. Yang, et al.., “The co-deposition coating of collagen IV and laminin on hyaluronic acid pattern for better biocompatibility on cardiovascular biomaterials,” Colloids Surf. B: Biointerfaces, vol. 196, p. 111307, 2020, https://doi.org/10.1016/j.colsurfb.2020.111307.Search in Google Scholar PubMed

[78] D. Shikha, U. Jha, S. K. Sinha, et al.., “Microstructure and biocompatibility investigation of biomaterial alumina after 30 keV and 60 keV nitrogen ion implantation,” Surf. Coat. Technol., vol. 203, pp. 2541–2545, 2009, https://doi.org/10.1016/j.surfcoat.2009.02.071.Search in Google Scholar

[79] 10993-3: Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity, ISO 10993-3, 2014, Available at: https://www.iso.org/standard/55614.html.Search in Google Scholar

[80] G. Schmalz and K. M. Galler, “Biocompatibility of biomaterials – lessons learned and considerations for the design of novel materials,” Dent. Mater., vol. 33, pp. 382–393, 2017, https://doi.org/10.1016/j.dental.2017.01.011.Search in Google Scholar PubMed

[81] A. Przekora, “The summary of the most important cell-biomaterial interactions that need to be considered during in vitro biocompatibility testing of bone scaffolds for tissue engineering applications,” Mater. Sci. Eng. C, vol. 97, pp. 1036–1051, 2019, https://doi.org/10.1016/j.msec.2019.01.061.Search in Google Scholar PubMed

[82] K. von der Mark and J. Park, “Engineering biocompatible implant surfaces Part II: cellular recognition of biomaterial surfaces: lessons from cell-matrix interactions,” Prog. Mater. Sci., vol. 58, pp. 327–381, 2013, https://doi.org/10.1016/j.pmatsci.2012.09.002.Search in Google Scholar

[83] S. Sathiskumar, S. Vanaraj, D. Sabarinathan, et al.., “Green synthesis of biocompatible nanostructured hydroxyapatite from Cirrhinus mrigala fish scale – a biowaste to biomaterial,” Ceram. Int., vol. 45, pp. 7804–7810, 2019, https://doi.org/10.1016/j.ceramint.2019.01.086.Search in Google Scholar

[84] M. M. J. P. E. Sthijns, M. J. Jetten, S. G. Mohammed, et al.., “Oxidative stress in pancreatic alpha and beta cells as a selection criterion for biocompatible biomaterials,” Biomaterials, vol. 267, p. 120449, 2021, https://doi.org/10.1016/j.biomaterials.2020.120449.Search in Google Scholar PubMed

[85] Y. Arteshi, A. Aghanejad, S. Davaran, and Y. Omidi, “Biocompatible and electroconductive polyaniline-based biomaterials for electrical stimulation,” Eur. Polym. J., vol. 108, pp. 150–170, 2018, https://doi.org/10.1016/j.eurpolymj.2018.08.036.Search in Google Scholar

[86] T. S. P. Rothenbücher, J. Ledin, D. Gibbs, H. Engqvist, C. Persson, and G. Hulsart-Billström, “Zebrafish embryo as a replacement model for initial biocompatibility studies of biomaterials and drug delivery systems,” Acta Biomater., vol. 100, pp. 235–243, 2019, https://doi.org/10.1016/j.actbio.2019.09.038.Search in Google Scholar PubMed

[87] A. Ładniak, M. Jurak, and A. E. Wiącek, “Physicochemical characteristics of chitosan-TiO2 biomaterial. 2. Wettability and biocompatibility,” Colloids Surf. A: Physicochem. Eng. Aspect., vol. 630, p. 127546, 2021, https://doi.org/10.1016/j.colsurfa.2021.127546.Search in Google Scholar

[88] E. P. Ivanova, K. Bazaka, and R. J. Crawford, “Cytotoxicity and biocompatibility of metallic biomaterials,” in New Functional Biomaterials for Medicine and Healthcare, Sawston, UK, Woodhead Publishing, 2014, pp. 148–172.10.1533/9781782422662.148Search in Google Scholar

[89] C. Constant, S. Nichols, É. Wagnac, Y. Petit, A. Desrochers, and V. Braïlovski, “Biocompatibility and mechanical stability of nitinol as biomaterial for intra-articular prosthetic devices,” Materialia, vol. 9, p. 100567, 2020, https://doi.org/10.1016/j.mtla.2019.100567.Search in Google Scholar

[90] A. Przekora, P. Kazimierczak, and M. Wojcik, “Ex vivo determination of chitosan/curdlan/hydroxyapatite biomaterial osseointegration with the use of human trabecular bone explant: new method for biocompatibility testing of bone implants reducing animal tests,” Mater. Sci. Eng. C, vol. 119, p. 111612, 2021, https://doi.org/10.1016/j.msec.2020.111612.Search in Google Scholar PubMed

[91] H.-C. Yang, B.-S. Lim, and Y.-K. Lee, “In vitro assessment of biocompatibility of biomaterials by using fluorescent yeast biosensor,” Curr. Appl. Phys., vol. 5, pp. 444–448, 2005, https://doi.org/10.1016/j.cap.2005.01.007.Search in Google Scholar
Published Online: 2023-04-27
Published in Print: 2023-04-25

© 2023 Walter de Gruyter GmbH, Berlin/Boston

Articles in the same Issue

  1. Frontmatter
  2. Effect of boric acid addition to seawater on wear and corrosion properties of ultrashort physical vapor deposited Ti layer on a 304 stainless steel
  3. Influence of welding parameters on the interface temperature field of TC4 titanium alloys/304 stainless steel friction stir lap joints
  4. Effect of buttering on the wear behavior of the SMA welded hardfacing layer in a low-carbon steel
  5. Additive manufacturing of hexagonal lattice structures: tensile tests and validation
  6. Dynamic fracture behavior of SA508-3 steel for nuclear power equipment under medium-and low-loading rates
  7. Determination of the size effect on the tensile properties of miniaturized specimens
  8. Heat treatment effects on near threshold region for AISI 4340 steels
  9. Biocompatibility of biomaterials and test methods: a review
  10. Mechanical and tribological behaviour of novel Al–12Si-based hybrid composites
  11. Characterization of dual phase boride coatings on Sverker 3 steel and simulation of boron diffusion
  12. Tribological behaviour of industrial waste based agave sisalana/glass fiber reinforced hybrid composites for marine applications
  13. Optimization of friction stir welding process parameters using multi-criteria decision making approach
  14. Effect of casting modification materials on cutting forces of an Al12Si alloy used in aircraft technology
  15. Effect of deep cryogenic processing cycles on surface roughness, dimensional stability and microstructure of high carbon high chromium tool steel for cutting tool and dies applications
https://doi.org/10.1515/mt-2022-0195
Keywords for this article
biocompatibility; biomaterials; biotechnology; implants; toxicology

Articles in the same Issue

  1. Frontmatter
  2. Effect of boric acid addition to seawater on wear and corrosion properties of ultrashort physical vapor deposited Ti layer on a 304 stainless steel
  3. Influence of welding parameters on the interface temperature field of TC4 titanium alloys/304 stainless steel friction stir lap joints
  4. Effect of buttering on the wear behavior of the SMA welded hardfacing layer in a low-carbon steel
  5. Additive manufacturing of hexagonal lattice structures: tensile tests and validation
  6. Dynamic fracture behavior of SA508-3 steel for nuclear power equipment under medium-and low-loading rates
  7. Determination of the size effect on the tensile properties of miniaturized specimens
  8. Heat treatment effects on near threshold region for AISI 4340 steels
  9. Biocompatibility of biomaterials and test methods: a review
  10. Mechanical and tribological behaviour of novel Al–12Si-based hybrid composites
  11. Characterization of dual phase boride coatings on Sverker 3 steel and simulation of boron diffusion
  12. Tribological behaviour of industrial waste based agave sisalana/glass fiber reinforced hybrid composites for marine applications
  13. Optimization of friction stir welding process parameters using multi-criteria decision making approach
  14. Effect of casting modification materials on cutting forces of an Al12Si alloy used in aircraft technology
  15. Effect of deep cryogenic processing cycles on surface roughness, dimensional stability and microstructure of high carbon high chromium tool steel for cutting tool and dies applications
Downloaded on 22.4.2026 from https://www.degruyterbrill.com/document/doi/10.1515/mt-2022-0195/html
Scroll to top button