References
- EN ISO 13485: Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes [Internet]. Geneva: Switzerland; [cited 2013 Jun 15]. Available from: http://www.iso.org/iso/catalogue_detail?csnumber=36786.
- Johnson JA. FDA regulation of medical devices. Congressional research service, June 25, (2012) [Internet]. Washington, DC: Federation of American Scientists; 2013 [cited 2013 Jul 13]. Available from: http://www.fas.org/sgp/crs/misc/R42130.pdf
- Wennerberg A, Albrektsson T. On implant surfaces: a review of the current knowledge and opinions. Int J Oral Maxillofac Implants. 2010;25(1):63–74.
- Parekh RB, Shetty O, Tabassum R. Surface modifications for endosseous dental implants. Int J Oral Implantol Clin Res. 2012;3(3):116–121.
- Abraham CM. A brief historical perspective on dental implants, their surface coatings and treatments. Open Dent J. 2014;8(1):50–55.
- Duan K, Wang R. Surface modifications of bone implants through wet chemistry. J Mater Chem. 2006;16:2309–2321.
- Ercan B, Kummer KM, Tarquinio KM, et al. Decreased Staphylococcus aureus biofilm growth on anodized nanotubular titanium and the effect of electrical stimulation. Acta Biomater. 2011;7:3003–3012.
- Campoccia D, Montanaro L, Arciola CR. The significance of infection related to orthopedic devices and issues of antibiotic resistance. Biomaterials. 2006;27:2331–2339.
- Yue C, Zhao B, Ren Y, et al. implant infection paradox: why do some succeed when others fail? Opinion and discussion paper. Eur Cells Mater. 2015;29:303–313.
- Zilberman M, Elsner JJ. Antibiotic-eluting medical devices for various applications. J Control Release. 2008;130:202–215.
- Price JS, Tencer AF, Arm DM, et al. Controlled release of antibiotics from coated orthopedic implants. J Biomed Mater Res. 1996;30(3):281–286.
- Stigter M, Bezemer J, de Groot K, et al. Incorporation of different antibiotics into carbonated hydroxyapatite coatings on titanium implants, release and antibiotic efficacy. J Control Release. 2004;99(1):127–137.
- Ren G, Hu D, Cheng EWC, et al. Characterisation of copper oxide nanoparticles for antimicrobial applications. Int J Antimicrob Agents. 2009;33:587–590.
- Ziąbka M, Dziadek M, Menaszek E, et al. Middle ear prosthesis with bactericidal efficacy – in vitro investigation. Molecules. 2017;22(10):1681.
- Cui Y, Zhao Y, Tian Y, et al. The molecular mechanism of action of bactericidal gold nanoparticles on Escherichia coli. Biomaterials. 2012;33:2327–2333.
- Edidin AA, Jewett CW, Kalinowski A, et al. Degradation of mechanical behavior in UHMWPE after natural and accelerated aging. Biomaterials. 2000;21:1451–1460.
- Begall K, Zimmermann H. Rekonstruktion der Gehorknochelchenkette mit Titan-Implantaten. Ergebnisse einer Multicenter-Studie. Laryngorhinootologie. 2000;79:139–145.
- Zahnert T, Bornitz M, Huttenbrink KB Calculation and experiments on the influence of prosthesis couplin to the middle ear transfer function. Middle ear mechanics in research and otology. Proceedings Of The 3rd Symposium; 2003; Matsuyama, Ehime, Japan. p. 83–90.
- Meister H, Mickenhagen A, Walger M, et al. Standardisierte Messungen der Schallübertragung verschiedener Mittelohrprothesen. HNO. 2000;48:204–208.
- Ovsianikov A, Chichkov B, Adunka O, et al. Rapid prototyping of ossicular replacement prostheses. Appl Surf Sci. 2007;253:6603–6607.
- Maassen MM, Lowenheim H, Pfister M, et al. Surgical-handling properties of the titanium prosthesis in ossiculoplasty. ENT- Ear, Nose Throat J. 2005;84:142–149.
- Ziąbka M, Menaszek E, Tarasiuk J, et al. Biocompatible nanocomposite implant with silver nanoparticles for otology—in vivo evaluation. Nanomaterials. 2018;8(10):764.
- Dowling DP, Miller IS, Ardhaoui M, et al. Effect of surface wettability and topography on the adhesion of osteosarcoma cells on plasma-modified polystyrene. J Biomater Appl. 2011;26:327–347.
- Teo AJT, Mishra A, Park I, et al. Polymeric biomaterials for medical implants & devices. ACS Biomater Sci Eng. 2016;2:454–472.
- Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. [cited 2001 Apr 4]. Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2001_20/dir_2001_20_en.pdf.
- Clinical trials regulation (EU) No 536/2014 of the European Parliament and of the council of 16 April 2014 on clinical trials on medicinal products for human use. [cited 2014 Apr 16]. Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf.
- Council Directive 93/42/EEC of the European Parliament and of the Council of 14 June 1993concerning medical devices. [cited 1993 Jun 14]. Available from: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF.
- Council directive 90/385/EEC of the European Parliament and of the council of 20 June 1990 on the approximation of the laws of the member states relating to active implantable medical devices. [cited 1990 Jun 20]. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31990L0385&from=EN.
- Directive 98/79/EC of the European Parliament and of the council of 27 October 1998 on in vitro diagnostic medical devices. [cited 1998 Oct 27]. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31998L0079&from=EN.
- National Drug Authority Guidelines for the conduct of clinical trials. [cited 2008]. Available from: http://apps.who.int/medicinedocs/documents/s19724en/s19724en.pdf.
- ISO 14155:2011. Clinical investigation of medical devices for human subjects – good clinical practice. [Internet]. Geneva: Switzerland. [cited 2011 Feb]. Available from: https://www.iso.org/standard/45557.html