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2018 | OriginalPaper | Buchkapitel

11. Biocompatibility

verfasst von : Vasif Hasirci, Nesrin Hasirci

Erschienen in: Fundamentals of Biomaterials

Verlag: Springer New York

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Abstract

One of the first definitions of a biomaterial was that of the Clemson University Advisory Board for Biomaterials [1] which was “a systemically and pharmacologically inert substance designed for implantation within or incorporation with living systems.” Biocompatibility was defined by Williams (2008) as “the ability of a material to perform with an appropriate host response in a specific application” [2]. According to ASTM on the other hand, it is defined as a “comparison of the tissue response produced through the close association of the implanted candidate material to its implant site within the host animal to that tissue response recognized and established as suitable with control materials.” Another definition of biocompatibility provided was “The condition of being compatible with living tissue by virtue of a lack of toxicity or ability to cause immunological rejection” [3].

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Literatur
1.
Zurück zum Zitat Clemson University Advisory Board for Biomaterials, 1976 Clemson University Advisory Board for Biomaterials, 1976
2.
Zurück zum Zitat Williams DF (2008) On the mechanisms of biocompatibility. Biomaterials 29(20):2,941–2,953CrossRef Williams DF (2008) On the mechanisms of biocompatibility. Biomaterials 29(20):2,941–2,953CrossRef
3.
Zurück zum Zitat McGraw-Hill Dictionary of Scientific & Technical Terms (2003) The McGraw-Hill Companies, Inc McGraw-Hill Dictionary of Scientific & Technical Terms (2003) The McGraw-Hill Companies, Inc
4.
Zurück zum Zitat Innovation and stagnation, challenge and opportunity on the critical path to new medical products, FDA March 2004 Innovation and stagnation, challenge and opportunity on the critical path to new medical products, FDA March 2004
5.
Zurück zum Zitat Anderson JM (2001) Biological responses to materials. Annu Rev Mater Res 31:81–110CrossRef Anderson JM (2001) Biological responses to materials. Annu Rev Mater Res 31:81–110CrossRef
7.
Zurück zum Zitat Food and Drug Administration Agency (2016) Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”. Center for Devices and Radiological Health, Rockville, MD, pp 48–49 Food and Drug Administration Agency (2016) Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”. Center for Devices and Radiological Health, Rockville, MD, pp 48–49
8.
Zurück zum Zitat Ouweneel DM, Eriksen E, Sjauw KD, van Dongen IM, Hirsch A, Packer EJ et al (2017) Percutaneous mechanical circulatory support versus intra-aortic balloon pump in cardiogenic shock after acute myocardial infarction. J Am Coll Cardiol 69(3):278–287CrossRef Ouweneel DM, Eriksen E, Sjauw KD, van Dongen IM, Hirsch A, Packer EJ et al (2017) Percutaneous mechanical circulatory support versus intra-aortic balloon pump in cardiogenic shock after acute myocardial infarction. J Am Coll Cardiol 69(3):278–287CrossRef
9.
Zurück zum Zitat Fortier A, Gullapalli V, Mirshams RA (2014) Review of biomechanical studies of arteries and their effect on stent performance. IJC Heart Vessels 4:12–18CrossRef Fortier A, Gullapalli V, Mirshams RA (2014) Review of biomechanical studies of arteries and their effect on stent performance. IJC Heart Vessels 4:12–18CrossRef
10.
Zurück zum Zitat Komiyama N, Chronos NA, Uren NG, Moore MP, Kelly AB, Harker LA et al (1999) The progression of thrombus in an ex-vivo shunt model evaluated by intravascular ultrasound radiofrequency analysis. Ultrasound Med Biol 25(4):561–566CrossRef Komiyama N, Chronos NA, Uren NG, Moore MP, Kelly AB, Harker LA et al (1999) The progression of thrombus in an ex-vivo shunt model evaluated by intravascular ultrasound radiofrequency analysis. Ultrasound Med Biol 25(4):561–566CrossRef
11.
Zurück zum Zitat The rules governing medicinal products in the european union. Volume 10 – Guidance documents applying to clinical trials, European Commission health and consumers directorate-general, health products and systems, medicinal products – Quality, safety and efficacy, Brussels, 11/04/2012, sanco.ddg1.d.6(2012)501417 The rules governing medicinal products in the european union. Volume 10 – Guidance documents applying to clinical trials, European Commission health and consumers directorate-general, health products and systems, medicinal products – Quality, safety and efficacy, Brussels, 11/04/2012, sanco.ddg1.d.6(2012)501417
12.
Zurück zum Zitat European Commission DG Health and Consumer, Directorate B, Unit B2 “Cosmetics and Medical Devices” Medical Devices: Guidance document- Classification of Medical Devices, MEDDEV 2. 4/1 Rev. 9 June 2010 European Commission DG Health and Consumer, Directorate B, Unit B2 “Cosmetics and Medical Devices” Medical Devices: Guidance document- Classification of Medical Devices, MEDDEV 2. 4/1 Rev. 9 June 2010
13.
Zurück zum Zitat Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices, Official Journal L 169, 12/07/1993 P. 0001–0043 Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices, Official Journal L 169, 12/07/1993 P. 0001–0043
14.
Zurück zum Zitat Kaplan AV, Baim DS, Smith JJ, Feigal DA, Simons M, Jefferys D, Fogarty TJ, Kuntz RE, Leon MB (2004) Medical device development: from prototype to regulatory approval. Circulation 109:3068–3072CrossRef Kaplan AV, Baim DS, Smith JJ, Feigal DA, Simons M, Jefferys D, Fogarty TJ, Kuntz RE, Leon MB (2004) Medical device development: from prototype to regulatory approval. Circulation 109:3068–3072CrossRef
Metadaten
Titel
Biocompatibility
verfasst von
Vasif Hasirci
Nesrin Hasirci
Copyright-Jahr
2018
Verlag
Springer New York
DOI
https://doi.org/10.1007/978-1-4939-8856-3_11

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