Biocompatibility

Biocompatibility is defined by The Williams Dictionary of Biomaterials as ‘the ability of a material to perform with an appropriate host response in a specific application’ (Williams, 1999).

From: MEMS for Biomedical Applications, 2012

Polymers in Biology and Medicine

J.M. Anderson, in Polymer Science: A Comprehensive Reference, 2012

Abstract

Biocompatibility is the most commonly used term to describe appropriate biological requirements of a biomaterial or biomaterials used in a medical device. Biocompatibility has also been described as the ability of a material to perform with an appropriate host response in a specific application. Biocompatibility or safety evaluation addresses the identification of an appropriate host response. The goal of this chapter is to provide a pathway or roadmap for the practical approach to the identification of biocompatibility and/or safety. This chapter discusses biocompatibility, materials for medical devices, and in vitro and in vivo tests for biocompatibility. It also discusses inflammation, wound healing, and the foreign body reaction; hemocompatibility; and immune responses in detail.

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Biomaterials and Clinical Use

M.R. Cohn, ... J.M. Lane, in Comprehensive Biomaterials II, 2017

7.16.2.1 Biocompatibility

Biocompatibility is the ability of an implant material to function in vivo without eliciting detrimental local or systemic responses in the body. Prior to their use in human fracture fixation, biomaterials undergo tissue and animal testing to determine their safety and efficacy. Biomaterials that elicit little or no host response such as cobalt–chromium metallic alloys can be thought of as inert materials. The importance of biocompatibility is demonstrated by the consequences of allergic reactions to nickel and chromium-containing stainless steel implants. The biological rejection of an implant leads to an inflammatory response mediated by immune cells and can necessitate removal of the implant. Different techniques like laser surface microtexturing and sintering processing have been used to enhance biocompatibility of Titanium alloys.15,16 Use of resorbable magnesium metal implants is a new concept in orthopedics, which are highly biocompatible. Much of the research into new biomaterials is focused on improving biocompatibility of implants, avoiding unnecessary complications.

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Scaffolds for intraocular lens

Safiyya Yousaf, ... Farshid Sefat, in Handbook of Tissue Engineering Scaffolds: Volume Two, 2019

61.6.1 Biocompatibility

Biocompatibility is a term used to describe the capability of an implanted prosthesis to exist in harmony with surrounding tissues [23]. Uveal biocompatibility refers to how well an IOL is tolerated inside the eye without causing deleterious changes and immunogenic responses. Other ways of defining biocompatibility include capsular biocompatibility, which is determined by the direct contact with the lens capsular bag and remnant lens epithelial cells. This interaction may consequence various entities including anterior capsule opacification, PCO, and lens epithelial cell ingrowth. Moreover, the aforementioned parameters assessed are fairly different between capsular and uveal biocompatibility as a particular IOL may exhibit poor capsular biocompatibility yet characterize minimal foreign body reactions on the surface of the lens. Therefore, the potential to calcify should always be taken into consideration when evaluating materials for ultimate biocompatibility after implantation [24–26].

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Biocompatibility and cytotoxicity of polymer sutures

Smitha Vijayan, ... M.S. Jisha, in Advanced Technologies and Polymer Materials for Surgical Sutures, 2023

11.6 Conclusion

Biocompatibility and cytotoxicity of the polymer sutures depends on the composition and mode of interaction of the suture with the tissue materials. Interaction of the material and the body is an important factor in determination of biocompatibility and cytotoxicity. Choosing the exact method and elucidation of biocompatibility and cytotoxicity is very important before using the suture materials. Higher compatibility and lower toxicity are the suitable property in case of suture materials. The methods used to study biocompatibility and cytotoxicity are based on certain guidelines set by FDA and ISO. Standardization and optimization of such tests are difficult and lengthy but it is very important to adhere with the standards.

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Biocompatibility, Surface Engineering, and Delivery of Drugs, Genes and Other Molecules

J.M. Anderson, in Comprehensive Biomaterials II, 2017

Abstract

This chapter presents biocompatibility (safety) evaluation of biomaterials, medical devices, and prostheses in the context of current standards and guidelines. The goal of this chapter is to provide an overview for the biological response evaluation, that is, biocompatibility evaluation, of end-stage ‘as-used’ medical devices, prostheses, and biomaterials. The chapter contains eight sections: biocompatibility; materials for medical devices; in vitro tests for biocompatibility; in vivo tests for biocompatibility; inflammation, wound healing, and the foreign body reaction; hemocompatibility; immune responses; and summary. It must be emphasized that standards, tests, and guidelines are constantly evolving and changing, and it can be anticipated that new information will provide new perspectives on immune response evaluation in the areas of tissue engineering and regenerative medicine.

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Biocompatibility of polymers

Abdulkadir Sanli, ... Aysu Aydınoğlu, in Handbook of Polymers in Medicine, 2023

Abstract

Biocompatibility is defined as the ability of a material to perform with an appropriate host response in a specific application. Biocompatible polymers have gained significant importance during the past decades due to their capability to meet specific requirements for various applications such as tissue engineering, genetic disease treatment, and drug delivery. Biocompatibility testing of polymer-based medical devices is an essential requirement for regulatory approval. “EN ISO 10993 Biological evaluation of medical devices” includes several substandards prepared to manage biological risk and evaluate the biocompatibility of medical devices. The source of the polymeric biomaterial is determined by which biocompatibility test methods should be applied to the material itself. In this chapter, we present biocompatibility test methods and the main requirements of some common biocompatible polymers. In addition, we introduce some typical biomedical applications of these polymers after a detailed explanation of common natural and synthetic polymers.

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Biocompatibility testing for medical textile products

Yimin Qin, in Medical Textile Materials, 2016

Abstract

Biocompatibility testing is an essential requirement for regulatory approval of medical devices such as a medical textile product. This chapter introduces the basic concept of biocompatibility testing outlined by the International Organization for Standardization (ISO), and describes the many tests developed for the evaluation of potential biological risks arising from the use of a medical textile product. In particular, some of the commonly used biocompatibility test methods, such as cytotoxicity testing, sensitization testing, irritation testing, systemic toxicity testing, genotoxicity testing, implantation testing, and hemocompatibility testing, are outlined.

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Aerogels as microbial disinfectant

Mohammad Oves, ... Iqbal M.I. Ismail, in Advances in Aerogel Composites for Environmental Remediation, 2021

6 Aerogel intracellular uptake, biocompatibility, toxicity, biodegradability

Biocompatibility is an important categorization that should be resolute with all materials used in biomedical applications. Biocompatibility testing of different materials, including polymers and biopolymers, necessitated a variety of in vivo and in vitro methods [112].The implant confirmed some biodegradation by macrophages, and there were no observable histopathologic symptoms of necrosis, calcification, tumorigenesis, gel migration in tissues, or contamination over the assessment period up to 8 months [113]. The bioactivity and biocompatibility of agarose gel were studied using an in vivo approach in a study by Fernández-Cosso and coworkers for the purpose of using it as a tissue filler in a subcutaneous implant. During the 8-month evaluation period, the implant indicated certain macrophage biodegradation, but no histopathologic signs of necrosis, calcification, tumorigenesis, gel migration in tissues, or infection were observed. Because of its biodegradation and metabolic fate in the body, the organic material chitosan is one of the most commonly studied and regularly used carriers in drug delivery systems [114]. In vitro cytotoxicity study was used to determine the biocompatibility of chitosan carrier in cells, and the results on cells were observed after 96 hours of toxic material exposure [115]. Onishi and colleagues investigated the biodegradability and distribution of 50% deacetylated chitin in the body. In vitro biodegradation characteristics were studied by incubation with lysozyme, which was found to effectively degrade chitosan. IP injection into mice was used to test body distribution, and the findings revealed no accumulation in the body and natural urinary excretion [116].

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Plasma Modified Polymeric Materials for Implant Applications

Ladislav Cvrček, Marta Horáková, in Non-Thermal Plasma Technology for Polymeric Materials, 2019

14.2.1.1 Biocompatibility

Biocompatibility is a complicated process depending on various factors. This process includes bio-functionality, bio-inertia, bioactivity, and biostability. Biocompatibility leads to the surrounding tissue and the human body accepting the synthetic implants without any undesirable immunity response, allergic reactions, inflammatory or chronical problems and, moreover, biocompatible materials are not carcinogenic. Biocompatibility strongly depends on the type of the application. The basic factors that influence biocompatibility are [3,5,8]:

1.

Interaction with the surroundings—influence of cytotoxins, toxicological or allergic reactions, carcinogenic or mutagenic reactions, inflammatory processes, degree and quality of the biodegradation, contact with human blood.

2.

Period of the implant application—long-term or short-term implant applications.

3.

Surface biocompatibility—suitability of the implanted surface for the host tissue (chemical, biological and morphological).

4.

Structural biocompatibility—optimal adaptability of the implant´s mechanical properties to the mechanical properties of the host tissue.

5.

Function—optimal friction coefficient, mechanical properties demanded by the application.

6.

Proportion—size and shape.

7.

Material—aggressiveness of the synthetic material to the host tissue and vice versa.

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Characteristics and applications of titanium oxide as a biomaterial for medical implants

M.H. Ahmed, ... E. Ahmed, in The Design and Manufacture of Medical Devices, 2012

1.3.1 Biocompatibility

Biocompatibility of a biomaterial is an essential system property arising from physical, chemical, biological, medical and design components (Braybrook, 1997). It implies its ability to perform with an appropriate response in the host for the specific application. Biocompatibility is a collection of processes involving different but interdependent interaction mechanisms between the biomaterial and living tissue (Williams, 2002). Thus, biocompatible materials need to have the following characteristics (Heimann, 2002):

appropriate mechanical loading requirements, such as strength, rigidity, surface hardness and wear resistance;

long-term storage capability and corrosion resistance, and resistance to chemical attack by physiological fluids;

non-inflammatory response;

non-toxic and non-carcinogenic, and not incite allergic or immunologic reactions;

appropriate density;

good manufacturability.

The biocompatibility of medical implants is affected by factors such as the design and form of the implant, the toxicity of the biomaterial, resistance of the medical device to chemical or structural degradation, the nature of reactions occurring at the biological interface and the skill of the surgeon inserting the device. These factors interact with the implantation area, such as in hard tissue or soft tissue, or in the cardiovascular system.

The biocompatibility of a material is determined by in vitro and in vivo tests, involving the interaction of the material with biological fluids and cells, and is measured in terms of its effects on blood and blood components. This involves measurement of haemocompatibility, cytotoxicity and stimulation of an immune response.

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