This article describes the nitriding methods of titanium alloys such as plasma nitriding and gas nitriding. It focuses on the interaction of titanium alloys, interaction of titanium with nitrogen, and the interaction of titanium with oxygen, carbon, and hydrogen. The article provides information on the wear and fatigue properties and corrosion resistance of nitrided titanium alloys, as well as the effect of nitriding on the biocompatibility of titanium. It also compares plasma-nitrided titanium alloys with alloy steels. It concludes with a short discussion on the effect of nitriding on the surface properties of titanium and two-phase a + ß alloys.

Ceramics are used widely in a number of different clinical applications in the human body. This article provides a brief history of the bioceramics field and information on the classification of the different types of bioceramics. These include bioinert ceramics, bioactive ceramics, and bioresorbable ceramics. The article describes the third-generation bioceramics, classified by Hench and Polak, such as silicate-substituted hydroxyapatite and bone morphogenic protein-carrying calcium phosphate coatings. It reviews several examination methods that are used to test the biocompatibility of ceramics, namely, biosafety testing, biofunctionality testing, bioactivity testing, and bioresorbability testing.

This article discusses the several aspects of biocompatibility of polymers, including selection of a suitable polymer, specific use of a material, contact of polymer on body site, and duration of the contact. It describes factors influencing the biological response to the polymer in a biocompatibility perspective. These include raw materials, manufacturing process, cleaning and sterilization, and biodegradation and biostability. The article reviews the general testing of polymer, such as chemical, mechanical and thermal tests, to ensure that the polymer is stable and has not been adversely altered due to sterilization or processing. It concludes with a description of the guidance, provided by the regulatory authorities, on the biocompatibility testing of polymers and polymer-containing devices that can aid in selecting the right analysis.

This article discusses the mechanisms of metal and alloy biocompatibility. It provides information on early testing and experience with metals in medical device applications. The article describes the response to severe corrosion of implant and particulate materials. It provides a description of metal binding and its effects on metabolic processes. The hypersensitive responses to metal ions are also reviewed. The article concludes with a discussion on possible cancer-causing effects of metallic biomaterials.

This article highlights corrosion resistance and ion release from main transition metallic bearings that are used as medical devices. It discusses the main issues associated with the in vivo presence of ions and their biocompatibility during the exposure of patients to different aspects of ion toxicity. These include ion concentration and accumulation in organisms, reactive oxygen species and oxidative stress, and carcinogenicity stimulated by the corrosion process and toxic ions release.

This article provides an overview of curing techniques, adhesive chemistries, surface preparation, adhesive selection, and medical applications for adhesives. The curing techniques are classified into moisture, irradiation, heat, and anaerobic. The article highlights the common types of curable adhesives used for medical device assembly, including acrylics, cyanoacrylates, epoxies, urethanes, and silicones. Other forms of adhesives, such as hot melts, bioadhesives, and pressure-sensitive adhesives, are also discussed. Adhesives are used for medical device assembly, hard-tissue attachment in the fields of orthopedics and dentistry, and soft-tissue attachment such as wound closure. The typical characteristics and applications of biocompatible medical device adhesives are listed in a table. The article concludes with a section on selection of materials for medical adhesives.

This article focuses on the specific aspects of nitinol that are of interest to medical device designers. It describes the physical metallurgy, physical properties, and tensile properties of the nitinol. The article discusses the factors influencing superelastic shape memory effects, fatigue, and corrosion in medical device design. It reviews the biocompatibility of nitinol based on corrosion behavior. The article describes the general principles, potential pitfalls, and key properties for manufacturing, heat treatment, and processing of nitinol.

This article provides a summary of biocompatibility or biological response of metals, ceramics, and polymers used in medical implant, along with their clinical issues. The polymers include ultrahigh-molecular-weight polyethylene, nonresorbable polymer, and resorbable polymers.

Titanium and its alloys have been used extensively in a wide variety of implant applications, such as artificial heart pumps, pacemaker cases, heart valve parts, and load-bearing bone or hip joint replacements or bone splints. This article discusses the properties of titanium and its alloys and presents titanium-base biomaterials in a table. Titanium components are produced in wrought, cast, and powder metallurgy (PM) form. The article describes forging, casting, and heat treating of titanium alloys for producing titanium components. Typical mechanical properties of titanium biomedical implant alloys are listed in a tabular form. The article presents an overview of surface-modification methods for titanium and its alloys implants. It concludes with a section on biocompatibility and in vivo corrosion of titanium alloys.

This article discusses the composition of major components of dental composite resins. The components include organic resin matrix, filler, coupling agents, and initiator-accelerator systems. The article provides a description of three steps in adhesive systems, namely, etching, priming, and the placement of a resin adhesive layer. It describes the properties of composite resins that are related to the amount and type of filler and resin-matrix compositions. The article also provides a discussion on the compositions, properties, and clinical applications of polyacid-modified composite resins and resin-modified glass-ionomer cements. It discusses the biodegradation and biocompatibility of resin-based restorative materials.

The biocompatibility of a material relates to its immunological response, toxicity profile, and ability to integrate with surrounding tissue without undesirable local or systemic effects on a patient. This article underscores the transformation of the medical device design ecosystem engaged as an integral part of the device ecosystem. It discusses the various applications of biomaterials, including orthopedic, cardiovascular, ophthalmic, and dental applications. The article describes the four major categories of biomaterials, such as metals, polymers, glass and ceramics, and composites. A discussion on natural materials, nanomaterials, and stem cells is also provided. The article concludes with information on examples of biomaterials applications, including endovascular devices, knee implants, and neurostimulation.

This article focuses on ceramics, glasses, glass-ceramics, and their derivatives, that is, inorganic-organic hybrids, in the forms of solid or porous bodies, oxide layers/coatings, and particles with sizes ranging from nanometers to micrometers, or even millimetres. These include inert crystalline ceramics, porous ceramics, calcium phosphate ceramics, and bioactive glasses. The article discusses the compositions of ceramics and carbon-base implant materials, and examines their differences in processing and structure. It describes the chemical and microstructural basis for their differences in physical properties, and relates properties and hard-tissue response to particular clinical applications. The article provides information on glass or glass-ceramic particles for cancer treatments.

This article provides the background of biological evaluation of medical devices. It discusses what the ISO 10993 standards require for polymeric biomaterials and presents examples of what qualitative and quantitative tests can be used to satisfy the requirements. The article describes infrared (IR) analysis and thermal analyses that are used extensively to fingerprint polymeric materials and should be a part of all polymeric biomaterials characterization programs. It also provides a discussion on the chemical characterization and risk assessment of extracts. Background information on risk assessments of extracts is also included. The four basic steps that are commonly used in the risk assessment process are discussed. These steps include hazard identification, dose-response assessment, and exposure assessment, and risk characterization.

Physically, tantalum is a dark, blue-gray, lusterless metal that exists in two crystalline forms: an alpha-phase with a body-centered cubic structure, and a brittle beta-phase with a tetragonal orientation. This article tabulates the physical and material properties of tantalum. It discusses the use of tantalum in medical electronics and the advantage of tantalum over stainless steel. The article describes the manufacturing and medical applications of tantalum foam.

Polymers offer a wide range of choices for medical applications because of their versatility in properties and processing. This article provides an overview of polymeric materials and the characteristics that make them a unique class of materials. It describes the ways to classify polymers, including the polymerization method, how the material deforms, or molecular origin or stability. The article contains tables that list common medical polymers used in medical devices. It describes the medical polymer selection criteria and regulatory aspects of materials selection failure analysis and prevention. Failure analysis and prevention processes to determine the root cause of failures that arise at different stages of the product life cycle are reviewed. The article describes the mechanisms of plastic product failure analysis. It discusses the trends in the use of medical polymers, such as high-performance polymers for implants, tissue engineering, and bioresorbable polymers.

This article outlines some of the selection criteria for choosing an implant material for biomedical devices in orthopedic, dental, soft-tissue, and cardiovascular applications. It details the development of implants based on materials, such as metallic implants, ceramic implants, and polymeric implants. The article discusses the specific problems associated with implant manufacturing processes and the consequent compromises in properties of functionally graded implants. It describes the manufacturing of the functionally-graded hip implant by using the LENS process. It reviews the four different types of tissue responses to the biomaterial. The article discusses the testing of implant failure, such as in vitro and in vivo assessment of tissue compatibility.

This article provides an overview of the fundamentals of tribology. It describes the advantages, disadvantages, and applications of pin-on-disk method, which is the most commonly used configuration for testing biomaterials and for the reproducible measurement of friction and wear. The article illustrates practical tribocorrosion setup that allows the user to perform wear tests in corrosive environments under well-defined electrochemical conditions and at controlled temperature. It describes the effect of changes in electrical contact resistance on tribological mode. The article discusses various in vivo environmental conditions in tribological tests. Some typical examples of biomaterials testing are also provided.

This article focuses on the use of noble and precious metals for biomedical applications. The noble metals include gold, platinum, palladium, ruthenium, rhodium, iridium, and osmium. The physical and mechanical properties of the noble and precious metals are presented in tables. A brief discussion on the ancient history of noble and precious metal use in dentistry is provided. The article discusses the use of direct gold dental filling materials, direct silver dental filling materials, traditional amalgam alloys, high-copper amalgam alloys, and gallium alloys in biomedical applications. Modern stents were developed as a result of balloon catheterization research. The article describes gold coatings and iridium oxide coatings for stents.

Total joint replacement in orthopedic surgery can be achieved by excision, interposition, and replacement arthroplasty. This article details the most common materials used in total replacement synovial joints, such as metals, ceramics, and ultrahigh molecular weight polyethylene (UHMWPE). The principal physical properties and tribological characteristics of these materials are summarized. The article discusses the pin-on-disk experiments and pin-on-plate experiments for determining friction and wear characteristics. It details the use of various types of joint simulators, such as hip joint simulators and knee joint simulators, to evaluate the performance of engineering tribological components in machine simulators. The article describes in vivo assessment of total joint replacement performance.

This article tabulates materials that are known to have been used in orthopaedic and/or cardiovascular medical devices. The materials are grouped as metals, ceramics and glasses, and synthetic polymers in order. These tables were compiled from the Medical Materials Database which is a product of ASM International and Granta Design available by license online and as an in-house version. The material usage was gleaned from over 24,000 U.S. Food and Drug Administration (USFDA), Center for Devices and Radiological Health, Premarket notifications (510k), and USFDA Premarket Approvals, and other device records that are a part of this database. The database includes other material categories as well. The usage of materials in predicate devices is an efficient tool in the material selection process aiming for regulatory approval.