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.

Structural applications for advanced ceramics include mineral processing equipment, machine tools, wear components, heat exchangers, automotive products, aerospace components, and medical products. This article begins with an overview of the wear-resistant applications and the parameters affecting wear of ceramics, namely, hardness, thermal conductivity, fracture toughness, and corrosion resistance. The next part of the article addresses temperature-resistant applications of advanced ceramics. Specific applications of ceramic materials addressed include cutting tools, pump and valve components, rolling elements and bearings, paper and wire manufacturing, biomedical implants, heat exchangers, adiabatic diesel engines, advanced gas turbines, and aerospace applications.

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.

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.

Titanium and its alloys are used in various applications owing to its high strength, stiffness, good toughness, low density, and good corrosion resistance. This article discusses the applications of titanium and titanium alloys in gas turbine engine components, aerospace pressure vessels, optic-system support structures, prosthetic devices, and applications requiring corrosion resistance and high strength. It explains the effects of alloying elements in titanium alloys as they play an important role in controlling the microstructure and properties and describes the secondary phases and martensitic transformations formed in titanium alloy systems. Information on commercial and semicommercial grades and alloys of titanium is tabulated. The article also discusses the different grades of titanium alloys such as alpha, near-alpha alloys, alpha-beta alloys, beta alloys, and advanced titanium alloys (titanium-matrix composites and titanium aluminides).

Impact or percussive wear is defined as the wear of a solid surface that is due to percussion, which is a repetitive exposure to dynamic contact by another body. Impact wear, however, has many analogies to the field of erosive wear. The main difference is that, in impact wear situations, the bodies tend to be large and contact in a well-defined location in a controlled way, unlike erosion where the eroding particles are small and interact randomly with the target surface. This article describes some generic features and modes of impact wear of metals, ceramics, and polymers. It discusses the processes involved in testing and modeling of impact wear, and includes two case studies.

Biomaterials are the man-made metallic, ceramic, and polymeric materials used for intracorporeal applications in the human body. This article primarily focuses on metallic materials. It provides information on basic metallurgy, biocompatibility, chemistry, and the orthopedic and dental applications of metallic biomaterials. A table compares the mechanical properties of some common implant materials with those of bone. The article also provides information on coatings, ceramics, polymers, composites, cements, and adhesives, especially where they interact with metallic materials.

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.

Zirconium and hafnium surfaces require cleaning and finishing prior to many processes including joining, heat treating, plating, forming, and final surface finishing. This article provides information on surface treatment processes, surface soil removal, blast cleaning, chemical descaling, pickling or etching, anodizing, autoclaving, polishing, buffing, vapor phase nitriding, and electroplating. It also provides several application examples.

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.

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 presents the principles of chemical vapor deposition (CVD) with illustrations. It discusses the types of CVD processes, namely, thermal CVD, plasma CVD, laser CVD, closed-reactor CVD, chemical vapor infiltration, and metal-organic CVD. The article reviews the CVD reactions of materials related to hard, tribological, and high-temperature coatings and to free-standing structures. It concludes by reviewing the advantages, disadvantages, and applications of CVD.

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 describes some of the mechanical/ electrochemical phenomena related to the in vivo degradation of metals used for biomedical applications. It discusses the properties and failure of these materials as they relate to stress-corrosion cracking (SCC) and corrosion fatigue (CF). The article presents the factors related to the use of surgical implants and their deterioration in the body environment, including biomedical aspects, chemical environment, and electrochemical fundamentals needed for characterizing CF and SCC. It provides a discussion on the use of metallic biomaterials in surgical implant applications, such as orthopedic, cardiovascular surgery, and dentistry. It addresses the key issues related to simulation of the in vivo environment, service conditions, and data interpretation. Theses include frequency of dynamic loading, electrolyte chemistry, applicable loading modes, cracking mode superposition, and surface area effects. The article describes the fundamentals of CF and SCC, testing methodology, and test findings from laboratory, in vivo, and retrieval studies.

This article reviews cleaning and finishing operations that have proven to be effective on titanium, its alloys, and semi-fabricated titanium products. It explains how to remove scale, tarnish films, grease, and other soils and how to achieve required finishes and/or improve wear and oxidation resistance through the use of polishing, buffing, and wire brushing operations. The article also covers a wide range of surface modification and coating processes, including ion implantation, diffusion, chemical and physical vapor deposition, plating, anodizing, and chemical conversion coatings as well as sprayed and sol-gel coatings and laser and electron-beam treatments.

This article reviews some concepts considered important for an understanding of processes used for preparing cobalt-chromium alloy implants, the microstructures resulting from this processing, and the resulting material properties. The review includes the solidification of alloys, diffusionless (martensitic) phase transformation as occurs with face-centered cubic to hexagonal close-packed transformation in cobalt-chromium alloys, stacking faults and twins and their role in this transformation. It also includes strengthening mechanisms that are responsible for the mechanical properties of cast and wrought cobalt alloys. The article contains tables that list the commonly used cobalt alloys and their biomedical applications and chemical compositions. It discusses the mechanical and corrosion properties of cobalt alloys, and provides a description of the microstructure of cobalt alloys.

This article describes the extrusion process, which converts soft, plastic material into a particular form using an extruder, or screw conveyer. It discusses the two main types of plastic extruders, twin-screw and single-screw, estimation of extruder capacity, and design and operations (heating, cooling, downstream sizing, corrugating, and crossheading) of the screw, the most important component of any extruder. It discusses the shapes produced by screw extrusion and the types of extrusion products produced by extrusion processes, including blown-film extrusion, flat-film or sheet extrusion, chill-roll film extrusion, pipe or tube extrusion, wire and cable coverings, extrusion coating, and profile extrusion, and provides some discussion on multiple-screw extruders. The article describes the dimensional accuracy of extrusion products, and lists common defects that occur frequently in the extrusion process.

This article focuses on the mechanisms, models, prevention, correction, and effects associated with decarburization inherited from semi-finished product processing prior to induction heating. It discusses the diffusion of carbon in austenitic iron, which has a face-centered cubic crystal structure that provides an interstitial path for the migration of the relatively small carbon atoms. The article describes the evolution of steel microstructure with progressive decarburization (in air) to a steady-state carbon gradient using an iron-iron carbide phase diagram. It provides useful information on the impact of alloying on vulnerability to decarburization, and the impact of decarburization on the mechanical properties of steels and cast irons. The article also describes the technological operations that potentially cause decarburization and the practical implications for induction hardening.

This article focuses on the analysis of materials and mechanical- (or biomechanical-) based medical device failures. It reviews the failure analysis practices, including evidence receipt, cleaning, nondestructive examination, destructive examination, exemplars analysis, and device redesign. The article examines the common failure modes, such as overload, fatigue, corrosion, hydrogen embrittlement, and fretting, of medical devices. The failure analysis of orthopedic implants, such as permanent prostheses and internal fixation devices, is described. The article reviews the failure mechanisms in some of the more common medical device materials, namely, stainless steels, titanium alloys, cobalt-base alloys, and nitinol. It presents case histories with examples for failure analysis.

Vacuum induction melting (VIM) is often done as the primary melting operation followed by secondary melting (remelting) operations. This article presents the process description of VIM and illustrates potential processing routes for products, which are cast from VIM ingots or electrodes. It describes the VIM refinement process, which includes removal of trace elements, nitrogen and hydrogen degassing, and deoxidation. The article concludes with information on production of nonferrous materials by VIM.