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 explains the general principles, potential pitfalls, and key properties for manufacturing, heat treatment, and processing of nitinol.

The term shape memory alloys (SMAs) refers to the group of metallic materials that demonstrate the ability to return to some previously defined shape or size when subjected to the appropriate thermal procedure. Materials that exhibit shape memory only upon heating are referred to as having a one-way shape memory. Some materials also undergo a change in shape upon recooling. These materials have a two-way shape memory. This article discusses the general characteristics of SMAs by using typical transformation versus temperature curve. It describes the processing, applications and properties (mechanical and physical) of commercial SMA alloys, namely nickel-titanium alloys and copper-base alloys.

This article discusses the history of shape memory alloys (SMAs) along with their properties, capabilities, and crystallography, including phase transformations that occur during thermal treatment. It describes the thermomechanical behaviors of SMAs and explains how to characterize them using differential scanning calorimeter (DSC) techniques as well as other methods. The article examines the most common shape memory alloys, namely, nickel-titanium and copper-base SMAs, and provides information on their respective properties.

This article is a detailed account of additive manufacturing (AM) processes for copper and copper alloys such as copper-chromium alloys, GRCop, oxide-dispersion-strengthened copper, copper-nickel alloys, copper-tin alloys, copper-zinc alloys, and copper-base shape memory alloys. The AM processes include binder jetting, ultrasonic additive manufacturing, directed-energy deposition, laser powder-bed fusion, and electron beam powder-bed fusion. The article presents a review of the literature and state of the art for copper alloy AM and features data on AM processes and industrial practices, copper alloys used, selected applications, material properties, and where applicable, compares these data and properties to traditionally processed materials. The data presented and the surrounding discussion focus on bulk metallurgical processing of copper components. The discussion covers the composition and performance criteria for copper alloys that have been reported for AM and discusses key differences in process-structure-property relationships compared to conventionally processed material. The article also provides information on feedstock considerations for copper powder handling.

This article explains how to prepare precious metal test samples for metallographic examination. It discusses cutting, mounting, grinding, polishing, and etching and addresses some of the challenges of working with small, relatively soft specimens. It includes dozens of example micrographs, comparing and contrasting the microstructural features of gold, platinum, iridium, palladium, and ruthenium-base alloys. It examines pure gold, intermetallic gold compounds, gold and platinum jewelry alloys, platinum-containing shape memory alloys, and alloys consisting of platinum, aluminum, and copper.

Martensite is a metastable structure that forms during athermal (nonisothermal) conditions. This article reviews the crystallographic theory, morphologies, orientation relationships, habit plane, and transformation temperature of ferrous martensite microstructures. It examines the stages of the tempering process involved in ferrous martensite. The article also describes the formation of the martensite structure in nonferrous systems. It concludes with a discussion on shape memory alloys.

This article provides information on nickel alloying elements, and the heat treatment processes of various nickel alloys for applications requiring corrosion resistance and/or high-temperature strength. These processes are homogenization, annealing, solution annealing, solution treating, stabilization treatment, age hardening, stress relieving, and stress equalizing. Discussion of furnaces, fixtures, and atmospheres is included. Nickel alloys used for the heat treatment processes include corrosion-resistant nickel alloys, heat-resistant nickel alloys, nickel-beryllium alloys, special-purpose alloys such as nitinol shape memory alloys, low-expansion alloys, electrical-resistance alloys and soft magnetic alloys. Finally, the article focuses on heat treatment modeling for selecting the appropriate heat treatment process.

The reflected light microscope is the most commonly used tool to study the microstructure of metals, composites, ceramics, minerals, and polymers. For the study of the microstructure of metals and alloys, light microscopy is employed in the reflected-light mode using either bright-field illumination, dark-field illumination, polarized light illumination, or differential interference contract, generally by the Nomarski technique. This article concentrates on how to reveal microstructure properly to enable the proper identification of the phases and constituents and, if needed, measuring the amount, size, and spacing of constituents, using the light optical microscope. The discussion covers the examination of microstructures using different illumination methods and includes a comparison between light optical images and scanning electron microscopy images of microstructure.

Abrasive wear is a surface-damage process with material loss caused by hard asperities or abrasive particles occurring when two surfaces are sliding against each other. There are two types of abrasive wear: two-body abrasion and three-body abrasion. This article discusses the abrasive wear mechanism in ductile materials and commonly used testers for evaluating the resistance of materials to abrasive wear. The testers include pin-on-disk, block-on-ring, block-on-drum, and dry sand/rubber wheel abrasion tester. The article reviews the abrasion resistance of metallic materials, ceramic materials, and polymeric materials. It discusses factors that influence abrasive wear, including the environment, hardness, toughness, microstructure, and lubrication.

Titanium has been recognized as an element with good mechanical and physical properties, alloying characteristics, and corrosion resistance. Providing an outline of general characteristics and types of titanium alloys, this article discusses the contemporary technology of titanium along with its market developments. It also discusses the application of titanium and titanium alloys in corrosive environments and in aerospace and automotive industries. The article describes the developments in titanium processing and materials technologies, which include the development of sponge production and melting processes, oxide dispersion-strengthened alloys by powder metallurgy techniques, titanium-base intermetallic compounds, and titanium-matrix composites.

Nickel in elemental form or alloyed with other metals and materials has made significant contributions to our present-day society and promises to continue to supply materials for a demanding future. This article provides a historical overview and physical metallurgy of nickel and nickel alloys. It lists and describes the compositions, mechanical and physical properties, and applications of commercial nickel and its alloys. The article briefly explains the forms of corrosion resulting from the exposure of nickel alloys to aqueous environments. It provides valuable information on the commercial forms of nickel alloys, namely, nickel-copper alloys, nickel-chromium and nickel-chromium-iron series, iron-nickel-chromium alloys, controlled-expansion alloys, nickel-iron low-expansion alloys, soft magnetic alloys, and welding alloys.

Microjoining methods are commonly used to fabricate medical components and devices. This article describes key challenges involved during microjoining of medical device components. The primary mechanisms used in microjoining for medical device applications include microresistance spot welding (MRSW) and laser welding. The article illustrates the fundamental principles involved in MRSW and laser welding. The article presents examples of various microjoining methods used in medical device applications, including pacemaker and nitinol microscopic forceps.

This article describes the different types of precipitation and transformation processes and their effects that can occur during heat treatment of various nonferrous alloys. The nonferrous alloys are aluminum alloys, copper alloys, magnesium alloys, nickel alloys, titanium alloys, cobalt alloys, zinc alloys, and heat treatable silver alloys, gold alloys, lead alloys, and tin alloys. It also provides a detailed discussion on the effects due to precipitation and transformation processes in these non-ferrous alloys.

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.

This article focuses on the basic metallurgy and machining parameters of classes of depleted and enriched uranium alloys. It provides information on the health precautions applicable to the machining of depleted uranium alloys. The article also discusses tool wear and the types of tools used in uranium alloy machining.

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 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.

This article reviews the understanding of corrosion interactions between alloys in complex geometries and in applications where there are significant cyclic stresses and potential for wear and fretting motion. These alloys include iron-base, titanium-base, and cobalt-base alloys. The article discusses the surface characteristics and electrochemical behavior of metallic biomaterials. It summaries the clinical context for mechanically assisted corrosion and describes mechanically assisted crevice corrosion. There have been several tests developed to investigate aspects of mechanically assisted corrosion. The article also explains the scratch test and the in vitro fretting corrosion test.

This article reviews the corrosion interactions between biomedical alloys, in particular iron-base, titanium-base, and cobalt-base alloys, in complex geometries and in applications where there are significant cyclic stresses and potential for wear and fretting motion. It discusses the nature of these metal surfaces and their propensity for corrosion reactions when combined with similar or different alloys in complex restrictive environments within the human body and under loading conditions. The article describes the factors that influence mechanically assisted crevice corrosion. It reviews the tests developed to investigate the aspects of mechanically assisted corrosion of metallic biomaterials: the scratch test and the in vitro fretting corrosion test.

This article is a compilation of color etchants that have been developed for a limited number of metals and alloys. It describes the optical methods for producing color, such as polarized light and differential interference contrast, with illustrations. The article discusses film formation and interference techniques such as anodizing, chemical etching, and tint etching. It provides a description of reagents that deposit sulfide films and molybdate films. The article concludes with a discussion on the thermal and vapor deposition methods to produce color.