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.

A thermosetting resin, or thermoset, is a synthetic organic polymer that cures to a solid, infusible mass by forming a three-dimensional network of covalent chemical bonds. Significant applications include construction and thermoset engineering plastics. This article discusses the general and family characteristics of thermosetting resin families, including allyls, aminos (urea formaldehyde and melamine formaldehyde), cyanates, epoxies, polybenzimidazoles, unsaturated polyesters, thermoset polyimides, phenolics, and vinyl esters. It also explains processing methods, including curing and curing agents. The article provides descriptions of commercial product forms and the wide array of applications of thermosetting resins. It also tabulates the performance properties (mechanical, thermal, electrical and chemical resistance) of some families of unfilled or unreinforced thermosetting resins and reinforced or filled grades.

This article describes the synthesis, manufacturing, and properties of both the neat soy-based resins and the glass, flax, and hemp composites. A tabulation of the fatty-acid distribution in various plant oils is provided. The article discusses synthetic pathways for triglyceride-based monomers and provides a discussion on acrylated epoxidized soybean oils (AESO), maleinized soyoil monoglyceride (SOMG/MA), and maleinized hydroxylated oil (HO/MA). The polymer properties of the AESO, SOMG/MA, and HO/MA are also discussed. The article explains the ballistic impact resistance of soy resin composites and concludes with a discussion on biodegradable composites.

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 explains 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 discusses the properties, chemical structures, and applications of different types of elastomers grouped based on their resistance to aging (oxidative degradation), solvents, and temperature. These include butadiene rubber, natural rubber, isoprene rubber, chloroprene rubber, styrene-butadiene rubber, aerylonitrile-butadiene (nitrile) rubber, isobutylene-isoprene (butyl) rubber, ethylene-propylene (-diene) rubber, and silicone rubber. The article also provides an outline of the concerns related to the processing stages of rubbers or elastomers, including mixing or compounding, shaping, and vulcanizing or crosslinking.

This article discusses several aspects of biocompatibility of polymers, including the selection of a suitable polymer, specific use of a material, contact of polymer on body site, and duration of the contact. It describes the factors influencing the biological response of the polymer from a biocompatibility perspective. These include raw materials, the manufacturing process, cleaning and sterilization processes, and biodegradation and biostability. The article reviews the general testing methods of polymers, such as chemical, mechanical and thermal. It concludes with a section on 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.

Engineering plastics offer unique product benefits based on physical properties, or combinations of physical properties, that allow vastly improved product performance. Providing an overview of the general characteristics and the mechanical and environmental stress response of engineering plastics, this article discusses various factors, including thermal, mechanical and electrical properties, environmental factors, and material cost that are important in the selection of engineering plastics for specific applications.

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

This article reviews the fundamental relationships between microstructure and mechanical properties for major classes of nonmetallic engineering materials: metals, ceramics and glasses, intermetallic compounds, polymers, and composites. It details the structures of inorganic crystalline solids, inorganic noncrystalline solids, and polymers. The article describes the various strengthening mechanisms of crystalline solids, namely, work hardening, solid-solution hardening, particle/precipitation hardening, and grain size hardening. Deformation and strengthening of composite materials, polymers, and glasses are reviewed. The article concludes with information on the two important aspects of the mechanical behavior of any class of engineering material: fatigue response and fracture resistance.

Molten salt baths are anhydrous, fused chemical baths used at elevated temperatures for a variety of industrial cleaning applications. This article discusses their applications in paint stripping, polymer removal, casting cleaning, glass removal, and plasma/flame spray removal. It provides an overview of the basic design and safety considerations of the salt bath equipment and describes the environmental impact of molten salt bath cleaning.

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 applications of biomaterials, including orthopedic, cardiovascular, ophthalmic, and dental applications. The article describes 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 examples of biomaterials applications, such as endovascular devices, knee implants, and neurostimulation.

The chemical composition of Kevlar aramid fiber is poly para-phenyleneterephthalamide. Para-aramid fibers belong to a class of materials known as liquid crystalline polymers. This article discusses the manufacture of aramid fibers and the major fiber forms, such as continuous filament yarns, rovings, woven fabrics, discontinuous staple and spun yarns, fabrics, and pulp. Key representative properties of para-aramid fibers are listed in a table. The article reviews the properties of aramid fibers, including tensile modulus, tensile strength, creep and fatigue, compressive properties, toughness, thermal properties, as well as electrical and optical properties. It concludes with a discussion on the environmental behavior of para-aramid fibers.

This article endeavors to familiarize the reader with a selection of different ionization designs and instrument components to provide knowledge for sorting the various analytical strategies in the field of solid analysis by mass spectrometry (MS). It begins with a description of the general principles of MS. This is followed by sections providing a basic understanding of instrumentation and discussing the operating requirements as well as practical considerations related to solid sample analysis by MS. Instrumentation discussed include the triple quadrupole mass spectrometer and the time-of-flight mass spectrometer. Inductively coupled plasma and thermal ionization MS provide atomic information, and direct analysis in real-time and matrix-assisted laser-desorption ionization MS are used to analyze molecular compositions. The article describes various factors pertinent to ionization methods, namely glow discharge mass spectrometry and secondary ion mass spectrometry. It concludes with a section on various examples of applications and interpretation of MS for various materials.

This article outlines the fundamentals of polymer science and emphasizes the aspects that are necessary and useful to applications of engineering plastics. The basic structure of polymers influences the properties of both polymers and the plastics made from them. An understanding of this basic structure permits the engineers to understand which polymers may be acceptable for a certain application, and which may not. There are various possible classification schemes for polymers. Typical classification categories include polymerization process, chemical elements that make up the monomer, or crystalline versus noncrystalline structure. The article describes the various aspects of chemical structure that are important to an understanding of polymer properties and, thus, affect eventual end uses. It discusses different types of names assigned to polymers. The article details the aspects of polymer structure and examines the properties of polymers and the way they are altered by structure.

This article lists functions of lubricants common to the majority of applications and processes. It discusses the lubricant candidates widely used in forging: conversion coatings with soaps (stearate compounds) and molybdenum disulfide for cold forging; oil-based thick, film oil or polymerbased lubricants and molybdenum disulfide for warm application; graphite suspensions in oil or water for hot forging steels; and glass films for titanium and superalloys hot forgings. The article describes the applications of lubricants in warm extrusion and forging, hot forging of steel, hot forging of aluminum, isothermal and hot die forging, and the extrusion of steel.

The corrosion process that occurs in industrial systems is often difficult to discern until extensive deterioration has occurred. For boilers to function properly, the incoming water must be processed to meet the water quality required for the boiler. This article discusses pretreatment methods of the incoming water and preboiler corrosion protection methods. It analyzes internal treatment and condensate treatment of boilers. The article discusses three types of cooling systems: once-through systems, open recirculating systems, and closed recirculating systems. The corrosion processes which occur in water-recirculating systems and the effect of dissolved gases, temperature, pH, suspended solids, dissolved salts, and scale deposition on corrosivity of water, are also reviewed. The article also considers anodic and cathodic inhibitors and the control of corrosion in municipal water systems.

Flammability is the ability of a material to undergo easy ignition and rapid flaming combustion. This article provides information on flammability tests of polymers and codes and regulations that cite these tests. Many organizations are involved in the characterization and specification of flammability properties, resulting in several categorization strategies for flammability tests, including tests for specific fire response characteristics, research tests versus acceptance tests, tests for different levels of severity, and tests for basis of origin. The article presents an overview on the basic approaches in improving the fire resistance of polymers and the burning process (heating, decomposition, ignition, combustion, and propagation). It provides a brief description on the test methods which are classified into two types, one based on fire response characteristics and the other on particular applications of polymeric materials.

This article provides an overview of the interfacial interactions with a lubricant film between a die and a metal, lubricant mechanisms, chemistry, qualification testing, application methods, and property test methods. It focuses on sheet metal-forming operations, although the discussions are relevant to metal-forming operations in general. The article also deals with lubricant selection as influenced by the metal to be formed and particular sheet-metal forming operations. The article also discusses some aspects of microbiology and toxicity in lubricants.

This article reviews the mechanical behavior and fracture characteristics that discriminate structural polymers from metals. It provides information on deformation, fracture, and crack propagation as well as the fractography involving the examination and interpretation of fracture surfaces, to determine the cause of failure. The fracture modes such as ductile fractures and brittle fractures are reviewed. The article also presents a detailed account of various fracture surface features. It concludes with several cases of field failure in various polymers that illustrate the applicability of available analytical tools in conjunction with an understanding of failure mechanisms.