This article discusses some of the additive manufacturing (AM) based fabrication of alloys and their respective mechanical, electrochemical, and in vivo performance. Firstly, it briefly discusses the three AM techniques that are most commonly used in the fabrication of metallic biomedical-based devices: binder jetting, powder-bed fusion, and directed-energy deposition. The article then characterizes the electrochemical properties of additive-manufactured/processed cobalt-chromium alloys. This is followed by sections providing an evaluation of the biological response to CoCr alloys in terms of the material and 3D printing fabrication. Discussion on the biological response as a function of direct cellular activity on the surface of CoCr alloys in static conditions (in vitro), in dynamic physiological conditions (in vivo), and in computer-simulated conditions (in silico) are further discussed in detail. Finally, the article provides information on the qualification and certification of AM-processed medical devices.

This article provides information on biomedical aspects such as active biological responses and the chemical environment characterizing the internal physiological milieu, as well as electrochemical fundamentals needed for characterizing corrosion fatigue (CF) and stress-corrosion cracking (SCC). It discusses some of the mechanical and electrochemical phenomena related to the in vivo degradation of materials used for biomedical applications. These materials include stainless steels, cobalt and titanium-base alloy systems, and dental amalgam. The article addresses key issues related to the simulation of the in vivo environment, service conditions, and data interpretation. The factors influencing susceptibility to CF and SCC are reviewed. The article describes the testing methodology of CF and SCC. It also summarizes findings from laboratory testing, in vivo testing and retrieval studies related to CF and SCC.

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

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.

Implant debris is known to cause local inflammation, local osteolysis, and, in some cases, local and systemic hypersensitivity. The debris can be stainless steel, cobalt alloy, and titanium alloy, and soluble debris obtained due to wear from all orthopedic implants. This article addresses the biologic aspects of implant debris, both locally and systemically. It describes debris-induced local effects, particle-induced proinflammatory responses, and debris-induced systemic effects. The article concludes with a discussion on the four systemic effects of implant debris, namely, neuropathic effects, hypersensitivity effects, carcinogenicity, and general toxicity.

This article provides a background to the biological evaluation of medical devices. It discusses what the ISO 10993 standards require for polymeric biomaterials and presents examples of qualitative and quantitative tests that can be used to satisfy these requirements. The article describes infrared (IR) and thermal analyses that are used extensively to fingerprint polymeric materials. It also presents 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 include hazard identification, dose-response assessment, and exposure assessment, and risk characterization.

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 discusses the classification of bioceramics. These include bioinert ceramics, bioactive ceramics, and bioresorbable ceramics. The article describes 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 used to test the biocompatibility of ceramics, namely, biosafety testing, biofunctionality testing, bioactivity testing, and bioresorbability testing.

One of the most frequently cited advantages of ceramics in dentistry relates to aesthetics, and the same applies for dental implants. Zirconia has emerged as the material of choice for nonmetal implants. This article introduces the reader to zirconia as an implant material, its properties, manufacturing processes, and the particular surface modifications and treatments that have rendered its surfaces biologically compatible with peri-implant soft and hard tissues.

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.

Additive manufacturing, or three-dimensional printing technologies, for biomedical applications is rather different from other engineering components, particularly for biomedical implants that are intended to be used within the human body. This article contains two sections: "Design and Manufacturing Considerations of 3D-Printed, Commercially Pure Titanium and Titanium Alloy-Based Orthopedic Implants" and "Device Testing Considerations Following FDA Guidance" for additive-manufactured medical devices. These are further subdivided into five major focus areas: materials; design, printing, printing characteristics and parameters as well as postprinting validation; removal of the many manufacturing material residues and sterilization; physical, chemical, and mechanical assessments of the final devices; and biological considerations of all the final devices including biocompatibility.

The human internal environment plays a vital role in the friction and wear of implants and prosthetic devices. This article describes the tribological/wear behavior of implants. It discusses the classification of active tribological pairs, namely, amphiarthosis joints and diarthosis joints. The article details the classification of total knee replacement, depending on the type of mechanical stability, including nonconstrained knee replacement, semiconstrained knee replacement, and constrained knee replacement. It also discusses the classifications of passive tribological pairs, namely, total disc replacement in the spine, dental implants, and temporomandibular joint. It describes the various testing methods for characterizing the implant materials used in hip, knee, spine, and dental applications. The article also describes the typical standards used for testing wear behavior of tribological pairs, namely, hip-wear simulation standards, knee-wear simulation standards, and spinal disc-wear simulation standards.

In the field of medical device development and testing, the corrosion of metallic parts can lead to significant adverse effects on the biocompatibility of the device. This article describes the mechanisms of metal and alloy biocompatibility. It reviews the response of implant metals and particulate materials to corrosion. The effect of metal ions from an implanted device on the human body is also discussed. The article concludes with information on the possible cancer-causing effects of metallic biomaterials.

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 the properties and hard-tissue response to particular clinical applications. The article also provides information on the glass or glass-ceramic particles used in cancer treatments.

This article tabulates the chemical composition of iron-base, titanium-base, and cobalt-base alloys and illustrates the microstructures of these materials. It discusses the surface morphology and chemistry of oxide-film-covered alloys and provides insights into the interaction. The article illustrates the interfacial structure of a biomaterial surface contacting with the biological environment. It describes the corrosion behavior of stainless steel, cobalt-base alloy, and titanium alloys. The electrochemical methods used for studying metallic biomaterials corrosion are also discussed. The article concludes with information on the biological consequences of in vivo corrosion and biocompatibility.

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 of implant and particulate materials to severe corrosion. It provides a description of metal binding and its effects on metabolic processes. Hypersensitive responses to metal ions are also reviewed. The article concludes with a discussion on the possible cancer-causing effects of metallic biomaterials.

This article provides an overview of additive manufacturing (AM) methods, the three-dimensional (3D)-AM-related market, and the medical additive manufactured applications. It focuses on the current scenario and future developments related to metal AM for medical applications. The discussion covers the benefits of using 3D-AM technology in the medical field, provides specific examples of medical devices fabricated by AM, reviews trends in metal implant development using AM, and presents future prospects for the development of novel high-performance medical devices via metal 3D-additive manufacturing.

This article describes the corrosion resistance and ion release from main transition metallic bearings 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 focuses on the effects of microscopic organisms and the by-products they produce on the electrochemical corrosion of metals. The general characteristics of the microorganisms that facilitate their influence on the electrochemistry of corrosion are discussed. The industries most often reported as being affected by microbiological corrosion are listed, along with the organisms usually implicated in the attack. The article explains that the influence of organisms can be addressed successfully for a corrosion control program by using four types of evidence: metallurgical, microbiological, chemical, and electrochemical. It provides information on the microbiologically influenced corrosion (MIC) of irons and steels, passive alloys (austenitic stainless steels), aluminum alloys, copper alloys, and composites. The article reviews the formation of microbial biofilms and macrofouling films. It also describes the general approaches taken to prevent MIC.

Stereolithographic (STL) additive manufacturing (AM) can be used to fabricate practical components. This article discusses the processes involved in STL-AM of biological scaffolds, providing information on bioscaffold processing, cavity arrangements, and microlattice distributions. Within the last topic, the sub-topic of scaffold modulation is discussed.