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.

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 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 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 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.

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.

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 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.

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 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 factors that influence mechanically assisted crevice corrosion. It reviews tests, such as scratch test and in vitro fretting corrosion test, developed to investigate the aspects of mechanically assisted corrosion 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 properties and hard-tissue response to particular clinical applications. The article provides information on glass or glass-ceramic particles for 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 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.