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 contains a table that lists the ISO standards for the biological evaluation of medical devices.

This article focuses on the modes of operation, physical basis, sample requirements, properties characterized, advantages, and limitations of the characterization methods used to evaluate the physical morphology and chemical properties of component surfaces for medical devices. These methods include light microscopy, scanning electron microscopy, atomic force microscopy, energy-dispersive X-ray spectroscopy, Auger electron spectroscopy, secondary ion mass spectrometry, X-ray photoelectron spectroscopy, Fourier transform infrared spectroscopy, and Raman spectroscopy.

The interaction of an implant with the human body environment may result in degradation of the implant, called corrosion. This article discusses the corrosion testing of metallic implants and implant materials. The corrosion environments for medical implants are the extracellular human body fluids, very complex solutions containing electrolytes and nonelectrolytes, inorganic and organic constituents, and gases. The article describes the fundamentals of electrochemical corrosion testing and provides a brief discussion on various types of corrosion tests. It illustrates corrosion current density determination by Tafel extrapolation, potentiodynamic measurement of the polarization resistance, electrochemical impedance measurement, and potentiostatic deaeration. Tests combining corrosion and mechanical forces, such as fretting corrosion tests, environment-assisted cracking tests, and ion-leaching tests are also discussed.

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.

Bearing in mind the three-legged stool approach of device design/manufacturing, patient factors, and surgical technique, this article aims to inform the failure analyst of the metallurgical and materials engineering aspects of a medical device failure investigation. It focuses on the device "failures" that include fracture, wear, and corrosion. The article first discusses failure modes of long-term orthopedic and cardiovascular implants. The article then focuses on short-term implants, typically bone screws and plates. Lastly, failure modes of surgical tools are discussed. The conclusion of this article presents several case studies illustrating the various failure modes discussed throughout.

The article presents an in-depth discussion on the various additive manufacturing techniques such as binder jetting, directed-energy deposition, material extrusion, material jetting, powder-bed fusion, sheet lamination, and vat polymerization processes. This article then discusses the different critical material aspects of additively manufactured medical devices, beginning with the preprinting phase (material consistency and recycling), the printing phase (build orientation), and the postprinting phase (part evaluation, biocompatibility, and sterilization) with supporting materials.

Additive manufacturing (AM), or three-dimensional (3D) printing, is a class of manufacturing processes that create the desired geometries of an object, or an assembly of objects, layer by layer or volumetrically. AM has been used extensively for manufacturing medical devices, due to its versatility to satisfy the specific needs of an intended medical field for the product/device. This article provides a comprehensive review of AM in medical devices by the medical specialty panels of the Food and Drug Administration (FDA) Code of Federal Regulations, Parts 862 to 892, including anesthesiology, ear and nose, general hospital, ophthalmic, plastic surgery, radiology, cardiovascular, orthopedic, dental, neurology, gynecology, obstetrics, physical medicine, urology, toxicology, and pathology. It is classified under these panels, and critical reviews and future outlooks are provided. The application of AM to fabricate medical devices in each panel is reviewed; lastly, a comparison is provided to reveal relevant gaps in each medical field.

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.

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 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 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.

Total joint replacement in orthopedic surgery can be achieved by excision, interposition, and replacement arthroplasty. This article details the most common materials used in total replacement synovial joints: metals, ceramics, and ultrahigh molecular weight polyethylene (UHMWPE). The principal physical properties and tribological characteristics of these materials are summarized. The article discusses pin-on-disk experiments and pin-on-plate experiments for determining friction and wear characteristics. It explains the use of various types of joint simulators, such as hip joint simulators and knee joint simulators, to evaluate the performance of engineering tribological components in machine simulators. The article concludes with a section on the in vivo assessment of total joint replacement performance.