This article discusses the conceptual and configuration design of special-purpose parts that are designed and manufactured especially for use in a particular application. It provides a discussion on the issues considered in designing of parts, including, functionality; the relationship of the part to the whole assembly or subassembly; material and process selection; configuration; and tolerances. The article discusses the qualitative physical reasoning and qualitative reasoning that assist in developing part configuration alternatives.

This article presents an overview of an engineering design process. Though the process is extremely complex, distinct stages of design activities are identified and described. The article illustrates guided iteration methodology that helps in problem solving in design. It describes the engineering conceptual design and configuration design of special-purpose parts. It discusses the parametric design methods of the parts and best practices that are used by successful firms to achieve the goals of quality, cost, time-to-market, and marketing flexibility.

Materials selection is an important engineering function in both the design and failure analysis of components. This article briefly reviews the general aspects of materials selection as a concern in proactive failure prevention during design and as a possible root cause of failed parts. It discusses the overall concept of design and describes the role of the materials engineer in the design and materials selection process. The article highlights the significance of materials selection in both the prevention and analysis of failures.

Materials selection is closely related to the objectives of failure analysis and prevention. This article briefly reviews the general aspects of materials selection as a concern in both proactive failure prevention during design and as a possible root cause of failed parts. Coverage is more conceptual, with general discussions on the following topics: design and failure prevention, materials selection in design, materials selection for failure prevention, and materials selection and failure analysis. Because materials selection is just one part of the design process, the overall concept of design is discussed. The article also describes the role of the materials engineer in the design and materials selection process. It provides information on the significance of materials selection in both the prevention and analysis of failures.

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.

This article introduces the fundamental concepts and the essential components of liquid chromatography (LC). It discusses the different modes of LC, such as liquid-solid chromatography, liquid-liquid chromatography, bonded-phase chromatograph, normal-phase chromatography, reversed-phase chromatography, ion-exchange chromatography, ion-pair chromatography, and size-exclusion chromatography. The article also includes a discussion on the qualitative and quantitative analyses and the applications of LC.

This article is a detailed account of the principles of electron-excited X-ray microanalysis. It begins by discussing the physical basis of electron-excited X-ray microanalysis and the advantages and limitations of energy dispersive spectrometry (EDS) and wavelength dispersive spectrometry for electron probe microanalysis. Key concepts for performing qualitative analysis and quantitative analysis by electron-excited X-ray spectrometry are then presented. Several sources that lead to measurement uncertainties in the k-ratio/matrix corrections protocol are provided, along with the significance of the raw analytical total. Sections on accuracy of the standards-based k-ratio/matrix corrections protocol with EDS and processes of analysis when severe peak overlap occurs are also included. The article provides information on low-atomic-number elements, iterative qualitative-quantitative analysis for complex compositions, and significance of standardless analysis in the EDS software. It ends with a section on the processes involved in elemental mapping for major and minor constituents.

Product design greatly influences the recycling and reuse of manufacturing materials. This article presents a design for recycling strategy based on ease of disassembly, minimizing process scrap, using readily recyclable materials, and labelling or otherwise identifying parts. It also discusses the concept of life-cycle analysis (LCA), a quantitative accounting of the environmental and economic costs of using a given material and the energy required to make, distribute, operate, and eventually dispose of the host product and its constituent materials. An important but often overlooked step in the LCA process is to identify potential improvement pathways.

Adhesive joints involve joining parts by bonding component parts together with an adhesive. This article provides a discussion on the purpose of testing adhesive joints and on the factors influencing mechanical strength of these joints. It describes the various tests used in the measurement of adhesive joint strength. These include qualitative tests, peel tests, lap shear tests, tensile tests, and adhesive fracture mechanics tests.

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.

Risk and hazard analysis can be effectively used during design reviews to provide valuable feedback to the design to avoid failures. This article discusses the types of risks, namely, real risk, statistical risk, predicted risk, and perceived risk. It describes the principle and technical methods of risk/hazard analysis practiced in the industry to identify possible hazards and the resources necessary to avoid or reduce risks. These methods include the failure mode and effect analysis, fault tree analysis, event tree analysis, risk/benefit analysis, safety analysis, and probabilistic estimates.

This article examines the concept of fractography as applied to elastomeric rubbery materials. It considers four general categories of physical root failure causes: design defects, material defects, manufacturing defects, and service life anomalies. Examples of real-world failures of rubber articles, with numerous accompanying figures, are representative of the four root failure categories.

Failure analysis is a process that is performed to determine the causes or factors that have led to an undesired loss of functionality. This article describes some of the factors and conditions that might be considered when approaching a failure analysis problem. It focuses on the key principles, objectives, practices, and procedures of failure analysis. The article provides guidelines on the preparation of a protocol for a failure analysis. It also demonstrates the proper approaches to failure analysis.

Electron probe microanalysis (EPMA) makes it possible to combine structural and compositional analysis in one operation. This article describes the basic concepts of microanalysis and the processing of EPMA that involves the measurement of the characteristic X-rays emitted from a microscopic part of a solid specimen bombarded by a beam of accelerated electrons. It provides information on the various aspects of energy-dispersive spectrometry (EDS) and wavelength-dispersive spectrometry (WDS), and elucidates the qualitative analysis of the major constituents of EDS and WDS. The article includes information on the analog and digital compositional mapping of elemental distribution, and describes the strengths and weaknesses of WDS and EDS spectrometers in X-ray mapping. It also outlines the application of EPMA for solving various problems in materials science.

X-ray powder diffraction (XRPD) techniques are used to characterize samples in the form of loose powders or aggregates of finely divided material that readily diffract x-rays in specified patterns. This article provides an introduction to XRPD, beginning with a review of sensing devices, including pinhole/Laue cameras, Debye-Scherrer/Gandolfi cameras, Guinier cameras, glancing angle cameras, conventional diffractometers, thin film diffractometers, Guinier diffractometers, and micro diffractometers. The article then describes several quantitative measurement methods, such as lattice parameter, absorption diffraction, spiking, and direct comparison, explaining where each may be used. It also identifies potential sources of error in XRPD measurements.

Accelerated life testing and aging methodologies are increasingly being used to generate engineering data for determining material property degradation and service life (or fitness for purpose) of plastic materials for hostile service conditions. This article presents an overview of accelerated life testing and aging of unreinforced and fiber-reinforced plastic materials for assessing long-term material properties and life expectancy in hostile service environments. It considers various environmental factors, such as temperature, humidity, pressure, weathering, liquid chemicals (i.e., alkalis and acids), ionizing radiation, and biological degradation, along with the combined effects of mechanical stress, temperature, and moisture (including environmental stress corrosion). The article also includes information on the use of accelerated testing for predicting material property degradation and long-term performance.

This article discusses the capabilities and limitations of various material characterization methods that assist in the selection of a proper analytical tool for analyzing particulate materials. Commonly used methods are microanalysis, surface analysis, and bulk analysis. The techniques used for performing microanalysis include scanning electron microscopy and electron probe X-ray microanalysis. The article describes surface analysis techniques, including Auger electron spectroscopy, X-ray photoelectron spectroscopy, and ion-scattering spectroscopy. Bulk analysis techniques, such as X-ray powder diffraction, inductively coupled plasma atomic emission spectroscopy, atomic absorption spectroscopy, and atomic fluorescence spectrometry, are also discussed.

Failure analysis is a process that is performed in order to determine the causes or factors that have led to an undesired loss of functionality. This article is intended to demonstrate proper approaches to failure analysis work. The goal of the proper approach is to allow the most useful and relevant information to be obtained. The discussion covers the principles and approaches in failure analysis work, objectives and scopes of failure analysis, the planning stages for failure analysis, the preparation of a protocol for a failure analysis, practices used by failure analysts, and procedures of failure analysis.

The goals of modeling diffusion bonding can be regarded as twofold: to optimize the selection of the process variables for a given material and to provide an understanding of the mechanisms by which bonding is achieved. This article describes the existing models of diffusion bonding with an assumption that the surfaces to be joined are free of contaminants and oxide, that bonding occurs between similar materials, and that the materials are single-phase metals. It discusses the mechanisms considered for diffusion bonding and limitations of existing models.

Computational fluid dynamics (CFD) is one of the tools available for understanding and predicting the performance of thermal-fluids systems. This article qualitatively describes the basic principles of CFD. The numerical methods, such as geometry description and discretization, used to solve the CFD equations are discussed. The article also demonstrates the application of CFD to a few casting problems.