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

The basic quality analysis tools are cause-and-effect diagrams, check sheets, control charts, histograms, Pareto charts, scatter diagrams, and run charts. This article reviews how the basic quality analysis tools are built upon to become a more advanced set of quality tools. It describes the advanced quality tools: advanced product quality planning, failure mode and effects analysis, control planning, measurement systems analysis, lean tools, statistical process control, production viability and tryout, and Six Sigma.

This article describes design factors for products used in engineering applications. The article groups these factors into three categories: functional requirements, analysis of total life cycle, and other major factors. These categories intersect and overlap, constituting a major challenge in engineering design. Performance specifications, risk and hazard analysis, design process, design for manufacture and assembly, design for quality, reliability in design, and redesign are considered for functional requirements. Life-cycle analysis considers raw-material extraction from the earth and product manufacture, use, recycling (including design for recycling), and disposal. The other major factors considered include evaluation of the current state of the art for a given design, designing to codes and standards, and human factors/ergonomics.

Probability of detection (POD) assesses the performance of a non-destructive evaluation (NDE)-based inspection, which is a method used to determine the capability of an inspection as a function of defect type and defect size. This article provides an overview of the concept of POD, why it is needed, the history behind the development of POD, how POD assessments are performed, and how modeling and simulation can be integrated into the execution of a POD assessment. It describes the methods by which POD is determined. This includes detail on the experimental process to acquire the needed data, the mathematical methods to obtain a POD curve, and techniques to assess uncertainty in the POD curve as it is obtained from a limited data set. The concept of model-assisted POD (MAPOD) is introduced, with additional details and representative examples of MAPOD.

Vibrothermography, also known as sonic thermography, sonic infrared (IR), thermosonics, and vibroacoustic thermography, is a nondestructive evaluation (NDE) technique for finding cracks and delaminations through vibration-induced heating. This article describes the four parts of the vibrothermography process: vibration of the specimen by a transducer; conversion of vibrational energy into heat by a crack, delamination, and other contacting surfaces; conduction of the heat to an external surface; and infrared detection of the heat with a thermal camera.

Both nondestructive testing (NDT) and nondestructive evaluation (NDE) use noninvasive measurement techniques to gain information about defects and various properties of materials, components, and structures. This article begins with a discussion on the historical development of quantitative measurement techniques, evaluation reliability, and quantitative interpretation of nondestructive inspection methods. The common nondestructive evaluation methods, along with their uses and limitations, are summarized in a table. The article conceptually illustrates the interplay of NDE and fracture mechanics in the damage tolerant approach. It concludes with information on pressure vessel applications that can be separated into three protocols used by military nuclear power, commercial nuclear power, and non-nuclear pressure vessels and/or fired boilers.

This article provides guidelines for the assessment of model quality in materials science and engineering. It discusses the fundamentals of model quality assessment and the calibration of mechanistic material models. The article reviews the considerations for the model verification during software implementation planning to identify suitable programs, software components, and programming languages. It describes the validity tests used in model validation, including boundary-value tests, degenerate problem tests, sensitivity tests, and benchmarking. The article also presents an example of model calibration, verification, and validation for the prediction of martensite start temperature of steels.

Porous coatings are used in the field of joint replacement, particularly in cementless total hip/knee arthroplasty. This article reviews the offerings and biomaterial properties in orthopedic surgery for the contemporary class of highly porous metals. It describes the traditional porous metal/coating having an open-cell structure, high porosity, and a microsctructure resembling that of cancellous bone. The traditional porous metal/coating includes fiber-metal mesh, cobalt-chromium (CoCr) beads, cancellous-structured titanium, and plasma spray. The article discusses other porous metal/coating due to the limitations of traditional porous metals for numerous open-cell-structured metals, such as titanium-base foams and trabecular metal.

The design process for ceramic materials is more complex than that of metals because of low-strain tolerance, low fracture toughness and brittleness. The application of structural ceramics to engineering systems hinges on the functional benefits to be derived and is manifested in the conceptual design for acceptable reliability. This article discusses the design considerations for the use of structural ceramics for engineering applications. It describes the conceptual design and deals with fast fracture reliability, lifetime reliability, joints, attachments, interfaces, and thermal shock in detailed design procedure. The article provides information on the proof testing of ceramics, and presents a short note on public domain software that helps determine the reliability of a loaded ceramic component. The article concludes with several design scenarios for gas turbine components, turbine wheels, ceramic valves, and sliding parts.

High-pressure die casting is a fast method for net shape manufacturing of parts from nonferrous alloys. This article reviews the automation technologies for the different stages or steps of the process. The steps include liquid metal pouring, injection, solidification, die open, part extraction, die lubrication, insert loading, and die close. Some manual aspects of the operations together with automation options are discussed. The article describes finishing steps, such as finish trimming, detailed deflashing, shot blast cleaning, and quality checks. Automation of the postcasting process is also discussed.

This article analyzes the estimates of the cost of corrosion, made in various countries at various times. The data are extrapolated to a 2004 base and then projected to the global economy. The chronological order of the countries are the United States of America, the United Kingdom, Australia, Japan, Canada, Germany, Poland, South Africa, Czechoslovakia, Belgium, Netherlands, Sweden, Finland, the Union of Soviet Socialist Republics, Kuwait, India, and the Basque Region.

Hot isostatic pressing (HIP) is used to eliminate porosity in castings. This article provides the history and an overview of the HIP system. It illustrates the reasons for using HIP and discusses the criteria for selecting HIP process parameters. The main mechanisms by which pores are eliminated during HIP are reviewed. The article describes the effect of HIP on the mechanical properties, shape, and structure of castings as well as the effect of inclusions on as-HIPed properties. It examines the problems encountered in HIP and their solution. The article concludes with information on the economics of HIP system.

This article discusses the standard conduct of coating failure investigation. As each failure is different, a specific coating failure may require increased emphasis on a given step, or additional work and/or steps may be required. This article covers the following topics: obtaining and analyzing background information, preliminary determination of site conditions, inspection equipment requirements, coating failure site investigation, sampling techniques, sample chain of custody, coordination with the coatings laboratory, report preparation, and sample retention.

The success of a reliable non-destructive evaluation (NDE) application depends greatly on the expertise and thoroughness of the NDE engineering that is performed. This article discusses the general considerations of NDE in terms of NDE response and NDE system management and schedule. It describes the NDE engineering and NDE process control, along with some case studies related to the applications of NDE. The article reviews various models for predicting NDE reliability, such as ultrasonic inspection model, eddy current inspection model, and radiographic inspection model. It concludes with an example that illustrates the integration of an ultrasonic reliability model with a CAD system.

Visual inspection (VI) is the oldest inspection technique man has used as a quality-control tool to evaluate products, assess their final form in terms of fabrication accuracy and external features based on experience, and decide on their acceptance or rejection. This article discusses the basic principles of visual inspection in terms of direct visual examination and indirect visual examination as well as advantages and limitations of visual inspection. It reviews the factors affecting the effectiveness of VI as a nondestructive testing (NDT): lighting conditions of observation, condition of surface under inspection, physical state/condition of inspector, proper training of personnel and level of expertise, and knowledge of applicable standards. The article provides schematic illustrations of rigid borescopes, fiberscopes, and videoscopes. It concludes with a discussion on automated optical inspection systems.

This article provides a clear but nonexhaustive description of the general principle of atomic emission, with a particular focus on instrumentation, and summarizes the main characteristics of the inductively coupled plasma optical emission spectrometer technique. Basic atomic theory as well as the instrument characteristics and their influence on the instrument performances are presented. The advantages, drawbacks, and developments of this technique are discussed, and, finally, alternative techniques and examples of applications are provided.

This article begins with discussion on forgeability and the factors affecting the forgeability of aluminum and aluminum alloys. It describes the types of forging methods and equipment and reviews critical elements in the overall aluminum forging process: die materials, die design, and die manufacture. The article discusses the critical aspects of various manufacturing elements of aluminum alloy forging, including the preparation of the forging stock, preheating stock, die heating, lubrication, trimming, forming and repair, cleaning, heat treatment, and inspection. It concludes with a discussion on the forging of advanced aluminum materials and aluminum alloy precision forgings.