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Book Chapter
Material and Chemical Characterization as a Part of the Biological Evaluation of Medical Devices
Available to PurchaseSeries: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005686
EISBN: 978-1-62708-198-6
... of biological safety must start with chemical and material characterization along with an assessment of toxicological risks as prescribed in ISO 10993-1, 10993-18, 10993-17, and 14971. Materials characterization forms the basis for understanding the composition of a medical device material and its potential...
Abstract
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.
Series: ASM Handbook
Volume: 2
Publisher: ASM International
Published: 01 January 1990
DOI: 10.31399/asm.hb.v02.a0001090
EISBN: 978-1-62708-162-7
... and specifications of germanium. The article describes the analytical and test methods of germanium, including gravimetric method, titrimetric method, and spectral method. It provides a short note on toxicology, and concludes with the uses of germanium in different fields. analytical methods electrical...
Abstract
Germanium is a semiconducting metalloid element found in Group IV A. Germanium is used in the field of electronics, infrared optics, and in the fields of gamma ray spectroscopy, catalysis, and fiber optics. This article discusses the sources, manufacturing, and processing of germanium, and focuses on the chemical properties of various germanium compounds, including germanium halides, germanates, germanides, germanes, inorganic, and organogermanium compounds. It also tabulates the physical, thermal, electronic, and optical properties of germanium, and explains the economical aspects and specifications of germanium. The article describes the analytical and test methods of germanium, including gravimetric method, titrimetric method, and spectral method. It provides a short note on toxicology, and concludes with the uses of germanium in different fields.
Series: ASM Handbook
Volume: 2
Publisher: ASM International
Published: 01 January 1990
DOI: 10.31399/asm.hb.v02.a0001119
EISBN: 978-1-62708-162-7
... Abstract Metal contamination of the environment reflects both natural sources and industrial activity, affecting human health. This article begins with a discussion on the level of metal exposure resulting in toxicological effects, the factors influencing toxicity of metals, and carcinogenicity...
Abstract
Metal contamination of the environment reflects both natural sources and industrial activity, affecting human health. This article begins with a discussion on the level of metal exposure resulting in toxicological effects, the factors influencing toxicity of metals, and carcinogenicity of metal compounds. It discusses some commonly used chelating agents for treating metal intoxication, and clinical effectiveness in treating poisoning by different metals. The metals discussed are grouped into four categories: (1) major toxic metals with multiple effects, including arsenic, beryllium, cadmium, chromium, lead, mercury, and nickel; (2) essential metals with potential for toxicity, including cobalt, copper, iron, manganese, molybdenum, selenium, and zinc; (3) metals with toxicity related to medical therapy, including aluminum, bismuth, gallium, gold, lithium, and platinum; and (4) minor toxic metals, including antimony, barium, indium, magnesium, silver, tellurium, thallium, tin, titanium, uranium, and vanadium. The main factors included in the discussion are their disposition, toxicity, biological factors and treatment.
Book Chapter
Developments and Trends in Additively Manufactured Medical Devices
Available to PurchaseSeries: ASM Handbook
Volume: 23A
Publisher: ASM International
Published: 12 September 2022
DOI: 10.31399/asm.hb.v23A.a0006902
EISBN: 978-1-62708-392-8
... 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...
Abstract
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.
Book Chapter
Petroleum Oil Quenchants
Available to PurchaseSeries: ASM Handbook
Volume: 4F
Publisher: ASM International
Published: 01 February 2024
DOI: 10.31399/asm.hb.v4F.a0007002
EISBN: 978-1-62708-450-5
... Abstract In this article, an in-depth overview of petroleum quenching oils is provided, including oil composition, use, mechanism of the oil quenching processes, oil degradation, toxicology and safety, and quenching bath maintenance. oil composition oil degradation oil quenchants oil...
Abstract
In this article, an in-depth overview of petroleum quenching oils is provided, including oil composition, use, mechanism of the oil quenching processes, oil degradation, toxicology and safety, and quenching bath maintenance.
Series: ASM Handbook
Volume: 5B
Publisher: ASM International
Published: 30 September 2015
DOI: 10.31399/asm.hb.v05b.a0006039
EISBN: 978-1-62708-172-6
... (having the ability to change genetic material, notably DNA), and teratogenic (having the ability to change physical and psychological development). The United States National Toxicology Program, run by the Department of Health and Human Services, released its 13th Report on Carcinogens on October 2...
Abstract
Bitumen for coating usage can best be categorized as two fundamental but very different types: asphalts and coal tars. This article provides a detailed discussion on asphalt and coal tar hot-melt applications; asphalt and coal tar emulsions; asphalt and coal tar cutbacks; and coal tar epoxies. It reviews the similarities between asphaltic and coal tar coatings and discusses the health and environmental concerns of these materials.
Book Chapter
Safety in Handling of Metal Powders
Available to PurchaseSeries: ASM Handbook
Volume: 24
Publisher: ASM International
Published: 15 June 2020
DOI: 10.31399/asm.hb.v24.a0006544
EISBN: 978-1-62708-290-7
...-to-volume ratio of the powders can increase their chemical reactivity in biological exposures (for example, inhalation or ingestion) and increase the risk of flash fires and dust explosions. Materials considered relatively benign in bulk can pose special toxicological and ecological risks when in a finely...
Abstract
During metal powder production, powder and/or dust handling, compaction, and part finishing operations, many safety and environmental risks exist. This article is a detailed account of the types of safety hazards that can exist and the issues that occur during metal powder handling, as well as recommendations and strategies that can be employed to both prevent and protect against damaging effects from powder exposure, fire and/or explosions, or environmental impact events.
Series: ASM Handbook
Volume: 9
Publisher: ASM International
Published: 01 December 2004
DOI: 10.31399/asm.hb.v09.a0005650
EISBN: 978-1-62708-177-1
... identification Composition and information on ingredients Hazards identification First aid measures Firefighting measures Accidental release measures Handling and storage Exposure controls/personal protection Physical and chemical properties Stability and reactivity Toxicological...
Abstract
This article describes the safety precautions required for using laboratory equipment. It reviews the various personal protective equipment specified on the Material Safety Data Sheets (MSDS) for laboratory chemicals and products. The article provides information on the storage and handling of etchants, solvents, acids, bases, and other chemicals. It describes the safety precautions and procedures for handling concentrated and dilute hydrofluoric acid. The article concludes with a discussion on the precautions to be followed in the event of spills and cleanup.
Book Chapter
Life-Cycle Engineering and Design
Available to PurchaseSeries: ASM Handbook
Volume: 20
Publisher: ASM International
Published: 01 January 1997
DOI: 10.31399/asm.hb.v20.a0002433
EISBN: 978-1-62708-194-8
... have been published by the Society of Environmental Toxicology and Chemistry (SETAC), the U.S. Environmental Protection Agency (EPA), the Canadian Standards Association (CSA), the Society for the Promotion of LCA Development (SPOLD), and various practitioners. For meaningful comparisons of the life...
Abstract
Life-cycle engineering is a part-, system-, or process-related tool for the investigation of environmental parameters based on technical and economic measures. This article focuses on life-cycle engineering as a method for evaluating impacts. It describes the four steps of life-cycle analysis, namely, goal definition and scoping, inventory analysis, impact assessment and interpretation, and improvement analysis. The article discusses the applications of life-cycle analysis results and presents a case history of life-cycle analysis of an automobile fender.
Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005659
EISBN: 978-1-62708-198-6
... function or the health of the patient, which requires that it does not induce a tumorigenic (cancer) nor a toxicological (e.g., cell death and tissue necrosis) response. Local tissue responses are defined as the cellular and tissue organization at the material/tissue interface. Ideally, it could...
Abstract
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.
Book Chapter
Chromate Conversion Coatings
Available to PurchaseBook: Surface Engineering
Series: ASM Handbook
Volume: 5
Publisher: ASM International
Published: 01 January 1994
DOI: 10.31399/asm.hb.v05.a0001275
EISBN: 978-1-62708-170-2
... 19. Brown G.M. , Shimizu K. , Kobayashi K. , Thompson G.E. , and Wood G.C. , in Corros. Sci. , Vol 33 , 1992 , p 1371 10.1016/0010-938X(92)90178-6 20. Kazantzis G. and Lilly L.J. , in Handbook on the Toxicology of Metals , Friberg L...
Abstract
This article briefly describes the basic attributes of chromate conversion coatings and the processes for applying them. It provides information on the influence of substrate microstructure on the performance of coating deposits and on the mechanism of substrate protection supplied by chromate coatings. The article also discusses the development of replacement technologies in response to environmental constraints that have developed around the use of chromium-base compounds.
Series: ASM Handbook
Volume: 11B
Publisher: ASM International
Published: 15 May 2022
DOI: 10.31399/asm.hb.v11B.a0006914
EISBN: 978-1-62708-395-9
.... The chemical compounds evolved during combustion can be analyzed using many standard analytical techniques, including infrared analysis, gas chromatography, mass spectrometry, and ion-selective electrodes. Toxicological studies generally involve the exposure of laboratory rats or mice to the gaseous products...
Abstract
A material is flammable if it is subject to easy ignition and rapidly flaming combustion. The plastics that are most widely used are the least expensive and tend to be the most flammable. This article describes the two basic approaches to improving the fire resistance of a polymeric material: modifying or substituting the basic polymer so that exposure to heat and oxygen will not produce rapid combustion, and using flame-retardant additives. It also provides an overview of the burning process and presents two flammability test methods.
Book Chapter
Gas Chromatography/Mass Spectrometry
Available to PurchaseSeries: ASM Handbook
Volume: 10
Publisher: ASM International
Published: 15 December 2019
DOI: 10.31399/asm.hb.v10.a0006664
EISBN: 978-1-62708-213-6
... are separated by a collision chamber. Mass spectrometry/mass spectrometry has been used successfully for protein sequencing and toxicology. The following sections of this article discuss in more detail GC/MS instrumentation, interpreting mass spectra, GC/MS methodology, and GC/MS advances. GC/MS...
Abstract
This article briefly describes the capabilities of gas chromatography/mass spectrometry, which is used to qualitatively and quantitatively determine organic (and some inorganic) compound purity and stability and to identify components in a mixture. The discussion covers in more detail gas chromatography/mass spectrometry (GC/MS) instrumentation, interpreting mass spectra, GC/MS methodology, and GC/MS advances. Sample preparation, which is very important in GC/MS to avoid erroneous data and to minimize maintenance and troubleshooting of the instrument, is also discussed. Further, the article highlights the state of the art in the MS detector technology.
Series: ASM Desk Editions
Publisher: ASM International
Published: 01 November 1995
DOI: 10.31399/asm.hb.emde.a0003029
EISBN: 978-1-62708-200-6
... analysis, gas chromatography, mass spectrometry, and ion-selective electrodes. Toxicological studies generally involve the exposure of rats or mice to the gaseous products of decomposition and/or combustion under controlled conditions. Test animals are monitored for incapacitation or lethality (death...
Abstract
Flammability is the ability of a material to undergo easy ignition and rapid flaming combustion. This article provides information on flammability tests of polymers and codes and regulations that cite these tests. Many organizations are involved in the characterization and specification of flammability properties, resulting in several categorization strategies for flammability tests, including tests for specific fire response characteristics, research tests versus acceptance tests, tests for different levels of severity, and tests for basis of origin. The article presents an overview on the basic approaches in improving the fire resistance of polymers and the burning process (heating, decomposition, ignition, combustion, and propagation). It provides a brief description on the test methods which are classified into two types, one based on fire response characteristics and the other on particular applications of polymeric materials.
Book Chapter
Sources of Materials Property Data and Information
Available to PurchaseSeries: ASM Handbook
Volume: 20
Publisher: ASM International
Published: 01 January 1997
DOI: 10.31399/asm.hb.v20.a0002467
EISBN: 978-1-62708-194-8
Abstract
This article examines material property data and the information needs at various points in the design, manufacture, and use cycle. It contains a table that lists the various sources of materials data. The article describes locating media for sources of data such as suppliers of databases and internet. It discusses the types of sources of data, including computer readable media, data centers, and print media. The article also reviews the methods for evaluation and interpretation of data and examines the processes of obtaining and reporting test data.
Book Chapter
Applications of Medical Implant Materials
Available to PurchaseSeries: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005660
EISBN: 978-1-62708-198-6
... for nanotechnology 47. Software for Bayesian-driven clinical trials National Center for Toxicological Research 57. Build infrastructure for electronic management of information on FDA-regulated products 60. Develop consensus on standards for using microarray data in personalized medicine Note...
Abstract
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 applications of biomaterials, including orthopedic, cardiovascular, ophthalmic, and dental applications. The article describes 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 examples of biomaterials applications, such as endovascular devices, knee implants, and neurostimulation.
Series: ASM Handbook Archive
Volume: 10
Publisher: ASM International
Published: 01 January 1986
DOI: 10.31399/asm.hb.v10.a0001732
EISBN: 978-1-62708-178-8
... fundamental applications that include studies of electronic properties of organic and inorganic molecules in gas, liquid, and solid phases. Fluorescence spectroscopy is routinely used for chemical analysis of various samples, including those of forensic, environmental, toxicological, clinical, biochemical...
Abstract
This article provides an introduction to the molecular fluorescence spectroscopy, and discusses the theory of fluorescence and its application to chemical analysis. It provides information on fluorescence that occurs in organic compounds and inorganic atoms and molecules. The article describes the instruments used in the spectroscopy, namely, radiation sources, sample holders, wavelength selectors, detectors, computers, and ratiometric instruments. The practical considerations include solvent effects, corrected spectra, wavelength calibration, temperature, and scattered light. The article also discusses the uses of some special techniques used in molecular fluorescence spectroscopy.
Book Chapter
Guidance for the Use of Protective Coatings in Municipal Potable Water Systems
Available to PurchaseSeries: ASM Handbook
Volume: 5B
Publisher: ASM International
Published: 30 September 2015
DOI: 10.31399/asm.hb.v05b.a0006040
EISBN: 978-1-62708-172-6
Abstract
This article presents information regarding the use of protective coatings in municipal potable water systems, including raw water collection and transmission, water treatment plants, and treated water distribution. It provides useful guidance for the selection and use of protective coatings in these municipal water systems. The most commonplace corrosion-damage mechanisms are highlighted. The article describes the most common materials of construction found in municipal water systems, namely, cast iron, ductile iron, carbon steel, precast concrete cylinder pipe and reinforced concrete pipe, prestressed concrete tanks, and stainless steel. It provides information on the most common generic coating systems used for new steel tanks and water storage tanks. It concludes with a discussion of quality watch-outs when selecting or using protective coatings in municipal water systems.
Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005676
EISBN: 978-1-62708-198-6
... with these materials with the hope of providing even an incremental relief to their patients. Without even the rudimentary understanding of contemporary biomaterial toxicology, several of these early experiments with synthetic plastics for medical applications led to failures, and such failures hindered...
Abstract
Polymers offer a wide range of choices for medical applications because of their versatility in properties and processing. This article provides an overview of polymeric materials and the characteristics that make them a unique class of materials. It describes the ways to classify polymers, including the polymerization method, how the material deforms, or molecular origin or stability. The article contains tables that list common medical polymers used in medical devices. It explains the medical polymer selection criteria and regulatory aspects of materials selection failure analysis and prevention. Failure analysis and prevention processes to determine the root cause of failures that arise at different stages of the product life cycle are reviewed. The article describes the mechanisms of plastic product failure analysis. It discusses the trends in the use of medical polymers, such as high-performance polymers for implants, tissue engineering, and bioresorbable polymers.
Book Chapter
Lubricants and Their Applications in Forging
Available to PurchaseSeries: ASM Handbook
Volume: 14A
Publisher: ASM International
Published: 01 January 2005
DOI: 10.31399/asm.hb.v14a.a0004032
EISBN: 978-1-62708-185-6
... always be borne in mind that the inert graphite is completely harmless from a toxicological point of view and that white forging lubricants must not have a detrimental effect on workplace conditions as a result of toxic decomposition of by-products ( Ref 55 , Ref 56 , Ref 57 , Ref 58 , Ref 59...
Abstract
This article lists functions of lubricants common to the majority of applications and processes. It discusses the lubricant candidates widely used in forging: conversion coatings with soaps (stearate compounds) and molybdenum disulfide for cold forging; oil-based thick, film oil or polymerbased lubricants and molybdenum disulfide for warm application; graphite suspensions in oil or water for hot forging steels; and glass films for titanium and superalloys hot forgings. The article describes the applications of lubricants in warm extrusion and forging, hot forging of steel, hot forging of aluminum, isothermal and hot die forging, and the extrusion of steel.
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