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sterilization
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Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005667
EISBN: 978-1-62708-198-6
... from a biocompatibility perspective. These include raw materials, the manufacturing process, cleaning and sterilization processes, and biodegradation and biostability. The article reviews the general testing methods of polymers, such as chemical, mechanical and thermal. It concludes with a section...
Abstract
This article discusses several aspects of biocompatibility of polymers, including the selection of a suitable polymer, specific use of a material, contact of polymer on body site, and duration of the contact. It describes the factors influencing the biological response of the polymer from a biocompatibility perspective. These include raw materials, the manufacturing process, cleaning and sterilization processes, and biodegradation and biostability. The article reviews the general testing methods of polymers, such as chemical, mechanical and thermal. It concludes with a section on the guidance, provided by the regulatory authorities, on the biocompatibility testing of polymers and polymer-containing devices that can aid in selecting the right analysis.
Series: ASM Handbook
Volume: 23A
Publisher: ASM International
Published: 12 September 2022
DOI: 10.31399/asm.hb.v23A.a0006862
EISBN: 978-1-62708-392-8
... 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...
Abstract
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.
Series: ASM Handbook
Volume: 23A
Publisher: ASM International
Published: 12 September 2022
DOI: 10.31399/asm.hb.v23A.a0006908
EISBN: 978-1-62708-392-8
..., printing characteristics and parameters as well as postprinting validation; removal of the many manufacturing material residues and sterilization; physical, chemical, and mechanical assessments of the final devices; and biological considerations of all the final devices including biocompatibility...
Abstract
Additive manufacturing, or three-dimensional printing technologies, for biomedical applications is rather different from other engineering components, particularly for biomedical implants that are intended to be used within the human body. This article contains two sections: "Design and Manufacturing Considerations of 3D-Printed, Commercially Pure Titanium and Titanium Alloy-Based Orthopedic Implants" and "Device Testing Considerations Following FDA Guidance" for additive-manufactured medical devices. These are further subdivided into five major focus areas: materials; design, printing, printing characteristics and parameters as well as postprinting validation; removal of the many manufacturing material residues and sterilization; physical, chemical, and mechanical assessments of the final devices; and biological considerations of all the final devices including biocompatibility.
Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005679
EISBN: 978-1-62708-198-6
... Selection of tests for interactions with blood ISO 10993-5 Tests for cyctotoxicity; in vitro methods ISO 10993-6 Tests for local effects after implantation ISO 10993-7 Ethylene oxide sterilization residuals ISO 10993-8 Withdrawn: Clinical investigation of medical devices ISO 10993-9...
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Published: 01 January 2000
Fig. 15 Fatigue plot illustrating the devastating effect of gamma radiation sterilization on the fatigue resistance of orthopedic grade ultrahigh molecular weight polyethylene used for total joint replacements
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Published: 01 January 2003
Fig. 19 Time dependence of R p for (a) Al 2024, (b) brass, and (c) mild steel during exposure to sterile artificial seawater and artificial seawater containing S. algae or S. ana. VNSS, Väätänen nine salts solution. K , kanamycin. Source: Ref 20
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Image
Published: 15 May 2022
Fig. 26 SEM fractographs of fatigue fracture surface of ultrahigh-molecular-weight polyethylene, using compact-tension specimens in the Paris regime. Direction of crack growth indicated by the white arrows. (a) Sterilized specimen tested at ambient temperatures. Original magnification: 1000
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Image
Published: 30 June 2023
/sterilization and (g) experimental testing. Reprinted from Ref 48 . (h) Regulation/application. Reprinted from public domain content
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Image
Published: 01 January 2005
Fig. 38 Pits were noticed in the bottom of a type 304 stainless steel three-way flange connector in a food-processing plant when viewed from above. The hot, acidic food (fruit products) passed through this location several times for each production batch. The system was sterilized in place
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Image
Published: 01 January 2005
maintenance for these tools. The hard surface coating, probably chromium-plated steel, was lost through overzealous and excessive grinding. The rust patterns seen in the photograph arose from indoor atmospheric corrosion of the exposed steel aggravated by moisture retention following steam sterilization
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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
... Rigid, high chemical resistance, good frictional and fatigue properties 125 260 175 350 Polyetheretherketone PEEK PEEK-OPTIMA High stiffness, radiation and hydrolysis resistant, repeat sterilization 145 290 335 635 Zeniva Data from multiple commercial sources Amorphous...
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.
Series: ASM Handbook
Volume: 23A
Publisher: ASM International
Published: 12 September 2022
DOI: 10.31399/asm.hb.v23A.a0006852
EISBN: 978-1-62708-392-8
... Color capabilities Biocompatibility Sterilization capability Material temperature and moisture resistance Transparency Molding or casting properties Whether a printer with multimaterial capabilities is needed In principle, a printing process should be selected based...
Abstract
This article provides highlights of the general process and workflow of creating a 3D-printed model from a medical image and discusses the applications of additively manufactured materials. It provides a brief background on Food and Drug Administration (FDA) classification and regulation of medical devices, with an emphasis on 3D-printed devices. Then, the article discusses two broad applications of 3D printing in craniofacial surgery: surgery and education. Next, it discusses, with respect to surgical applications, preoperative planning, use in the operating room, surgical guides, and implants. The article includes sections on education that focus on the use of 3D-printed surgical simulators and other tools to teach medical students and residents. It briefly touches on the FDA regulations associated with the respective application of 3D printing in medicine. Lastly, the article briefly discusses the state of medical billing and reimbursement for this service.
Series: ASM Handbook
Volume: 11A
Publisher: ASM International
Published: 30 August 2021
DOI: 10.31399/asm.hb.v11A.a0006811
EISBN: 978-1-62708-329-4
... in Fig. 2 . Corrosion Given the aggressive chemical environment within the human body, corrosion processes can also take place on orthopedic implants and can contribute to failures. Although less common in orthopedic implants, cleaning and sterilization methods may also contribute to corrosion...
Abstract
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.
Series: ASM Handbook
Volume: 6A
Publisher: ASM International
Published: 31 October 2011
DOI: 10.31399/asm.hb.v06a.a0005622
EISBN: 978-1-62708-174-0
... of penetration increase on nickel alloy 600; 185 A, 9.5 V, 75 mm/min (3 in./min) travel speed. Without (top) and with (bottom) DeepTIG. Courtesy of the Edison Welding Institute Typical components and joints using the SS-7 penetrating compound in the GTAW of stainless steel include: Sterilization...
Abstract
Penetration-enhanced gas tungsten arc welding (GTAW) processes have been referred to variously as flux tungsten inert gas (TIG), A-TIG, and GTAW with a penetration-enhancing compound. This article provides a discussion on the principles of operation, advantages, disadvantages, procedures, and applications of GTAW. It also includes information on the equipment used and health and safety issues associated with GTAW.
Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005666
EISBN: 978-1-62708-198-6
..., and TNFα, which are thought to be three of the signature cytokines of this process. Courtesy of BioEngineering Solutions Inc. Recent advances in immuno-orthopaedic science have resulted in greater understanding of how sterile, ogenic stimuli such as implant debris can elicit an immune response when...
Abstract
Implant debris is known to cause local inflammation, local osteolysis, and, in some cases, local and systemic hypersensitivity. The debris can be stainless steel, cobalt alloy, and titanium alloy, and soluble debris obtained due to wear from all orthopedic implants. This article addresses the biologic aspects of implant debris, both locally and systemically. It describes debris-induced local effects, particle-induced proinflammatory responses, and debris-induced systemic effects. The article concludes with a discussion on the four systemic effects of implant debris, namely, neuropathic effects, hypersensitivity effects, carcinogenicity, and general toxicity.
Series: ASM Handbook
Volume: 24A
Publisher: ASM International
Published: 30 June 2023
DOI: 10.31399/asm.hb.v24A.a0006966
EISBN: 978-1-62708-439-0
... Binder jetting Computational testing Elbow and humerus Directed-energy deposition Fabrication and postprocessing/ sterilization Spine cages and replacements Bioactivity: Drug delivery Biodegradable implants Sheet lamination Experimental testing Rib reconstruction Regulation...
Abstract
This article provides an overview of currently available metal AM processes for the medical industry; outlines a step-by-step review of the typical workflow for design, manufacturing, evaluation, and implantation of patient-specific AM devices; and examines the existing research trends in medical applications of AM with specific focus on metallic biomedical implants. Finally, challenges and opportunities for future developments in AM pertaining to the medical field are also explored.
Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005684
EISBN: 978-1-62708-198-6
... ). Similar implantable surgical clips have also been used on the vas deferens in sterilization procedures ( Ref 19 ). Tantalum has also been used in the form of intraarterial stents ( Ref 20 ) and biliary stents ( Ref 21 ) on a limited basis. More recently, tantalum has found a rather unique biomedical...
Abstract
Physically, tantalum is a dark, blue-gray, lusterless metal that exists in two crystalline forms: an alpha-phase with a body-centered cubic structure, and a brittle beta-phase with a tetragonal orientation. This article tabulates the physical and material properties of tantalum. It discusses the use of tantalum in medical electronics and the advantage of tantalum over stainless steel. The article describes the manufacturing and medical applications of tantalum foam.
Series: ASM Handbook
Volume: 23A
Publisher: ASM International
Published: 12 September 2022
DOI: 10.31399/asm.hb.v23A.a0006853
EISBN: 978-1-62708-392-8
... methylene groups that orient and stabilize the monolayer. Therefore, by carefully composing the mixture of substrate, SAM solution, and subsequent terminal functionalization, a multitude of subsequent molecule adhesions is feasible ( Ref 63 – 76 ). Packing and Sterilization After the surface...
Abstract
One of the most frequently cited advantages of ceramics in dentistry relates to aesthetics, and the same applies for dental implants. Zirconia has emerged as the material of choice for nonmetal implants. This article introduces the reader to zirconia as an implant material, its properties, manufacturing processes, and the particular surface modifications and treatments that have rendered its surfaces biologically compatible with peri-implant soft and hard tissues.
Book Chapter
Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005673
EISBN: 978-1-62708-198-6
...). Austenitic stainless steels find applications in nonimplantable medical devices where good corrosion resistance and moderate strength are required, for example, canulae, dental impression trays, guide pins, holloware, hypodermic needles, guide wires, steam sterilizers, storage cabinets and work surfaces...
Abstract
Stainless steels are used for medical implants and surgical tools due to the excellent combination of properties, such as cost, strength, corrosion resistance, and ease of cleaning. This article describes the classifications of stainless steels, such as austenitic stainless steels, martensitic stainless steels, ferritic stainless steels, precipitation-hardening stainless steels, and duplex stainless steels. It contains a table that lists common medical device applications for stainless steels. The article discusses the physical metallurgy and physical and mechanical properties of stainless steels. Medical device considerations for stainless steels, such as fatigue strength, corrosion resistance, and passivation techniques, are reviewed. The article explains the process features of implant-grade stainless steels, including type 316L, type 316LVM, nitrogen-strengthened, ASTM F1314, ASTM F1586, ASTM F2229, and ASTM F2581 stainless steels.
Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005672
EISBN: 978-1-62708-198-6
... 13 A variety of cyanoacrylate formulations are available with varying viscosities, cure times, and cured properties. They offer the advantages of substrate versatility and rapid cure. However, autoclaving is not appropriate for cyanoacrylates as a sterilization method. A potential drawback...
Abstract
This article provides an overview of curing techniques, adhesive chemistries, surface preparation, adhesive selection, and medical applications of adhesives. The curing techniques are classified into moisture, irradiation, heat, and anaerobic. The article highlights the common types of curable adhesives used for medical device assemblies, including acrylics, cyanoacrylates, epoxies, urethanes, and silicones. Other forms of adhesives, such as hot melts, bioadhesives, and pressure-sensitive adhesives, are also discussed. The typical characteristics and applications of biocompatible medical device adhesives are listed in a table. The article concludes with a section on the selection of materials for medical adhesives.
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