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Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005652
EISBN: 978-1-62708-198-6
...Abstract Abstract 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...
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
...Abstract Abstract This article contains a table that lists the ISO standards for the biological evaluation of medical devices. biological evaluation medical devices List of ISO Standards for Biological Evaluation of Medical Devices (<xref rid="a0005679-ref1" ref-type="bibr">Ref 1...
Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005685
EISBN: 978-1-62708-198-6
...Abstract Abstract 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...
Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005683
EISBN: 978-1-62708-198-6
... tests, and ion-leaching tests are also discussed. corrosion current density corrosion testing electrochemical corrosion testing electrochemical impedance measurement environment-assisted cracking tests fretting corrosion tests galvanic corrosion tests ion-leaching tests medical devices...
Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005686
EISBN: 978-1-62708-198-6
...Abstract 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...
Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.9781627081986
EISBN: 978-1-62708-198-6
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
...Abstract 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...
Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005680
EISBN: 978-1-62708-198-6
...Abstract Abstract 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...
Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005687
EISBN: 978-1-62708-198-6
...Abstract Abstract 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...
Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005657
EISBN: 978-1-62708-198-6
...Abstract Abstract 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...
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Published: 01 June 2012
Fig. 1 Categorization of medical device technology More
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Published: 30 August 2021
Fig. 1 Timeline of medical device milestones (top) and United States Food and Drug Administration (FDA) medical device regulation (bottom) More
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Published: 01 January 2002
Fig. 9 Fracture in a thin medical device manufactured from type D 2 tool steel. (a) View showing a fractured massive carbide and associated matrix crack. Scanning electron micrograph. 1187× (b) Cross section through a cracked region in a similar part showing brittle fracture in the carbides More
Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005678
EISBN: 978-1-62708-198-6
... assessment knee joint simulators medical implants metals orthopedic surgery physical properties pin-on-disk experiments pin-on-plate experiments total joint replacement total replacement synovial joints tribological characteristics ultrahigh molecular weight polyethylene wear SYNOVIAL JOINTS...
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
... 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...
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
... 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...
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
... 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...
Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005658
EISBN: 978-1-62708-198-6
...Abstract Abstract 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...
Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005660
EISBN: 978-1-62708-198-6
...Abstract 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...
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
... sterilization thermal testing POLYMERS have a range of features and benefits that have revolutionized manufacturing processes, allowing mass-production methods such as injection molding to enter new marketplaces such as the medical device arena. The additional properties of polymers, such as their high...