Author: Joseph R. Davis
Publisher: ASM International(OH)
ISBN:
Category : Medical
Languages : en
Pages : 360
Book Description
The Handbook of Materials for Medical Devices provides an in-depth review of the properties, processing, and selection of materials used in the environment of the human body - an environment that is surprisingly hostile and aggressive. Among the application areas described are orthopedics (hips, knees, and spinal and fracture fixation), cardiology (stents, heart valves, pacemakers), surgical instruments, and restorative dentistry. Materials discussed include metals and alloys, ceramics, glasses, and glass-ceramics, polymeric materials, composites, coatings, and adhesives and cements. The book is divided into three major sections. The first section provides an expansive overview of biomaterials and their use in medical devices. Charts and diagrams illustrate/list the many parts of the body that can be replaced by manmade materials. Case histories document some of the more common and successful medical device applications. Biocompatibility and mechanical requirements for implantable devices are also reviewed. The second section of the handbook deals with medical (nondental) applications. Stainless steels, cobalt-chromium alloys, titanium alloys, shape memory alloys, and tantalum are among the metallic materials described. Similar information is provided on nonmetallic materials, including new coatings that offer lubricity, biocompatibility, and antimicrobial action to device surfaces. Other coatings can be used to release drugs or make implanted devices more visible to imaging systems. The final section addresses biomaterials for dental applications. Emphasis is placed on corrosion and tribological behavior and corresponding test procedures to determine corrosion and wear resistance. Contents: Introduction: Overview of Biomaterials and Their use in Medical Devices; Physical and Mechanical Requirements for Medical Device Materials. Medical (Nondental) Applications: Metallic Materials; Corrosion of Metallic Implants and Prosthetic Devices; Failure Analysis of Metallic Orthopedic Implants; Ceramic Materials; Polymeric Materials; Adhesives and Cements; Coatings. Dental Applications: Biomaterials for Dental Applications; Tarnish and Corrosion of Dental Alloys; Friction and Wear of Dental Materials; Index.
Handbook of Materials for Medical Devices
Author: Joseph R. Davis
Publisher: ASM International(OH)
ISBN:
Category : Medical
Languages : en
Pages : 360
Book Description
The Handbook of Materials for Medical Devices provides an in-depth review of the properties, processing, and selection of materials used in the environment of the human body - an environment that is surprisingly hostile and aggressive. Among the application areas described are orthopedics (hips, knees, and spinal and fracture fixation), cardiology (stents, heart valves, pacemakers), surgical instruments, and restorative dentistry. Materials discussed include metals and alloys, ceramics, glasses, and glass-ceramics, polymeric materials, composites, coatings, and adhesives and cements. The book is divided into three major sections. The first section provides an expansive overview of biomaterials and their use in medical devices. Charts and diagrams illustrate/list the many parts of the body that can be replaced by manmade materials. Case histories document some of the more common and successful medical device applications. Biocompatibility and mechanical requirements for implantable devices are also reviewed. The second section of the handbook deals with medical (nondental) applications. Stainless steels, cobalt-chromium alloys, titanium alloys, shape memory alloys, and tantalum are among the metallic materials described. Similar information is provided on nonmetallic materials, including new coatings that offer lubricity, biocompatibility, and antimicrobial action to device surfaces. Other coatings can be used to release drugs or make implanted devices more visible to imaging systems. The final section addresses biomaterials for dental applications. Emphasis is placed on corrosion and tribological behavior and corresponding test procedures to determine corrosion and wear resistance. Contents: Introduction: Overview of Biomaterials and Their use in Medical Devices; Physical and Mechanical Requirements for Medical Device Materials. Medical (Nondental) Applications: Metallic Materials; Corrosion of Metallic Implants and Prosthetic Devices; Failure Analysis of Metallic Orthopedic Implants; Ceramic Materials; Polymeric Materials; Adhesives and Cements; Coatings. Dental Applications: Biomaterials for Dental Applications; Tarnish and Corrosion of Dental Alloys; Friction and Wear of Dental Materials; Index.
Publisher: ASM International(OH)
ISBN:
Category : Medical
Languages : en
Pages : 360
Book Description
The Handbook of Materials for Medical Devices provides an in-depth review of the properties, processing, and selection of materials used in the environment of the human body - an environment that is surprisingly hostile and aggressive. Among the application areas described are orthopedics (hips, knees, and spinal and fracture fixation), cardiology (stents, heart valves, pacemakers), surgical instruments, and restorative dentistry. Materials discussed include metals and alloys, ceramics, glasses, and glass-ceramics, polymeric materials, composites, coatings, and adhesives and cements. The book is divided into three major sections. The first section provides an expansive overview of biomaterials and their use in medical devices. Charts and diagrams illustrate/list the many parts of the body that can be replaced by manmade materials. Case histories document some of the more common and successful medical device applications. Biocompatibility and mechanical requirements for implantable devices are also reviewed. The second section of the handbook deals with medical (nondental) applications. Stainless steels, cobalt-chromium alloys, titanium alloys, shape memory alloys, and tantalum are among the metallic materials described. Similar information is provided on nonmetallic materials, including new coatings that offer lubricity, biocompatibility, and antimicrobial action to device surfaces. Other coatings can be used to release drugs or make implanted devices more visible to imaging systems. The final section addresses biomaterials for dental applications. Emphasis is placed on corrosion and tribological behavior and corresponding test procedures to determine corrosion and wear resistance. Contents: Introduction: Overview of Biomaterials and Their use in Medical Devices; Physical and Mechanical Requirements for Medical Device Materials. Medical (Nondental) Applications: Metallic Materials; Corrosion of Metallic Implants and Prosthetic Devices; Failure Analysis of Metallic Orthopedic Implants; Ceramic Materials; Polymeric Materials; Adhesives and Cements; Coatings. Dental Applications: Biomaterials for Dental Applications; Tarnish and Corrosion of Dental Alloys; Friction and Wear of Dental Materials; Index.
Handbook of Medical Device Design
Author: Richard C. Fries
Publisher: CRC Press
ISBN: 9780824703998
Category : Medical
Languages : en
Pages : 798
Book Description
The Handbook of Medical Device Design provides a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives. It identifies how to determine and document customer needs and device requirements. It also establishes reliability and quality metrics for the duration of the product development cycle. Topics include
Publisher: CRC Press
ISBN: 9780824703998
Category : Medical
Languages : en
Pages : 798
Book Description
The Handbook of Medical Device Design provides a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives. It identifies how to determine and document customer needs and device requirements. It also establishes reliability and quality metrics for the duration of the product development cycle. Topics include
Handbook of Human Factors in Medical Device Design
Author: Matthew Bret Weinger
Publisher: CRC Press
ISBN: 1420063510
Category : Technology & Engineering
Languages : en
Pages : 822
Book Description
Developed to promote the design of safe, effective, and usable medical devices, Handbook of Human Factors in Medical Device Design provides a single convenient source of authoritative information to support evidence-based design and evaluation of medical device user interfaces using rigorous human factors engineering principles. It offers guidance
Publisher: CRC Press
ISBN: 1420063510
Category : Technology & Engineering
Languages : en
Pages : 822
Book Description
Developed to promote the design of safe, effective, and usable medical devices, Handbook of Human Factors in Medical Device Design provides a single convenient source of authoritative information to support evidence-based design and evaluation of medical device user interfaces using rigorous human factors engineering principles. It offers guidance
The Medical Device R&D Handbook
Author: Theodore R. Kucklick
Publisher: CRC Press
ISBN: 1420038354
Category : Medical
Languages : en
Pages : 376
Book Description
The Medical Device R&D Handbook presents a wealth of information for the hands-on design and building of medical devices. Detailed information on such diverse topics as catheter building, prototyping, materials, processes, regulatory issues, and much more are available in this convenient handbook for the first time. The Medical Device R&D Ha
Publisher: CRC Press
ISBN: 1420038354
Category : Medical
Languages : en
Pages : 376
Book Description
The Medical Device R&D Handbook presents a wealth of information for the hands-on design and building of medical devices. Detailed information on such diverse topics as catheter building, prototyping, materials, processes, regulatory issues, and much more are available in this convenient handbook for the first time. The Medical Device R&D Ha
Medical Regulatory Affairs
Author: Jack Wong
Publisher: CRC Press
ISBN: 1000440516
Category : Medical
Languages : en
Pages : 806
Book Description
This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
Publisher: CRC Press
ISBN: 1000440516
Category : Medical
Languages : en
Pages : 806
Book Description
This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
Handbook of Medical Device Regulatory Affairs in Asia
Author: Jack Wong
Publisher: CRC Press
ISBN: 0429996764
Category : Medical
Languages : en
Pages : 475
Book Description
Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.
Publisher: CRC Press
ISBN: 0429996764
Category : Medical
Languages : en
Pages : 475
Book Description
Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.
PEEK Biomaterials Handbook
Author: Steven M. Kurtz
Publisher: William Andrew
ISBN: 143774463X
Category : Medical
Languages : en
Pages : 309
Book Description
PEEK biomaterials are currently used in thousands of spinal fusion patients around the world every year. Durability, biocompatibility and excellent resistance to aggressive sterilization procedures make PEEK a polymer of choice, replacing metal in orthopedic implants, from spinal implants and hip replacements to finger joints and dental implants. This Handbook brings together experts in many different facets related to PEEK clinical performance as well as in the areas of materials science, tribology, and biology to provide a complete reference for specialists in the field of plastics, biomaterials, medical device design and surgical applications. Steven Kurtz, author of the well respected UHMWPE Biomaterials Handbook and Director of the Implant Research Center at Drexel University, has developed a one-stop reference covering the processing and blending of PEEK, its properties and biotribology, and the expanding range of medical implants using PEEK: spinal implants, hip and knee replacement, etc. Covering materials science, tribology and applications Provides a complete reference for specialists in the field of plastics, biomaterials, biomedical engineering and medical device design and surgical applications
Publisher: William Andrew
ISBN: 143774463X
Category : Medical
Languages : en
Pages : 309
Book Description
PEEK biomaterials are currently used in thousands of spinal fusion patients around the world every year. Durability, biocompatibility and excellent resistance to aggressive sterilization procedures make PEEK a polymer of choice, replacing metal in orthopedic implants, from spinal implants and hip replacements to finger joints and dental implants. This Handbook brings together experts in many different facets related to PEEK clinical performance as well as in the areas of materials science, tribology, and biology to provide a complete reference for specialists in the field of plastics, biomaterials, medical device design and surgical applications. Steven Kurtz, author of the well respected UHMWPE Biomaterials Handbook and Director of the Implant Research Center at Drexel University, has developed a one-stop reference covering the processing and blending of PEEK, its properties and biotribology, and the expanding range of medical implants using PEEK: spinal implants, hip and knee replacement, etc. Covering materials science, tribology and applications Provides a complete reference for specialists in the field of plastics, biomaterials, biomedical engineering and medical device design and surgical applications
Medical Devices
Author: Seeram Ramakrishna
Publisher: Woodhead Publishing
ISBN: 0081002912
Category : Medical
Languages : en
Pages : 253
Book Description
Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. - Provides readers with a global perspective on medical device regulations - Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards - Includes a useful case study demonstrating the design and approval process
Publisher: Woodhead Publishing
ISBN: 0081002912
Category : Medical
Languages : en
Pages : 253
Book Description
Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. - Provides readers with a global perspective on medical device regulations - Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards - Includes a useful case study demonstrating the design and approval process
Handbook of Biomaterials Biocompatibility
Author: Masoud Mozafari
Publisher: Woodhead Publishing
ISBN: 9780081029671
Category : Technology & Engineering
Languages : en
Pages : 0
Book Description
Handbook of Biomaterials Biocompatibility is a systematic reference on host response to different biomaterials, taking into account their physical, mechanical and chemical properties. The book reviews recent progress in the design and study of biomaterials biocompatibility, along with current understanding on how to control immune system response. Sections provide the fundamental theories and challenges of biomaterials biocompatibility, the role of different biomaterials physicochemical surface properties on cell responses, cell responses to different physicochemical properties of polymers, ceramics, metals, carbons and nanomaterials, and biomaterials in different tissues, such as the cardiac, nervous system, cartilage and bone. This resource will be suitable for those working in the fields of materials science, regenerative engineering, medicine, medical devices and nanotechnology.
Publisher: Woodhead Publishing
ISBN: 9780081029671
Category : Technology & Engineering
Languages : en
Pages : 0
Book Description
Handbook of Biomaterials Biocompatibility is a systematic reference on host response to different biomaterials, taking into account their physical, mechanical and chemical properties. The book reviews recent progress in the design and study of biomaterials biocompatibility, along with current understanding on how to control immune system response. Sections provide the fundamental theories and challenges of biomaterials biocompatibility, the role of different biomaterials physicochemical surface properties on cell responses, cell responses to different physicochemical properties of polymers, ceramics, metals, carbons and nanomaterials, and biomaterials in different tissues, such as the cardiac, nervous system, cartilage and bone. This resource will be suitable for those working in the fields of materials science, regenerative engineering, medicine, medical devices and nanotechnology.
Plastics in Medical Devices
Author: Vinny R. Sastri
Publisher: Elsevier
ISBN: 081552028X
Category : Technology & Engineering
Languages : en
Pages : 289
Book Description
No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.
Publisher: Elsevier
ISBN: 081552028X
Category : Technology & Engineering
Languages : en
Pages : 289
Book Description
No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.