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SEDL / STP / STP800-EB
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STP800
Medical Devices: Measurements, Quality Assurance, and Standards
Caceres CA, Yolken HT, Jones RJ, Piehler HR
Pages: 314
Published: 1983
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This publication provides physicians, scientists, and members of industry and government with a comprehensive overview of the role and impact of medical standards and measurements on health care. The insights, discussions, and recommendations presented in this text are representative of many individuals' contributions. However, coordination of this endeavor is due to joint participation by three primary organizations: the National Bureau of Standards, the American Medical Association, and ASTM. One central theme of this book addresses the need to integrate the physician's views with business and standards development organizations.
Table of Contents
Introduction
Preface: Standards Development in the Medical Device Field
Acknowledgments
Overview
Overview
Overview
Overview
Chapter 1—Reference Bases for Accurate Measurement
Yolken H.
Chapter 2—Diagnosis Is Measurement: Measurement Is the Basis for Standards
Caceres C., Hanlin D.
Chapter 3—Design and Performance Standards
Rowe W.
Chapter 4—Metabolic Function Data: Clinical Chemistry Standards
Bowers G.
Chapter 5—Physiologic Function Data: Standards and Technology Transfer Potentials
Zalesky P.
Chapter 6—Testing Tools: Development of Measurement Standards for Edge Characterization of Intraocular Lenses
Teague E., Scire F., Vahey D., Mueller E.
Chapter 7—Biomaterials: Orthopedic Implants
Laing, P., Galante J., Lautenschlager E.
Chapter 8—Clinical Measurement Instruments: Blood Pressure Measurements and Devices
Bruner J.
Chapter 9—Computerized Medical Technology: Meeting the Challenge and Issue of Standards
Eden H., Macks G.
Chapter 10—Broad Goals for a Standards-Development Organization
Brown P.
Chapter 11—Applications, Pitfalls, and Alternatives of Medical Device Standards
Houston M.
Chapter 12—A Broad View of Needs in Standards Development in the Medical Field
Caceres C., Hanlin D., Schick J.
Chapter 13—Determination of Information and Communication Needs: Computers in Medicine
Devey G.
Chapter 14—Development of Compatibility for Clinical Effectiveness: Monitoring Devices
Kirchhoff W., Doyle F.
Chapter 15—Quality Assurance Implementation: Diagnostic Instrumentation
Lewis A., Podolsky L., Anbar M.
Chapter 16—Assessment of Standards Needs: Implantable Devices and Treatment
Horowitz E.
Chapter 17—Devices and Compatibility: The Innovation Process and Standards
Kahn A.
Chapter 18—Evaluating Medical Devices for the Clinical Environment
Jones R.
Chapter 19—Disposable Devices in Clinical Therapy: Foley Catheters—A Model for the Development of a Standard
Boyarsky S.
Chapter 20—Therapeutic Assist Devices: Hydrocephalic Shunt
Watt C.
Chapter 21—Complex Electronics in Clinical Therapy: Clinical Use of Cardiac Pacemakers
Parsonnet V., Bernstein A., Raythen W.
Chapter 22—Standardized Labeling and Packaging as a Device for Prevention of Medication Errors
Wang B., Turndorf H.
Chapter 23—Technology Awareness: Electrical Safety, the Clinical Environment, and Standards
Staewen W., Kagey K.
Chapter 24—Clinical Environment and the Law: Product Liability
Piehler H.
Chapter 25—Consideration of the Medical and Health Care Environment: Standards and Clinicians
Caceres C., Hanlin D., Schick J.
Index to Key Concepts
Alphabetical Index
Committee: F04
Paper ID: STP800-EB
DOI: 10.1520/STP800-EB
ISBN-EB: 978-0-8031-4866-6
 ASTM International is a member of CrossRef.
0-8031-0235-6
978-0-8031-0235-4
STP800-EB
STP 800
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