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    Medical Devices: Measurements, Quality Assurance, and Standards

    Caceres CA, Yolken HT, Jones RJ, Piehler HR
    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


    Preface: Standards Development in the Medical Device Field






    Chapter 1—Reference Bases for Accurate Measurement

    Chapter 2—Diagnosis Is Measurement: Measurement Is the Basis for Standards

    Chapter 3—Design and Performance Standards

    Chapter 4—Metabolic Function Data: Clinical Chemistry Standards

    Chapter 5—Physiologic Function Data: Standards and Technology Transfer Potentials

    Chapter 6—Testing Tools: Development of Measurement Standards for Edge Characterization of Intraocular Lenses

    Chapter 7—Biomaterials: Orthopedic Implants

    Chapter 8—Clinical Measurement Instruments: Blood Pressure Measurements and Devices

    Chapter 9—Computerized Medical Technology: Meeting the Challenge and Issue of Standards

    Chapter 10—Broad Goals for a Standards-Development Organization

    Chapter 11—Applications, Pitfalls, and Alternatives of Medical Device Standards

    Chapter 12—A Broad View of Needs in Standards Development in the Medical Field

    Chapter 13—Determination of Information and Communication Needs: Computers in Medicine

    Chapter 14—Development of Compatibility for Clinical Effectiveness: Monitoring Devices

    Chapter 15—Quality Assurance Implementation: Diagnostic Instrumentation

    Chapter 16—Assessment of Standards Needs: Implantable Devices and Treatment

    Chapter 17—Devices and Compatibility: The Innovation Process and Standards

    Chapter 18—Evaluating Medical Devices for the Clinical Environment

    Chapter 19—Disposable Devices in Clinical Therapy: Foley Catheters—A Model for the Development of a Standard

    Chapter 20—Therapeutic Assist Devices: Hydrocephalic Shunt

    Chapter 21—Complex Electronics in Clinical Therapy: Clinical Use of Cardiac Pacemakers

    Chapter 22—Standardized Labeling and Packaging as a Device for Prevention of Medication Errors

    Chapter 23—Technology Awareness: Electrical Safety, the Clinical Environment, and Standards

    Chapter 24—Clinical Environment and the Law: Product Liability

    Chapter 25—Consideration of the Medical and Health Care Environment: Standards and Clinicians

    Committee: F04

    DOI: 10.1520/STP800-EB

    ISBN-EB: 978-0-8031-4866-6

    ISBN-13: 978-0-8031-0235-4