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
    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
    Mueller E., Scire F., Teague E., Vahey D.

    Chapter 7—Biomaterials: Orthopedic Implants
    Galante J., Laing, P., 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
    Doyle F., Kirchhoff W.

    Chapter 15—Quality Assurance Implementation: Diagnostic Instrumentation
    Anbar M., Lewis A., Podolsky L.

    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
    Bernstein A., Parsonnet V., Raythen W.

    Chapter 22—Standardized Labeling and Packaging as a Device for Prevention of Medication Errors
    Turndorf H., Wang B.

    Chapter 23—Technology Awareness: Electrical Safety, the Clinical Environment, and Standards
    Hammer G., Kagey K., Staewen W.

    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

    DOI: 10.1520/STP800-EB

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

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

    ASTM International is a member of CrossRef.