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  • AAMI TIR66 : 2017

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    GUIDANCE FOR THE CREATION OF PHYSIOLOGIC DATA AND WAVEFORM DATABASES TO DEMONSTRATE REASONABLE ASSURANCE OF THE SAFETY AND EFFECTIVENESS OF ALARM SYSTEM ALGORITHMS

    Available format(s):  Hardcopy, PDF

    Superseded date:  18-04-2020

    Language(s):  English

    Published date:  01-01-2017

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Table of Contents - (Show below) - (Hide below)

    Glossary of equivalent standards
    Committee representation
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Database requirements
    5 Waveform acquisition and synthesis
    6 Application of waveform databases
      to testing
    7 Use of a database for algorithm
      development
    8 ALARM SYSTEM algorithm optimization
      and tuning
    Bibliography
    Terminology - Alphabetized index of defined terms

    Abstract - (Show below) - (Hide below)

    Specifies the nomenclature, ingredients, and principles for the development, annotation and use of physiologic waveform databases for developing and testing the performance of INTELLIGENT ALARM SYSTEM algorithms, and to test ALARM SYSTEMS incorporating such algorithms.

    General Product Information - (Show below) - (Hide below)

    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

    Standards Referencing This Book - (Show below) - (Hide below)

    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    AAMI EC57 : 2012 TESTING AND REPORTING PERFORMANCE RESULTS OF CARDIAC RHYTHM AND ST SEGMENT MEASUREMENT ALGORITHMS
    IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    AAMI TIR24 : 1999 ACQUISITION AND USE OF PHYSIOLOGIC WAVEFORM DATABASES FOR TESTING OF MEDICAL DEVICES
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