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AL - Alarms (Medical Device Alarms) Committee | AAMI

    https://www.aami.org/detail-pages/Standards-Committee/al-alarms-(medical-device-alarms)-committee
    AAMI TIR66: 2017, Guidance for the creation of physiologic waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms. AAMI TIR71: 2017, Guidance for logging of alarm system data. …

IEC 60601-1-8:2006 - Medical electrical equipment - ISO

    https://www.iso.org/standard/41986.html
    Abstract. Specifies basic safety and essential performance requirements and tests for alarm systems in medical electrical equipment and medical electrical systems and to …

The Joint Commission Medical device alarm safety …

    https://www.jointcommission.org/-/media/tjc/documents/resources/patient-safety-topics/sentinel-event/sea_50_alarms_4_26_16.pdf
    Many medical devices have alarm systems; among them are bedside physiologic monitors that include ECG (electrocardiogram) machines, pulse …

Recognized Consensus Standards - Food and Drug …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=41529
    Recognized Consensus Standards FDA Home Medical Devices Databases 510 (k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | …



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