• AAMI TIR71 : 2017

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    GUIDANCE FOR LOGGING OF ALARM SYSTEM DATA

    Available format(s):  Hardcopy, PDF

    Superseded date:  25-01-2021

    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 Guidance on MEE/MES logs
    5 Categories of LOGS
    Bibliography

    Abstract - (Show below) - (Hide below)

    Gives guidance to MANUFACTURERS of MEDICAL ELECTRICAL EQUIPMENT (MEE) and MEDICAL ELECTRICAL SYSTEMS (MES) that generate ALARM CONDITIONS and/or ALARM SIGNALS to meet the requirements for logging of ALARM SYSTEM data and support investigative activities performed by MANUFACTURERS and RESPONSIBLE ORGANIZATIONS.

    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    Status Superseded
    Superseded By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)

    AAMI/IEC TIR80001-2-5:2014 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-5: APPLICATION GUIDANCE - GUIDANCE ON DISTRIBUTED ALARM SYSTEMS
    AAMI IEC 62366-1 : 2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    ANSI/AAMI/IEC 60601-1-8:2006/A2:2021 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
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