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  • BS EN 60601-1-8 : 2007

    Current The latest, up-to-date edition.

    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 (IEC 60601-1-8:2006)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2007

    Publisher:  British Standards Institution

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

    INTRODUCTION
    1 Scope, object and related standards
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 ME EQUIPMENT identification marking and documents
    6 ALARM SYSTEMS
    Annex A (informative) - General guidance and rationale
    Annex B (informative) - Guide to marking and labelling
            requirements for ME EQUIPMENT and
            ME SYSTEMS
    Annex C (normative) - Symbols on marking
    Annex D (informative) - Guidance for auditory ALARM SIGNALS
    Annex E (informative) - Verbal ALARM SIGNALS
    Annex F (normative) - Reserved melodies for ALARM SIGNALS
    Bibliography
    Index of defined terms used in this collateral standard
    Annex ZA (normative) - Normative references to international
             publications with their corresponding European
             publications
    Annex ZZ (informative) - Coverage of Essential Requirements
             of EC Directives

    Abstract - (Show below) - (Hide below)

    Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

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

    Committee CH/62/1
    Development Note Supersedes BS EN 475. (02/2004) Supersedes 02/562586 DC. (10/2004) Supersedes 11/30206856 DC. (06/2013) 2007 Edition Re-issued in July 2017 & incorporates AMD 11 2017. 2007 + A1 2013 Edition remains current and will be withdrawn on 07/01/2020. (07/2017)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    AAMI HE48 : 1993 HUMAN FACTORS ENGINEERING GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES
    ISO 3744:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
    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 TR 60513:1994 Fundamental aspects of safety standards for medical electrical equipment
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO 11429:1996 Ergonomics System of auditory and visual danger and information signals
    EN 61672-1:2013 Electroacoustics - Sound level meters - Part 1: Specifications
    EN ISO 3744:2010 Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Engineering methods for an essentially free field over a reflecting plane (ISO 3744:2010)
    ISO 11428:1996 Ergonomics Visual danger signals General requirements, design and testing
    EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 9703-2:1994 Anaesthesia and respiratory care alarm signals — Part 2: Auditory alarm signals
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