• I.S. EN 60601-2-37:2008

    Current The latest, up-to-date edition.

    MEDICAL ELECTRICAL EQUIPMENT - PART 2-37: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC MEDICAL DIAGNOSTIC AND MONITORING EQUIPMENT

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2008

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    FOREWORD
    INTRODUCTION
    201.1 Scope, object and related standards
    201.2 Normative references
    201.3 Terms and definitions
    201.4 General requirements
    201.5 General requirements for testing ME EQUIPMENT
    201.6 Classification of ME EQUIPMENT and ME SYSTEMS
    201.7 ME EQUIPMENT identification, marking and documents
    201.8 Protection against electrical HAZARDS from ME EQUIPMENT
    201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT
           and ME SYSTEMS
    201.10 Protection against unwanted and excessive radiation
           HAZARDS
    201.11 Protection against excessive temperatures and other
           HAZARDS
    201.12 Accuracy of controls and instruments and protection
           against hazardous outputs
    201.13 Hazardous situations and fault conditions
    201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
    201.15 Construction of ME EQUIPMENT
    201.16 ME SYSTEMS
    201.17 Electromagnetic compatibility of ME EQUIPMENT and
           ME SYSTEMS
    202.6 ELECTROMAGNETIC COMPATIBILITY
    Annex AA (informative) - Guidance and rationale
             for particular subclauses
    Annex BB (informative) - Guidance in classification
             according to CISPR 11
    Annex CC (informative) - Guidance to the
             MANUFACTURER on the interpretation
             of TI and MI to to be used to inform the
             OPERATOR
    Annex DD (informative) - Example set-up to
             measure surface temperature of externally
             applied TRANSDUCER ASSEMBLIES
    Annex EE (informative) - Acoustic output table intended
             for 3rd parties
    Bibliography
    Index of defined terms
    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 ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME EQUIPMENT.

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    Development Note For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current

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

    IEC 62127-1:2007+AMD1:2013 CSV Ultrasonics - Hydrophones - Part 1: Measurement and characterizationof medical ultrasonic fields up to 40 MHz
    ISO/IEC Guide 98:1993 Guide to the expression of uncertainty in measurement (GUM)
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
    IEC 61157:2007+AMD1:2013 CSV Standard means for the reporting of the acoustic output of medicaldiagnostic ultrasonic equipment
    IEC 62359:2010+AMD1:2017 CSV Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
    EN 62127-1:2007/A1:2013 ULTRASONICS - HYDROPHONES - PART 1: MEASUREMENT AND CHARACTERIZATION OF MEDICAL ULTRASONIC FIELDS UP TO 40 MHZ (IEC 62127-1:2007/A1:2013)
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