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    I.S. EN 60601-2-36:2015

    Current The latest, up-to-date edition.

    MEDICAL ELECTRICAL EQUIPMENT - PART 2-36: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2015

    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 for ME EQUIPMENT
    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 ELECTROMAGNETIC COMPATIBILITY - Requirements
           and tests
    Annexes
    Annex AA (informative) - Particular guidance and rationale
    Annex BB (informative) - Definition of coordinates, FOCUS
             and TARGET LOCATION
    Bibliography
    Index of defined terms used in this particular standard
    Annex ZA (normative) - Normative references to
             international publications with their
             corresponding European publications
    Annex ZZ (informative) - Coverage of Essential
             Requirements of EU Directives

    Abstract - (Show below) - (Hide below)

    Pertains to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment for EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in 201.3.206 including equipment for other medical applications of therapeutic extracorporeally induced focused PRESSURE PULSES, hereafter referred to as ME EQUIPMENT.

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

    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)

    EN 10002-1 : 2001 METALLIC MATERIALS - TENSILE TESTING - PART 1: METHOD OF TEST AT AMBIENT TEMPERATURE
    IEC 60601-2-5:2009 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 61689:2013 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
    IEC 61846:1998 Ultrasonics - Pressure pulse lithotripters - Characteristics of fields
    IEC 62555:2013 Ultrasonics - Power measurement - High intensity therapeutic ultrasound (HITU) transducers and systems
    EN 61846:1998 Ultrasonics - Pressure pulse lithotripters - Characteristics of fields
    IEC 60601-2-62:2013 Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    DIN 50100:2015-11 (Draft) LOAD CONTROLLED FATIGUE TESTING - EXECUTION AND EVALUATION OF CYCLIC TESTS AT CONSTANT LOAD AMPLITUDES ON METALLIC SPECIMENS AND COMPONENTS
    IEC TS 62556:2014 Ultrasonics - Field characterization - Specification and measurement of field parameters for high intensity therapeutic ultrasound (HITU) transducers and systems
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