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  • BS EN 60601-2-5:2015

    Current The latest, up-to-date edition.

    Medical electrical equipment Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-11-2015

    Publisher:  British Standards Institution

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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 of 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 Electromagnetic compatibility - Requirements and tests
    Annexes
    Annex AA (informative) - Particular guidance and rationale
    Annex BB (informative) - Example set-up to measure surface
             temperature of externally applied TRANSDUCER
             ASSEMBLIES
    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 the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC PHYSIOTHERAPY EQUIPMENT, hereafter referred to as ME EQUIPMENT.

    Scope - (Show below) - (Hide below)

    This Particular Standard specifies requirements and tests for the safety of ultrasonic physiotherapy equipment. It amends and supplements IEC 60601-1 (second edition, 1988) including Amendments 1 and 2, hereinafter referred to as the General Standard. This Particular Standard takes into account IEC 60601-1-2 and IEC 61689.

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

    Committee CH/62/4
    Development Note Supersedes BS 5724-2.5(1985). (04/2001) Supersedes 99/560234 DC. (10/2005) 2001 Edition remains active & will be withdrawn on 15/09/2018. Supersedes 08/30173423 DC. (11/2015)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    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 61161:2013 Ultrasonics - Power measurement - Radiation force balances and performance requirements
    IEC 61689:2013 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
    IEC 60050-802:2011 International Electrotechnical Vocabulary (IEV) - Part 802: Ultrasonics
    EN 61161:2013 Ultrasonics - Power measurement - Radiation force balances and performance requirements
    IEC 60469-1:1987 Pulse techniques and apparatus. Part 1: Pulse terms and definitions
    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 61689:2013 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
    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
    EN 60601-2-36:2015 Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
    EN 62127-2:2007/A2:2017 ULTRASONICS - HYDROPHONES - PART 2: CALIBRATION FOR ULTRASONIC FIELDS UP TO 40 MHZ
    IEC TS 62462:2007 Ultrasonics - Output Test - Guide for the maintenance of ultrasound physiotherapy systems
    IEC 62127-2:2007+AMD1:2013+AMD2:2017 CSV Ultrasonics - Hydrophones - Part 2: Calibration for ultrasonic fields up to 40 MHz
    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)
    IEC 60601-2-36:2014 Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
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