• EN 61689:2013

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz

    Available format(s): 

    Superseded date:  29-04-2022

    Language(s): 

    Published date:  19-04-2013

    Publisher:  European Committee for Standards - Electrical

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

    FOREWORD
    INTRODUCTION
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 List of symbols
    5 Ultrasonic field specifications
    6 Conditions of measurement and test equipment
      used
    7 Type testing reference procedures and measurements
    8 Routine measurement procedure
    9 Sampling and uncertainty determination
    Annex A (informative) - Guidance for performance
            and safety
    Annex B (normative) - Raster scan measurement and
            analysis procedures
    Annex C (normative) - Diametrical or line scan
            measurement and analysis procedures
    Annex D (informative) - Rationale concerning the beam
            cross-sectional area definition
    Annex E (informative) - Factor used to convert the
            beam cross-sectional area (A[BCS]) at the face
            of the treatment head to the effective
            radiating area (A[ER])
    Annex F (informative) - Determining acoustic power
            through radiation force measurements
    Annex G (informative) - Validity of low-power measurements
            of the beam cross-sectional area (A[BCS])
    Annex H (informative) - Influence of hydrophone effective
            diameter
    Annex I (informative) - Effective radiating area measurement
            using a radiation force balance and absorbing
            apertures
    Annex J (informative) - Guidance on uncertainty determination
    Bibliography
    Annex ZA (normative) - Normative references to international
             publications with their corresponding European
             publications

    Abstract - (Show below) - (Hide below)

    IEC 61689:2013 is applicable to ultrasonic equipment designed for physiotherapy containing an ultrasonic transducer generating continuous or quasi-continuous wave ultrasound in the frequency range 0,5 MHz to 5 MHz. This standard only relates to ultrasonic physiotherapy equipment employing a single plane non-focusing circular transducer per treatment head, producing static beams perpendicular to the face of the treatment head. This standard specifies: - methods of measurement and characterization of the output of ultrasonic physiotherapy equipment based on reference testing methods; - characteristics to be specified by manufacturers of ultrasonic physiotherapy equipment based on reference testing methods; - guidelines for safety of the ultrasonic field generated by ultrasonic physiotherapy equipment; - methods of measurement and characterization of the output of ultrasonic physiotherapy equipment based on routine testing methods; - and acceptance criteria for aspects of the output of ultrasonic physiotherapy equipment based on routine testing methods. Therapeutic value and methods of use of ultrasonic physiotherapy equipment are not covered by the scope of this standard. This third edition cancels and replaces the second edition published in 2007. It constitutes a technical revision which includes the following significant technical changes with respect to the previous edition: - restriction introduced of 0,2 W/cm2 effective intensity during hydrophone measurements for treatment heads with ka≤20, to limit the likelihood of cavitation; - change in the factor Fac, to determine the effective radiating area, from 1,354 to 1,333; - and change to SI units for terms and definitions.

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

    Committee CLC/SR 87
    Development Note To be read in conjunction with EN 60601-2-5. (12/2007) Supersedes UNE EN 61689. (10/2010)
    Document Type Standard
    Publisher European Committee for Standards - Electrical
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    BS EN 60601-2-36:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
    CEI EN 61161 : 2014 ULTRASONICS - POWER MEASUREMENT - RADIATION FORCE BALANCES AND PERFORMANCE REQUIREMENTS
    I.S. EN 60601-2-5:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-5: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC PHYSIOTHERAPY EQUIPMENT
    CEI EN 60601-2-62 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-62: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) EQUIPMENT
    BS EN 62127-1 : 2007 ULTRASONICS - HYDROPHONES - PART 1: MEASUREMENT AND CHARACTERIZATION OF MEDICAL ULTRASONIC FIELDS UP TO 40 MHZ
    I.S. EN 60601-2-62:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-62: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) EQUIPMENT
    EN 61161:2013 Ultrasonics - Power measurement - Radiation force balances and performance requirements
    UNE-EN 60601-2-5:2016 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
    BS EN 61828:2002 Ultrasonics. Focusing transducers. Definitions and measurement methods for the transmitted fields
    BS EN 60601-2-5:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
    CEI EN 61828 : 2003 ULTRASONICS - FOCUSING TRANSDUCERS - DEFINITIONS AND MEASUREMENT METHODS FOR THE TRANSMITTED FIELDS
    I.S. EN 62127-1:2007 ULTRASONICS - HYDROPHONES - PART 1: MEASUREMENT AND CHARACTERIZATION OF MEDICAL ULTRASONIC FIELDS UP TO 40 MHZ (IEC 62127-1:2007 (EQV))
    EN 61828:2001 Ultrasonics - Focusing transducers - Definitions and measurement methods for the transmitted fields
    BS EN 61161:2013 Ultrasonics. Power measurement. Radiation force balances and performance requirements
    I.S. EN 61161:2013 ULTRASONICS - POWER MEASUREMENT - RADIATION FORCE BALANCES AND PERFORMANCE REQUIREMENTS (IEC 61161:2013 (EQV))
    BS EN 60601-2-62:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
    I.S. EN 62127-2:2007 ULTRASONICS - HYDROPHONES - PART 2: CALIBRATION FOR ULTRASONIC FIELDS UP TO 40 MHZ
    CEI EN 60601-2-5 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-5: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC PHYSIOTHERAPY EQUIPMENT
    EN 62127-2:2007/A2:2017 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)
    EN 60601-2-5:2015 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
    EN 60601-2-62:2015 Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
    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

    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
    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 61161:2013 Ultrasonics - Power measurement - Radiation force balances and performance requirements
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60050-802:2011 International Electrotechnical Vocabulary (IEV) - Part 802: Ultrasonics
    IEC 61828:2001 Ultrasonics - Focusing transducers - Definitions and measurement methods for the transmitted fields
    EN 60601-2-5:2015 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
    IEC TR 60854:1986 Methods of measuring the performance of ultrasonic pulse-echo diagnostic equipment
    IEC TR 62781:2012 Ultrasonics - Conditioning of water for ultrasonic measurements
    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 60050-801:1994 International Electrotechnical Vocabulary (IEV) - Part 801: Acoustics and electroacoustics
    IEC 62127-3:2007+AMD1:2013 CSV Ultrasonics - Hydrophones - Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz
    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)
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