• IEC TS 62556:2014

    Current The latest, up-to-date edition.

    Ultrasonics - Field characterization - Specification and measurement of field parameters for high intensity therapeutic ultrasound (HITU) transducers and systems

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    Language(s):  English

    Published date:  24-04-2014

    Publisher:  International Electrotechnical Committee

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    Abstract - (Show below) - (Hide below)

    IEC TS 62556:2014 is a technical specification applicable to high intensity therapeutic ultrasound (HITU) devices. It specifies the relevant parameters for quantifying the field; the measurement methods at relatively low output levels and methodology for extrapolating these to higher therapeutic level fields; some considerations of sidelobes and pre-focal maxima; and parameters relevant to HITU transducers of different construction and geometry, including non-focusing, focusing with or without lenses, collimated, diverging and convergent transducers, multi-element transducers, scanning transducers and multiple sources. This technical specification is intended to support the ultrasonic measurement requirements given in IEC 60601-2-62. These specifications would have use in quality assurance, safety testing, and the standardization of communications regarding the clinical performance of HITU systems. Where possible, this technical specification incorporates specifications from other related standards. This technical specification does not apply to the following types of devices, which are covered by other standards: lithotripters (see IEC 61846); surgical equipment (see IEC 61847); and physiotherapy devices (see IEC 61689).

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

    Committee TC 87
    Development Note Stability date: 2017. (04/2014)
    Document Type Technical Specification
    Publisher International Electrotechnical Committee
    Status Current

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

    IEC 61511-3:2016 Functional safety - Safety instrumented systems for the process industry sector - Part 3: Guidance for the determination of the required safety integrity levels
    BS EN 60601-2-36:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
    I.S. EN 62555:2014 ULTRASONICS - POWER MEASUREMENT - HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) TRANSDUCERS AND SYSTEMS
    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 61511-3:2017 Functional safety. Safety instrumented systems for the process industry sector Guidance for the determination of the required safety integrity levels
    I.S. 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
    CSA C22.2 No. 60601.2.36 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-36: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY
    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
    IEC 61511-3 REDLINE : 2.0 FUNCTIONAL SAFETY - SAFETY INSTRUMENTED SYSTEMS FOR THE PROCESS INDUSTRY SECTOR - PART 3: GUIDANCE FOR THE DETERMINATION OF THE REQUIRED SAFETY INTEGRITY LEVELS
    BS EN 62555:2014 Ultrasonics. Power measurement. High intensity therapeutic ultrasound (HITU) transducers and systems
    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
    CSA C22.2 No. 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
    I.S. EN 61511-3:2017 FUNCTIONAL SAFETY - SAFETY INSTRUMENTED SYSTEMS FOR THE PROCESS INDUSTRY SECTOR - PART 3: GUIDANCE FOR THE DETERMINATION OF THE REQUIRED SAFETY INTEGRITY LEVELS
    12/30191872 DC : 0 BS EN 60601-2-62 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-62: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) SYSTEM
    15/30326099 DC : 0 BS EN 61828 - ULTRASONICS - FOCUSING TRANSDUCERS - DEFINITIONS AND MEASUREMENT METHODS FOR THE TRANSMITTED FIELDS
    12/30253196 DC : 0 BS EN 60601-2-36 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-36: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTRACORPOREALLY INDUCED LITHOTRIPSY
    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 60601-2-36:2014 Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
    IEC 62555:2013 Ultrasonics - Power measurement - High intensity therapeutic ultrasound (HITU) transducers and systems
    EN 61511-3:2017 Functional safety - Safety instrumented systems for the process industry sector - Part 3: Guidance for the determination of the required safety integrity levels
    EN 62555:2014 Ultrasonics - Power measurement - High intensity therapeutic ultrasound (HITU) transducers and systems
    IEC 61511-3:2016 RLV Functional safety - Safety instrumented systems for the process industry sector - Part 3: Guidance for the determination of the required safety integrity levels
    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 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 62555:2013 Ultrasonics - Power measurement - High intensity therapeutic ultrasound (HITU) transducers and systems
    IEC 61828:2001 Ultrasonics - Focusing transducers - Definitions and measurement methods for the transmitted fields
    IEC TR 62781:2012 Ultrasonics - Conditioning of water for ultrasonic measurements
    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 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
    IEC TR 62649:2010 Requirements for measurement standards for high intensity therapeutic ultrasound (HITU) devices
    IEC TS 61949:2007 Ultrasonics - Field characterization - In situ exposure estimation in finite-amplitude ultrasonic beams
    ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
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