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IEC 61689:2013

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

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

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Superseded date

08-03-2022

Language(s)

English - French

Published date

26-02-2013

€358.68
Excluding VAT

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

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.

This publication is to be read in conjunction with IEC 60601-2-5:2009.

Committee
TC 87
DevelopmentNote
Supersedes IEC 60150 (03/2001) To be used in conjunction with IEC 60601-2-5. (08/2007) Stability Date: 2018. (11/2017)
DocumentType
Standard
Pages
124
PublisherName
International Electrotechnical Committee
Status
Superseded
SupersededBy
Supersedes

PD IEC/TS 62556:2014 Ultrasonics. Field characterization. Specification and measurement of field parameters for high intensity therapeutic ultrasound (HITU) transducers and systems
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
08/30173423 DC : DRAFT JULY 2008 BS EN 60601-2-5 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-5: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC PHYSIOTHERAPY EQUIPMENT
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
UNE-IEC 60050-802:2011 International Electrotechnical Vocabulary (IEV) - Part 802: Ultrasonics
CSA C22.2 No. 60601.2.5 : 2011 : R2016 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
CSA CISPR 11 : 2004 : R2017 INDUSTRIAL, SCIENTIFIC AND MEDICAL (ISM) RADIO-FREQUENCY EQUIPMENT - ELECTROMAGNETIC DISTURBANCE CHARACTERISTICS - LIMITS AND METHODS OF MEASUREMENT
NF 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
NF EN 62127-1 : 2008 AMD 1 2013 ULTRASONICS - HYDROPHONES - PART 1: MEASUREMENT AND CHARACTERIZATION OF MEDICAL ULTRASONIC FIELDS UP TO 40 MHZ
EN 61161:2013 Ultrasonics - Power measurement - Radiation force balances and performance requirements
EN 61157:2007/A1:2013 STANDARD MEANS FOR THE REPORTING OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC ULTRASONIC EQUIPMENT (IEC 61157:2007/A1:2013)
NF EN 61828 : 2006 ULTRASONICS - FOCUSING TRANSDUCERS - DEFINITIONS AND MEASUREMENT METHODS FOR THE TRANSMITTED FIELDS
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
08/30177589 DC : DRAFT FEB 2008 BS EN 62359 - ULTRASONIC - FIELD CHARACTERIZATION - TEST METHODS FOR THE DETERMINATION OF THERMAL AND MECHANICAL INDICES RELATED TO MEDICAL DIAGNOSTIC ULTRASONIC FIELDS
BS EN 61157 : 2007 STANDARD MEANS FOR THE REPORTING OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC ULTRASONIC EQUIPMENT
PD IEC/TS 62462:2017 Ultrasonics. Output test. Guidance for the maintenance of ultrasound physiotherapy systems
CEI EN 61828 : 2003 ULTRASONICS - FOCUSING TRANSDUCERS - DEFINITIONS AND MEASUREMENT METHODS FOR THE TRANSMITTED FIELDS
IEC TS 62556:2014 Ultrasonics - Field characterization - Specification and measurement of field parameters for high intensity therapeutic ultrasound (HITU) transducers and systems
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 CISPR 11 : 2004 : INC : AMD 2 : 2010 INDUSTRIAL, SCIENTIFIC AND MEDICAL (ISM) RADIO-FREQUENCY EQUIPMENT - ELECTROMAGNETIC DISTURBANCE CHARACTERISTICS - LIMITS AND METHODS OF MEASUREMENT
CSA CISPR 11 : 2004 INDUSTRIAL, SCIENTIFIC AND MEDICAL (ISM) RADIO-FREQUENCY EQUIPMENT - ELECTROMAGNETIC DISTURBANCE CHARACTERISTICS - LIMITS AND METHODS OF MEASUREMENT
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
I.S. EN 62359:2011 ULTRASONICS - FIELD CHARACTERIZATION - TEST METHODS FOR THE DETERMINATION OF THERMAL AND MECHANICAL INDICES RELATED TO MEDICAL DIAGNOSTIC ULTRASONIC FIELDS
IEC 62127-2:2007+AMD1:2013+AMD2:2017 CSV Ultrasonics - Hydrophones - Part 2: Calibration for ultrasonic fields up to 40 MHz
EN 61828:2001 Ultrasonics - Focusing transducers - Definitions and measurement methods for the transmitted fields
I.S. EN 61157:2007 STANDARD MEANS FOR THE REPORTING OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC ULTRASONIC EQUIPMENT (IEC 61157:2007 (EQV))
ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
BS EN 61161:2013 Ultrasonics. Power measurement. Radiation force balances and performance requirements
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
BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
UNE-EN 55011:2011 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
BS EN 62359 : 2011 ULTRASONICS - FIELD CHARACTERIZATION - TEST METHODS FOR THE DETERMINATION OF THERMAL AND MECHANICAL INDICES RELATED TO MEDICAL DIAGNOSTIC ULTRASONIC FIELDS
I.S. EN 61161:2013 ULTRASONICS - POWER MEASUREMENT - RADIATION FORCE BALANCES AND PERFORMANCE REQUIREMENTS (IEC 61161:2013 (EQV))
CSA C22.2 No. 601.2.5 : 0 MEDICAL ELECTRICAL EQUIPMENT - PART 2-5: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ULTRASONIC PHYSIOTHERAPY 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
CSA C22.2 No. 60601.2.5:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-5: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC PHYSIOTHERAPY EQUIPMENT
NF EN 60601-2-5 : 2005 MEDICAL ELECTRICAL EQUIPMENT - PART 2-5: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ULTRASONIC PHYSIOTHERAPY EQUIPMENT
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
05/30141146 DC : DRAFT OCT 2005
04/30111610 DC : 0
CEI EN 62359 : 2012 ULTRASONICS - FIELD CHARACTERIZATION - TEST METHODS FOR THE DETERMINATION OF THERMAL AND MECHANICAL INDICES RELATED TO MEDICAL DIAGNOSTIC ULTRASONIC FIELDS
I.S. EN 62127-2:2007 ULTRASONICS - HYDROPHONES - PART 2: CALIBRATION FOR ULTRASONIC FIELDS UP TO 40 MHZ
CEI EN 55011 : 2017 INDUSTRIAL, SCIENTIFIC AND MEDICAL EQUIPMENT - RADIO-FREQUENCY DISTURBANCE CHARACTERISTICS - LIMITS AND METHODS OF MEASUREMENT
IEC TS 62462:2007 Ultrasonics - Output Test - Guide for the maintenance of ultrasound physiotherapy systems
IEC 60050-802:2011 International Electrotechnical Vocabulary (IEV) - Part 802: Ultrasonics
IEC 61161:2013 Ultrasonics - Power measurement - Radiation force balances and performance requirements
IEC 61828:2001 Ultrasonics - Focusing transducers - Definitions and measurement methods for the transmitted fields
IEC 62127-1:2007+AMD1:2013 CSV Ultrasonics - Hydrophones - Part 1: Measurement and characterizationof medical ultrasonic fields up to 40 MHz
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 61157:2007+AMD1:2013 CSV Standard means for the reporting of the acoustic output of medicaldiagnostic ultrasonic equipment
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
11/30228838 DC : 0 BS EN 61157 A1 - STANDARD MEANS FOR THE REPORTING OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC ULTRASONIC EQUIPMENT
17/30355518 DC : 0 BS EN 63045 - ULTRASONICS - NON-FOCUSING AND WEAKLY FOCUSING PRESSURE PULSE SOURCES - CHARACTERISTICS OF FIELDS
15/30330876 DC : 0 BS EN 62127-2+A2 - ULTRASONICS - HYDROPHONES - PART 2: CALIBRATION FOR ULTRASONIC FIELDS UP TO 40 MHZ
12/30263969 DC : 0 BS EN 55011 - GENERAL MAINTENANCE FOR CISPR 11 ED.5.1
11/30228497 DC : 0 BS EN 61161 - ULTRASONICS - POWER MEASUREMENT - RADIATION FORCE BALANCES AND PERFORMANCE REQUIREMENTS
CSA CISPR 11 : 2004 : INC : AMD 2 : 2010 : R2013 INDUSTRIAL, SCIENTIFIC AND MEDICAL (ISM) RADIO-FREQUENCY EQUIPMENT - ELECTROMAGNETIC DISTURBANCE CHARACTERISTICS - LIMITS AND METHODS OF MEASUREMENT
IEC TR 62649:2010 Requirements for measurement standards for high intensity therapeutic ultrasound (HITU) devices
IEC 60601-2-5:2009 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
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))
CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
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)
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 60601-2-5:2015 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
EN 62359:2011/A1:2018 ULTRASONICS - FIELD CHARACTERIZATION - TEST METHODS FOR THE DETERMINATION OF THERMAL AND MECHANICAL INDICES RELATED TO MEDICAL DIAGNOSTIC ULTRASONIC FIELDS
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

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
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
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

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