IEC 61689:2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
03-08-2022
English - French
02-26-2013
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 |
| Standards | Relationship |
| NF EN 61689 : 2013 | Identical |
| GOST IEC 61689 : 2016 | Identical |
| NEN EN IEC 61689 : 2013 | Identical |
| DIN EN 61689 : 2013 | Identical |
| VDE 0754-3 : 2013 | Identical |
| CEI EN 61689 : 2013 | Identical |
| EN 61689:2013 | Identical |
| OVE/ONORM EN 61689 : 2014 | Identical |
| 04/30115966 DC : DRAFT JUL 2004 | Identical |
| NEN 11689 : 1997 | Identical |
| BS EN 61689:2013 | Identical |
| UNE-EN 61689:2013 | Identical |
| GOST R IEC 61689 : 2013 | Identical |
| SN EN 61689 : 1996 | Identical |
| UNE-EN 61689:1999 | Identical |
| 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 |
| CISPR 11 REDLINE : 6ED 2015 | INDUSTRIAL, SCIENTIFIC AND MEDICAL EQUIPMENT - RADIO-FREQUENCY DISTURBANCE CHARACTERISTICS - LIMITS AND METHODS OF MEASUREMENT |
| 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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