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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
29-04-2022
19-04-2013
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
Annex ZA (normative) - Normative references to international
publications with their corresponding European
publications
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.
Committee |
CLC/SR 87
|
DevelopmentNote |
To be read in conjunction with EN 60601-2-5. (12/2007) Supersedes UNE EN 61689. (10/2010)
|
DocumentType |
Standard
|
PublisherName |
European Committee for Standards - Electrical
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
Standards | Relationship |
PN EN 61689 : 2013 | Identical |
UNE-EN 61689:2013 | Identical |
I.S. EN 61689:2013 | Identical |
CEI EN 61689 : 2013 | Identical |
NEN EN IEC 61689 : 2013 | Identical |
DIN EN 61689 : 2013 | Identical |
VDE 0754-3 : 2013 | Identical |
NBN EN 61689 : 2013 | Identical |
IEC 61689:2013 | Identical |
NF EN 61689 : 2013 | Identical |
UNE-EN 61689:1999 | Identical |
BS EN 61689:2013 | Identical |
SN EN 61689 : 1996 | Identical |
OVE/ONORM EN 61689 : 2014 | Identical |
PNE-FprEN 61689 | Identical |
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 |
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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