IEC TR 62649:2010
Current
The latest, up-to-date edition.
Requirements for measurement standards for high intensity therapeutic ultrasound (HITU) devices
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English
28-04-2010
FOREWORD
INTRODUCTION
1 Scope
2 Background
3 Limitations of existing standard methods
4 Survey of experts
5 Existing literature for measurement of HITU fields
6 Discussion
7 Recommendations
Annex A (informative) - Detailed responses to questionnaire
Annex B (informative) - Definitions in selected ultrasound
standards
Annex C (informative) - Chinese national standard
Bibliography
IEC/TR 62649:2010(E) is relevant to the measurement and specification of ultrasound fields intended for medical therapeutic purposes. Lithotripsy and physiotherapy are excluded, since there are existing International Standards for these applications. IEC/TR 62649:2010 establishes:
- topics where there is a consensus that the development of International Standards would benefit the industries and/or patients;
- topics where the writing of standards should start immediately;
- topics where the writing of technical specifications should start immediately in order to gain practical experience and establish consensus prior to standardisation;
- topics which require future standardisation but where further research is required before initiating the writing of standards or technical specifications. IEC/TR 62649:2010 addresses primarily the requirements for measurement standards related to high intensity therapeutic ultrasound (HITU) [also known as high intensity focused ultrasound (HIFU)] fields which are both high intensity and focused and where the main mechanism for action is thermal. However, aspects of the discussion, conclusions and any resulting standards or technical specifications may also be relevant to therapeutic applications which are either focused or high intensity or where the main mechanism is not thermal. Scientific literature has been reviewed and responses to a questionnaire which was sent to experts around the world are reported.
DevelopmentNote |
Stability Date: 2020. (09/2017)
|
DocumentType |
Technical Report
|
Pages |
93
|
PublisherName |
International Electrotechnical Committee
|
Status |
Current
|
Standards | Relationship |
NEN NPR IEC/TR 62649 : 2010 | Identical |
CEI EN 62555 : 2014 | ULTRASONICS - POWER MEASUREMENT - HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) TRANSDUCERS AND SYSTEMS |
I.S. 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 |
IEC TS 62556:2014 | Ultrasonics - Field characterization - Specification and measurement of field parameters for high intensity therapeutic ultrasound (HITU) transducers and systems |
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 62555:2014 | Ultrasonics. Power measurement. High intensity therapeutic ultrasound (HITU) transducers and systems |
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 |
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 |
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 62555:2013 | Ultrasonics - Power measurement - High intensity therapeutic ultrasound (HITU) transducers and systems |
11/30209557 DC : 0 | BS EN 62555 - ULTRASONICS - POWER MEASUREMENT - OUTPUT POWER MEASUREMENT FOR HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) TRANSDUCERS AND SYSTEMS |
EN 62555:2014 | Ultrasonics - Power measurement - High intensity therapeutic ultrasound (HITU) transducers and systems |
IEC 60601-2-37:2007+AMD1:2015 CSV | Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
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 61689:2013 | Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz |
IEC 61828:2001 | Ultrasonics - Focusing transducers - Definitions and measurement methods for the transmitted fields |
IEC 61101:1991 | The absolute calibration of hydrophones using the planar scanning technique in the frequency range 0.5 MHz to 15 MHz |
IEC 60866:1987 | Characteristics and calibration of hydrophones for operation in the frequency range 0.5 MHz to 15 MHz |
IEC TS 62306:2006 | Ultrasonics - Field characterisation - Test objects for determining temperature elevation in diagnostic ultrasound fields |
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 |
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