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IEC TR 62649:2010

Current

Current

The latest, up-to-date edition.

Requirements for measurement standards for high intensity therapeutic ultrasound (HITU) devices

Available format(s)

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

Language(s)

English

Published date

28-04-2010

€389.87
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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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