IEC 62359:2010+AMD1:2017 CSV
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The latest, up-to-date edition.
Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
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29-09-2017
IEC 62359:2010+A1:2017 is applicable to medical diagnostic ultrasound fields. It establishes:
- parameters related to thermal and non-thermal exposure aspects of diagnostic ultrasonic fields;
- methods for the determination of an exposure parameter relating to temperature rise in theoretical tissue-equivalent models, resulting from absorption of ultrasound;
- methods for the determination of an exposure parameter appropriate to certain non-thermal effects.
This second edition cancels and replaces the first edition, published in 2005. It constitutes a technical revision. Major changes with respect to the previous edition include the following:
- The methods of determination set out in the first edition of this standard were based on those contained in the American standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (ODS) and were intended to yield identical results. While this second edition also follows the ODS in principal and uses the same basic formulae and assumptions (see Annex A), it contains a few significant modifications which deviate from the ODS.
- One of the primary issues dealt with in preparing this second edition of IEC 62359 was "missing" TI equations. In Edition 1 there were not enough equations to make complete "at-surface" and "below-surface" summations for TIS and TIB in combined-operating modes. Thus major changes with respect to the previous edition are related to the introduction of new calculations of thermal indices to take into account both "at-surface" and "below-surface" thermal effects. The contents of the corrigendum of March 2011 have been included in this copy. This consolidated version consists of the second edition (2010) and its amendment 1 (2017). Therefore, no need to order amendment in addition to this publication.
Committee |
TC 87
|
DevelopmentNote |
Stability Date: 2019. (10/2017)
|
DocumentType |
Standard
|
Pages |
169
|
PublisherName |
International Electrotechnical Committee
|
Status |
Current
|
Supersedes |
Standards | Relationship |
NF EN 62359 : 2011 | Identical |
GOST R IEC 62359 : 2011 | Identical |
NBN EN 62359 : 2011 | Identical |
I.S. EN 62359:2011 | Identical |
SN EN 62359 : 2005 | Identical |
UNE-EN 62359:2011 | Identical |
BS EN 62359 : 2011 | Identical |
CEI EN 62359 : 2012 | Identical |
DIN EN 62359:2011-11 | Identical |
NEN EN IEC 62359 : 2011 AMD 1 2018 | Identical |
EN 62359:2011/A1:2018 | Identical |
PN EN 62359 : 2011 AMD 1 2018 | Identical |
CLC/TS 61949:2008 | Ultrasonics - Field characterization - In situ exposure estimation in finite-amplitude ultrasonic beams |
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 |
S.R. CLC/TS 61949:2008 | ULTRASONICS - FIELD CHARACTERIZATION - IN SITU EXPOSURE ESTIMATION IN FINITE-AMPLITUDE ULTRASONIC BEAMS |
BS EN 62127-1 : 2007 | ULTRASONICS - HYDROPHONES - PART 1: MEASUREMENT AND CHARACTERIZATION OF MEDICAL ULTRASONIC FIELDS UP TO 40 MHZ |
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 |
PD IEC/TR 62799:2013 | Models for evaluation of thermal hazard in medical diagnostic ultrasonic fields |
I.S. EN 60601-2-37:2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-37: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC MEDICAL DIAGNOSTIC AND MONITORING 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)) |
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 |
12/30256177 DC : 0 | BS EN 60601-2-37 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-37: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC MEDICAL DIAGNOSTIC AND MONITORING 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 |
BS EN 60601-2-37 : 2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-37: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC MEDICAL DIAGNOSTIC AND MONITORING 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 |
IEC TS 61949:2007 | Ultrasonics - Field characterization - In situ exposure estimation in finite-amplitude ultrasonic beams |
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 |
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 |
CEI CLC/TS 61949 : 2011 | ULTRASONICS - FIELD CHARACTERIZATION - IN SITU EXPOSURE ESTIMATION IN FINITE-AMPLITUDE ULTRASONIC BEAMS |
IEC TR 62799:2013 | Models for evaluation of thermal hazard in medical diagnostic ultrasonic 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 |
06/30139700 DC : DRAFT JUN 2006 | IEC 60601-2-37 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-37: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ULTRASONIC MEDICAL DIAGNOSTIC AND MONITORING EQUIPMENT |
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 |
NF EN 60601-2-37 : 2008 AMD 1 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-37: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC MEDICAL DIAGNOSTIC AND MONITORING EQUIPMENT |
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 60601-2-37:2008/A1:2015 | Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring 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 |
CSA C22.2 No. 60601.2.37 : 2008 : R2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-37: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC MEDICAL DIAGNOSTIC AND MONITORING EQUIPMENT |
CSA C22.2 No. 60601.2.37:2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-37: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC MEDICAL DIAGNOSTIC AND MONITORING EQUIPMENT |
IEC 62127-1:2007+AMD1:2013 CSV | Ultrasonics - Hydrophones - Part 1: Measurement and characterizationof medical ultrasonic fields up to 40 MHz |
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 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 TR 60854:1986 | Methods of measuring the performance of ultrasonic pulse-echo diagnostic equipment |
NEMA UD 2-2004 (R2009) | ACOUSTIC OUTPUT MEASUREMENT STANDARD FOR DIAGNOSTIC ULTRASOUND EQUIPMENT |
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 |
IEC 61157:2007+AMD1:2013 CSV | Standard means for the reporting of the acoustic output of medicaldiagnostic ultrasonic equipment |
ISO/IEC Guide 98-3:2008 | Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) |
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