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IEC 61157:2007+AMD1:2013 CSV

Current

Current

The latest, up-to-date edition.

Standard means for the reporting of the acoustic output of medicaldiagnostic ultrasonic equipment

Available format(s)

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

Language(s)

English - French

Published date

28-01-2013

£298.03
Excluding VAT

FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms, definitions and symbols
4 Requirements
5 Compliance statement
6 Test methods
7 Presentation of results
Annex A (normative) - Presentation of acoustic output
        information
Annex B (informative) - Reporting requirements for
        extensive systems
Annex C (informative) - Rationale
Index of defined terms
Bibliography

IEC 61157:2007+A1:2013 specifies a standard means and format for the reporting of the acoustic output of medical diagnostic ultrasonic equipment. The numerical values for reporting purposes represent the average values for the maximum output conditions for a given discrete- or combined-operating mode and are derived from measurements made in water. Intensity parameters are specified in this standard, but these are regarded as derived quantities that are meaningful only under certain assumptions related to the ultrasonic field being measured. This International Standard is applicable to medical diagnostic ultrasonic equipment. It provides a set of traceable acoustic parameters describing the acoustic fields. It defines a standard means and format for the reporting of the acoustic output information. It also describes a reduced dataset recommended for equipment generating low acoustic output levels. This second edition cancels and replaces the first edition published in 1992. This edition constitutes a minor revision. The changes with respect to the previous edition are listed hereafter:
- maintenance on this standard and the referenced standards IEC 61161 and IEC 62127-1;
- and a clause on compliance has been added. The contents of the corrigendum of August 2008 have been included in this copy. The French version of this standard has not been voted upon. This consolidated version consists of the second edition (2007) and its amendment 1 (2013). Therefore, no need to order amendment in addition to this publication.

Committee
TC 87
DevelopmentNote
Stability Date: 2018. (11/2017)
DocumentType
Standard
Pages
68
PublisherName
International Electrotechnical Committee
Status
Current
Supersedes

CEI EN 61161 : 2014 ULTRASONICS - POWER MEASUREMENT - RADIATION FORCE BALANCES AND PERFORMANCE REQUIREMENTS
DD IEC/TS 62306:2006 Ultrasonics. Field characterisation. Test objects for determining temperature elevation in diagnostic ultrasound fields
BS EN 62127-1 : 2007 ULTRASONICS - HYDROPHONES - PART 1: MEASUREMENT AND CHARACTERIZATION OF MEDICAL ULTRASONIC FIELDS UP TO 40 MHZ
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 62359:2011 ULTRASONICS - FIELD CHARACTERIZATION - TEST METHODS FOR THE DETERMINATION OF THERMAL AND MECHANICAL INDICES RELATED TO MEDICAL DIAGNOSTIC ULTRASONIC FIELDS
EN 61161:2013 Ultrasonics - Power measurement - Radiation force balances and performance requirements
NF EN 61828 : 2006 ULTRASONICS - FOCUSING TRANSDUCERS - DEFINITIONS AND MEASUREMENT METHODS FOR THE TRANSMITTED FIELDS
04/30115954 DC : DRAFT JUL 2004
BS EN 61391-1 : 2006 ULTRASONICS - PULSE-ECHO SCANNERS - PART 1: TECHNIQUES FOR CALIBRATING SPATIAL MEASUREMENT SYSTEMS AND MEASUREMENT OF SYSTEM POINT-SPREAD FUNCTION RESPONSE
BS EN 61828:2002 Ultrasonics. Focusing transducers. Definitions and measurement methods for the transmitted fields
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
CEI EN 61828 : 2003 ULTRASONICS - FOCUSING TRANSDUCERS - DEFINITIONS AND MEASUREMENT METHODS FOR THE TRANSMITTED FIELDS
EN 61828:2001 Ultrasonics - Focusing transducers - Definitions and measurement methods for the transmitted fields
05/30129161 DC : DRAFT FEB 2005
BS EN 61161:2013 Ultrasonics. Power measurement. Radiation force balances and performance requirements
I.S. EN 61266:1997 ULTRASONICS - HAND-HELD PROBE DOPPLER FOETAL HEARTBEAT DETECTORS - PERFORMANCE REQUIREMENTS AND METHODS OF MEASUREMENT AND REPORTING
07/30161032 DC : 0 BS EN 61391-2 - ULTRASONICS - PULSE ECHO SCANNERS - PART 2: TECHNIQUES FOR MEASUREMENT OF MAXIMUM DEPTH OF VISUALIZATION AND THE DISPLAYED DYNAMIC RANGE
BS EN 62359 : 2011 ULTRASONICS - FIELD CHARACTERIZATION - TEST METHODS FOR THE DETERMINATION OF THERMAL AND MECHANICAL INDICES RELATED TO MEDICAL DIAGNOSTIC ULTRASONIC FIELDS
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
I.S. EN 61161:2013 ULTRASONICS - POWER MEASUREMENT - RADIATION FORCE BALANCES AND PERFORMANCE REQUIREMENTS (IEC 61161:2013 (EQV))
IEC TS 62306:2006 Ultrasonics - Field characterisation - Test objects for determining temperature elevation in diagnostic ultrasound fields
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
CEI EN 61391-1 : 2007 ULTRASONICS - PULSE-ECHO SCANNERS - PART 1: TECHNIQUES FOR CALIBRATING SPATIAL MEASUREMENT SYSTEMS AND MEASUREMENT OF SYSTEM POINT-SPREAD FUNCTION RESPONSE
I.S. EN 61391-1:2006 Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of system point-spread function response
15/30326099 DC : 0 BS EN 61828 - ULTRASONICS - FOCUSING TRANSDUCERS - DEFINITIONS AND MEASUREMENT METHODS FOR THE TRANSMITTED FIELDS
CEI EN 61266 : 1998 ULTRASONICS - HAND-HELD PROBE DOPPLER FOETAL HEARTBEAT DETECTORS - PERFORMANCE REQUIREMENTS AND METHODS OF MEASUREMENT AND REPORTING
IEC 61161:2013 Ultrasonics - Power measurement - Radiation force balances and performance requirements
IEC 61391-1:2006+AMD1:2017 CSV Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement systems and measurement of point-spread function response
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 61266:1994 Ultrasonics - Hand-held probe Doppler foetal heartbeat detectors - Performance requirements and methods of measurement and reporting
17/30353724 DC : 0 BS EN 62359:2011/A1 - ULTRASONICS - FIELD CHARACTERIZATION - TEST METHODS FOR THE DETERMINATION OF THERMAL AND MECHANICAL INDICES RELATED TO MEDICAL DIAGNOSTIC ULTRASONIC FIELDS
11/30228497 DC : 0 BS EN 61161 - ULTRASONICS - POWER MEASUREMENT - RADIATION FORCE BALANCES AND PERFORMANCE REQUIREMENTS
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))
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 61391-1:2006/A1:2017 ULTRASONICS - PULSE-ECHO SCANNERS - PART 1: TECHNIQUES FOR CALIBRATING SPATIAL MEASUREMENT SYSTEMS AND MEASUREMENT OF SYSTEM POINT-SPREAD FUNCTION RESPONSE (IEC 61391-1:2006/A1:2017)
EN 61266:1995 Ultrasonics - Hand-held probe Doppler foetal heartbeat detectors - Performance requirements and methods of measurement and reporting
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 62359:2011/A1:2018 ULTRASONICS - FIELD CHARACTERIZATION - TEST METHODS FOR THE DETERMINATION OF THERMAL AND MECHANICAL INDICES RELATED TO 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 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 60050-802:2011 International Electrotechnical Vocabulary (IEV) - Part 802: Ultrasonics
IEC TR 60854:1986 Methods of measuring the performance of ultrasonic pulse-echo diagnostic equipment
IEC 60050-801:1994 International Electrotechnical Vocabulary (IEV) - Part 801: Acoustics and electroacoustics
ISO 16269-6:2014 Statistical interpretation of data — Part 6: Determination of statistical tolerance intervals
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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