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EN 62127-1:2007/A1:2013

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

ULTRASONICS - HYDROPHONES - PART 1: MEASUREMENT AND CHARACTERIZATION OF MEDICAL ULTRASONIC FIELDS UP TO 40 MHZ (IEC 62127-1:2007/A1:2013)
Superseded date

06-03-2022

Published date

03-22-2013

FOREWORD
INTRODUCTION
1 Scope and object
2 Normative references
3 Terms, definitions and symbols
4 List of symbols
5 Measurement requirements
6 Measurement procedure
7 Beam characterization
8 Requirements for specific ultrasonic fields
9 Compliance statement
Annex A (informative) - General rationale
Annex B (informative) - Hydrophones and positioning
Annex C (informative) - Acoustic pressure and intensity
Annex D (informative) - Voltage to pressure conversion
Annex E (informative) - Correction for spatial averaging
Annex F (informative) - Acoustic output parameters for
        multi-mode medical ultrasonic fields in the absence
        of scan-frame synchronization
Annex G (informative) - Propagation medium and degassing
Annex H (informative) - Specific ultrasonic fields
Annex I (informative) - Assessment of uncertainty in
        the acoustic quantities obtained by hydrophone
        measurements
Annex J (informative) - Transducer and hydrophone
        positioning systems
Annex K (informative) - Beamwidth midpoint method
Bibliography
Annex ZA (normative) - Normative references to
         international publications with their corresponding
         European publications

Defines methods of use of calibrated hydrophones for the measurement in liquids of acoustic fields generated by ultrasonic medical equipment operating in the frequency range up to 40 MHz.

Committee
SR 87
DevelopmentNote
Together with EN 62127-2 and EN 62127-3 supersedes EN 61101, EN 61102, EN 61220 and EN 62092. (06/2008) Supersedes UNE EN 61101, UNE EN 61102 & UNE EN 61220. (09/2010)
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Superseded
Supersedes

CLC/TS 61949:2008 Ultrasonics - Field characterization - In situ exposure estimation in finite-amplitude ultrasonic beams
PREN 1127-1 : DRAFT 2017 EXPLOSIVE ATMOSPHERES - EXPLOSION PREVENTION AND PROTECTION - PART 1: BASIC CONCEPTS AND METHODOLOGY
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
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 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
BS EN 62127-2 : 2007 ULTRASONICS - HYDROPHONES - PART 2: CALIBRATION FOR 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
BS EN 62127-3 : 2007 ULTRASONICS - HYDROPHONES - PART 3: PROPERTIES OF HYDROPHONES FOR ULTRASONIC FIELDS UP TO 40 MHZ
17/30365866 DC : 0 BS EN 1127-1 - EXPLOSIVE ATMOSPHERES - EXPLOSION PREVENTION AND PROTECTION - PART 1: BASIC CONCEPTS AND METHODOLOGY
I.S. EN 61391-2:2010 ULTRASONICS - PULSE-ECHO SCANNERS - PART 2: MEASUREMENT OF MAXIMUM DEPTH OF PENETRATION AND LOCAL DYNAMIC RANGE
EN 61689:2013 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
EN 61391-2:2010 Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range
EN 61157:2007/A1:2013 STANDARD MEANS FOR THE REPORTING OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC ULTRASONIC EQUIPMENT (IEC 61157:2007/A1:2013)
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
CEI EN 61391-2 : 2011 ULTRASONICS - PULSE-ECHO SCANNERS - PART 2: MEASUREMENT OF MAXIMUM DEPTH OF PENETRATION AND LOCAL DYNAMIC RANGE
BS EN 60601-2-5:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
BS EN 61157 : 2007 STANDARD MEANS FOR THE REPORTING OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC ULTRASONIC EQUIPMENT
CEI EN 61689 : 2013 ULTRASONICS - PHYSIOTHERAPY SYSTEMS - FIELD SPECIFICATIONS AND METHODS OF MEASUREMENT IN THE FREQUENCY RANGE 0,5 MHZ TO 5 MHZ
BS EN 61689:2013 Ultrasonics. Physiotherapy systems. Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
I.S. EN 62359:2011 ULTRASONICS - FIELD CHARACTERIZATION - TEST METHODS FOR THE DETERMINATION OF THERMAL AND MECHANICAL INDICES RELATED TO MEDICAL DIAGNOSTIC ULTRASONIC FIELDS
BS EN 45502-1:2015 Implants for surgery. Active implantable medical devices General requirements for safety, marking and for information to be provided by the manufacturer
I.S. EN 45502-1:2015 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
I.S. EN 61157:2007 STANDARD MEANS FOR THE REPORTING OF THE ACOUSTIC OUTPUT OF MEDICAL DIAGNOSTIC ULTRASONIC EQUIPMENT (IEC 61157:2007 (EQV))
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
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
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
I.S. EN 61689:2013 ULTRASONICS - PHYSIOTHERAPY SYSTEMS - FIELD SPECIFICATIONS AND METHODS OF MEASUREMENT IN THE FREQUENCY RANGE 0,5 MHZ TO 5 MHZ (IEC 61689:2013 (EQV))
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 60601-2-5:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-5: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ULTRASONIC PHYSIOTHERAPY EQUIPMENT
EN 45502-1:2015 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
13/30233325 DC : 0 BS EN 45502-1 - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER
CEI CLC/TS 61949 : 2011 ULTRASONICS - FIELD CHARACTERIZATION - IN SITU EXPOSURE ESTIMATION IN FINITE-AMPLITUDE ULTRASONIC BEAMS
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
PREN 45502-1 : DRAFT 2013 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND INFORMATION TO BE PROVIDED BY THE MANUFACTURER
BS EN 61391-2:2010 Ultrasonics. Pulse-echo scanners Measurement of maximum depth of penetration and local dynamic range
I.S. EN 62127-3:2007 ULTRASONICS - HYDROPHONES - PART 3: PROPERTIES OF HYDROPHONES FOR ULTRASONIC FIELDS UP TO 40 MHZ (IEC 62127-3:2007 (EQV))
EN 62127-3:2007/A1:2013 ULTRASONICS - HYDROPHONES - PART 3: PROPERTIES OF HYDROPHONES FOR ULTRASONIC FIELDS UP TO 40 MHZ (IEC 62127-3:2007/A1:2013)
EN 62127-2:2007/A2:2017 ULTRASONICS - HYDROPHONES - PART 2: CALIBRATION FOR ULTRASONIC FIELDS UP TO 40 MHZ
EN 45502-1 : 2015 IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER
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 60601-2-5:2015 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
EN 60601-2-37:2008/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
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 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 60565:2006 Underwater acoustics - Hydrophones - Calibration in the frequency range 0,01 Hz to 1 MHz
EN 62127-3:2007/A1:2013 ULTRASONICS - HYDROPHONES - PART 3: PROPERTIES OF HYDROPHONES FOR ULTRASONIC FIELDS UP TO 40 MHZ (IEC 62127-3:2007/A1:2013)
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 61846:1998 Ultrasonics - Pressure pulse lithotripters - Characteristics of fields
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 61828:2001 Ultrasonics - Focusing transducers - Definitions and measurement methods for the transmitted fields
EN 61846:1998 Ultrasonics - Pressure pulse lithotripters - Characteristics of fields
IEC 61847:1998 Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
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
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
NEMA UD 2-2004 (R2009) ACOUSTIC OUTPUT MEASUREMENT STANDARD FOR DIAGNOSTIC ULTRASOUND EQUIPMENT
EN 61689:2013 Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz
IEC 62127-3:2007+AMD1:2013 CSV Ultrasonics - Hydrophones - Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz
ISO 16269-6:2014 Statistical interpretation of data Part 6: Determination of statistical tolerance intervals
EN 62127-2:2007/A2:2017 ULTRASONICS - HYDROPHONES - PART 2: CALIBRATION 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 60565:2007 Underwater acoustics - Hydrophones - Calibration in the frequency range 0,01 Hz to 1 MHz
IEC TS 61949:2007 Ultrasonics - Field characterization - In situ exposure estimation in finite-amplitude ultrasonic beams
IEC 61157:2007+AMD1:2013 CSV Standard means for the reporting of the acoustic output of medicaldiagnostic ultrasonic equipment
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 61847:1998 Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
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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