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Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date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
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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)
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| DocumentType |
Standard
|
| PublisherName |
European Committee for Standards - Electrical
|
| Status |
Superseded
|
| Supersedes |
| Standards | Relationship |
| IEC 62127-1:2007/AMD1:2013 | Identical |
| UNE-EN 62127-1:2007/A1:2013 | Identical |
| CEI EN 62127-1/A1:2014 | Identical |
| SN EN 62127-1:2007+A1:2013 | Identical |
| BS EN 62127-1 : 2007 | Identical |
| I.S. EN 62127-1:2007 | Identical |
| PN EN 62127-1 : 2008 AMD 1 2013 | Identical |
| NF EN 62127-1 : 2008 AMD 1 2013 | Identical |
| IEC 62127-1:2007+AMD1:2013 CSV | Identical |
| NEN EN IEC 62127-1 : 2007 AMD 1 2013 | Identical |
| DIN EN 62127-1:2013-11 | Identical |
| NBN EN 62127-1 : 2008 AMD 1 2013 | Identical |
| PNE-EN 62127-1:2007/FprA1 | Identical |
| BS EN 62127-1:2007+A1:2013 | Identical |
| 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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