EN 61157:2007/A1:2013
(Amendment)Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment
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.
NOTE The information tabulated in this standard format can be used for
a) exposure planning for biological effects studies;
b) exposure data for prospective epidemiological studies conducted using exposure conditions similar to those reported in this standard. In the absence of actual exposure data for retrospective epidemiological studies, the information tabulated in this standard format might also be used with
cautionary comment.
Normverfahren für die Angabe der akustischen Ausgangsgrößen von medizinischen Ultraschalldiagnostikgeräten
Critères normalisés de déclaration des émissions acoustiques des appareils de diagnostic médical à ultrasons
Standardni načini poročanja o akustičnem izhodu medicinske ultrazvočne diagnostične opreme - Dopolnilo A1 (IEC 61157:2007/A1:2013)
General Information
- Status
- Published
- Publication Date
- 21-Mar-2013
- Withdrawal Date
- 03-Mar-2016
- Technical Committee
- CLC/SR 87 - CLC/SR 87
- Drafting Committee
- IEC/TC 87 - IEC_TC_87
- Current Stage
- 6060 - Document made available - Publishing
- Start Date
- 22-Mar-2013
- Completion Date
- 22-Mar-2013
Relations
- Effective Date
- 29-Jan-2023
Overview
EN 61157:2007/A1:2013 (IEC 61157 amendment 1) specifies standard means for reporting the acoustic output of medical diagnostic ultrasonic equipment. It defines the information format, terminology and symbols, measurement references and compliance criteria required for consistent, comparable documentation of ultrasound acoustic emissions from diagnostic systems.
Key Topics
- Scope of reporting: Required acoustic output parameters (e.g., peak pressure, temporal-average intensities, power output, beam dimensions, distance z to measurement plane, frequency and bandwidth). Annex A provides an example data-sheet layout.
- Definitions and symbols: Updated and clarified terms (e.g., derived instantaneous intensity, beam area definitions A_b,6 and A_b,20, beamwidths, pulse and scan metrics) aligned with IEC 62127-1.
- Operating mode data sheets: Standardized fields for detailed operating-mode reporting, including pulse repetition rate (prr) for non-scanning modes, scan repetition rate (srr), number of ultrasonic scan lines (n_sl) and number of pulses per scan line (n_pps).
- Measurement references: Normative linkage to hydrophone measurement and field characterization standards (notably IEC 62127-1) and to vocabulary and uncertainty guidance (IEC 60050-801/802, ISO 16269-6, ISO/IEC Guide 98-3 GUM).
- Uncertainty and compliance: Requirements for reporting the arithmetic mean from at least n ≥ 3 nominally identical systems and the overall expanded uncertainty (95% confidence). Production tolerance intervals are to be interpreted per ISO 16269-6.
- Datasets for low-output equipment: Special provisions indicating when simplified reporting is acceptable (e.g., Table A.1 need not be completed for very low acoustic output).
Applications
- Manufacturers: prepare standardized acoustic-output datasheets for product labeling, technical files and pre-market submissions.
- Test laboratories and calibration facilities: structure measurement reports and uncertainty budgets in line with the standard and IEC 62127-1 hydrophone methods.
- Regulatory authorities and clinical engineers: evaluate and compare acoustic outputs across diagnostic ultrasound devices for safety assessment and clinical acceptance.
- Design and QA teams: use the standardized reporting fields to monitor production scatter, demonstrate compliance and communicate limits of operation.
Related Standards
- IEC 62127-1: Measurement and characterization of medical ultrasonic fields (hydrophones)
- IEC/TR 60854: Methods for pulse-echo performance measurement
- IEC 61689: Ultrasonics - physiotherapy systems (related measurement practice)
- IEC 60050-801/802 (vocabularies), ISO 16269-6 (tolerance intervals), ISO/IEC Guide 98-3 (GUM - uncertainty)
This amendment harmonizes terminology, updates normative references and clarifies reporting requirements to improve comparability and traceability of ultrasound acoustic output information across Europe and internationally.
Frequently Asked Questions
EN 61157:2007/A1:2013 is a amendment published by CLC. Its full title is "Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment". This standard covers: 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. NOTE The information tabulated in this standard format can be used for a) exposure planning for biological effects studies; b) exposure data for prospective epidemiological studies conducted using exposure conditions similar to those reported in this standard. In the absence of actual exposure data for retrospective epidemiological studies, the information tabulated in this standard format might also be used with cautionary comment.
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. NOTE The information tabulated in this standard format can be used for a) exposure planning for biological effects studies; b) exposure data for prospective epidemiological studies conducted using exposure conditions similar to those reported in this standard. In the absence of actual exposure data for retrospective epidemiological studies, the information tabulated in this standard format might also be used with cautionary comment.
EN 61157:2007/A1:2013 is classified under the following ICS (International Classification for Standards) categories: 11.040.50 - Radiographic equipment; 17.140.50 - Electroacoustics. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 61157:2007/A1:2013 has the following relationships with other standards: It is inter standard links to EN 61157:2007. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase EN 61157:2007/A1:2013 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CLC standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2014
6WDQGDUGQLQDþLQLSRURþDQMDRDNXVWLþQHPL]KRGXPHGLFLQVNHXOWUD]YRþQH
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Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic
equipment
Normverfahren für die Angabe der akustischen Ausgangsgrößen von medizinischen
Ultraschalldiagnostikgeräten
Moyens normalisés pour la déclaration des émissions acoustiques des appareils de
diagnostic médical à ultrasons
Ta slovenski standard je istoveten z: EN 61157:2007/A1:2013
ICS:
11.040.50 Radiografska oprema Radiographic equipment
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
17.140.50 Elektroakustika Electroacoustics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 61157/A1
NORME EUROPÉENNE
March 2013
EUROPÄISCHE NORM
ICS 11.040.50; 17.140.50
English version
Standard means for the reporting of the acoustic output
of medical diagnostic ultrasonic equipment
(IEC 61157:2007/A1:2013)
Critères normalisés de déclaration Normverfahren für die Angabe
des émissions acoustiques des appareils der akustischen Ausgangsgrößen
de diagnostic médical à ultrasons von medizinischen
(CEI 61157:2007/A1:2013) Ultraschalldiagnostikgeräten
(IEC 61157:2007/A1:2013)
This amendment A1 modifies the European Standard EN 61157:2007; it was approved by CENELEC on 2013-
03-04. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate
the conditions for giving this amendment the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the CEN-CENELEC Management Centre or to any CENELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language
made by translation under the responsibility of a CENELEC member into its own language and notified to the
CEN-CENELEC Management Centre has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus,
the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Management Centre: Avenue Marnix 17, B - 1000 Brussels
© 2013 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 61157:2007/A1:2013 E
Foreword
The text of document 87/517/FDIS, future amendment 1 to edition 2 of IEC 61157, prepared by
IEC/TC 87 "Ultrasonics" was submitted to the IEC-CENELEC parallel vote and approved by
CENELEC as EN 61157:2007/A1:2013.
The following dates are fixed:
(dop) 2013-12-04
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2016-03-04
standards conflicting with the
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
Endorsement notice
The text of the International Standard IEC 61157:2007/A1:2013 was approved by CENELEC as a
European Standard without any modification.
In the Bibliography of EN 61157:2007, replace the existing text with the following:
IEC 61689 NOTE Harmonised as EN 61689.
- 3 - EN 61157:2007/A1:2013
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
Replacements and addition to Annex ZA of EN 61157:2007.
Publication Year Title EN/HD Year
Replace the dated references to IEC 60050-801:1994, ISO 16269-6:2005 and
ISO/IEC Guide 98:1994 by the following undated references:
IEC 60050-801 - International Electrotechnical - -
Vocabulary (IEV) -
Chapter 801: Acoustics and electroacoustics
ISO 16269-6 - Statistical interpretation of data - - -
Part 6: Determination of statistical tolerance
intervals
ISO/IEC Guide 98-3 - Uncertainty of measurement - - -
Part 3: Guide to the expression of
uncertainty in measurement (GUM:1995)
Replace the existing reference to IEC 62127-1 with the following:
IEC 62127-1 2007 Ultrasonics - Hydrophones - EN 62127-1 2007
+ corr. August 2008 Part 1: Measurement and characterization of + A1 2013
+ A1 2013 medical ultrasonic fields up to 40 MHz
Add the following new reference:
IEC 60050-802 - International Electrotechnical Vocabulary - - -
Part 802: Ultrasonics
IEC 61157 ®
Edition 2.0 2013-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Standard means for the reporting of the acoustic output of medical diagnostic
ultrasonic equipment
Critères normalisés de déclaration des émissions acoustiques des appareils de
diagnostic médical à ultrasons
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX H
ICS 11.040.50, 17.140.50 ISBN 978-2-83220-586-0
– 2 – 61157 Amend.1 © IEC:2013
FOREWORD
This amendment has been prepared by IEC technical committee 87: Ultrasonics.
The text of this amendment is based on the following documents:
FDIS Report on voting
87/517/FDIS 87/523/RVD
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC web site under
“http://webstore.iec.ch” in the data related to the specific publication. At this date, the
publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
_____________
2 Normative references
Replace the dated references to IEC 60050-801:1994, ISO 16269-6:2005 and ISO/IEC Guide
98:1994 by the following undated references:
IEC 60050-801, International Electrotechnical Vocabulary – Chapter 801: Acoustics and
electroacoustics
ISO 16269-6, Statistical interpretation of data – Part 6: Determination of statistical tolerance
intervals
ISO/IEC Guide 98-3, Uncertainty of measurement – Part 3: Guide to the expression of
uncertainty in measurement (GUM:1995)
Replace the existing reference to IEC 62127-1 with the following:
IEC 62127-1:2007, Ultrasonics – Hydrophones – Part 1: Measurement and characterization of
medical ultrasonic fields up to 40 MHz
Amendment 1:2013
Add the following new reference:
IEC 60050-802, International Electrotechnical Vocabulary – Chapter 802: Ultrasonics
61157 Amend.1 © IEC:2013 – 3 –
3 Terms, definitions and symbols
Replace in definitions 3.14, 3.20, 3.31 and 3.32 “expressed in watts per metre squared” by
“expressed in watts per square metre”
Replace in definitions 3.6 and 3.18 “expressed in metres squared” by “expressed in square
metres”
3.2
acoustic pulse waveform
Remove the numbering from Note 1 and replace existing Note 2 by the following:
[SOURCE: IEC 62127-1:2007, definition 3.1]
3.4.1
zero-crossing acoustic-working frequency
f
awf
Replace the existing text of the definition by the following:
number, n, of consecutive half-cycles (irrespective of polarity) divided by twice the time
between the commencement of the first half-cycle and the end of the n-th half-cycle
NOTE 1 None of the n consecutive half-cycles should show evidence of phase change.
NOTE 2 The measurement should be performed at terminals in the receiver, that are as close as possible to the
receiving transducer (hydrophone) and, in all cases, before rectification.
NOTE 3 This frequency is determined according to the procedure specified in IEC/TR 60854.
NOTE 4 This frequency is intended for continuous-wave systems only.
[SOURCE: IEC 62127-1:2007/Amendment 1:—, definition 3.3.1]
3.4.2
arithmetic-mea
...
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