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

Moyens normalisés pour la 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
02-Jan-2014
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
16-Dec-2013
Due Date
20-Feb-2014
Completion Date
03-Jan-2014

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SLOVENSKI STANDARD
SIST EN 61157:2008/A1:2014
01-februar-2014
6WDQGDUGQLQDþLQLSRURþDQMDRDNXVWLþQHPL]KRGXPHGLFLQVNHXOWUD]YRþQH
GLDJQRVWLþQHRSUHPH'RSROQLOR$ ,(&$

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
SIST EN 61157:2008/A1:2014 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 61157:2008/A1:2014
---------------------- Page: 2 ----------------------
SIST EN 61157:2008/A1:2014
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
---------------------- Page: 3 ----------------------
SIST EN 61157:2008/A1:2014
EN 61157:2007/A1:2013 - 2 -
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.
---------------------- Page: 4 ----------------------
SIST EN 61157:2008/A1:2014
- 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
---------------------- Page: 5 ----------------------
SIST EN 61157:2008/A1:2014
---------------------- Page: 6 ----------------------
SIST EN 61157:2008/A1:2014
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

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 7 ----------------------
SIST EN 61157:2008/A1:2014
– 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

---------------------- Page: 8 ----------------------
SIST EN 61157:2008/A1:2014
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
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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