SIST EN 60601-2-37:2008/A1:2015
(Amendment)Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Medizinische elektrische Geräte - Teil 2-37: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Ultraschallgeräten für die medizinische Diagnose und Überwachung
Appareils électromédicaux - Partie 2-37: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de diagnostic et de surveillance médicaux à ultrasons
Medicinska električna oprema - 2-37. del: Posebne zahteve za osnovno varnost in bistvene lastnosti ultrazvočne medicinske diagnostične in nadzorovalne opreme - Dopolnilo A1
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2015
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLXOWUD]YRþQHPHGLFLQVNHGLDJQRVWLþQHLQQDG]RURYDOQHRSUHPH
'RSROQLOR$
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and
essential performance of ultrasonic medical diagnostic and monitoring equipment
Medizinische elektrische Geräte - Teil 2-37: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Ultraschallgeräten für die
medizinische Diagnose und Überwachung
Appareils électromédicaux - Partie 2-37: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de diagnostic et de surveillance médicaux
à ultrasons
Ta slovenski standard je istoveten z: EN 60601-2-37:2008/A1:2015
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN 60601-2-37:2008/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2015
ICS 11.040.55; 17.140.50
English Version
Medical electrical equipment - Part 2-37: Particular requirements
for the basic safety and essential performance of ultrasonic
medical diagnostic and monitoring equipment
(IEC 60601-2-37:2007/A1:2015)
Appareils électromédicaux - Partie 2-37: Exigences Medizinische elektrische Geräte - Teil 2-37: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils de diagnostic et de surveillance wesentlichen Leistungsmerkmale von Ultraschallgeräten für
médicaux à ultrasons die medizinische Diagnose und Überwachung
(IEC 60601-2-37:2007/A1:2015) (IEC 60601-2-37:2007/A1:2015)
This amendment A1 modifies the European Standard EN 60601-2-37:2008; it was approved by CENELEC on 2015-07-13. 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.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-37:2008/A1:2015 E
European foreword
The text of document 62B/978/FDIS, future IEC 60601-2-37:2008/A1, prepared by SC 62B "Diagnostic
imaging equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to the
IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-37:2008/A1:2015.
The following dates are fixed:
(dop) 2016-04-13
• 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) 2018-07-13
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.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive.
For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in EN 60601-2-
37:2008/A11:2011.
Endorsement notice
The text of the International Standard IEC 60601-2-37:2007/A1:2015 was approved by CENELEC as
a European Standard without any modification.
In the Bibliography of EN 60601-2-37:2008, the following note has to be added for the standard
indicated:
IEC 61157:2007 NOTE Harmonized as EN 61157:2007.
IEC 60601-1-11:2015 NOTE Harmonized as EN 60601-1-11:2015.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.
Addition:
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment -- Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - + corrigendum Mar. 2010
+ A1 2012 + A1 2013
- - + A12 2014
IEC 60601-2-18 2009 Medical electrical equipment -- Part 2-18: - -
Particular requirements for basic safety and
essential performance of endoscopic
equipment
IEC 62127-1 2007 Ultrasonics - Hydrophones -- Part 1: EN 62127-1 2007
Measurement and characterization of
medical ultrasonic fields up to 40 MHz
+ A1 2013 + A1 2013
IEC 62359 2010 Ultrasonics - Field characterization - Test EN 62359 2011
methods for the determination of thermal
and mechanical indices related to medical
diagnostic ultrasonic fields
IEC 60601-2-37 ®
Edition 2.0 2015-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –
Part 2-37: Particular requirements for the basic safety and essential performance
of ultrasonic medical diagnostic and monitoring equipment
Appareils électromédicaux –
Partie 2-37: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de diagnostic et de surveillance médicaux à ultrasons
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55; 17.140.50 ISBN 978-2-8322-2699-5
– 2 – IEC 60601-2-37:2007/AMD1:2015
© IEC 2015
FOREWORD
This amendment has been prepared by subcommittee 62B: Diagnostic imaging equipment, of
IEC technical committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62B/978/FDIS 62B/988/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.
_____________
INTRODUCTION TO AMENDMENT 1
The second edition of IEC 60601-2-37 was published in 2007. Since that publication, the
parent standard, IEC 60601-1:2005, entered maintenance, under which an amendment
(IEC 60601-1:2005/AMD1:2012) and a consolidated edition 3.1 (IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012) were published. This amendment to IEC 60601-2-37:2007
addresses three issues:
1) technical changes proposed by National Committees as a result of 4 years of practical
usage,
2) technical and editorial changes resulting from the amended general standard
IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 and its collateral standards
IEC 60601-1-xx, and
3) technical changes as a result of maintenance to normative references.
IEC 60601-2-37:2007/AMD1:2015 – 3 –
© IEC 2015
201.1.1 *Scope
Replace “Addition:” with “Replacement:”
201.2 Normative references
Replace the existing text of this subclause by the following:
Clause 2 of the general standard applies except as follows:
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-2-18:2009, Medical electrical equipment – Part 2-18: Particular requirements for
the basic safety and essential performance of endoscopic equipment
IEC 62127-1:2007, Ultrasonics – Hydrophones – Part 1: Measurement and characterization of
medical ultrasonic fields up to 40 MHz
IEC 62127-1:2007/AMD1:2013
IEC 62359:2010, Ultrasonics – Field characterization – Test methods for the determination of
thermal and mechanical indices related to medical diagnostic ultrasonic fields
201.3 Terminology and definitions
Replace the existing title of this clause with the following:
201.3 Terms and definitions
201.3.201
Replace the existing text of the term and definition by the following:
BONE THERMAL INDEX
TIB
THERMAL INDEX for applications such as foetal (second and third trimester), in which the
ultrasound beam passes through soft tissue and a focal region is in the immediate vicinity of
bone
Unit: None
[SOURCE: IEC 62359:2010, 3.17, modified – The definition no longer refers to neonatal
cephalic applications, and the original notes have been deleted]
_____________
There exists a consolidated edition (3.1) including IEC 60601-1:2005 and its Amendment 1 (2012).
There exists a consolidated edition (1.1) including IEC 62127-1:2007 and its Amendment 1 (2013).
– 4 – IEC 60601-2-37:2007/AMD1:2015
© IEC 2015
201.3.203
Replace the existing text of the term and definition by the following:
CRANIAL-BONE THERMAL INDEX
TIC
THERMAL INDEX for applications in which the ultrasound beam passes through bone near the
beam entrance into the body, such as paediatric and adult cranial or neonatal cephalic
applications
Unit: None
[SOURCE: IEC 62359:2010, 3.21, modified – The definition now includes a reference to
neonatal cephalic applications, and the original notes have been deleted.]
201.3.211
PRUDENT USE STATEMENT
Replace the existing text of the definition by the following:
affirmation of the principle that only necessary clinical information should be acquired and
that high exposure levels and long exposure times should be avoided
[SOURCE: IEC 62359:2010, 3.40, modified – The definition has been reworded.]
201.3.213
Replace the existing text of the term and definition by the following:
SOFT TISSUE THERMAL INDEX
TIS
THERMAL INDEX related to soft tissues
Unit: None.
[SOURCE: IEC 62359:2010, 3.52, modified – The original notes have been deleted.]
201.3.214
Replace the existing text of the term and definition by the following:
THERMAL INDEX
TI
ratio of ATTENUATED OUTPUT POWER at a specified point to the ATTENUATED OUTPUT POWER
required to raise the temperature at that point in a specific tissue model by 1 °C
Unit: None
[SOURCE: IEC 62359:2010, 3.56, modified – The term "ATTENUATED ACOUSTIC POWER" has
been replaced twice by the term "ATTENUATED OUTPUT POWER", and the original note has been
deleted.]
201.3.215
TRANSDUCER ASSEMBLY
Replace the existing text of the definition by the following:
those parts of ULTRASONIC DIAGNOSTIC EQUIPMENT comprising the ULTRASONIC TRANSDUCER
and/or ULTRASONIC TRANSDUCER ELEMENT GROUP, together with any integral components, such
as an acoustic lens or integral stand-off
Note 1 to entry: The TRANSDUCER ASSEMBLY is usually separable from the ultrasound instrument console.
IEC 60601-2-37:2007/AMD1:2015 – 5 –
© IEC 2015
[SOURCE: IEC 62127-1:2007, 3.69, modified – the original term "medical diagnostic
ultrasound equipment" has been replaced by "ULTRASONIC DIAGNOSTIC EQUIPMENT" in the
definition.]
201.3.216
TRANSMIT PATTERN
Add, at the end of the term and definition, the following source reference:
[SOURCE: IEC 62359:2010, 3.58]
201.3.218
ULTRASONIC TRANSDUCER
Replace the existing text of the term and definition by the following:
device capable of converting electrical energy to mechanical energy within the ultrasonic
frequency range and/or reciprocally of converting mechanical energy to electrical energy
[SOURCE: IEC 62127-1:2007/AMD1:2013, 3.73]
Add the following new definitions:
201.3.219
ATTENUATED PULSE-AVERAGE INTENSITY
I
pa,a
value of the acoustic PULSE-AVERAGE INTENSITY after attenuation and at a specified point, and
given by
(−azf /10 dB)
awf
I = I (z)10
pa,a pa
where
a is the ACOUSTIC ATTENUATION COEFFICIENT as defined in IEC 62359:2010, definition 3.1;
z is the distance from the EXTERNAL TRANSDUCER APER
...
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