IEC 60601-2-37:2007/AMD1:2015

Amendment 1 - Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

Amendement 1 - 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

General Information

• Status: Published
• Publication Date: 07-Jun-2015
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 17.140.50 - Electroacoustics
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Drafting Committee: MT 34 - TC 62/SC 62B/MT 34

Relations

• Amends: IEC 60601-2-37:2007 - Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
• Effective Date: 05-Sep-2023
• Revised: IEC 60601-2-37:2024 - Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

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
IEC 60601-2-37:2007-08/AMD1:2015-06(en-fr)

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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 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 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 APERTURE to the point of interest;
f is the ACOUSTIC WORKING FREQUENCY as defined in IEC 62359:2010, definition 3.4;
awf
I (z) is the PULSE-AVERAGE INTENSITY measured in water as defined in IEC 62127-1:2007
pa
and IEC 62127-1:2007/AMD1:2013, definition 3.47.
–2
Unit: W m
201.3.220
NUMBER OF PULSES PER ULTRASONIC SCAN LINE
the number of acoustic pulses travelling along a particular ULTRASONIC SCAN LINE
Note 1 to entry: Here ULTRASONIC SCAN LINE refers to the path of acoustic pulses on a particular BEAM AXIS in
SCANNING and NON-SCANNING MODES.
Note 2 to entry: This number can be used in the calculation of any ultrasound temporal average value from
HYDROPHONE measurements.
Note 3 to entry: The following shows an example of the NUMBER OF PULSES PER ULTRASONIC SCAN LINE and the
NUMBER OF ULTRASONIC SCAN LINES (“;” indicates the end of a frame):
1 2 3 4; 1 2 3 4; 1 2 3 4… n =1; n = 4
pps sl
1 1 2 2 3 3 4 4; 1 1 2 2 3 3 4 4; … n =2; n = 4
pps sl
1 1 1 1 2 2 2 2 3 3 3 3 4 4 4 4; 1 1 1 1 2 2 2 2 3 3 3 3 4 4 4 4; … n = 4; n = 4
pps sl
1 1 2 2 3 3 4 4 1 1 1 2 2 2 3 3 3 4 4 4; 1 1 2 2 3 3 4 4 1 1 1 2 2 2 3 3 3 4 4 4; … n = 5; n = 4 (within one frame
pps sl
the pulses down each line
...