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

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• withdrawn,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 may not occur contiguously).

– 6 – IEC 60601-2-37:2007/AMD1:2015
© IEC 2015
Within one frame, all scan lines may not have the same n value. An example is: 1 2 2 3 3 4; 1 2 2 3 3 4; … avg
pps
n =1,5; max n = 2; n = 4
pps pps sl
[SOURCE: IEC 61157: 2007/AMD1:2013, 3.45, modified – The fourth example in the Note 3 to
entry has been corrected.]
201.3.221
ULTRASOUND ENDOSCOPE
ENDOSCOPE with built-in ULTRASOUND TRANSDUCERS.
201.3.222
ENDOSCOPE
medical instrument having viewing means, with or without optics, introduced into a body
cavity through a natural or surgically created body opening for examination, diagnosis or
therapy
Note 1 to entry: ENDOSCOPES may be of rigid, flexible or capsule type, each of which may have different image
pick-up systems (e.g. via lenses or electronic/ultrasonic sensors) and different image transmission systems (e.g.
optical (via lenses or fibre bundles), or electrical/electronic).
Note 2 to entry: Note 1 to entry differs from NOTE 1 of definition 3.1 in ISO 8600-1 in order to include 'capsule'
endoscopes.
[SOURCE: IEC 60601-2-18:2009, 201.3.203]
201.3.223
DEPTH FOR PEAK PULSE-INTENSITY INTEGRAL
z
pii
position of maximum SPATIAL-PEAK TEMPORAL-AVERAGE INTENSITY for NON-SCANNING MODE
components, determined beyond the BREAK-POINT DEPTH, z , on the BEAM-AXIS
bp
201.3.224
DEPTH FOR PEAK ATTENUATED PULSE-INTENSITY INTEGRAL
z
pii, a
position of maximum ATTENUATED SPATIAL-PEAK TEMPORAL-AVERAGE INTENSITY for NON-
SCANNING MODE components, determined beyond the BREAK-POINT DEPTH, z , on the BEAM-
bp
AXIS
Unit: m
Note 1 to entry: BEAM-AXIS and BREAK-POINT DEPTH are defined in IEC 62359.
201.3.225
DEPTH FOR PEAK SUM OF PULSE-INTENSITY INTEGRALS
z
sii
position of maximum SPATIAL-PEAK TEMPORAL-AVERAGE INTENSITY for SCANNING MODE
components, determined beyond the BREAK-POINT DEPTH, z , on the BEAM-AXIS
bp
Unit: m
Note 1 to entry: BEAM-AXIS and BREAK-POINT DEPTH are defined in IEC 62359.
Note 2 to entry: The subscript ‘sii’ indicates the scan intensity integral (sii). The sii for SCANNING MODE
components at a particular point is determined from the sum over a complete scan frame of the PULSE-INTENSITY
INTEGRALS of the ULTRASONIC SCAN LINES that make up the scanning components of a combined mode. Non-
scanned components are excluded from the sum. See IEC 62359 and IEC 62127-1 for more details.
201.3.226
DEPTH FOR PEAK SUM OF ATTENUATED PULSE-INTENSITY INTEGRALS
z
sii,α
position of maximum ATTENUATED SPATIAL-PEAK TEMPORAL-AVERAGE INTENSITY for SCANNING
MODE components, determined beyond the BREAK-POINT DEPTH, z , on THE BEAM-AXIS
bp
Unit: m
© IEC 2015
Note 1 to entry: BEAM-AXIS and BREAK-POINT DEPTH are defined in IEC 62359.
Note 2 to entry: The subscript “sii” indicates the “Scan Intensity Integral” that is the sum at a particular point of
the PULSE-INTENSITY INTEGRALS of the ULTRASONIC SCAN LINES comprising a SCANNING MODE component. See
IEC 62359 and IEC 62127-1 for additional details.
201.3.227
DEPTH FOR MECHANICAL INDEX
z
MI
depth on the BEAM-AXIS from the EXTERNAL TRANSDUCER APERTURE to the plane of maximum
ATTENUATED PULSE INTENSITY INTEGRAL (pii )
a
Unit: m
[SOURCE: IEC 62359:2010, 3.23]
Replace the existing table by the following:
Table 201.101 – List of symbols
Symbol Term Reference
A = –12 dB OUTPUT BEAM AREA IEC 62359
aprt
d = EQUIVALENT BEAM DIAMETER IEC 62359
eq
f = ACOUSTIC WORKING FREQUENCY IEC 62359
awf
I = ATTENUATED PULSE-AVERAGE INTENSITY
pa,a
pii = PULSE-INTENSITY INTEGRAL IEC 62359
pii = ATTENUATED PULSE-INTENSITY INTEGRAL IEC 62359
a
I = ATTENUATED SPATIAL-PEAK PULSE-AVERAGE INTENSITY
sppa,a
I = SPATIAL-PEAK, TEMPORAL-AVERAGE INTENSITY IEC 62359
spta
I = ATTENUATED SPATIAL-PEAK TEMPORAL-AVERAGE INTENSITY IEC 62359
spta,a
I (z) = ATTENUATED TEMPORAL-AVERAGE INTENSITY IEC 62359
ta,a
MI = MECHANICAL INDEX IEC 62359
P = OUTPUT POWER IEC 62359
P = ATTENUATED OUTPUT POWER IEC 62359

a
p = ATTENUATED PEAK-RAREFACTIONAL ACOUSTIC PRESSURE IEC 62359
r,a
p = PEAK-RAREFACTIONAL ACOUSTIC PRESSURE IEC 62359
r
n = NUMBER OF PULSES PER ULTRASONIC SCAN LINE IEC 61157
pps
prr = PULSE REPETITION RATE IEC 62359
srr = SCAN REPETITION RATE IEC 62127-1
TI = THERMAL INDEX IEC 62359
TIB = BONE THERMAL INDEX IEC 62359
TIC = CRANIAL-BONE THERMAL INDEX IEC 62359
TIS = SOFT-TISSUE THERMAL INDEX IEC 62359
t = PULSE DURATION IEC 62359,
d
X, Y = –12 dB OUTPUT BEAM DIMENSIONS IEC 62359
z = DEPTH FOR TIB IEC 62359
b
z = BREAK-POINT DEPTH IEC 62359
bp
z = DEPTH FOR PEAK PULSE-INTENSITY INTEGRAL
pii
z = DEPTH FOR MECHANICAL INDEX IEC 62359
MI
z = DEPTH FOR PEAK ATTENUATED PULSE INTENSITY INTEGRAL
pii,α
z = DEPTH FOR PEAK SUM OF PULSE INTENSITY INTEGRALS

sii
z = DEPTH FOR PEAK SUM OF ATTENUATED PULSE INTENSITY INTEGRALS
sii,α
z = DEPTH FOR TIS IEC 62359
s
– 8 – IEC 60601-2-37:2007/AMD1:2015
© IEC 2015
201.4 General requirements
Add the following new subclause:
201.4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
Addition:
An ULTRASOUND ENDOSCOPE where the imaging means is limited to ultrasound shall be
considered an ULTRASOUND TRANSDUCER and shall meet the requirements of this particular
standard.
NOTE Examples of such ULTRASOUND TRANSDUCERS include transvaginal, transesophageal (TEE), rectal,
laparoscopic and other similar intra-cavity probes.
An ULTRASOUND ENDOSCOPE having imaging means in addition to ultrasound shall also meet
the requirements of 201.11.6.5 of IEC 60601-2-18:2009.
NOTE Examples of such additional imaging means include optical and CCD.
201.7 ME EQUIPMENT identification, marking and documents
201.7.9.2.2 *Warning and safety notices
Add, at the end of this subclause, the following new text:
Transesophageal probes shall be removed from the PATIENT prior to application of a
defibrillator.
The outer surface of the portions of TRANSDUCER ASSEMBLY which is intended to be inserted
into a PATIENT should be checked to ensure that there are no unintended rough surfaces,
sharp edges or protrusions which may cause harm.
As the use of ULTRASONIC DIAGNOSTIC EQUIPMENT is increasing in the home care area, special
attention should be paid to provide information to this type of user. How this is addressed
should be documented in the RISK MANAGEMENT FILE. See IEC 60601-1-11.
201.7.9.2.12 Cleaning, disinfection and sterilization
Delete the instruction concerning the addition of the note and the text of the added note.
Add, after the additional third dashed item, the following new note:
NOTE This list of parameters is neither exhaustive nor mandatory.
201.7.9.3 Technical description
201.7.9.3.101 Technical data regarding acoustic output levels (see also Table 201.103)
Replace the existing title and text of this subclause by the following:
201.7.9.3.101 *Technical data regarding acoustic output levels
For each mode, provide the maximum value of each THERMAL and MECHANICAL INDEX. These
data shall be provided following Table 201.103 and listed in the ACCOMPANYING DOCUMENTS.
For a TRANSDUCER ASSEMBLY and ultrasound instrument console that satisfies all of the
exemption conditions cited in 201.12.4.2 a) and b), information declared in the ACCOMPANYING
DOCUMENTS shall state that the THERMAL INDICES and the MECHANICAL INDEX are 1,0 or less for
all device settings.
© IEC 2015
NOTE 1 For table 201.103, see Annex AA for a description of “Maximum Index Value’ and (for TIS and TIB) ‘Index
Component Values’
NOTE 2 An operating mode can be interpreted to be any DISCRETE-OPERATING MODE (like B, M) as well as any
COMBINED-OPERATING MODE (like B+D+CFM).
NOTE 3 Per IEC 62359:2010, the z and z values are entered for non-scanned (component) modes.
s b
rd
NOTE 4 Annex EE provides an example table to allow 3 parties to recalculate the TI and MI values for each
operating mode, including the contributions from each mode in COMBINED-OPERATING MODES.
Table 201.103 – Acoustic output reporting table
Replace the existing table with the following:

– 10 – IEC 60601-2-37:2007/AMD1:2015
© IEC 2015
Table 201.103 – Acoustic output reporting table
MODE _______________
MI TIS TIB TIC
Index label
At Below At Below
surface surface surface surface
Maximum index value    
Index component value     
p at z (MPa) 
r,α MI
P (mW)    
P (mW)   
1x1
z (cm)   
Acoustic
s
Parameters
z (cm)    
b
z (cm) 
MI
z (cm) 
pii,α
f (MHz)    
awf
prr (Hz) 
srr (Hz) 
n 
pps
Other
I at z (W/cm ) 
pa,α pii,α
Information
I at z or z (mW/cm ) 
spta,α pii,α sii,α
I at z or z (mW/cm ) 
spta pii sii
p at z (MPa) 
r pii
Control 1
Control 2
Control 3
Operating
control Control 4
conditions
Control 5
…
Control x
NOTE 1 Only one operating condition per index.
NOTE 2 Data should be entered for “at surface” and “below surface” both in the columns related to TIS or TIB.
NOTE 3 Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for
transcranial or neonatal cephalic uses.
NOTE 4 If the requirements of 201.12.4.2a) are met, it is not required to enter any data in the columns related
to TIS, TIB or TIC.
NOTE 5 If the requirements of 201.12.4.2b) are met, it is not required to enter any data in the column related
to MI.
NOTE 6 “” indicates cells where a numerical value should be entered. The equipment setting related to the
index has to be entered in the operating control section.
NOTE 7 The depths z and z apply to NON-SCANNING MODES, while the depths z and z apply to
pii pii,α sii sii,α
SCANNING MODES.
© IEC 2015
201.11 Protection against excessive temperature and other HAZARDS
201.11.1.2.2 *APPLIED PARTS not intended to supply heat to a PATIENT
Add the following phrase at the end of the existing text of the note:
“
, but excluding the cable”
201.11.1.3 *Measurements
Replace the indication "Amendment:" and the existing text of the instruction with the following:
“Addition:
For the applied part of the TRANSDUCER ASSEMBLY, replace the third paragraph and the
remaining text of the subclause with the following:”
201.11.1.3.1.1 Simulated use
Add the following new note after NOTE 2:
NOTE 3 For the purposes of this test, thermal equilibrium may be considered reached when the rate of change of
temperature of the APPLIED PART is <= 0,2 °C per minute for three consecutive minutes.
201.11.1.3.1.2 *Still air
Add the following new note at the end of this subclause:
NOTE “In still air” means an environment without air movement (flow) and an air temperature of 23 °C ± 3 °C
stable within 0,5 °C. Otherwise it is recommended that one corrects for temperature drift.
201.11.1.3.2 Operating settings
Replace the entire existing text of this subclause with the following:
Operate the ULTRASONIC DIAGNOSTIC EQUIPMENT at a setting that gives the highest surface
temperature of APPLIED PART of the TRANSDUCER ASSEMBLY. The transmit parameters of the
test shall be recorded in the test report.
201.11.1.3.4 Temperature measurement
Replace the existing first paragraph with the following:
The temperature of the TRANSDUCER ASSEMBLY should be measured by any appropriate means
such as infra-red radiometry or thermocouple methods.
Replace the existing third paragraph with the following:
The size of the temperature measurement area of the sensor, or the focus size in case of an
infra-red measurement system, should be such that any averaging effect is minimized.
Replace the existing fifth paragraph with the following:
The measurement uncertainty shall be recorded in the test report.
Add the following new note before the existing notes:

– 12 – IEC 60601-2-37:2007/AMD1:2015
© IEC 2015
NOTE 1 As part of measurement uncertainty determination, the measurement set-up can be used to make surface
temperature measurements of ULTRASONIC TRANSDUCERS of known maximum surface temperature. It is
recommended that the measurement set-up be validated.
Renumber the existing NOTE 1 as NOTE 2.
Replace the existing text of NOTE 2 with the following:
NOTE 3 Any means to measure the temperature can be a type that is not overly sensitive to direct ultrasonic
heating (for example if a thermocouple is used, it can be a thin film or fine wire type). Additional factors, such as
effects of conductive losses, ultrasonic heating and spatial averaging on the measurement sensors or its
connecting cables” after “averaging”, are also relevant when assessing the measurement uncertainty.
Renumber the existing NOTE 3 as NOTE 4.

Table 201.104 – Overview of the tests noted under 201.11.1.3
Replace the existing text of the table with the following new table:
Table 201.104 – Overview of the tests noted under 201.11.1.3
Transducer type  External use Invasive use
Test to be applied 
201.11.1.3.1.1 a) Temperature Initially temperature of the Initially test object maintained
Simulated use test surface of the test object at the at not less than 37 °C
object / transducer interface
The temperature shall not
shall not be less than 33 °C
exceed 43 °C
and shall be in thermal
equilibrium.
The temperature shall not
exceed 43 °C
b) Temperature rise Initially the temperature at the Initially the temperature at the
object-transducer interface object-transducer interface
shall be between 20 °C and shall be between 20 °C and
33 °C and shall be in thermal 37 °C.
equilibrium.
The ambient temperature shall
The ambient temperature shall be 23 °C ± 3 °C.
be 23 °C ± 3 °C.
The temperature rise shall not
The temperature rise shall not exceed 6 °C.
exceed 10 °C.
201.11.1.3.1.2 Temperature rise The ambient temperature shall be 23 °C ± 3 °C and shall be in
Still air test thermal equilibrium.
(no gel)
Initially the temperature at the surface of the TRANSDUCER
ASSEMBLY shall be the ambient temperature
The temperature rise shall not exceed 27 °C.

201.11.6.5 *Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS
Reposition Note 1 to follow the third paragraph, directly before the compliance statement.
Replace the existing text of the compliance statement (the fourth paragraph) as follows:
Compliance is checked by the test prescribed in IEC 60529 for IPX7, with the exception of
14.2.7 a) and b).
© IEC 2015
201.12.4.2 Indication of parameters relevant to safety
Replace the existing text of item d) with the following
d) If the ULTRASONIC DIAGNOSTIC EQUIPMENT is intended solely for adult cephalic applications,
then the THERMAL INDEX display need only include the CRANIAL-BONE THERMAL INDEX when it
exceeds a value of 0,4 and is capable of exceeding a value of 1,0.
202.6.2.1.10 *Compliance criteria
Replace the existing instruction concerning the amendment with the following:
Replacement of dashes 8 through 11 as follows:
Annex AA – Guidance and rationale for particular subclauses
Add, after the rationale for 201.7.9.2.2, the following new text:
Concerning 201.7.9.3.101 Technical data regarding acoustic output levels
Maximum Index Value
For the THERMAL INDEX: following 5.6.2 of IEC 62359:2010, including Table 1:
For TIS and TIB, the Maximum Index Value is the larger of the sum of the ‘at surface’ Index
Component Values and the sum of the ‘below-surface’ Index Component Values;
For TIC, the Maximum Index Value is the sum of the ‘at-surface’ non-scanned and scanned
TIC Index Component Values.
For MI, following 5.6.3 of IEC 62359:2010, the Maximum Index Value is the largest
MECHANICAL INDEX of all active TRANSMIT PATTERNS. i.e. the Maximum Index Value is the
largest of the MI Index Component Values of the active DISCRETE-OPERATING MODES in a
COMBINED-OPERATING MODE
Add, after the rationale for 201.11.1.3, the following new text:
Concerning 201.11.1.3.1.2 Still air
For some TRANSDUCER ASSEMBLIES such as mechanically rocked 3D probes, or solid state
probes with integrated multiplexing electronics, the temperature of the APPLIED PART (surface
temperatures) may not stabilize at an initial steady-state temperature equal to the air-ambient
temperature when the acoustic power is ‘off’ (i.e.: non-energized transducer elements).
Rather, a fixed offset temperature may exist.
In such cases, the initial APPLIED PART temperature shall be the ambient temperature plus a
steady-state offset temperature, and the final surface temperature shall be considered as the
sum of the measured APPLIED PART temperature rise obtained during the 30 min test plus the
offset temperature plus 23 °C.

– 14 – IEC 60601-2-37:2007/AMD1:2015
© IEC 2015
Annex DD – Example set-up to measure surface temperature of externally
applied TRANSDUCER ASSEMBLIES
Table DD.1 – Acoustic and thermal properties of tissues & materials
Replace, in the "Source" column of the table, each of the four existing references to "ICRU
rep. 113, 1998 [11]" by a new reference to "ICRU rep. 61, 1998 [26]", as follows:
Source
ICRU rep.61 1998 [26]
Chivers 1978 [28]
ICRU rep.61 1998 [26]
ICRU rep.61 1998 [26]
ICRU rep.61 1998 [26]
TNO / Dow Corning
TNO (Soft Tissue Model)
Add after existing Annex DD, the following new Annex EE:
Annex EE
(informative)
Acoustic output table intended for 3rd parties
Table EE.1 provides an example acoustic output table to allow 3rd parties to recalculate the
TI and MI values for each operating mode, including the contributions from each mode in
COMBINED-OPERATING MODES.
The ‘Index Component Values’ for MI and TIC are the index values for each DISCRETE-
OPERATING MODE comprising the operating mode.
The ‘Index Component Values’ for TIS and TIB are the values of the ‘at-surface’ and below-
DISCRETE-OPERATING MODE comprising the operating mode.
surface’ TI formulations for each
NOTE 1 See Annex AA for descriptions of “Maximum Index Value’ and ‘Index Component Values’.
NOTE 2 An operating mode can be interpreted to be any DISCRETE-OPERATING MODE (like B, M) as well as any
COMBINED-OPERATING MODE (like B+D+CFM).

© IEC 2015
MODE: _____________________
TIS TIB TIC
Non-
Scan Non-scan Scan Non-scan Scan
scan
Index Label MI
At At Below At At Below At At
surface surface surface surface surface surface surface surface
Maximum Index Value    
Index Component Value         
p at z (MPa) 
r,α MI
P (mW)      
P (mW)    
1x1
Min. of
[P (z ) , I (z )x1cm ] 
α s ta,α s
(mW)
z (cm)  
s
Associated
z (cm)    
bp
Acoustic
Parameters z (cm)    
b
z (cm)
  
pii
z (cm) 
MI
d at z (cm)    
eq b
f (MHz)       
awf
X (cm)      
Dim of A
aprt
Y (cm)      
Mode Components       
t (µsec) 
d
prr (Hz) 
srr (Hz) 
Other
p at z (MPa)

r pii
Information
d at z (cm)    
eq pii
I at z (W/cm ) 
pa,α pii,α
FLx (cm)     
Focal Length
FLy (cm)     
Control 1
Control 2
Control 3
Operating
Control Control 4
Conditions
Control 5
…
Control x
NOTE 1 Only one operating condition per Index.
NOTE 2 Data can be entered for each component transmit pattern active in COMBINED-OPERATING MODES.
NOTE 3 Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or
neonatal cephalic uses.
NOTE 4 If the requirements of 201.12.4.2a) are met, it is not required to enter any data in the columns related to TIS,
TIB or TIC.
NOTE 5 If the requirements of 201.12.4.2b) are met, it is not required to enter any data in the column related to MI.
NOTE 6 Focal Length is a NOMINAL value.
NOTE 7 “” indicates cells where one or more numerical value should be entered. The equipment setting related to the
index has to be entered in the operating control section.
NOTE 8 “Mode Component” identifies the DISCRETE-OPERATING MODES in a COMBINED-OPERATING MODE. As an example
of the labelling of Mode Components, see section 4.1 of IEC 61157.

– 16 – IEC 60601-2-37:2007/AMD1:2015
© IEC 2015
Bibliography
Replace existing item [18] with:
[18] American Institute of Ultrasound in Medicine (AIUM), National Electrical Manufacturers
Association (NEMA), Acoustic Output Measurement Standard for Diagnostic
Ultrasound Equipment, Rev.1. American Institute of Ultrasound in Medicine & National
Electrical Manufacturers Association, 2004.
Add the following new references:
[38] IEC 61157:2007, Standard means for the reporting of the acoustic output of medical
diagnostic ultrasonic equipment
IEC 61157:2007/AMD1:2013
[39] IEC 60601-1-11:2015, Medical electrical equipment – General requirements for basic
safety and essential performance – Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems used in the home healthcare
environment
_____________
There exists a consolidated edition (2.1) including IEC 61157:2007 and its Amendment 1 (2013).

© IEC 2015
Index of defined terms
Add the following new terms:
ACOUSTIC ATTENUATION COEFFICIENT . IEC 62359:2010, 3.1
ACOUSTIC WORKING FREQUENCY . IEC 62127-1:2007 /AMD1:2013, 3.3
ATTENUATED OUTPUT POWER . IEC 62359:2010, 3.6
ATTENUATED PULSE-AVERAGE INTENSITY . 201.3.219
ATTENUATED PULSE-INTENSITY INTEGRAL . IEC 62359:2010, 3.8
BEAM AXIS . IEC 62359:2010, 3.13
BREAK POINT DEPTH . IEC 62359:2010, 3.19
DEPTH FOR PEAK ATTENUATED PULSE-INTENSITY INTEGRAL . .201.3.223
DEPTH FOR PEAK SUM OF PULSE-INTENSITY INTEGRALS . 201.3.224
DEPTH FOR PEAK SUM OF ATTENUATED PULSE-INTENSITY INTEGRALS . 201.3.225
ENDOSCOPE . 201.3.222
EQUIVALENT BEAM DIAMETER . IEC 62359:2010, 3.30
EXTERNAL TRANSDUCER APERTURE . IEC 62359: 2010, 3.31
HYDROPHONE . IEC 62127-1:2007, 3.30
NOMINAL . IEC 60601-1:2012, 3.69
NUMBER OF PULSES PER ULTRASONIC SCAN LINE . 201.3.220
NUMBER OF ULTRASONIC SCAN LINES . IEC 61157:2007/AMD1:2013, 3.46
PULSE AVERAGE INTENSITY . IEC 62127-1:2007/AMD1:2013, 3.47
ULTRASOUND ENDOSCOPE . 201.3.221
ULTRASONIC SCAN LINE . IEC 62127-1:2007, 3.71

_____________
– 18 – IEC 60601-2-37:2007/AMD1:2015
© IEC 2015
AVANT-PROPOS
Le présent amendement a été établi par le sous-comité 62B: Appareils d’imagerie de
diagnostic, du comité d’études 62 de l’IEC: Equipements électriques dans la pratique
médicale.
Le texte de cet amendement est issu des documents suivants:
FDIS Rapport de vote
62B/978/FDIS 62B/988/RVD
Le rapport de vote indiqué dans le tableau ci-dessus donne toute information sur le vote
ayant abouti à l'approbation de cet amendement.
Le comité a décidé que le contenu de cet amendement et de la publication de base ne sera
pas modifié avant la date de stabilité indiquée sur le site web de l'IEC sous
"http://webstore.iec.ch" dans les données relatives à la publication recherchée. A cette date,
la publication sera
• reconduite,
• supprimée,
• remplacée par une édition révisée, ou
• amendée.
_____________
INTRODUCTION À L’AMENDEMENT 1
La deuxième édition de l'IEC 60601-2-37 a été publiée en 2007. Depuis cette publication, la
norme de base IEC 60601-1:2005 est entrée dans une phase de maintenance au cours de
laquelle un amendement (IEC 60601-1:2005/AMD1:2012) et une édition 3.1 consolidée
(IEC 60601-1:2005 et IEC 60601-1:2005/AMD1:2012) ont été publiés. Le présent
amendement à l’IEC 60601-2-37:2007 concerne trois aspects:
1) des modifications techniques proposées par les Comités Nationaux suite à 4 années
d'utilisation pratique,
2) des modifications techniques et éditoriales, conséquences de la norme générale amendée
IEC 60601-1:2005 et IEC 60601-1:2005/AMD1:2012 et de ses normes collatérales
IEC 60601-1-xx, et
3) des modifications techniques résultant de la maintenance des références normatives.

© IEC 2015
201.1.1 *Domaine d'application
Remplacer "Addition:" par "Remplacement:"
201.2 Références normatives
Remplacer le texte existant de ce paragraphe par le texte suivant:
L’Article 2 de la norme générale s’applique, avec l’exception suivante:
Addition:
IEC 60601-1:2005, Appareils électromédicaux – Partie 1: Exigences générales pour la
sécurité de base et les performances essentielles
IEC 60601-1:2005/AMD1:2012
IEC 60601-2-18:2009, Appareils électromédicaux – Partie 2-18: Exigences particulières pour
la sécurité de base et les performances essentielles des appareils d'endoscopie
IEC 62127-1:2007, Ultrasons – Hydrophones – Partie 1: Mesurage et caractérisation des
champs ultrasoniques médicaux jusqu'à 40 MHz
IEC 62127-1:2007/AMD1:2013
IEC 62359:2010, Ultrasons – Caractérisation du champ – Méthodes d'essai pour la
détermination d'indices thermique et mécanique des champs d'ultrasons utilisés pour le
diagnostic médical
201.3 Terminologie et définitions
Remplacer le titre existant de cet article par ce qui suit:
201.3 Termes et définitions
201.3.201
Remplacer le texte existant du terme et de la définition par ce qui suit:
INDICE THERMIQUE OSSEUX
TIB
INDICE THERMIQUE pour des applications dans lesquelles le faisceau d’ultrasons traverse des
tissus mous et où une région focale se trouve à proximité d’un os, telles que les applications
fœtales (second et troisième trimestres)
Unité: Aucune
[SOURCE: IEC 62359:2010, 3.17, modifiée – La définition ne fait plus référence aux
applications céphaliques néonatales, et les notes originales ont été supprimées]
_____________
Il existe une édition consolidée (3.1) comprenant l'IEC 60601-1:2005 et son Amendement 1 (2012).
Il existe une édition consolidée (1.1) comprenant l'IEC 62127-1:2007 et son Amendement 1 (2013).

– 20 – IEC 60601-2-37:2007/AMD1:2015
© IEC 2015
201.3.203
Remplacer le texte existant du terme et de la définition par ce qui suit:
INDICE THERMIQUE CRÂNIEN
TIC
INDICE THERMIQUE pour des applications dans lesquelles le faisceau d'ultrasons traverse l’os
situé à proximité de l'entrée du faisceau dans le corps, telles que des examens crâniens
pédiatriques et chez l'adulte ou céphaliques néonataux
Unité: Aucune
[SOURCE: IEC 62359:2010, 3.21, modifiée – La définition comprend désormais une référence
aux applications céphaliques néonatales, et les notes originales ont été supprimées.]
201.3.211
DÉCLARATION D'USAGE PRUDENT
Remplacer le texte existant de la définition par ce qui suit:
affirmation du principe indiquant qu'il convient d’acquérir uniquement les informations
cliniques nécessaires et qu'il convient d’éviter les niveaux d’exposition élevés et les temps
d’exposition longs
[SOURCE: IEC 62359:2010, 3.40, modifiée – La définition a été reformulée.]
201.3.213
Remplacer le texte existant du terme et de la définition par ce qui suit:
INDICE THERMIQUE DES TISSUS MOUS
TIS
INDICE THERMIQUE relatif aux tissus mous
Unité: Aucune.
[SOURCE: IEC 62359:2010, 3.52, modifiée – Les notes originales ont été supprimées.]
201.3.214
Remplacer le texte existant du terme et de la définition par ce qui suit:
INDICE THERMIQUE
TI
rapport de la PUISSANCE D'ÉMISSION ATTÉNUÉE en un point spécifié, à la PUISSANCE D’ÉMISSION
ATTÉNUÉE requise pour élever la température de 1 °C en ce point dans un modèle de tissu
spécifique
Unité: Aucune
[
...