IEC 60601-2-50:2020

IEC 60601-2-50 ®
Edition 3.0 2020-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-50: Particular requirements for the basic safety and essential performance
of infant phototherapy equipment
Appareils électromédicaux –
Partie 2-50: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de photothérapie pour nouveau-nés
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IEC 60601-2-50 ®
Edition 3.0 2020-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-50: Particular requirements for the basic safety and essential
performance of infant phototherapy equipment
Appareils électromédicaux –
Partie 2-50: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de photothérapie pour nouveau-nés
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.60 ISBN 978-2-8322-8721-7
– 2 – IEC 60601-2-50:2020 © IEC 2020
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 11
201.5 General requirements for testing ME EQUIPMENT . 11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201.10 Protection against unwanted and excessive radiation HAZARDS . 16
201.11 Protection against excessive temperatures and other HAZARDS . 16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 17
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 19
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 19
201.15 Construction of ME EQUIPMENT . 19
201.16 ME SYSTEMS . 20
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 20
202 Electromagnetic disturbances – Requirements and tests . 20
Annexes . 21
Annex AA (informative) Particular guidance and rationale . 22
Bibliography . 27
Index of defined terms used in this document . 29

Figure 201.101 – Example of a measuring grid . 17
Figure 201.102 – Layout of weight test devices . 19

Table 201.101 – List of symbols, abbreviations and acronyms . 10
Table AA.1 – UV radiation exposure limits and spectral weighting function . 25

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-50: Particular requirements for the basic safety and
essential performance of infant phototherapy equipment

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
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2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
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6) All users should ensure that they have the latest edition of this publication.
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
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9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-50 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This third edition cancels and replaces the second edition published in 2009 and
Amendment 1:2016. This edition constitutes a technical revision.
This edition includes the following significant technical change with respect to the previous
edition: re-dating of normative references.

– 4 – IEC 60601-2-50:2020 © IEC 2020
The text of this International Standard d is based on the following documents:
FDIS Report on voting
62D/1767/FDIS 62D/1775/RVD
Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used:
– requirements and definitions: roman type;
– test specifications: italic type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this document are preceded by the term “Clause” followed by
the clause number. References to subclauses within this particular standard are by number
only.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Clause 7 of the
ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this document;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.

The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests. It is the recommendation of the committee that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication.

– 6 – IEC 60601-2-50:2020 © IEC 2020
INTRODUCTION
The minimum safety requirements specified in this particular standard are considered to
provide for a practical degree of safety in the operation of INFANT PHOTOTHERAPY EQUIPMENT.

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-50: Particular requirements for the basic safety and
essential performance of infant phototherapy equipment

201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT
PHOTOTHERAPY EQUIPMENT, as defined in 201.3.203, also referred to as ME EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this document are not covered by specific requirements in this document,
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This particular standard specifies safety requirements for INFANT PHOTOTHERAPY EQUIPMENT,
but alternate methods of compliance with a specific clause by demonstrating equivalent safety
will not be judged as non-compliant if the MANUFACTURER has demonstrated in his RISK
MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an
acceptable level when weighed against the benefit of treatment from the device.
This document does not apply to:
– devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information,
see IEC 60601-2-35 [1] ;
– INFANT INCUBATORS; for information, see IEC 60601-2-19 [2];
– INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20 [3];
– INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [4].
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for INFANT PHOTOTHERAPY EQUIPMENT (as defined in 201.3.203),
which reduce the safety HAZARDS to PATIENTS and OPERATORS as much as possible and to
specify tests for demonstrating compliance with these requirements.
_____________
The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –

Part 1: General requirements for basic safety and essential performance.
The figures between brackets refer to the Bibliography.

– 8 – IEC 60601-2-50:2020 © IEC 2020
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2:2014 applies as modified in Clause 202. IEC 60601-1-3 and IEC 60601-1-10
do not apply. All other published collateral standards in the IEC 60601-1 series apply as
published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are referred to in this
particular standard as the general standard. Collateral standards are referred to by their
document number.
The numbering of clauses and subclauses of this particular standards corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this document addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this document addresses the content of Clause 4 of the IEC 60601-1-3
collateral standard, etc.). The changes to the text of the general standard and applicable
collateral standards are specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.147, additional definitions in this document are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this document" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.

Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
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
Replacement:
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic disturbances –
Requirements and tests
201.3 Terms and definitions
For the purposes of this document, the terms and definitions specified in IEC 60601-1:2005
and IEC 60601-1:2005/AMD1:2012, and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An index of defined terms is found on page 29. A list of symbols, abbreviations and acronyms used in this
particular standard is given in Table 201.101.
Replacement:
201.3.76
PATIENT
INFANT, as specified under 201.3.202, who is being treated by means of visible radiation from
INFANT PHOTOTHERAPY EQUIPMENT, as specified under 201.3.203
Addition:
201.3.201
EFFECTIVE IRRADIATED AREA
surface on which the PATIENT rests according to the intended position and which is irradiated
by the INFANT PHOTOTHERAPY EQUIPMENT
Note 1 to entry: The EFFECTIVE IRRADIATED AREA is the intended treatment surface which is illuminated by the
phototherapy light. The area of 60 cm × 30 cm is used as a standard-sized surface unless specified differently in
the ACCOMPANYING DOCUMENTS.
– 10 – IEC 60601-2-50:2020 © IEC 2020
201.3.202
INFANT
PATIENT up to the age of three months and a weight less than 10 kg
201.3.203
* INFANT PHOTOTHERAPY EQUIPMENT
ME EQUIPMENT which emits in the main radiation spectrum in the range between 400 nm and
550 nm for reducing the concentration of bilirubin in the body of INFANTS
201.3.204
TOTAL IRRADIANCE FOR BILIRUBIN
E
bi
irradiance equal to the total of all irradiance in the range between 400 nm and 550 nm
Table 201.101 – List of symbols, abbreviations and acronyms
Abbreviation Term
AAP American Academy of Pediatrics
°C degrees Celsius (unit of temperature)
dB(A) decibel A-weighted to human frequency response (a logarithmic measure of sound intensity)
bandwidth (in nanometres)
∆
λ
E irradiance (radiant power incidence per unit area on a surface)
E irradiance for bilirubin (total irradiance for 400 nm to 550 nm)
bi
E effective irradiance
eff
E spectral irradiance
λ
EL exposure limit
G uniformity of irradiance (unitless)
GHz gigahertz (unit of frequency)
h hour (unit of time)
IR infrared radiation (with wavelengths between 700 nm and 1 mm)
IR-A A region of infrared radiation (with wavelengths between 700 nm and 1 400 nm)
IR-B B region of infrared radiation (with wavelengths between 1,4 µm and 3 µm)
IR-C C region of infrared radiation (with wavelengths between 3 µm and 8 µm)
kg kilograms (unit of mass)
lambda (unit of wavelength)
λ
m meter (unit of length)
MHz megahertz (unit of frequency)
min minute (unit of time)
µW/cm microwatts per square centimetre (unit of irradiance)
nm nanometre (unit of length)
N newton (unit of force)
s second (unit of time)
S relative spectral effectiveness (unitless)
λ
UV ultraviolet radiation (with wavelength shorter than visible light)
UV-A near-ultraviolet region (with wavelengths between 315 nm and 400 nm)
V/m volts per meter (unit of electric field intensity)
W/cm watts per square centimetre (unit of irradiance)
W/m watts per square meter (unit of irradiance)

201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 * ESSENTIAL PERFORMANCE
Replacement:
There are no additional ESSENTIAL PERFORMANCE requirements for INFANT PHOTOTHERAPY
EQUIPMENT.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.4 Other conditions
Additional subclauses:
201.5.4.101 * Pre-ageing
The following general operating conditions shall be taken into account for radiation
measurements of INFANT PHOTOTHERAPY EQUIPMENT.
After 5 h of pre-ageing of the radiator source, or after the pre-ageing time specified by the
MANUFACTURER, if the MANUFACTURER has specified a different pre-ageing time in the
ACCOMPANYING DOCUMENTS, the initial values of TOTAL IRRADIANCE FOR BILIRUBIN E for the
bi
INFANT PHOTOTHERAPY EQUIPMENT shall be measured at the normal operating conditions for the
different irradiance settings defined by the MANUFACTURER.
201.5.4.102 Position of measurements
The radiation measurements shall be taken in the operating position of the lamp of the INFANT
PHOTOTHERAPY EQUIPMENT at a distance specified by the MANUFACTURER disclosed in the
instructions for use (see 201.7.9.2.9).
201.5.4.103 Stabilization period
The radiation measurements shall be taken when all important parameters for measurements
have reached stable conditions. The stabilization period shall be at least 0,5 h, or longer,
unless the MANUFACTURER states a different time in the ACCOMPANYING DOCUMENTS.
201.5.4.104 * Arrangement in space
The INFANT PHOTOTHERAPY EQUIPMENT shall be oriented as specified by the MANUFACTURER in
the instructions for use (see 201.7.9.2.9).
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
201.6.3 Protection against harmful ingress of water or particulate matter
Addition:
– 12 – IEC 60601-2-50:2020 © IEC 2020
201.6.3.101 INFANT PHOTOTHERAPY EQUIPMENT located under the PATIENT
If INFANT PHOTOTHERAPY EQUIPMENT is located under the PATIENT, it shall at least comply with
IPX3 specified in IEC 60529.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT PARTS (see also
Table C.1 of the general standard)
Additional subclause:
201.7.2.101 * Safety sign for PATIENT eye shield
A safety sign indicating the requirement for eye shields for the PATIENT shall be used if the
PATIENT’S eyes can be exposed to the INFANT PHOTOTHERAPY EQUIPMENT’S radiation. See
symbol ISO 7010-M025 in IEC TR 60878:2015.
201.7.3.1 Heating elements or lamp holders
Addition:
The types of lamps specified or recommended by the MANUFACTURER shall be indicated.
201.7.9.2.2 Warning and safety notices
Addition:
The instructions for use shall also include the following:
a) a statement that the INFANT PHOTOTHERAPY EQUIPMENT should be used only by
appropriately trained personnel and under the direction of qualified medical personnel
familiar with currently known RISKS and benefits of INFANT PHOTOTHERAPY EQUIPMENT use;
b) a statement by the MANUFACTURER explaining the effect of varying ambient conditions on
the PATIENT, for example varying ambient temperatures, different radiation sources
(sunlight), etc.;
c) if necessary, a notice giving information about the filter and the protective barrier required
for NORMAL USE;
d) a notice that some PATIENTS’ water balance may be disturbed;
e) a notice that PATIENTS adjacent to the INFANT PHOTOTHERAPY EQUIPMENT may need to be
protected, and a notice and details about additional protective measures (e.g. shields,
protective glasses);
f) a notice that the PATIENT’S bilirubin values shall be measured regularly;
g) a notice that the use of reflective foils may cause hazardous body temperatures, if
relevant to the type of INFANT PHOTOTHERAPY EQUIPMENT;
h) advice to supply the PATIENT with an eye shield, whenever the PATIENT’S eye can be
exposed to the INFANT PHOTOTHERAPY EQUIPMENT’S radiation;
*i) the warning notice that the OPERATOR may experience some effects during prolonged
exposure to the area irradiated by the INFANT PHOTOTHERAPY EQUIPMENT;
j) a notice stating if the INFANT PHOTOTHERAPY EQUIPMENT should not be treated with
flammable solutions (antiseptics, cleaning agents, etc.);
k) a notice that blue light can hinder clinical observations by masking skin colour changes,
such as cyanosis;
l) a notice that, due to photochemical effects, drugs and infusion liquids shall not be stored
in the radiation area;
m) a statement advising the OPERATOR of any RISKS associated with operating the INFANT
in the presence of gases that can support combustion (e.g.
PHOTOTHERAPY EQUIPMENT
oxygen, nitrous oxide, anaesthetic agents), and how to properly use the INFANT
PHOTOTHERAPY EQUIPMENT in the presence of these gases.
201.7.9.2.5 ME EQUIPMENT description
Addition:
The instructions for use shall also contain:
EFFECTIVE IRRADIATED AREA
a) a graphical representation, including figures, of the size of the
and its position with respect to the INFANT PHOTOTHERAPY EQUIPMENT;
b) a graphical representation of the spectral intensity distribution for the INFANT
PHOTOTHERAPY EQUIPMENT over the wavelength range defined in 201.3.203. The TOTAL
E emitted by the INFANT PHOTOTHERAPY EQUIPMENT shall be
IRRADIANCE FOR BILIRUBIN
bi
integrated over wavelength intervals of 5 nm or less for the wavelength range defined in
201.3.203;
c) the spectral sensitivity function curve of the measurement device if the integral method for
TOTAL IRRADIANCE FOR BILIRUBIN E emitted by the INFANT PHOTOTHERAPY EQUIPMENT is
bi
measured under the condition of 201.12.1.104;
d) the pre-ageing time, if the time is different from 5 h;
e) the stabilization period, if the period is different from 0,5 h; and
f) the maximum noise level measured under the condition of 201.9.6.2.
If alternative types of lamps are recommended by the MANUFACTURER, all the requirements of
this subclause apply for each type of lamp.
201.7.9.2.9 Operating instructions
Addition:
a) The TOTAL IRRADIANCE FOR BILIRUBIN E as measured according to the MANUFACTURER’S
bi
instructions shall be stated along with information on how this TOTAL IRRADIANCE FOR
BILIRUBIN E is affected by the distance between the INFANT PHOTOTHERAPY EQUIPMENT and
bi
EFFECTIVE IRRADIATED AREA.
the
b) The instructions for use shall contain information about the distance between the INFANT
PHOTOTHERAPY EQUIPMENT and the EFFECTIVE IRRADIATED AREA. If the distance between the
INFANT PHOTOTHERAPY EQUIPMENT and the EFFECTIVE IRRADIATED AREA is adjustable, the
MANUFACTURER shall describe how the OPERATOR can keep to the permissible distances.
c) The instructions for use shall inform the OPERATOR about the necessity of temperature
measurements on the PATIENT, if the INFANT PHOTOTHERAPY EQUIPMENT will influence the
body temperature of the PATIENT.
d) The instructions for use shall inform the OPERATOR about the impact of INFANT
PHOTOTHERAPY EQUIPMENT on the heat supply in thermotherapy devices (INFANT
INCUBATORS, INFANT TRANSPORT INCUBATORS, INFANT RADIANT WARMERS, devices supplying
heat via BLANKETS, PADS or MATTRESSES) and on the PATIENT’S body temperature when the
INFANT PHOTOTHERAPY is used in combination with one of these warming therapy devices.
e) The instructions for use shall inform the OPERATOR that the use of the baby controlled
mode of the INFANT INCUBATOR, INFANT TRANSPORT INCUBATORS an INFANT RADIANT WARMER
or devices supplying heat via BLANKETS, PADS or MATTRESSES is recommended when the
INFANT PHOTOTHERAPY is used in combination with one of these warming therapy devices,
otherwise the set air temperature of the incubator or the heater output of the INFANT
RADIANT WARMER or HEATED MATTRESS shall be reduced according to the body temperature
measurements.
– 14 – IEC 60601-2-50:2020 © IEC 2020
201.7.9.2.13 Maintenance
Addition:
The instructions for use shall also contain:
OPERATOR about the limited lifetime of the radiation
a) if applicable, details informing the
source;
*b) information about how to measure the TOTAL IRRADIANCE FOR BILIRUBIN E and about its
bi
rate of decay versus hours used and provide a recommendation of when the light source
should be verified and replaced;
c) the notice that, if there are several lamps in the INFANT PHOTOTHERAPY EQUIPMENT, all
lamps shall be changed at the same time;
d) the notice that the lamps which are recommended by the MANUFACTURER shall be used and
that the use of other lamps, which are not approved by the MANUFACTURER, can influence
the safety and effectiveness of the phototherapy;
PATIENT from falling off the
e) a notice that protective devices intended to prevent the
EFFECTIVE IRRADIATED AREA shall be inspected regularly with respect to their safety
function.
201.7.9.2.14 ACCESSORIES, supplementary equipment, used material
Addition:
The instructions for use shall contain details about the maximum permissible weight of
auxiliary devices/objects on surfaces mounted on the INFANT PHOTOTHERAPY EQUIPMENT, if
shelves are an integrated part of the INFANT PHOTOTHERAPY EQUIPMENT.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies, except as follows:
201.9.2.1 General
Addition:
If the INFANT PHOTOTHERAPY EQUIPMENT can be adjusted in height, it shall not be able to
contact the PATIENT by a failure of the locking device.
201.9.5.1 Protective means
Addition:
A protective device for the limitation of radiation, referred to as a filter, shall be removable
only by means of TOOLS.
If applicable, if the PATIENT is lying directly under the INFANT PHOTOTHERAPY EQUIPMENT, a
protection against falling glass splinters is absolutely necessary.
Compliance with this requirement is checked by visual inspection.

201.9.6.2 * Acoustic energy
Replacement:
The noise caused by the INFANT PHOTOTHERAPY EQUIPMENT shall not exceed the level given by
the MANUFACTURER in the instructions for use and in no case shall it exceed 60 dB(A).
Compliance with this requirement is checked by the following test:
With the microphone of a sound level meter complying with the requirements of IEC 61672-1
placed in the position of the PATIENT, the measured sound level shall not exceed the specified
values. The background level shall be at least 10 dB(A) below the measuring value of the
INFANT PHOTOTHERAPY EQUIPMENT.
201.9.8 MECHANICAL HAZARDS associated with support systems
Additional subclause:
201.9.8.101 Supports and mounting brackets for ACCESSORIES
Supports and mounting brackets for ACCESSORIES shall be suitable and of adequate strength
for their purpose.
Compliance is checked by inspection and by the following test:
A gradually increasing force is applied so as to act vertically through the centre of the
supports and mounting brackets, for examples an ACCESSORY shelf in the extended position
MANUFACTURER’S recommended load. The force is increased from zero in a 5 s to 10 s
with a
interval, until it equals three times the recommended load and is sustained for a period of
1 min. There shall be no evidence of damage to the items under test.
201.9.8.3 Strength of PATIENT or OPERATOR support or suspension systems
201.9.8.3.1 * General
Addition:
NOTE The normal load for an INFANT is reduced to 10 kg (see 201.3.202).
Additional subclause:
201.9.8.3.101 Barriers
For devices with an integral bed, suitable barriers shall prevent the PATIENT from falling off. If
such protective devices are intended to facilitate access to the PATIENT, as soon as they have
been opened or removed, they shall remain in the locked position under test conditions.
The mechanical strength of the barriers shall be maintained under the test conditions given
below. It shall not be possible for the barriers to appear to be properly locked or fixed if they
are not.
Compliance with this requirement is checked by visual inspection and by the following test:
With all access port doors deliberately made as insecure as possible, without the use of a
TOOL, whilst still appearing to be engaged, a horizontal force shall be applied to the centre of
the access port door. The force shall be increased gradually from zero to 20 N in an interval
of 5 s to 10 s and shall be held at maximum for 5 s.

– 16 – IEC 60601-2-50:2020 © IEC 2020
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies, except as follows:
201.10.5 * Other visible electromagnetic radiation
Subclause 10.5 of the general standard applies.
201.10.6 * Infrared radiation
Replacement:
2 2
Infrared radiation shall not exceed 10 mW/cm (100 W/m ) for λ between 760 nm and
1 400 nm at any point of the EFFECTIVE IRRADIATED AREA.
Compliance with this requirement is checked by spectral measurement in NORMAL CONDITION
of use after the stabilization period.
201.10.7 * Ultraviolet radiation
Addition:
–5 2 –4 2
Effective ultraviolet irradiance shall not exceed 1,0 × 10 mW/cm (1,0 × 10 W/m ) for λ
between 180 nm and 400 nm at any point of the EFFECTIVE IRRADIATED AREA.
Compliance with this requirement is checked by spectral measurement in NORMAL CONDITION
of use after the stabilization period.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
201.11.1 * Excessive temperatures in ME EQUIPMENT
Addition:
NOTE INFANT PHOTOTHERAPY EQUIPMENT can be used or combined with INFANT INCUBATORS, INFANT TRANSPORT
INCUBATORS or INFANT RADIANT WARMERS.
201.11.1.2.2 APPLIED PARTS not intended to supply heat to a PATIENT
Replacement:
The temperature of those surfaces that are intended to come into contact with the PATIENT
shall not exceed 40 °C. The temperature of other surfaces that are accessible for the PATIENT
shall not exceed 40 °C for metal surfaces and 43 °C for other materials. These requirements
shall apply in NORMAL CONDITIONS and SINGLE FAULT CONDITIONS.
Compliance with this requirement is checked by inspection and review of documentation.
201.11.2 * Fire prevention
Subclause 11.2 of the general standard applies.

201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT
Addition:
The ME EQUIPMENT shall be so designed that an interruption and a restoration of the power
supply up to 10 min stops the treatment with an information of the OPERATOR or do not change
preset values.
Compliance is checked by switching the SUPPLY MAINS off and then switching on and
inspecting the ME EQUIPMENT.
201.12 Accuracy of controls and instruments and protection against
hazardous outputs
Clause 12 of the general standard applies, except as follows:
201.12.1 Accuracy of controls and instruments
Addition:
201.12.1.101 Irradiance distribution
The distribution of the TOTAL IRRADIANCE FOR BILIRUBIN E on the EFFECTIVE IRRADIATED AREA
bi
shall be determined. For this purpose, the measuring grid with the measuring points shall be
established as follows.
The measuring area shall be divided into a number of congruent rectangular or square partial
surfaces according to Figure 201.101. The grid is centred to cover the whole EFFECTIVE
IRRADIATED AREA, so that the measuring points are covered by the maximum of the TOTAL
IRRADIANCE FOR BILIRUBIN E . The measuring points are identical with the centres of the partial
bi
surfaces. The distances between the measuring points on the grid shall not exceed 0,1 m.

NOTE m, n are the number of partial surfaces in the direction of length a and width b.
Figure 201.101 – Example of a measuring grid

– 18 – IEC 60601-2-50:2020 © IEC 2020
201.12.1.102 Measuring principles
The values of the TOTAL IRRADIANCE FOR BILIRUBIN E and their distribution on the EFFECTIVE
bi
IRRADIATED AREA shall be measured, using all measuring points as defined in the measuring
grid in 201.12.1.101.
These values can be determined either by spectroradiometric measurements followed by an
arithmetical evaluation or by measurements with a radiometer whose lens has a limited
spectral sensitivity to the INFANT PHOTOTHERAPY EQUIPMENT (see 201.3.203).
201.12.1.103 * Spectral method
With this method, the spectral irradiance E is measured as a function of the wavelength.
λ
The TOTAL IRRADIANCE FOR BILIRUBIN E is calculated by the numeric integration of the
bi
measured values between the wavelength of 400 nm and 550 nm.
201.12.1.104 Integral method
With the integral method, the TOTAL IRRADIANCE FOR BILIRUBIN E is measured with a
bi
radiometer calibrated to measure the irradiance of the source spectrum utilized by the INFANT
PHOTOTHERAPY EQUIPMENT between 400 nm and 550 nm.
201.12.1.105 * TOTAL IRRADIANCE FOR BILIRUBIN E after pre-ageing
bi
The TOTAL IRRADIANCE FOR BILIRUBIN E after pre-ageing shall comply w
...

IEC 60601-2-50 ®
Edition 3.1 2023-10
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-50: Particular requirements for the basic safety and essential performance
of infant phototherapy equipment

Appareils électromédicaux –
Partie 2-50: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de photothérapie pour nouveau-nés

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IEC 60601-2-50 ®
Edition 3.1 2023-10
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-50: Particular requirements for the basic safety and essential performance
of infant phototherapy equipment
Appareils électromédicaux –
Partie 2-50: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de photothérapie pour nouveau-nés
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.60 ISBN 978-2-8322-7755-3

IEC 60601-2-50 ®
Edition 3.1 2023-10
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 2-50: Particular requirements for the basic safety and essential performance
of infant phototherapy equipment

Appareils électromédicaux –
Partie 2-50: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de photothérapie pour nouveau-nés

– 2 – IEC 60601-2-50:2020+AMD1:2023 CSV
© IEC 2023
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
INTRODUCTION to Amendment 1 . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 11
201.5 General requirements for testing ME EQUIPMENT . 11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201.10 Protection against unwanted and excessive radiation HAZARDS . 16
201.11 Protection against excessive temperatures and other HAZARDS . 16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 17
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 19
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 19
201.15 Construction of ME EQUIPMENT . 19
201.16 ME SYSTEMS . 20
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 20
202 Electromagnetic disturbances – Requirements and tests . 20
Annexes . 21
Annex AA (informative) Particular guidance and rationale . 22
Bibliography . 28
Index of defined terms used in this document . 30

Figure 201.101 – Example of a measuring grid . 17
Figure 201.102 – Layout of weight test devices . 19

Table 201.101 – List of symbols, abbreviations and acronyms . 10
Table AA.1 – UV radiation exposure limits and spectral weighting function . 25

© IEC 2023
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-50: Particular requirements for the basic safety and
essential performance of infant phototherapy equipment

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
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services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
This consolidated version of the official IEC Standard and its amendment has been
prepared for user convenience.
IEC 60601-2-50 edition 3.1 contains the third edition (2020-09) [documents
62D/1767/FDIS and 62D/1775/RVD] and its amendment 1 (2023-10) [documents
62D/2069/FDIS and 62D/2087/RVD].
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendment 1. Additions are in green text, deletions are in strikethrough
red text. A separate Final version with all changes accepted is available in this
publication.
– 4 – IEC 60601-2-50:2020+AMD1:2023 CSV
© IEC 2023
International standard IEC 60601-2-50 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This third edition constitutes a technical revision.
This edition includes the following significant technical change with respect to the previous
edition: re-dating of normative references.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used:
– requirements and definitions: roman type;
– test specifications: italic type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this document are preceded by the term “Clause” followed by
the clause number. References to subclauses within this particular standard are by number
only.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Clause 7 of the
ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this document;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.

© IEC 2023
The committee has decided that the contents of this document and its amendment will remain
unchanged until the stability date indicated on the IEC website under webstore.iec.ch in the
data related to the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests. It is the recommendation of the committee that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
– 6 – IEC 60601-2-50:2020+AMD1:2023 CSV
© IEC 2023
INTRODUCTION
The minimum safety requirements specified in this particular standard are considered to
provide for a practical degree of safety in the operation of INFANT PHOTOTHERAPY EQUIPMENT.

INTRODUCTION to Amendment 1
At the October 2019 meeting of IEC SC 62D in Shanghai, China, the subcommittee discussed
the need for administrative/technical changes to most 62D standards after completion of the
amendment projects within the IEC 60601‑1 series. Those projects were all completed and
the amendments published in 2020.
The full list of IEC SC 62D documents that will be amended or revised can be found within the
IEC document 62D/1792/DC. The results and comments on the DC can be found within
62D/1808/INF. The review report for this amendment is 62D/1814/RR.

© IEC 2023
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-50: Particular requirements for the basic safety and
essential performance of infant phototherapy equipment

201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT
PHOTOTHERAPY EQUIPMENT, as defined in 201.3.203, also referred to as ME EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this document are not covered by specific requirements in this document,
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This particular standard specifies safety requirements for INFANT PHOTOTHERAPY EQUIPMENT,
but alternate methods of compliance with a specific clause by demonstrating equivalent safety
will not be judged as non-compliant if the MANUFACTURER has demonstrated in his RISK
MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an
acceptable level when weighed against the benefit of treatment from the device.
This document does not apply to:
– devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information,
see IEC 60601-2-35 [1] ;
– INFANT INCUBATORS; for information, see IEC 60601-2-19 [2];
– INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20 [3];
– INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [4].
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for INFANT PHOTOTHERAPY EQUIPMENT (as defined in 201.3.203),
which reduce the safety HAZARDS to PATIENTS and OPERATORS as much as possible and to
specify tests for demonstrating compliance with these requirements.
_____________
The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020,

Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
The figures between brackets refer to the Bibliography.

– 8 – IEC 60601-2-50:2020+AMD1:2023 CSV
© IEC 2023
201.1.3 * Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2:2014 and IEC 60601‑1‑2:2014/AMD1:2020 applies apply as modified in Clause
202. IEC 60601-1-3 and IEC 60601-1-10 do not apply. All other published collateral standards
in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601‑1:2005/AMD2:2020 are referred to in this particular standard as the general
standard. Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standards corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this document addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this document addresses the content of Clause 4 of the IEC 60601-1-3
collateral standard, etc.). The changes to the text of the general standard and applicable
collateral standards are specified by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.147, additional definitions in this document are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this document" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.

© IEC 2023
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
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 60601‑1:2005/AMD2:2020
Replacement:
IEC 60601‑1‑2:2014, Medical electrical equipment – Part 1‑2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic disturbances –
Requirements and tests
IEC 60601‑1‑2:2014/AMD1:2020
201.3 Terms and definitions
For the purposes of this document, the terms and definitions specified in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020, and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An index of defined terms is found on page 30. A list of symbols, abbreviations and acronyms used in this
particular standard is given in Table 201.101.
Replacement:
201.3.76
PATIENT
INFANT, as specified under 201.3.202, who is being treated by means of visible radiation from
INFANT PHOTOTHERAPY EQUIPMENT, as specified under 201.3.203
Addition:
201.3.201
EFFECTIVE IRRADIATED AREA
surface on which the PATIENT rests according to the intended position and which is irradiated
by the INFANT PHOTOTHERAPY EQUIPMENT
Note 1 to entry: The EFFECTIVE IRRADIATED AREA is the intended treatment surface which is illuminated by the
phototherapy light. The area of 60 cm × 30 cm is used as a standard-sized surface unless specified differently in
the ACCOMPANYING DOCUMENTS.
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© IEC 2023
201.3.202
INFANT
PATIENT up to the age of three months and a weight less than 10 kg
Note 1 to entry: INFANT includes premature/pre‑born baby and neonate baby/newborn baby.
201.3.203
* INFANT PHOTOTHERAPY EQUIPMENT
ME EQUIPMENT which emits in the main radiation spectrum in the range between 400 nm and
550 nm for reducing the concentration of bilirubin in the body of INFANTS
201.3.204
TOTAL IRRADIANCE FOR BILIRUBIN
E
bi
irradiance equal to the total of all irradiance in the range between 400 nm and 550 nm
Table 201.101 – List of symbols, abbreviations and acronyms
Abbreviation Term
AAP American Academy of Pediatrics
°C degrees Celsius (unit of temperature)
dB(A) decibel A-weighted to human frequency response (a logarithmic measure of sound intensity)
∆ bandwidth (in nanometres)
λ
E irradiance (radiant power incidence per unit area on a surface)
E irradiance for bilirubin (total irradiance for 400 nm to 550 nm)
bi
E effective irradiance
eff
E spectral irradiance
λ
EL exposure limit
G uniformity of irradiance (unitless)
GHz gigahertz (unit of frequency)
h hour (unit of time)
IR infrared radiation (with wavelengths between 700 nm and 1 mm)
IR-A A region of infrared radiation (with wavelengths between 700 nm and 1 400 nm)
IR-B
B region of infrared radiation (with wavelengths between 1,4 µm and 3 µm)
IR-C
C region of infrared radiation (with wavelengths between 3 µm and 8 µm 1 mm)
kg kilograms (unit of mass)
λ lambda (unit of wavelength)
m meter (unit of length)
MHz megahertz (unit of frequency)
min minute (unit of time)
microwatts per square centimetre (unit of irradiance)
µW/cm
nm nanometre (unit of length)
N newton (unit of force)
s second (unit of time)
S relative spectral effectiveness (unitless)
λ
UV ultraviolet radiation (with wavelength shorter than visible light)
UV-A near-ultraviolet region (with wavelengths between 315 nm and 400 nm)
V/m volts per meter (unit of electric field intensity)
W/cm watts per square centimetre (unit of irradiance)
W/m watts per square meter (unit of irradiance)

© IEC 2023
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 * ESSENTIAL PERFORMANCE
Replacement Addition:
There are no additional ESSENTIAL PERFORMANCE requirements for INFANT PHOTOTHERAPY
EQUIPMENT.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.4 Other conditions
Additional subclauses:
201.5.4.101 * Pre-ageing
The following general operating conditions shall be taken into account for radiation
measurements of INFANT PHOTOTHERAPY EQUIPMENT.
After 5 h of pre-ageing of the radiator source, or after the pre-ageing time specified by the
MANUFACTURER, if the MANUFACTURER has specified a different pre-ageing time in the
ACCOMPANYING DOCUMENTS, the initial values of TOTAL IRRADIANCE FOR BILIRUBIN E for the
bi
INFANT PHOTOTHERAPY EQUIPMENT shall be measured at the normal operating conditions for the
different irradiance settings defined by the MANUFACTURER.
201.5.4.102 Position of measurements
The radiation measurements shall be taken in the operating position of the lamp of the INFANT
PHOTOTHERAPY EQUIPMENT at a distance specified by the MANUFACTURER disclosed in the
instructions for use (see 201.7.9.2.9).
201.5.4.103 Stabilization period
The radiation measurements shall be taken when all important parameters for measurements
have reached stable conditions. The stabilization period shall be at least 0,5 h, or longer,
unless the MANUFACTURER states a different time in the ACCOMPANYING DOCUMENTS.
201.5.4.104 * Arrangement in space
The INFANT PHOTOTHERAPY EQUIPMENT shall be oriented as specified by the MANUFACTURER in
the instructions for use (see 201.7.9.2.9).
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
201.6.3 Protection against harmful ingress of water or particulate matter
Addition:
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© IEC 2023
201.6.3.101 INFANT PHOTOTHERAPY EQUIPMENT located under the PATIENT
If INFANT PHOTOTHERAPY EQUIPMENT is located under the PATIENT, it shall at least comply with
IPX3 specified in IEC 60529.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT PARTS (see also
Table C.1 of the general standard)
Additional subclause:
201.7.2.101 * Safety sign for PATIENT eye shield
A safety sign indicating the requirement for eye shields for the PATIENT shall be used if the
PATIENT’S eyes can be exposed to the INFANT PHOTOTHERAPY EQUIPMENT’S radiation. See
symbol ISO 7010-M025 in IEC TR 60878:2015.
201.7.3.1 Heating elements or lamp holders
Addition:
The types of lamps specified or recommended by the MANUFACTURER shall be indicated.
201.7.9.2.2 Warning and safety notices
Addition:
The instructions for use shall also include the following:
a) a statement that the INFANT PHOTOTHERAPY EQUIPMENT should be used only by
appropriately trained personnel and under the direction of qualified medical personnel
familiar with currently known RISKS and benefits of INFANT PHOTOTHERAPY EQUIPMENT use;
b) a statement by the MANUFACTURER explaining the effect of varying ambient conditions on
the PATIENT, for example varying ambient temperatures, different radiation sources
(sunlight), etc.;
c) if necessary, a notice giving information about the filter and the protective barrier required
for NORMAL USE;
d) a notice that some PATIENTS’ water balance may be disturbed;
e) a notice that PATIENTS adjacent to the INFANT PHOTOTHERAPY EQUIPMENT may need to be
protected, and a notice and details about additional protective measures (e.g. shields,
protective glasses);
f) a notice that the PATIENT’S bilirubin values shall be measured regularly;
g) a notice that the use of reflective foils may cause hazardous body temperatures, if
relevant to the type of INFANT PHOTOTHERAPY EQUIPMENT;
h) advice to supply the PATIENT with an eye shield, whenever the PATIENT’S eye can be
exposed to the INFANT PHOTOTHERAPY EQUIPMENT’S radiation;
*i) the warning notice that the OPERATOR may experience some effects during prolonged
exposure to the area irradiated by the INFANT PHOTOTHERAPY EQUIPMENT;
j) a notice stating if the INFANT PHOTOTHERAPY EQUIPMENT should not be treated with
flammable solutions (antiseptics, cleaning agents, etc.);
k) a notice that blue light can hinder clinical observations by masking skin colour changes,
such as cyanosis;
© IEC 2023
l) a notice that, due to photochemical effects, drugs and infusion liquids shall not be stored
in the radiation area;
m) a statement advising the OPERATOR of any RISKS associated with operating the INFANT
in the presence of gases that can support combustion (e.g.
PHOTOTHERAPY EQUIPMENT
oxygen, nitrous oxide, anaesthetic agents), and how to properly use the INFANT
PHOTOTHERAPY EQUIPMENT in the presence of these gases.
201.7.9.2.5 ME EQUIPMENT description
Addition:
The instructions for use shall also contain:
EFFECTIVE IRRADIATED AREA
a) a graphical representation, including figures, of the size of the
and its position with respect to the INFANT PHOTOTHERAPY EQUIPMENT;
b) a graphical representation of the spectral intensity distribution for the INFANT
PHOTOTHERAPY EQUIPMENT over the wavelength range defined in 201.3.203. The TOTAL
E emitted by the INFANT PHOTOTHERAPY EQUIPMENT shall be
IRRADIANCE FOR BILIRUBIN
bi
integrated over wavelength intervals of 5 nm or less for the wavelength range defined in
201.3.203;
c) the spectral sensitivity function curve of the measurement device if the integral method for
TOTAL IRRADIANCE FOR BILIRUBIN E emitted by the INFANT PHOTOTHERAPY EQUIPMENT is
bi
measured under the condition of 201.12.1.104;
d) the pre-ageing time, if the time is different from 5 h;
e) the stabilization period, if the period is different from 0,5 h; and
f) the maximum noise level measured under the condition of 201.9.6.2.
If alternative types of lamps are recommended by the MANUFACTURER, all the requirements of
this subclause apply for each type of lamp.
201.7.9.2.9 Operating instructions
Addition:
a) The TOTAL IRRADIANCE FOR BILIRUBIN E as measured according to the MANUFACTURER’S
bi
instructions shall be stated along with information on how this TOTAL IRRADIANCE FOR
BILIRUBIN E is affected by the distance between the INFANT PHOTOTHERAPY EQUIPMENT and
bi
EFFECTIVE IRRADIATED AREA.
the
b) The instructions for use shall contain information about the distance between the INFANT
PHOTOTHERAPY EQUIPMENT and the EFFECTIVE IRRADIATED AREA. If the distance between the
INFANT PHOTOTHERAPY EQUIPMENT and the EFFECTIVE IRRADIATED AREA is adjustable, the
MANUFACTURER shall describe how the OPERATOR can keep to the permissible distances.
c) The instructions for use shall inform the OPERATOR about the necessity of temperature
measurements on the PATIENT, if the INFANT PHOTOTHERAPY EQUIPMENT will influence the
body temperature of the PATIENT.
d) The instructions for use shall inform the OPERATOR about the impact of INFANT
PHOTOTHERAPY EQUIPMENT on the heat supply in thermotherapy devices (INFANT
INCUBATORS, INFANT TRANSPORT INCUBATORS, INFANT RADIANT WARMERS, devices supplying
heat via BLANKETS, PADS or MATTRESSES) and on the PATIENT’S body temperature when the
INFANT PHOTOTHERAPY is used in combination with one of these warming therapy devices.
e) The instructions for use shall inform the OPERATOR that the use of the baby controlled
mode of the INFANT INCUBATOR, INFANT TRANSPORT INCUBATORS an INFANT RADIANT WARMER
or devices supplying heat via BLANKETS, PADS or MATTRESSES is recommended when the
INFANT PHOTOTHERAPY is used in combination with one of these warming therapy devices,
otherwise the set air temperature of the incubator or the heater output of the INFANT
RADIANT WARMER or HEATED MATTRESS shall be reduced according to the body temperature
measurements.
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© IEC 2023
201.7.9.2.13 Maintenance
Addition:
The instructions for use shall also contain:
OPERATOR about the limited lifetime of the radiation
a) if applicable, details informing the
source;
*b) information about how to measure the TOTAL IRRADIANCE FOR BILIRUBIN E and about its
bi
rate of decay versus hours used and provide a recommendation of when the light source
should be verified and replaced;
c) the notice that, if there are several lamps in the INFANT PHOTOTHERAPY EQUIPMENT, all
lamps shall be changed at the same time;
d) the notice that the lamps which are recommended by the MANUFACTURER shall be used and
that the use of other lamps, which are not approved by the MANUFACTURER, can influence
the safety and effectiveness of the phototherapy;
PATIENT from falling off the
e) a notice that protective devices intended to prevent the
EFFECTIVE IRRADIATED AREA shall be inspected regularly with respect to their safety
function.
201.7.9.2.14 ACCESSORIES, supplementary equipment, used material
Addition:
The instructions for use shall contain details about the maximum permissible weight of
auxiliary devices/objects on surfaces mounted on the INFANT PHOTOTHERAPY EQUIPMENT, if
shelves are an integrated part of the INFANT PHOTOTHERAPY EQUIPMENT.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies, except as follows:
201.9.2.1 General
Addition:
If the INFANT PHOTOTHERAPY EQUIPMENT can be adjusted in height, it shall not be able to
contact the PATIENT by a failure of the locking device.
201.9.5.1 Protective means
Addition:
A protective device for the limitation of radiation, referred to as a filter, shall be removable
only by means of TOOLS.
If applicable, if the PATIENT is lying directly under the INFANT PHOTOTHERAPY EQUIPMENT, a
protection against falling glass splinters is absolutely necessary.
Compliance with this requirement is checked by visual inspection.

© IEC 2023
201.9.6.2 * Acoustic energy
Replacement:
The noise caused by the INFANT PHOTOTHERAPY EQUIPMENT shall not exceed the level given by
the MANUFACTURER in the instructions for use and in no case shall it exceed 60 dB(A).
Compliance with this requirement is checked by the following test:
With the microphone of a sound level meter complying with the requirements of IEC 61672-1
placed in the position of the PATIENT, the measured sound level shall not exceed the specified
values. The background level shall be at least 10 dB(A) below the measuring value of the
INFANT PHOTOTHERAPY EQUIPMENT.
201.9.8 MECHANICAL HAZARDS associated with support systems
Additional subclause:
201.9.8.101 Supports and mounting brackets for ACCESSORIES
Supports and mounting brackets for ACCESSORIES shall be suitable and of adequate strength
for their purpose.
Compliance is checked by inspection and by the following test:
A gradually increasing force is applied so as to act vertically through the centre of the
supports and mounting brackets, for examples an ACCESSORY shelf in the extended position
MANUFACTURER’S recommended load. The force is increased from zero in a 5 s to 10 s
with a
interval, until it equals three times the recommended load and is sustained for a period of
1 min. There shall be no evidence of damage to the items under test.
201.9.8.3 Strength of PATIENT or OPERATOR support or suspension systems
201.9.8.3.1 * General
Addition:
NOTE The normal load for an INFANT is reduced to 10 kg (see 201.3.202).
Additional subclause:
201.9.8.3.101 Barriers
For devices with an integral bed, suitable barriers shall prevent the PATIENT from falling off. If
such protective devices are intended to facilitate access to the PATIENT, as soon as they have
been opened or removed, they shall remain in the locked position under test conditions.
The mechanical strength of the barriers shall be maintained under the test conditions given
below. It shall not be possible for the barriers to appear to be properly locked or fixed if they
are not.
Compliance with this requirement is checked by visual inspection and by the following test:
With all access port doors deliberately made as insecure as possible, without the use of a
TOOL, whilst still appearing to be engaged, a horizontal force shall be applied to the centre of
the access port door. The force shall be increased gradually from zero to 20 N in an interval
of 5 s to 10 s and shall be held at maximum for 5 s.

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© IEC 2023
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies, except as follows:
201.10.5 * Other visible electromagnetic radiation
Subclause 10.5 of the general standard applies.
201.10.6 * Infrared radiation
Replacement:
2 2
Infrared radiation shall not exceed 10 mW/cm (100 W/m ) for λ between 760 nm and
1 400 nm at any point of the EFFECTIVE IRRADIATED AREA.
Compliance with this requirement is checked by spectral measurement in NORMAL CONDITION
of use after the stabilization period.
201.10.7 * Ultraviolet radiation
Addition:
–5 2 –4 2
Effective ultraviolet irradiance shall not exceed 1,0 × 10 mW/cm (1,0 × 10 W/m ) for λ
between 180 nm and 400 nm at any point of the EFFECTIVE IRRADIATED AREA.
Compliance with this requirement is checked by spectral measurement in NORMAL CONDITION
of use after the stabilization period.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
201.11.1 * Excessive temperatures in ME EQUIPMENT
Addition:
NOTE INFANT PHOTOTHERAPY EQUIPMENT can be used or combined with INFANT INCUBATORS, INFANT TRANSPORT
INCUBATORS or INFANT RADIANT WARMERS.
201.11.1.2.2 APPLIED PARTS not intended to supply heat to a PATIENT
Replacement:
The temperature of those surfaces that are intended to come into contact with the PATIENT
shall not exceed 40 °C. The temperature of other surfaces that are accessible for the PATIENT
shall not exceed 40 °C for metal surfaces and 43 °C for other materials. These requirements
shall apply in NORMAL CONDITIONS and SINGLE FAULT CONDITIONS.
Compliance with this requirement is checked by inspection and review of documentation.
201.11.2 * Fire prevention
Subclause 11.2 of the general standard applies.

© IEC 2023
201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT
Addition:
The ME EQUIPMENT shall be so designed that an interruption and a restoration of the power
supply up to 10 min stops the treatment with an information of the OPERATOR or do not change
preset values.
Compliance is checked by switching the SUPPLY MAINS off and then switching on and
inspecting the ME EQUIPMENT.
201.12
...