EN 60601-2-50:2009

SLOVENSKI STANDARD
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Medical electrical equipment - Part 2-50: Particular requirements for basic safety and
essential performance of infant phototherapy equipment (IEC 60601-2-50:2009)
Medizinische elektrische Geräte - Teil 2-50: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Säuglings-Phototherapiegeräten
(IEC 60601-2-50:2009)
Appareils électromédicaux- Partie 2-50: Exigences particulières de sécurité de base et
de performances essentielles des appareils de photothérapie pour nouveau-nés (CEI
60601-2-50:2009)
Ta slovenski standard je istoveten z: EN 60601-2-50:200X
ICS:
11.040.60 Terapevtska oprema Therapy equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60601-2-50
NORME EUROPÉENNE
May 2009
EUROPÄISCHE NORM
ICS 11.040.60 Supersedes EN 60601-2-50:2002

English version
Medical electrical equipment -
Part 2-50: Particular requirements
for the basic safety and essential performance
of infant phototherapy equipment
(IEC 60601-2-50:2009)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-50: Exigences particulières Teil 2-50: Besondere Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
des appareils de photothérapie von Säuglings-Phototherapiegeräten
pour nouveau-nés (IEC 60601-2-50:2009)
(CEI 60601-2-50:2009)
This European Standard was approved by CENELEC on 2009-05-01. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: Avenue Marnix 17, B - 1000 Brussels

© 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-50:2009 E
Foreword
The text of document 62D/736A/FDIS, future edition 2 of IEC 60601-2-50, prepared by SC 62D,
Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the
IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-50 on 2009-05-01.
This European Standard supersedes EN 60601-2-50:2002.
Specific technical changes from EN 60601-2-50:2002 include:
– requiring graphical representation of the spectral irradiance in the instructions for use (this was
previously optional; see 201.7.9.2.5 b));
– requirements for support and mounting brackets for ACCESSORIES (see 201.9.8.101);
– requiring restoration of any preset values upon interruption and restoration of the power supply, if
applicable (see 201.11.8); and
– corrections to the first four exposure limits (ELs) listed in Table AA.1.
Minor changes from EN 60601-2-50:2002 include replacing the figure containing the eye protection
symbol with a reference to this same symbol in IEC 60878 (see 201.7.2.101), defining an INFANT (see
201.3.202) and clarifying the titles for subclauses 201.5.4.102 and 201.5.4.103.
The main purpose, however, is to provide consistency with the general standard EN 60601-1:2006. This
pediatric equipment for which the committee is responsible.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2010-02-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2012-05-01
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive MDD (93/42/EEC). See Annex ZZ.
In this standard, 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 standard, 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).
- 3 - EN 60601-2-50:2009
References to clauses within this standard are preceded by the term “Clause” followed by the clause
number. References to subclauses within this particular standard are by number only.
In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb:
− “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
− “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
− “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.
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-50:2009 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 60335-2-27 NOTE  Harmonized as EN 60335-2-27:1997 (not modified).
IEC 60601-2-19 NOTE  Harmonized as EN 60601-2-19:2009 (not modified).
IEC 60601-2-21 NOTE  Harmonized as EN 60601-2-21:2009 (not modified).
ISO 3743-1 NOTE  Harmonized as EN ISO 3743-1:1995 (not modified).
__________
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Annex ZA of EN 60601-1:2006 applies, except as follows:

Publication Year Title EN/HD Year

Replace the reference to IEC 60601-1-2 by:

IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
(mod) Part 1-2: General requirements for basic
safety and essential performance - Collateral
Standard: Electromagnetic compatibility -
Requirements and tests
- 5 - EN 60601-2-50:2009
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
___________
IEC 60601-2-50 ®
Edition 2.0 2009-03
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
PRICE CODE
INTERNATIONALE
U
CODE PRIX
ICS 11.040.60 ISBN 2-8318-1034-3
– 2 – 60601-2-50 © IEC:2009
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.10
201.5 General requirements for testing of ME EQUIPMENT.11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .11
201.7 ME EQUIPMENT identification, marking and documents.11
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.15
201.11 Protection against excessive temperatures and other HAZARDS.16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs.16
201.13 HAZARDOUS SITUATIONS and fault conditions.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 compatibility .20
Annexes .20
Annex AA (informative) Particular guidance and rationale.21
Bibliography.26
Index of defined terms used in this particular standard.28

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 .24

60601-2-50 © IEC:2009 – 3 –
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 provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
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
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
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.
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 second edition cancels and replaces the first edition published in 2000. This edition
constitutes a technical revision.
Specific technical changes from the previous edition of this particular standard include:
– requiring graphical representation of the spectral irradiance in the instructions for use (this
was previously optional; see 201.7.9.2.5 b));
– requirements for support and mounting brackets for ACCESSORIES (see 201.9.8.101);
– requiring restoration of any preset values upon interruption and restoration of the power
supply, if applicable (see 201.11.8); and
– corrections to the first four exposure limits (ELs) listed in Table AA.1.

– 4 – 60601-2-50 © IEC:2009
Minor changes from the previous edition of this particular standard include replacing the
figure containing the eye protection symbol with a reference to this same symbol in IEC 60878
(see 201.7.2.101), defining an INFANT (see 201.3.202) and clarifying the titles for subclauses
201.5.4.102 and 201.5.4.103.
The main purpose of this new edition, however, is to provide consistency with the third edition
of the general standard. This edition further provides consistency with the four other particular
standards related to pediatric equipment for which the committee is responsible.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/736A/FDIS 62D/765/RVD
Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, 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 standard, 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 standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “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.

60601-2-50 © IEC:2009 – 5 –
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result 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.
– 6 – 60601-2-50 © IEC:2009
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.
This particular standard amends and supplements IEC 60601-1:2005, Medical electrical
equipment – Part 1: General requirements for basic safety and essential performance,
hereinafter referred to as the general standard.
The requirements are followed by specifications for the relevant tests.
A general guidance and rationale for the requirements of this particular standard are given in
Annex AA.
It is considered that knowledge of the reasons for these requirements will not only facilitate
the proper application of this particular standard but will, in due course, expedite any revision
necessitated by changes in clinical practice or as a result of developments in technology.
However, this annex does not form part of the requirements of this standard.

60601-2-50 © IEC:2009 – 7 –
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
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT
PHOTOTHERAPY EQUIPMENT, as defined in 201.3.203 of this standard, 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 standard are not covered by specific requirements in this standard
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 particular standard does not apply to:
– devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use, for information
see IEC 80601-2-35;
– INFANT INCUBATORS; for information see IEC 60601-2-19;
– INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20;
– INFANT RADIANT WARMERS; for information see IEC 60601-2-21.
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.
—————————
1)
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for

basic safety and essential performance.

– 8 – 60601-2-50 © IEC:2009
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 2 of this particular standard.
2)
IEC 60601-1-2 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 is 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 standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard 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 particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard 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 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses or figures 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.
—————————
2)
IEC 60601-1-10:2007, Medical electrical equipment – Part 1-10: General requirements for basic safety and
essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop
controllers
60601-2-50 © IEC:2009 – 9 –
The term "this standard" 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 beginning on page 26.
Clause 2 of the general standard applies, except as follows:
Amendment:
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
apply, except as follows:
NOTE An index of defined terms is found beginning on page 28. 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 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.
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

– 10 – 60601-2-50 © IEC:2009
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)
Δ Bandwidth (in nanometers)
λ
E Irradiance (radiant power incidence per unit area on a surface)
E Irradiance for bilirubin (total irradiance for 400 nm – 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)
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 Nanometer (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:
60601-2-50 © IEC:2009 – 11 –
There are no additional ESSENTIAL PERFORMANCE requirements for INFANT PHOTOTHERAPY
EQUIPMENT.
201.5 General requirements for testing of 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
INFANT
The radiation measurements shall be taken in the operating position of the lamp of the
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 subclause 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 particular matter
Additional subclause:
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:

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201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT PARTS
Additional subclause:
201.7.2.101 * Safety sign for PATIENT eye shield
A safety sign for requiring 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 number Safety 02
in IEC 60878.
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, e.g. 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;
k) a notice that blue light can hinder clinical observations by masking skin color changes,
such as cyanosis;
j) a notice in case it is not allowed to treat the INFANT PHOTOTHERAPY EQUIPMENT with
flammable solutions (antiseptics, cleaning agents, etc.);
l) a notice that, due to photo 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
PHOTOTHERAPY EQUIPMENT in the presence of gases that can support combustion (e.g.
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
Additions:
60601-2-50 © IEC:2009 – 13 –
The instructions for use shall also contain:
a) a graphical representation, including figures, of the size of the EFFECTIVE SURFACE AREA
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
IRRADIANCE FOR BILIRUBIN E emitted by the INFANT PHOTOTHERAPY EQUIPMENT shall be
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
the EFFECTIVE SURFACE AREA;
b) The instructions for use shall contain information about the distance between the INFANT
PHOTOTHERAPY EQUIPMENT and the EFFECTIVE SURFACE AREA. If the distance between the
INFANT PHOTOTHERAPY EQUIPMENT and the EFFECTIVE SURFACE AREA is adjustable, the
MANUFACTURER has to 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 has to be reduced according to the body
temperature measurements.
201.7.9.2.13 Maintenance
Addition:
The instructions for use shall also contain
a) details informing the OPERATOR about the limited lifetime of the radiation 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;

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c) the notice that if there are several lamps in the INFANT PHOTOTHERAPY EQUIPMENT, all
lamps have to 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;
e) a notice that protective devices intended to prevent the PATIENT from falling off the
EFFECTIVE SURFACE 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.
Compliance with this requirement is checked by visual inspection.
NOTE If applicable, if the PATIENT is lying directly under the INFANT PHOTOTHERAPY EQUIPMENT, a protection
against falling glass splinters is absolutely necessary.
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:
The microphone of a sound level meter complying with type III requirements of IEC 60651
shall be placed in the position of the PATIENT. The measuring value shall not exceed the
values given. The background level shall be at least 10 dB(A) below the measuring value of
the INFANT PHOTOTHERAPY EQUIPMENT. The measuring room shall comply with a reverberation
test room (ISO 3743).
60601-2-50 © IEC:2009 – 15 –
201.9.8 HAZARDS associated with support systems
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
PATIENT, as soon as they have
such protective devices are intended to facilitate access to the
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
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