IEC 60601-2-50

This is a preview of "S+ IEC 60601-2-50 Ed...". Click here to purchase the full version from the ANSI store.

®
Edition 3.0 2020-09
REDLINE VERSION

INTERNATIONAL
STANDARD

colour
inside

Medical electrical equipment –

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

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION

ICS 11.040.60 ISBN 978-2-8322-8841-2

Warning! Make sure that you obtained this publication from an authorized distributor.

® Registered trademark of the International Electrotechnical Commission

 –2–
This is a preview of "S+ IEC 60601-2-50 Ed...". Click here toIEC 60601-2-50:2020 RLV © IEC 2020
purchase the full version from the ANSI store.

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 of ME EQUIPMENT ................................................ 11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .................................................... 11
201.7 M E 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 ............................. 17
201.12 Accuracy of controls and instruments and protection against hazardous
outputs .......................................................................................................................... 17
201.13 H AZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT ............................... 20
201.14 P ROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS ( PEMS ) ............................................. 20
201.15 Construction of ME EQUIPMENT ............................................................................... 20
201.16 M E SYSTEMS .......................................................................................................... 20
201.17 Electromagnetic COMPATIBILITY disturbances of ME EQUIPMENT and
ME SYSTEMS ................................................................................................................... 20
202 Electromagnetic disturbances – Requirements and tests ............................................... 20
Annexes ............................................................................................................................... 22
Annex AA (informative) Particular guidance and rationale ................................................... 23
Bibliography .......................................................................................................................... 28
Index of defined terms used in this document ....................................................................... 30

Figure 201.101 – Example of a measuring grid ..................................................................... 18

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 ........................... 26
This is IEC 60601-2-50:2020 RLV © IEC 2020
a preview –3–
of "S+ IEC 60601-2-50 Ed...". Click here to purchase the full version from the ANSI store.

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
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
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
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.

This redline version of the official IEC Standard allows the user to identify the changes
made to the previous edition. A vertical bar appears in the margin wherever a change
has been made. Additions are in green text, deletions are in strikethrough red text.
 –4–
This is a preview of "S+ IEC 60601-2-50 Ed...". Click here toIEC 60601-2-50:2020 RLV © IEC 2020
purchase the full version from the ANSI store.

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.

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 C LAUSE 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.
This is IEC 60601-2-50:2020 RLV © IEC 2020
a preview –5–
of "S+ IEC 60601-2-50 Ed...". Click here to purchase the full version from the ANSI store.
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.

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–
This is a preview of "S+ IEC 60601-2-50 Ed...". Click here toIEC 60601-2-50:2020 RLV © IEC 2020
purchase the full version from the ANSI store.

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.
This is IEC 60601-2-50:2020 RLV © IEC 2020
a preview –7–
of "S+ IEC 60601-2-50 Ed...". Click here to purchase the full version from the ANSI store.

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 1 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.

H AZARDS 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 80601-2-35 IEC 60601-2-35 [1] 2;
– 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.

_____________
1 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.
2 The figures between brackets refer to the Bibliography.
 –8–
This is a preview of "S+ IEC 60601-2-50 Ed...". Click here toIEC 60601-2-50:2020 RLV © IEC 2020
purchase the full version from the ANSI store.
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 3)
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 is 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 3.139 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.

_____________
3) 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
IEC 60601-2-50:2020 RLV © IEC 2020 –9–

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:

Amendment

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 60601-1-2:20072014, Medical electrical equipment – Part 1-2: General requirements for
basic safety and essential performance – Collateral standard: Electromagnetic compatibility
disturbances – Requirements and tests

201.3 Terms and definitions

For the purposes of this document, the terms and definitions given specified in
IEC 60601­1:2005 and IEC 60601­1:2005/AMD1:2012, apply, except as follows 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
 IEC 60601-2-50
This is a preview of "S+ IEC 60601-2-50 Ed...". Click here to purchase the full version from the ANSI store.

®
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
IEC 60601-2-50:2020-09(en-fr)
 –2– IEC 60601-2-50:2020 © IEC 2020
This is a preview of "S+ IEC 60601-2-50 Ed...". Click here to purchase the full version from the ANSI store.

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 M E 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 H AZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT ............................... 19
201.14 P ROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS ( PEMS ) ............................................. 19
201.15 Construction of ME EQUIPMENT ............................................................................... 19
201.16 M E 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
This is IEC 60601-2-50:2020 © IEC 2020
a preview –3–
of "S+ IEC 60601-2-50 Ed...". Click here to purchase the full version from the ANSI store.

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
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
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
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 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
This is a preview of "S+ IEC 60601-2-50 Ed...". Click here to purchase the full version from the ANSI store.
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 C LAUSE 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.
This is IEC 60601-2-50:2020 © IEC 2020
a preview –5–
of "S+ IEC 60601-2-50 Ed...". Click here to purchase the full version from the ANSI store.
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
This is a preview of "S+ IEC 60601-2-50 Ed...". Click here to purchase the full version from the ANSI store.

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 is IEC 60601-2-50:2020 © IEC 2020
a preview –7–
of "S+ IEC 60601-2-50 Ed...". Click here to purchase the full version from the ANSI store.

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 1 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.

H AZARDS 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] 2;
– 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.

_____________
1 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.
2 The figures between brackets refer to the Bibliography.
 –8– IEC 60601-2-50:2020 © IEC 2020
This is a preview of "S+ IEC 60601-2-50 Ed...". Click here to purchase the full version from the ANSI store.
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.
IEC 60601-2-50:2020 © IEC 2020 –9–

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 60601­1:2005
and IEC 60601­1:2005/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 .
 – 32 – IEC 60601-2-50:2020 © IEC 2020
This is a preview of "S+ IEC 60601-2-50 Ed...". Click here to purchase the full version from the ANSI store.

SOMMAIRE
INTRODUCTION ................................................................................................................... 36
201.1 Domaine d’application, objet et normes connexes ................................................... 37
201.2 Références normatives............................................................................................ 39
201.3 Termes et définitions ............................................................................................... 39
201.4 Exigences générales ............................................................................................... 41
201.5 Exigences générales relatives aux essais des APPAREILS EM ................................... 41
201.6 Classification des APPAREILS EM et des SYSTEMES EM ............................................... 42
201.7 Identification, marquage et documentation des APPAREILS EM .................................. 42
201.8 Protection contre les DANGERS d'origine électrique des APPAREILS EM ...................... 45
201.9 Protection contre les DANGERS MECANIQUES des APPAREILS EM et des
SYSTEMES EM ........................................................................................................... 45

201.10 Protection contre les DANGERS dus aux rayonnements involontaires ou

excessifs ................................................................................................................. 47
201.11 Protection contre les températures excessives et les autres DANGERS ..................... 47
201.12 Précision des commandes et des instruments et protection contre les
caractéristiques de sortie dangereuses ................................................................... 48
201.13 S ITUATIONS DANGEREUSES et conditions de défaut pour les APPAREILS EM ................. 50
201.14 S YSTEMES ELECTROMEDICAUX PROGRAMMABLES ( SEMP ) .............................................. 50
201.15 Construction de l’ APPAREIL EM ................................................................................. 51
201.16 S YSTEMES EM ........................................................................................................... 51
201.17 Compatibilité électromagnétique des APPAREILS EM et des SYSTEMES EM .................. 51
202 Perturbations électromagnétiques – Exigences et essais ........................................ 51
Annexes ............................................................................................................................... 52
Annexe A (informative) Guide particulier et justifications ...................................................... 53
Bibliographie ......................................................................................................................... 59
Index des termes définis utilisés dans le présent document .................................................. 61

Figure 201.101 – Exemple de grille de mesure ..................................................................... 48

Figure 201.102 – Implantation des dispositifs d'essai de poids ............................................. 50

Tableau 201.101 – Liste des symboles, abréviations et acronymes ....................................... 40

Tableau AA.1 – Limites d'exposition aux rayonnements UV et fonction de pondération
spectrale ............................................................................................................................... 56
This is IEC 60601-2-50:2020 © IEC 2020
a preview – 33 –
of "S+ IEC 60601-2-50 Ed...". Click here to purchase the full version from the ANSI store.

COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE

____________

APPAREILS ÉLECTROMÉDICAUX –

Partie 2-50: Exigences particulières pour la sécurité

de base et les performances essentielles des appareils
de photothérapie pour nouveau-nés

AVANT-PROPOS
1) La Commission Electrotechnique Internationale (IEC) est une organisation mondiale de normalisation
composée de l'ensemble des comités électrotechniques nationaux (Comités nationaux de l’IEC). L’IEC a pour
objet de favoriser la coopération internationale pour toutes les questions de normalisation dans les domaines
de l'électricité et de l'électronique. A cet effet, l’IEC – entre autres activités – publie des Normes
internationales, des Spécifications techniques, des Rapports techniques, des Spécifications accessibles au
public (PAS) et des Guides (ci-après dénommés "Publication(s) de l’IEC"). Leur élaboration est confiée à des
comités d'études, aux travaux desquels tout Comité national intéressé par le sujet traité peut participer. Les
organisations internationales, gouvernementales et non gouvernementales, en liaison avec l’IEC, participent
également aux travaux. L’IEC collabore étroitement avec l'Organisation Internationale de Normalisation (ISO),
selon des conditions fixées par accord entre les deux organisations.
2) Les décisions ou accords officiels de l’IEC concernant les questions techniques représentent, dans la mesure
du possible, un accord international sur les sujets étudiés, étant donné que les Comités nationaux de l’IEC
intéressés sont représentés dans chaque comité d’études.
3) Les Publications de l’IEC se présentent sous la forme de recommandations internationales et sont agréées
comme telles par les Comités nationaux de l’IEC. Tous les efforts raisonnables sont entrepris afin que l’IEC
s'assure de l'exactitude du contenu technique de ses publications; l’IEC ne peut pas être tenue responsable de
l'éventuelle mauvaise utilisation ou interprétation qui en est faite par un quelconque utilisateur final.
4) Dans le but d'encourager l'uniformité internationale, les Comités nationaux de l’IEC s'engagent, dans toute la
mesure possible, à appliquer de façon transparente les Publications de l’IEC dans leurs publications nationales
et régionales. Toutes divergences entre toutes Publications de l’IEC et toutes publications nationales ou
régionales correspondantes doivent être indiquées en termes clairs dans ces dernières.
5) L’IEC elle-même ne fournit aucune attestation de conformité. Des organismes de certification indépendants
fournissent des services d'évaluation de conformité et, dans certains secteurs, accèdent aux marques de
conformité de l’IEC. L’IEC n'est responsable d'aucun des services effectués par les organismes de certification
indépendants.
6) Tous les utilisateurs doivent s'assurer qu'ils sont en possession de la dernière édition de cette publication.
7) Aucune responsabilité ne doit être imputée à l’IEC, à ses administrateurs, employés, auxiliaires ou
mandataires, y compris ses experts particuliers et les membres de ses comités d'études et des Comités
nationaux de l’IEC, pour tout préjudice causé en cas de dommages corporels et matériels, ou de tout autre
dommage de quelque nature que ce soit, directe ou indirecte, ou pour supporter les coûts (y compris les frais
de justice) et les dépenses découlant de la publication ou de l'utilisation de cette Publication de l’IEC ou de
toute autre Publication de l’IEC, ou au crédit qui lui est accordé.
8) L'attention est attirée sur les références normatives citées dans cette publication. L'utilisation de publications
référencées est obligatoire pour une application correcte de la présente publication.
9) L’attention est attirée sur le fait que certains des éléments de la présente Publication de l’IEC peuvent faire
l’objet de droits de brevet. L’IEC ne saurait être tenue pour responsable de ne pas avoir identifié de tels droits
de brevets et de ne pas avoir signalé leur existence.

La Norme internationale IEC 60601-2-50 a été établie par le sous-comité 62D: Appareils
électromédicaux, du comité d'études 62 de l’IEC: Équipements électriques dans la pratique
médicale.

Cette troisième édition annule et remplace la deuxième édition parue en 2009 et son
Amendement 1 (2016). Cette édition constitue une révision technique.

Cette édition inclut la modification technique majeure suivante par rapport à l'édition
précédente: nouvelle datation des références normatives.
 – 34 – IEC 60601-2-50:2020 © IEC 2020
This is a preview of "S+ IEC 60601-2-50 Ed...". Click here to purchase the full version from the ANSI store.
Le texte de cette Norme internationale est issu des documents suivants:

FDIS Rapport de vote

62D/1767/FDIS 62D/1775/RVD

Le rapport de vote indiqué dans le tableau ci-dessus donne toute information sur le vote ayant
abouti à l'approbation de cette Norme internationale.

La version française de la norme n’a pas été soumise au vote.

Ce document a été rédigé selon les Directives ISO/IEC, Partie 2.

Dans le présent document, les caractères d'imprimerie suivants sont utilisés:

– exigences et définitions: caractères romains;

– modalités d'essais: caractères italiques;
– indications de nature informative apparaissant hors des tableaux, comme les notes, les exemples et les
références: petits caractères. Le texte normatif à l'intérieur des tableaux est également en petits caractères;
– TERMES DEFINIS A L ’A RTICLE 3 DE LA NORME GENERALE , DE LA PRESENTE NORME PARTICULIERE
OU COMME NOTES : PETITES MAJUSCULES .

Concernant la structure du présent document, le terme:

– «article» désigne l'une des dix-sept sections numérotées dans la table des matières, avec
toutes ses subdivisions (par exemple, l'Article 7 inclut les paragraphes 7.1, 7.2, etc.);
– «paragraphe» désigne une subdivision numérotée d'un article (par exemple, 7.1, 7.2 et
7.2.1 sont tous des paragraphes appartenant à l'Article 7).

Dans le présent document, les références à des articles sont précédées du mot «Article» suivi
du numéro de l'article concerné. Dans la présente norme particulière, les références aux
paragraphes utilisent uniquement le numéro du paragraphe concerné.

Dans le présent document, la conjonction «ou» est utilisée avec la valeur d'un «ou inclusif»,
ainsi un énoncé est vrai si une combinaison des conditions, quelle qu'elle soit est vraie.

Les formes verbales utilisées dans la présente norme sont conformes à l'usage donné à
l'Article 7 des Directives ISO/IEC, Partie 2. Pour les besoins du présent document:

– «devoir» mis au présent de l'indicatif signifie que la satisfaction à une exigence ou à un

essai est impérative pour la conformité au présent document;
– «il convient/il est recommandé» signifie que la satisfaction à une exigence ou à un essai
est recommandée, mais n'est pas obligatoire pour la conformité au présent document;
– «pouvoir» mis au présent de l'indicatif est utilisé pour décrire un moyen admissible pour
satisfaire à une exigence ou à un essai.

Lorsqu'un astérisque (*) est utilisé comme premier caractère devant un titre, ou au début d'un
titre d'alinéa ou de tableau, il indique l'existence d'une recommandation ou d'une justification
à consulter à l’Annexe A.

Une liste de toutes les parties de la série IEC 60601, publiées sous le titre général: Appareils
électromédicaux, peut être consultée sur le site web de l’IEC.
This is IEC 60601-2-50:2020 © IEC 2020
a preview – 35 –
of "S+ IEC 60601-2-50 Ed...". Click here to purchase the full version from the ANSI store.
Le comité a décidé que le contenu de ce document ne sera pas modifié avant la date de
stabilité indiquée sur le site web de l'IEC sous «http://webstore.iec.ch» dans les données
relatives au document recherché. À cette date, le document sera

• reconduit,
• supprimé,
• remplacé par une édition révisée, ou
• amendé.
NOTE L'attention des utilisateurs du présent document est attirée sur le fait que les fabricants d'appareils et les
organismes d'essai peuvent avoir besoin d'une période transitoire après la publication d'une nouvelle
publication IEC, ou d'une publication amendée ou révisée, pour fabriquer des produits conformes aux nouvelles
exigences et pour adapter leurs équipements aux nouveaux essais ou aux essais révisés. Le comité recommande
que le contenu de cette publication soit entériné au niveau national au plus tôt 3 ans après la date de publication .
 – 36 – IEC 60601-2-50:2020 © IEC 2020
This is a preview of "S+ IEC 60601-2-50 Ed...". Click here to purchase the full version from the ANSI store.

INTRODUCTION

Les exigences minimales de sécurité spécifiées dans la présente norme particulière sont
considérées comme assurant un degré pratique de sécurité dans le fonctionnement des
APPAREILS DE PHOTOTHERAPIE POUR NOUVEAU - NES .
This is IEC 60601-2-50:2020 © IEC 2020
a preview – 37 –
of "S+ IEC 60601-2-50 Ed...". Click here to purchase the full version from the ANSI store.

APPAREILS ÉLECTROMÉDICAUX –

Partie 2-50: Exigences particulières pour la sécurité

de base et les performances essentielles des appareils
de photothérapie pour nouveau-nés

201.1 Domaine d’application, objet et normes connexes

L'Article 1 de la norme générale 1 s'applique avec les exceptions suivantes:

201.1.1 * Domaine d'application

Remplacement:

La présente partie de l'IEC 60601 s’applique à la SECURITE DE BASE et aux PERFORMANCES

ESSENTIELLES des APPAREILS DE PHOTOTHERAPIE POUR NOUVEAU - NES , tels que définis
au 201.3.203, également désignés sous le terme APPAREILS EM .

Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux

APPAREILS EM ou uniquement aux SYSTEMES EM , le titre et le contenu de cet article ou de ce
paragraphe l'indiquent. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois
aux APPAREILS EM et aux SYSTEMES EM , selon le cas.

Les DANGERS inhérents à la fonction physiologique prévue des APPAREILS EM ou des

SYSTEMES EM dans le cadre du domaine d'application du présent document ne sont pas
couverts par des exigences spécifiques contenues dans le présent document, à l'exception
de 7.2.13 et de 8.4.1 de la norme générale.

NOTE Voir aussi 4.2 de la norme générale.

La présente norme particulière spécifie les exigences de sécurité relatives aux APPAREILS DE
PHOTOTHERAPIE POUR NOUVEAU - NES , mais des méthodes alternatives de conformité à un article
spécifique, en démontrant un niveau équivalent de sécurité, ne sont pas considérées comme
non conformes, si le FABRICANT a démontré dans son DOSSIER DE GESTION DES RISQUES que le
RISQUE présenté par le DANGER s’est révélé avoir un niveau acceptable, lorsqu’il a été évalué
par rapport aux avantages du traitement présentés par le dispositif.

Le présent document ne s'applique pas aux:

– dispositifs délivrant de la chaleur par l'intermédiaire de COUVERTURES , COUSSINS ou

MATELAS en usage médical; voir l’IEC 60601-2-35 [1] 2 à titre informatif;

– INCUBATEURS POUR NOUVEAU - NES , voir l’IEC 60601-2-19 [2] à titre informatif;
– INCUBATEURS DE TRANSPORT POUR NOUVEAU - NES ; voir l’IEC 60601-2-20 [3] à titre informatif;
– INCUBATEURS RADIANTS POUR NOUVEAU - NES , voir l’IEC 60601-2-21 [4] à titre informatif.

—————————
1) La norme générale est constituée de l’IEC 60601-1:2005 et de l’IEC 60601-1:2005/AMD1:2012, Appareils
électromédicaux – Partie 1: Exigences générales pour la sécurité de base et les performances essentielles.
2 Les chiffres entre crochets se réfèrent à la Bibliographie.
 – 38 – IEC 60601-2-50:2020 © IEC 2020
This is a preview of "S+ IEC 60601-2-50 Ed...". Click here to purchase the full version from the ANSI store.

201.1.2 Objet

Remplacement:

L'objet de la présente norme particulière est d'établir des exigences particulières pour la
SECURITE DE BASE et les PERFORMANCES ESSENTIELLES des APPAREILS DE PHOTOTHERAPIE POUR
NOUVEAU - NES (définis au 201.3.203), qui réduisent le plus possible les DANGERS liés à la
sécurité pour les PATIENTS et les OPERATEURS , et de spécifier des essais pour démontrer la
conformité à ces exigences.

201.1.3 Normes collatérales

Addition:

La présente norme particulière se rapporte aux normes collatérales applicables répertoriées à

l’Article 2 de la norme générale et à l’Article 201.2 de la présente norme particulière.

L’IEC 60601-1-2:2014 s’applique telle que modifiée dans l’Article 202. L’IEC 60601-1-3 et
l’IEC 60601-1-10 ne s'appliquent pas. Toutes les autres normes collatérales publiées dans la
série IEC 60601-1 s’appliquent telles que publiées.

201.1.4 Normes particulières

Remplacement:

Dans la série IEC 60601, des normes particulières peuvent modifier, remplacer ou supprimer
des exigences contenues dans la norme générale et dans les normes collatérales en fonction
de ce qui est approprié à l' APPAREIL EM particulier à l’étude, et elles peuvent ajouter d’autres
exigences de SECURITE DE BASE et de PERFORMANCES ESSENTIELLES .

Une exigence d'une norme particulière prévaut sur l'exigence correspondante de la norme
générale.

Par souci de concision, dans la présente norme particulière, l’IEC 60601-1:2005 et

l’IEC 60601-1:2005/AMD1:2012 sont désignées par le terme «norme générale». Les normes
collatérales sont désignées par leur numéro de document.

La numérotation des articles et paragraphes de la présente norme particulière correspond à

celle de la norme générale avec le préfixe «201» (par exemple 201.1 dans le présent
document aborde le contenu de l'Article 1 de la norme générale) ou à celle de la norme
collatérale applicable avec le préfixe «20x», où x est le ou les derniers chiffres du numéro de
document de la norme collatérale (par exemple 202.4 dans la présente norme particulière
aborde le contenu de l'Article 4 de la norme collatérale IEC 60601-1-2, 203.4 dans la
présente norme particulière aborde le contenu de l'Article 4 de la norme collatérale
IEC 60601-1-3, etc.). Les modifications apportées au texte de la norme générale et des
normes collatérales applicables sont spécifiées en utilisant les termes suivants:

«Remplacement» signifie que l'article ou le paragraphe de la norme générale ou de la norme

collatérale applicable est remplacé complètement par le texte de la présente norme
particulière.

«Addition» signifie que le texte de la présente norme particulière vient s'ajouter aux
exigences de la norme générale ou de la norme collatérale applicable.

«Modification» signifie que l'article ou le paragraphe de la norme générale ou de la norme

collatérale applicable est modifié comme indiqué par le texte de la présente norme
particulière.
IEC 60601-2-50:2020 © IEC 2020 – 39 –

Les paragraphes, figures ou tableaux ajoutés à la norme générale sont numérotés à partir de
201.101. Toutefois, en raison du fait que les définitions dans la norme générale sont
numérotées 3.1 à 3.147, les définitions complémentaires dans le présent document sont
numérotées à partir de 201.3.201. Les annexes complémentaires sont nommées AA, BB, etc.,
et les points complémentaires aa), bb), etc.

Les paragraphes, figures ou tableaux ajoutés à une norme collatérale sont numérotés à partir
de 20x, où «x» est le chiffre de la norme collatérale, par exemple 202 pour l’IEC 60601-1-2,
203 pour l’IEC 60601-1-3, etc.

L'expression «le présent document» est utilisée pour se référer à la norme générale, à toutes
les normes collatérales applicables et à la présente norme particulière, considérées
ensemble.

Lorsque la présente norme particulière ne comprend pas d'article ou de paragraphe

correspondant, l'article ou le paragraphe de la norme générale ou de la norme collatérale
applicable, qui peut être sans objet, s'applique sans modification; lorsqu'il est demandé
qu'une partie quelconque de la norme générale ou de la norme collatérale applicable, bien
que pertinente, ne s'applique pas, cela est expressément mentionné dans la présente norme
particulière.

201.2 Références normatives

NOTE Une liste de références informatives est donnée dans la Bibliographie.

L'Article 2 de la norme générale s'applique avec les exceptions suivantes:

Addition:

IEC 60601-1:2005, Appareils électromédicaux – Partie 1: Exigences générales pour la

sécurité de base et les performances essentielles
IEC 60601-1:2005/AMD1:2012

Remplacement:

IEC 60601-1-2:2014, Appareils électromédicaux – Partie 1-2: Exigences générales pour la

sécurité de base et les performances essentielles – Norme collatérale: Perturbations
électromagnétiques – Exigences et essais

201.3 Termes et définitions

Pour les besoins du présent document, les termes et définitions de l’IEC 60601­1:2005 et
l’IEC 60601­1:2005/AMD1:2012, ainsi que les suivants s’appliquent.

L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées
en normalisation, consultables aux adresses suivantes:

• IEC Electropedia: disponible à l’adresse http://www.electropedia.org/

• ISO Online browsing platform: disponible à l’adresse http://www.iso.org/obp
NOTE Un index des termes définis est donné à partir de la page 61. Une liste des symboles, abréviations et
acronymes utilisés dans la présente norme particulière est donnée dans le Tableau 201.101.