IEC 60601-2-50:2009

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

IEC 60601-2-50:2009 establishes particular basic safety and essential performance requirements for infant phototherapy equipment, which reduce the safety hazards to patients and operators as much as possible, and specifies tests for demonstrating compliance with these requirements. This second edition cancels and replaces the first edition published in 2000. This edition constitutes a technical revision. The main purpose of this new edition 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 contents of the corrigendum of August 2010 have been included in this copy.

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

La CEI 60601-2-50:2009 établit des exigences particulières pour la sécurité de base et les performances essentielles des appareils de photothérapie pour nouveau-nés, afin de réduire autant que possible les dangers pour les patients et les opérateurs, et spécifie des essais pour démontrer la conformité à ces exigences. Cette deuxième édition annule et remplace la première édition parue en 2000. Cette édition constitue une révision technique. L'objectif principal de cette nouvelle édition est d'assurer la cohérence avec la troisième édition de la norme générale. De plus, la présente édition assure la cohérence avec les quatre autres normes particulières relatives aux appareils pédiatriques dont le comité est responsable. Le contenu du corrigendum d'août 2010 a été pris en considération dans cet exemplaire.

General Information

• Status: Published
• Publication Date: 23-Mar-2009
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: MT 21 - TC 62/SC 62D/MT 21
• Current Stage: DELPUB - Deleted Publication
• Start Date: 28-Dec-2018
• Completion Date: 02-Sep-2020

Relations

• Amended By: IEC 60601-2-50:2009/AMD1:2016 - Amendment 1 - Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
• Effective Date: 05-Sep-2023
• Corrected By: IEC 60601-2-50:2009/COR1:2010 - Corrigendum 1 - Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
• Effective Date: 05-Sep-2023
• Revised: IEC 60601-2-50:2020 - Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-50:2000 - Medical electrical equipment - Part 2-50: Particular requirements for the safety of infant phototherapy equipment
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-50:2000/COR1:2001 - Corrigendum 1 - Medical electrical equipment - Part 2-50: Particular requirements for the safety of infant phototherapy equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

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

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by
any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or
IEC's member National Committee in the country of the requester.
If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,
please contact the address below or your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de la CEI ou du Comité national de la CEI du pays du demandeur.
Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette
publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.

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About the IEC
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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 978-2-88910-225-9
– 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,
incl
...

IEC 60601-2-50 ®
Edition 2.1 2016-04
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-50: Particular requirements for the basic safety and essential performance
of infant phototherapy equipment

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

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form

or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from

either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or

your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie

et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des

questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.

IEC Central Office Tel.: [phone]
3, rue de Varembé Fax: [phone]
CH-1211 Geneva 20 [e-mail]
Switzerland www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.

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Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

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IEC 60601-2-50 ®
Edition 2.1 2016-04
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 2-50: Particular requirements for the basic safety and essential

performance of infant phototherapy equipment

Appareils électromédicaux –
Partie 2-50: Exigences particulières pour la sécurité de base et les

performances essentielles des appareils de photothérapie pour nouveau-nés

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.60 ISBN 978-2-8322-3380-1

IEC 60601-2-50 ®
Edition 2.1 2016-04
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 2-50: Particular requirements for the basic safety and essential performance
of infant phototherapy equipment

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

– 2 – IEC 60601-2-50:2009+AMD1:2016 CSV
© IEC 2016
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

© IEC 2016
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.
This Consolidated version of IEC 60601-2-50 bears the edition number 2.1. It consists
of This consolidated version of the official IEC Standard and its amendment has been
prepared for user convenience.
IEC 60601-2-50 edition 2.1 contains the second edition (2009-03) [documents 62D/736A/
FDIS and 62D/765/RVD], its corrigendum 1 (2010-08) and its amendment 1 (2016-04)
[documents 62D/1327/FDIS and 62D/1348/RVD].
In this Redline version, a
...