IEC 60601-2-41:2009

Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis

IEC 60601-2-41:2009 applies to the basic safety and essential performance of surgical luminaires and luminaires for diagnosis. It amends and supplements IEC 60601-1 (third Edition 2005), hereinafter referred to as the general standard. This second edition cancels and replaces the first edition published in 2000. This edition constitutes a technical revision to be consistent with the third edition of the IEC 60601-1.

Appareils électromédicaux - Partie 2-41: Exigences particulières pour la sécurité de base et les performances essentielles des éclairages chirurgicaux et des éclairages de diagnostic

La CEI 60601-2-41:2009 s'applique à la sécurité de base et aux performances essentielles des éclairages chirurgicaux et des éclairages de diagnostic. Elle modifie et complète la CEI 60601-1 (troisième édition 2005), appelée norme générale dans la présente Norme. Cette deuxième édition annule et remplace la première édition publiée en 2000. Cette édition constitue une révision technique permettant l'alignement de la norme sur la troisième édition de la CEI 60601-1.

General Information

• Status: Published
• Publication Date: 28-Oct-2013
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: MT 27 - TC 62/SC 62D/MT 27
• Current Stage: DELPUB - Deleted Publication
• Start Date: 23-Feb-2018
• Completion Date: 03-Sep-2021

Relations

• Amended By: IEC 60601-2-41:2009/AMD1:2013 - Amendment 1 - Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-41:2000 - Medical electrical equipment - Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-41 ®
Edition 2.0 2009-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-41: Particular requirements for the basic safety and essential performance
of surgical luminaires and luminaires for diagnosis

Appareils électromédicaux –
Partie 2-41: Exigences particulières pour la sécurité de base et les performances
essentielles des éclairages chirurgicaux et des éclairages de diagnostic

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
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

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IEC 60601-2-41 ®
Edition 2.0 2009-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-41: Particular requirements for the basic safety and essential
performance of surgical luminaires and luminaires for diagnosis

Appareils électromédicaux –
Partie 2-41: Exigences particulières pour la sécurité de base et les
performances essentielles des éclairages chirurgicaux et des éclairages de
diagnostic
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
W
CODE PRIX
ICS 11.040.20; 11.040.55; 11.040.99 ISBN 978-2-88910-222-8
– 2 – 60601-2-41 © IEC:2009
CONTENTS
FOREWORD.4
INTRODUCTION.6
201.1 Scope, object and related standards.7
201.2 Normative references .8
201.3 Terms and definitions .9
201.4 General requirements.12
201.5 General requirements for testing of ME EQUIPMENT .13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .13
201.7 ME EQUIPMENT Identification, marking and documents.14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT .15
201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS .15
201.10 Protection against unwanted and excessive radiation HAZARDS .18
201.11 Protection against excessive temperatures and other HAZARDS .18
201.12 Accuracy of controls and instruments and protection against hazardous
outputs .19
201.13 HAZARDOUS SITUATIONS and fault conditions .33
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).33
201.15 Construction of ME EQUIPMENT .33
201.16 ME SYSTEMS .33
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS.33
Annex AA (informative) Guidance and rationale for particular clauses and subclauses.35
Bibliography.38
Index of defined terms .39

Figure 201.101 – Example of power supplies for SURGICAL LUMINAIRES .10
Figure 201.102 – DETACHABLE HANDLE attachment and detachment tests.16
Figure 201.103 – Test for ease of motion.17
Figure 201.104 – Light distribution.22
Figure 201.105 – CENTRAL ILLUMINANCE measurement.24
Figure 201.106 – Measurements of LIGHT FIELD DIAMETER and diameter at 50 % of
CENTRAL ILLUMINANCE .24
Figure 201.107 – Illuminance measurement with one mask.25
Figure 201.108 – Illuminance measurement with two masks .25
Figure 201.109 – Illuminance measurement with four different positions of the two
masks.26
Figure 201.110 – Tube for illuminance measurement .27
Figure 201.111 – Detail of the inner surface of the tube (example) .27
Figure 201.112 – Illuminance measurement at the bottom of a cavity, with one mask .28
Figure 201.113 – Illuminance measurement at the bottom of a cavity, with two masks .29
Figure 201.114 – Illuminance measurement at the bottom of a cavity, with four different
positions of the two masks.30
Figure 201.115 – Measurement of DEPTH OF ILLUMINATION .31
Figure AA.1 – Changeover cycle to an emergency backup system .36

60601-2-41 © IEC:2009 – 3 –
Table 201.101 – Classification of SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS.12
Table 201.102 – Distributed ESSENTIAL PERFORMANCE requirements .13
Table 201.103 – Allowable maximum temperatures for ME EQUIPMENT parts that are
likely to be touched.19

– 4 – 60601-2-41 © IEC:2009
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-41: Particular requirements for the basic safety and essential
performance of surgical luminaires and luminaires for diagnosis

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, 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 60601-2-41 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 to be consistent with the third edition of the IEC 60601-1.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/773/FDIS 62D/787/RVD
Fu
...

IEC 60601-2-41 ®
Edition 2.1 2013-10
CONSOLIDATED
VERSION
VERSION
CONSOLIDÉE
colour
inside
Medical electrical equipment –
Part 2-41: Particular requirements for the basic safety and essential performance
of surgical luminaires and luminaires for diagnosis

Appareils électromédicaux –
Partie 2-41: Exigences particulières pour la sécurité de base et les performances
essentielles des éclairages chirurgicaux et des éclairages de diagnostic

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.

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.

Useful links:
IEC publications search - www.iec.ch/searchpub Electropedia - www.electropedia.org
The advanced search enables you to find IEC publications The world's leading online dictionary of electronic and
by a variety of criteria (reference number, text, technical electrical terms containing more than 30 000 terms and
committee,…). definitions in English and French, with equivalent terms in
It also gives information on projects, replaced and additional languages. Also known as the International
withdrawn publications. Electrotechnical Vocabulary (IEV) on-line.

IEC Just Published - webstore.iec.ch/justpublished Customer Service Centre - webstore.iec.ch/csc
Stay up to date on all new IEC publications. Just Published If you wish to give us your feedback on this publication
details all new publications released. Available on-line and or need further assistance, please contact the
also once a month by email. Customer Service Centre: [e-mail].

A propos de la CEI
La Commission Electrotechnique Internationale (CEI) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications CEI
Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possédez
l’édition la plus récente, un corrigendum ou amendement peut avoir été publié.

Liens utiles:
Recherche de publications CEI - www.iec.ch/searchpub Electropedia - www.electropedia.org
La recherche avancée vous permet de trouver des Le premier dictionnaire en ligne au monde de termes
publications CEI en utilisant différents critères (numéro de électroniques et électriques. Il contient plus de 30 000
référence, texte, comité d’études,…). termes et définitions en anglais et en français, ainsi que
Elle donne aussi des informations sur les projets et les les termes équivalents dans les langues additionnelles.
publications remplacées ou retirées. Egalement appelé Vocabulaire Electrotechnique
International (VEI) en ligne.
Just Published CEI - webstore.iec.ch/justpublished
Service Clients - webstore.iec.ch/csc
Restez informé sur les nouvelles publications de la CEI.
Just Published détaille les nouvelles publications parues. Si vous désirez nous donner des commentaires sur
Disponible en ligne et aussi une fois par mois par email. cette publication ou si vous avez des questions
contactez-nous: [e-mail].
IEC 60601-2-41 ®
Edition 2.1 2013-10
CONSOLIDATED
VERSION
VERSION
CONSOLIDÉE
colour
inside
Medical electrical equipment –

Part 2-41: Particular requirements for the basic safety and essential performance

of surgical luminaires and luminaires for diagnosis

Appareils électromédicaux –
Partie 2-41: Exigences particulières pour la sécurité de base et les performances

essentielles des éclairages chirurgicaux et des éclairages de diagnostic

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.20; 11.040.55; 11.040.99 ISBN 978-2-8322-1184-7

IEC 60601-2-41 ®
Edition 2.1 2013-10
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 2-41: Particular requirements for the basic safety and essential performance
of surgical luminaires and luminaires for diagnosis

Appareils électromédicaux –
Partie 2-41: Exigences particulières pour la sécurité de base et les performances
essentielles des éclairages chirurgicaux et des éclairages de diagnostic

– 2 – 60601-2-41  IEC:2009+A1:2013

CONTENTS
FOREWORD . 4

INTRODUCTION . 6

INTRODUCTION TO THE AMENDMENT . 7

201.1 Scope, object and related standards . 8

201.2 Normative references . 9

201.3 Terms and definitions . 10

201.4 General requirements . 14

201.5 General requirements for testing of ME EQUIPMENT . 14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 14
201.7 ME EQUIPMENT Identification, marking and documents. 15
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 16
201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS . 16
201.10 Protection against unwanted and excessive radiation HAZARDS . 20
201.11 Protection against excessive temperatures and other HAZARDS . 20
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 21
201.13 HAZARDOUS SITUATIONS and fault conditions . 34
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 34
201.15 Construction of ME EQUIPMENT . 34
201.16 ME SYSTEMS . 34
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 34
Annex AA (informative) Guidance and rationale for particular clauses and subclauses. 36
Bibliography . 39
Index of defined terms . 40

Figure 201.101 – Example of power supplies for SURGICAL LUMINAIRES . 11
Figure 201.102 – DETACHABLE HANDLE attachment and detachment tests . 17
Figure 201.103 – Test for ease of motion . 19
Figure 201.104 – Light distribution . 23
Figure 201.105 – CENTRAL ILLUMINANCE measurement . 25

Figure 201.106 – Measurements of LIGHT FIELD DIAMETER and diameter at 50 % of
CENTRAL ILLUMINANCE . 25
Figure 201.107 – Illuminance measurement with one mask . 26
Figure 201.108 – Illuminance measurement with two masks . 26
Figure 201.109 – Illuminance measurement with four different positions of the two
masks . 27
Figure 201.110 – Tube for illuminance measurement . 28
Figure 201.111 – Detail of the inner surface of the tube (example) . 28
Figure 201.112 – Illuminance measurement at the bottom of a cavity, with one mask . 29
Figure 201.113 – Illuminance measurement at the bottom of a cavity, with two masks . 30
Figure 201.114 – Illuminance measurement at the bottom of a cavity, with four different
positions of the two masks . 31
Figure 201.115 – Measurement of DEPTH OF ILLUMINATION . 32

60601-2-41  IEC:2009+A1:2013 – 3 –

Figure AA.1 – Changeover cycle to an emergency backup system . 38

Table 201.101 – Classification of SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS. 13

Table 201.102 – Distributed ESSENTIAL PERFORMANCE requirements . 13

Table 201.103 – Allowable maximum temperatures for ME EQUIPMENT parts that are

likely to be touched . 20

– 4 – 60601-2-41  IEC:2009+A1:2013

INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-41: Particular requirements for the basic safety and essential

performance of surgical luminaires and luminaires for diagnosis

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, 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, whet
...