EN IEC 60601-2-41:2021

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

IEC 60601-2-41:2021 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS, hereafter 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. This particular standard does not apply to – headlights; – endoscopes, laparoscopes and their light sources, which are covered by IEC 60601-2-18; – luminaires used in dentistry, which are covered by ISO 9680; – luminaires for general purposes, which are covered by IEC 60598-2-1 and IEC 60598-2-4; – luminaires dedicated to therapeutic purposes; – special purpose lights with different conditions of use such as light sources intended solely for decontamination of air and surfaces, UV lights for dermatological diagnosis, slit lamps for ophthalmology, lights for surgical microscopes and lights for surgical navigation systems; – lights connected to surgical instruments, such as luminous retractors; – luminaires for emergency lighting, which are covered by IEC 60598-2-22. SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS are medical devices and not general lighting equipment. IEC 60601-2-41:2021 cancels and replaces the second edition published in 2009 and Amendment 1:2013. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) revised the statement of essential performance; b) added exposure limits, test conditions, calculation methods and safety warnings related to photobiological hazards; c) removed the terms “MINOR SURGICAL LUMINAIRES” and “MAJOR SURGICAL LUMINAIRES”; d) added definitions of MAXIMUM ILLUMINANCE DISTANCE and REFERENCE DISTANCE and allowed MANUFACTURERS to measure some performance characteristics at the REFERENCE DISTANCE that they specify; e) replaced the region of acceptable chromaticity in (x,y) colour space with a requirement for Du,v; f) added a requirement for acceptable drift of the lighthead when attached to the suspension system; g) added a requirement for fluid ingress protection; h) revised Table 201.101 of IEC 60601-2-41:2009 and IEC 60601-2-41:2009/AMD1:2013 and moved it to Annex BB; i) specified a new device for measuring SHADOW DILUTION in a simulated cavity; j) specified test conditions for luminaires equipped with distance sensors.

Medizinische elektrische Geräte - Teil 2-41: Besondere Festlegungen für die grundlegende Sicherheit und die wesentlichen Leistungsmerkmale von Operationsleuchten und Untersuchungsleuchten

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

L'IEC 60601-2-41:2021 s’applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des ECLAIRAGES CHIRURGICAUX et des ECLAIRAGES DE DIAGNOSTIC, désignés ci-après sous le terme APPAREILS EM. Dans le cas où un article ou un paragraphe est spécifiquement prévu pour s’appliquer aux APPAREILS EM uniquement ou aux SYSTEMES EM uniquement, le titre et le contenu de cet article ou de ce paragraphe le mentionnent. Lorsque ce n’est pas le cas, l’article ou le paragraphe s’applique aux APPAREILS EM et aux SYSTEMES EM, le cas échéant. La présente norme particulière ne s’applique pas aux – lampes frontales; – endoscopes, laparoscopes et à leurs sources de lumière, qui sont couverts par l’IEC 60601-2-18; – éclairages utilisés pour les soins dentaires, qui sont couverts par l’ISO 9680; – luminaires à usage général, qui sont couverts par l’IEC 60598-2-1 et l’IEC 60598-2-4; – éclairages à usage thérapeutique; – lampes à usages spéciaux avec différentes conditions d’utilisation comme les sources de lumière destinées uniquement à la décontamination de l’air et des surfaces, lampes à ultraviolets pour diagnostic dermatologique, les lampes à fente pour l’ophtalmologie, les lampes pour microscopes chirurgicaux et les lampes pour systèmes de navigation chirurgicale; – lampes montées sur des instruments chirurgicaux, tels que les écarteurs lumineux; – luminaires pour éclairage de secours, qui sont couverts par l’IEC 60598-2-22. Les ECLAIRAGES CHIRURGICAUX et les ECLAIRAGES DE DIAGNOSTIC sont des dispositifs médicaux et non des appareils d’éclairage général. L'IEC 60601-2-41:2021 annule et remplace la deuxième édition parue en 2009 et l'Amendement 1:2013. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: a) révision des énoncés relatifs aux performances essentielles; b) ajout des limites d’exposition, des conditions d’essai, des méthodes de calcul et des avertissements de sécurité relatifs aux dangers photobiologiques; c) suppression des termes "ECLAIRAGES CHIRURGICAUX MINEURS" et "ECLAIRAGES CHIRURGICAUX MAJEURS"; d) ajout des définitions des termes DISTANCE D’ECLAIREMENT MAXIMAL et DISTANCE DE REFERENCE et permission aux FABRICANTS de mesurer certaines caractéristiques de performance à la distance de référence qu’ils spécifient; e) remplacement de la zone de chromaticité acceptable dans l’espace de couleur (x, y) par une exigence relative à Du,v; f) ajout d’une exigence relative à la dérive acceptable du projecteur lorsque celui-ci est fixé au système de suspension; g) ajout d’une exigence relative à la protection contre la pénétration d’un liquide; h) révision et déplacement à l’Annexe BB du Tableau 201.101 de l’IEC 60601-2-41:2009 et de l’IEC 60601-2-41:2009/AMD1:2013; i) spécification d’un nouvel appareil de mesure de l’ATTENUATION DE L’OMBRE dans une cavité simulée; j) spécification des conditions d’essai pour les éclairages équipés de capteurs de distance.

Medicinska električna oprema - 2-41. del: Posebne zahteve za osnovno varnost in bistvene lastnosti kirurških in diagnostičnih svetilk (IEC 60601-2-41:2021)

Ta del standarda IEC 60601 se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI KIRURŠKIH IN DIAGNOSTIČNIH SVETILK, v nadaljevanju »ELEKTROMEDICINSKA OPREMA«. Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME. Ta standard se ne uporablja za: – reflektorje; – endoskope, laparoskope in njihove svetlobne vire, ki so zajeti v standardu IEC 60601-2-18; – svetilke, ki se uporabljajo v zobozdravstvu in so zajete v standardu ISO 9680; – svetilke za splošne namene, ki jih zajemata IEC 60598-2-1 in IEC 60598-2-4; – svetilke za terapevtske namene; – luči za posebne namene z različnimi pogoji uporabe, kot so svetlobni viri, namenjeni izključno za dekontaminacijo zraka in površin, UV-luči za dermatološko diagnostiko, šprančne svetilke za oftalmologijo, luči za kirurške mikroskope in luči za kirurške navigacijske sisteme; – luči, povezane s kirurškimi instrumenti, kot so svetleči retraktorji; – svetilke za zasilno razsvetljavo, ki so zajete v standardu IEC 60598-2-22. OPOMBA: Glej tudi točko 4.2 splošnega standarda. KIRURŠKE in DIAGNOSTIČNE SVETILKE so medicinski pripomočki in ne splošna oprema za osvetlitev.

General Information

• Status: Published
• Publication Date: 16-Dec-2021
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 17-Dec-2021
• Completion Date: 17-Dec-2021
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/565 - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Mandate: M/MDR - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
• Ref Project: SIST EN IEC 60601-2-41:2022 - Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis (IEC 60601-2-41:2021)

Relations

• Replaces: EN 60601-2-41:2009/A1:2015 - Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis
• Effective Date: 23-Jan-2023
• Replaces: EN 60601-2-41:2009/A11:2011 - Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis
• Effective Date: 23-Jan-2023
• Replaces: EN 60601-2-41:2009 - Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis
• Effective Date: 07-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2022
Nadomešča:
SIST EN 60601-2-41:2010
SIST EN 60601-2-41:2010/A1:2015
SIST EN 60601-2-41:2010/A11:2012
Medicinska električna oprema - 2-41. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti kirurških in diagnostičnih svetilk (IEC 60601-2-41:2021)
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-
41:2021)
Medizinische elektrische Geräte - Teil 2-41: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Operationsleuchten und
Untersuchungsleuchten (IEC 60601-2-41:2021)
Appareils électromédicaux - Partie 2-41: Exigences particulières pour la sécurité de base
et les performances essentielles des éclairages chirurgicaux et des éclairages de
diagnostic (IEC 60601-2-41:2021)
Ta slovenski standard je istoveten z: EN IEC 60601-2-41:2021
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
11.040.55 Diagnostična oprema Diagnostic equipment
29.140.40 Svetila Luminaires
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 60101-2-41

NORME EUROPÉENNE
EUROPÄISCHE NORM December 2021
ICS 11.040.20; 11.040.55; 11.040.99 Supersedes EN 60601-2-41:2009 and all of its
amendments and corrigenda (if any)
English Version
Medical electrical equipment - Part 2-41: Particular requirements
for the basic safety and essential performance of surgical
luminaires and luminaires for diagnosis
(IEC 60601-2-41:2021)
Appareils électromédicaux - Partie 2-41: Exigences Medizinische elektrische Geräte - Teil 2-41: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des éclairages chirurgicaux et des éclairages wesentlichen Leistungsmerkmale von Operationsleuchten
de diagnostic und Untersuchungsleuchten
(IEC 60601-2-41:2021) (IEC 60601-2-41:2021)
This European Standard was approved by CENELEC on 2021-10-08. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60101-2-41:2021 E

EN IEC 60101-2-41:2021 (E)
European foreword
The text of document 62D/1859/FDIS, future edition 3 of IEC 60601-2-41, prepared by SC 62D
“Electromedical equipment” of IEC/TC 62 “Electrical equipment in medical practice” was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 60101-2-41:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022–07–08
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024–10–08
document have to be withdrawn
This document supersedes EN 60601-2-41:2009 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-2-41:2021 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60364-7-710:2002 NOTE Harmonized as HD 60364-7-710:2012 (modified)
IEC 60598-1 NOTE Harmonized as EN IEC 60598-1
IEC 60598-2-1 NOTE Harmonized as EN IEC 60598-2-1
IEC 60598-2-4 NOTE Harmonized as EN 60598-2-4
IEC 60598-2-22 NOTE Harmonized as EN 60598-2-22
IEC 60598-2-25 NOTE Harmonized as EN 60598-2-25
IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10
IEC 60601-2-18 NOTE Harmonized as EN 60601-2-18
IEC 60601-2-50 NOTE Harmonized as EN IEC 60601-2-50
ISO 9680 NOTE Harmonized as EN ISO 9680
EN IEC 60101-2-41:2021 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the
relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cenelec.eu.
The Annex ZA of EN 60601-1:2006 and EN 60601-1:2006/A1:2013 apply with the following changes:
Publication Year Title EN/HD Year
Add the following references:
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- -  + corrigendum Mar. 2010
+ A1 2012  + A1 2013
- -  + A12 2014
IEC 62471 (mod) 2006 Photobiological safety of lamps and lamp EN 62471 2008
systems
ISO/CIE 11664-1 - Colorimetry - Part 1: CIE standard EN ISO/CIE 11664-1 -
colorimetric observers
ISO/CIE 19476 2014 Characterization of the performance of - -
illuminance meters and luminance meters
ANSI C78.377 2017 Specifications for the Chromaticity of Solid - -
State Lighting (SSL) Products
CIE 13.3 1995 Method of measurement and specifying - -
colour rendering properties of light sources
CIE 15 2018 Colorimetry - -
Replace the following references:
IEC 60529 1989 Degrees of protection provided by EN 60529 1991
enclosures (IP Code)
- -  + corrigendum May 1993
+ A1 1999  + A1 2000
+ A2 2013  + A2 2013
EN IEC 60101-2-41:2021 (E)
IEC 60601-1-2 2014 Medical electrical equipment - Part 1–2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
IEC 60601-1-6 2010 Medical electrical equipment - Part 1–6: EN 60601-1-6 2010
General requirements for basic safety and
essential performance - Collateral
standard: Usability
IEC 60601-2-41 ®
Edition 3.0 2021-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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 978-2-8322-1001-3

– 2 – IEC 60601-2-41:2021 © IEC 2021
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 10
201.4 General requirements . 15
201.5 General requirements for testing ME EQUIPMENT . 15
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 16
201.7 ME EQUIPMENT identification, marking and documents . 17
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 19
201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS . 19
201.10 * Protection against unwanted and excessive radiation HAZARDS . 23
201.11 Protection against excessive temperatures and other HAZARDS . 38
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 40
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 41
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 41
201.15 Construction of ME EQUIPMENT . 41
201.16 ME SYSTEMS . 41
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 42
Annexes . 43
Annex AA (informative) Particular guidance and rationale . 44
Annex BB (informative) Requirements for SURGICAL LUMINAIRES and LUMINAIRES FOR
DIAGNOSIS . 50
Annex CC (informative) Technical information for conducting tests . 52
Bibliography . 58
Index of defined terms used in this particular standard . 59

Figure 201.101 – Examples of providing power to a SURGICAL LUMINAIRE . 11
Figure 201.102 – Examples of different distance and illuminance terms . 14
Figure 201.103 – DETACHABLE HANDLE attachment and detachment tests . 20
Figure 201.104 – Test for ease of motion . 22
Figure 201.105 – Light distribution . 25
Figure 201.106 – CENTRAL ILLUMINANCE measurement . 26
Figure 201.107 – Measurements for determining LIGHT FIELD DIAMETERs d and d . 26
10 50
Figure 201.108 – Illuminance measurement with one mask . 27
Figure 201.109 – Illuminance measurement with two masks . 28
Figure 201.110 – Illuminance measurement with four different positions of two masks . 29
Figure 201.111 – Simulated cavity for illuminance measurements . 30
Figure 201.112 – Illuminance measurement at the bottom of a simulated cavity, with
one mask . 30
Figure 201.113 – Illuminance measurement at the bottom of a simulated cavity, with
two masks. 31
Figure 201.114 – Illuminance measurement at the bottom of a simulated cavity, with
four different positions of two masks . 32

IEC 60601-2-41:2021 © IEC 2021 – 3 –
Figure 201.115 – Measurement of DEPTH OF ILLUMINATION . 33
Figure 201.116 – Caution symbol for hot surface . 39
Figure CC.1 – Location of the illuminance meter and ma
...