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)

This part of IEC 60601 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.
NOTE See also 4.2 of the general standard.
SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS are medical devices and not general
lighting equipment.

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)

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
06-Jan-2022
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
24-Dec-2021
Due Date
28-Feb-2022
Completion Date
07-Jan-2022

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SLOVENSKI STANDARD
SIST EN IEC 60601-2-41:2022
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
SIST EN IEC 60601-2-41:2022 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN IEC 60601-2-41:2022
---------------------- Page: 2 ----------------------
SIST EN IEC 60601-2-41:2022
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
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SIST EN IEC 60601-2-41:2022
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
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SIST EN IEC 60601-2-41:2022
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
---------------------- Page: 5 ----------------------
SIST EN IEC 60601-2-41:2022
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
---------------------- Page: 6 ----------------------
SIST EN IEC 60601-2-41:2022
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

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

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 7 ----------------------
SIST EN IEC 60601-2-41:2022
– 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

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SIST EN IEC 60601-2-41:2022
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 mask on the luminaire ......................... 54

Figure CC.2 – Movement of the illuminance meter and mask on the luminaire ...................... 55

Figure CC.3 – Location of the spectrometer and mask on the luminaire ................................ 55

Figure CC.4 – Test conditions for measuring illuminance at 500 mm ..................................... 56

Figure CC.5 – Test method for maintaining the measurement distance ................................. 56

Table 23 – Allowable maximum temperatures for ME EQUIPMENT parts that are likely to

be touched ............................................................................................................................ 39

Table AA.1 – Summary of photobiological HAZARDS and exposure limits ................................ 45

Table BB.1 – Summary of requirements for SURGICAL LUMINAIRES and LUMINAIRES FOR

DIAGNOSIS ............................................................................................................................. 50

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SIST EN IEC 60601-2-41:2022
– 4 – IEC 60601-2-41:2021 © IEC 2021
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,

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.

IEC 60601-2-41 has been prepared by subcommittee 62D: Electromedical equipment, of IEC

technical committee 62: Electrical equipment in medical practice. It is an International Standard.

An annex in this publication contains an embedded Microsoft Excel file intended to help in

organizing data and calculating exposures associated with photobiological HAZARDS. This file is

intended to be used as a complement and does not form an integral part of the publication.

This third edition 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”;

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SIST EN IEC 60601-2-41:2022
IEC 60601-2-41:2021 © IEC 2021 – 5 –

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

D ;
u,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.
The text of this International Standard is based on the following documents:
FDIS Report on voting
62D/1859/FDIS 62D/1879/RVD

Full information on the voting for its approval can be found in the report on voting indicated in

the above table.
The language used for the development of this International Standard is English.

This document has been drafted in accordance with the ISO/IEC Directives, Part 2, and

developed in accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC

Supplement, available at www.iec.ch/members_experts/refdocs. The main document types

developed by IEC are described in greater detail at www.iec.ch/standardsdev/publications.

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 CLAUSE 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.
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SIST EN IEC 60601-2-41:2022
– 6 – IEC 60601-2-41:2021 © IEC 2021

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.

The committee has decided that the contents of this document will remain unchanged until the

stability date indicated on the IEC website under webstore.iec.ch in the data related to the

specific publication. 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 committees 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 publication using a colour printer.

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SIST EN IEC 60601-2-41:2022
IEC 60601-2-41:2021 © IEC 2021 – 7 –
INTRODUCTION

This particular standard concerns the basic safety and essential performance of SURGICAL

LUMINAIRES and LUMINAIRES FOR DIAGNOSIS.

It amends and supplements IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, hereinafter

referred to as the "general standard".

The requirements of this particular standard take priority over those of the general standard.

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SIST EN IEC 60601-2-41:2022
– 8 – IEC 60601-2-41:2021 © IEC 2021
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-41: Particular requirements for the basic safety and essential
performance of surgical luminaires and luminaires for diagnosis
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:

This part of IEC 60601 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.
NOTE See also 4.2 of the general standard.

SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS are medical devices and not general

lighting equipment.
201.1.2 Object
Replacement:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL

PERFORMANCE requirements for SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS as defined

in 201.3.
___________

The general standard is IEC 60601-1 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment – Part 1:

General requirements for basic safety and essential performance.
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SIST EN IEC 60601-2-41:2022
IEC 60601-2-41:2021 © IEC 2021 – 9 –
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 60601-1-3, IEC 60601-1-10, IEC 60601-1-11 and IEC 60601-1-12 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 standard 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 particular standard addresses the content of Clause 4 of the IEC 60601-1-3 collateral

standard, etc.). The changes to the text of the general standard and applicable collateral

standards are specified using 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 particul
...

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