SIST EN IEC 60601-2-41:2022

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 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

– 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”;

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.

– 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.

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.

– 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.

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 particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of the
general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, since definitions in the general standard are
numbered 3.1 through 3.147, additional definitions in this document are numbered beginning
from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses or figures which are additional to those of a collateral standard are numbered
starting from 20x, where "x" is the number of the collateral standard, e.g. 202 for IEC 60601‑1‑2,
203 for IEC 60601-1-3, etc.
The term "this document" is used to refer to the general standard, any applicable collateral
standards and this particular standard taken together.

– 10 – IEC 60601-2-41:2021 © IEC 2021
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general standard
or applicable collateral standard, although possibly relevant, is not to be applied, a statement
to that effect is given in this particular standard.
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of the general standard applies, except as follows:
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 62471:2006, Photobiological safety of lamps and lamp systems
ISO/CIE 11664-1, Colorimetry – Part 1: CIE standard 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 Measuring and Specifying Colour Rendering Properties of Light
Sources
CIE 15:2018, Colorimetry
Replacement:
IEC 60529:1989, Degrees of protection provided by enclosures (IP Code)
IEC 60529:1989/AMD1:1999
IEC 60529:1989/AMD2:2013
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral Standard: Electromagnetic disturbances –
Requirements and tests
IEC 60601-1-6:2014, Medical electrical equipment – Part 1-6: General requirements for basic
safety and essential performance – Collateral standard: Usability
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012 and the following apply:
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp

IEC 60601-2-41:2021 © IEC 2021 – 11 –
NOTE An index of defined terms is found on page 55.
201.3.63
MEDICAL ELECTRICAL EQUIPMENT
ME EQUIPMENT
Addition:
NOTE 101 See Figure 201.101 as an example of possible ways in which power can be supplied to a SURGICAL
LUMINAIRE.
Figure 201.101 – Examples of providing power to a SURGICAL LUMINAIRE
Additional terms and definitions:
201.3.201
CENTRAL ILLUMINANCE
E
C,Ref
illuminance at the REFERENCE DISTANCE (D ) at the LIGHT FIELD CENTRE (LFC)
Ref
SEE: Figure 201.102.
– 12 – IEC 60601-2-41:2021 © IEC 2021
201.3.202
DEPTH OF ILLUMINATION ABOVE 60 %
distance along the beam axis at which the illuminance reaches at least 60 % of the CENTRAL
ILLUMINANCE (E )
C,Ref
201.3.203
DETACHABLE HANDLE
ACCESSORY that is intended to be grasped by the user to allow positioning and adjustment of
the luminaire, and which can be removed from the ME EQUIPMENT
Note 1 to entry: The DETACHABLE HANDLE can be sterilisable to allow it to be contacted directly without compromising
aseptic technique. A single-use handle cover is not considered a DETACHABLE HANDLE.
201.3.204
LIGHT FIELD CENTRE
LFC
point of maximum illuminance in a plane perpendicular to the beam direction
Note 1 to entry: The LIGHT FIELD CENTRE is the reference point for measurements of the spatial distribution of the
light field.
201.3.205
LIGHT FIELD DIAMETER
d
average distance along lines through the LIGHT FIELD CENTRE between points where the
illuminance reaches 10 % of E
C,Ref
Note 1 to entry: This definition does not require or imply that the light field is round.
201.3.206
LUMINAIRE FOR DIAGNOSIS
luminaire to illuminate the body of the PATIENT locally to support treatment and diagnosis which
could be interrupted without causing a HAZARDOUS SITUATION for the PATIENT
Note 1 to entry: A LUMINAIRE FOR DIAGNOSIS is not intended to be used for surgery. See Annex BB for a summary of
the differences in requirements between those for a LUMINAIRE FOR DIAGNOSIS and those for a SURGICAL LUMINAIRE.
201.3.207
MAXIMUM CENTRAL ILLUMINANCE
E
C,MI
maximum value of illuminance at the LIGHT FIELD CENTRE
SEE: Figure 201.102.
Note 1 to entry: E is obtained at the maximum illuminance distance with the MAXIMUM IRRADIANCE SETTINGS of
C,MI
the ME EQUIPMENT.
201.3.208
* MAXIMUM ILLUMINANCE DISTANCE
D
MI
distance from the light emitting surface of the ME EQUIPMENT to the position along the luminaire
axis where the illuminance reaches its maximum value, but not less than 200 mm
SEE: Figure 201.102.
Note 1 to entry: The MAXIMUM ILLUMINANCE DISTANCE is determined by measuring the illuminance over a range of
distances.
IEC 60601-2-41:2021 © IEC 2021 – 13 –
Note 2 to entry: The MAXIMUM ILLUMINANCE DISTANCE is the distance at which measurements of exposures related
to safety are taken.
201.3.209
MAXIMUM IRRADIANCE SETTINGS
settings of the ME EQUIPMENT that provide the highest irradiance at the MAXIMUM ILLUMINANCE
DISTANCE
Note 1 to entry: Such settings, if adjustable, can include LIGHT FIELD DIAMETER, correlated colour temperature,
illuminance level, operating mode, etc.
Note 2 to entry: There can be different MAXIMUM IRRADIANCE SETTINGS for different types of risks, such as total,
actinic UV, UV-A, blue light and retinal thermal irradiance HAZARDS.
Note 3 to entry: The MANUFACTURER shall identify the MAXIMUM IRRADIANCE SETTINGS for each risk.
201.3.210
MAXIMUM RADIANCE SETTINGS
settings of the ME EQUIPMENT that provide the highest radiance
Note 1 to entry: Such settings, if adjustable, can include LIGHT FIELD DIAMETER, correlated colour temperature,
illuminance level, operating mode, etc.
Note 2 to entry: There can be different MAXIMUM RADIANCE SETTINGS for different types of risks, such as blue light
and retinal thermal radiance HAZARDS.
Note 3 to entry: The MANUFACTURER shall identify the MAXIMUM RADIANCE SETTINGS for each risk.
201.3.211
REFERENCE DISTANCE
D
Ref
distance from the light emitting surface of the ME EQUIPMENT at which reference measurements
of light performance characteristics are taken
Note 1 to entry: See Figure 201.102 and Figure 201.103, and definitions 201.3.201 for CENTRAL ILLUMINANCE
(E ), 201.3.207 for MAXIMUM CENTRAL ILLUMINANCE (E ), and 201.3.208 for MAXIMUM ILLUMINANCE DISTANCE
C,Ref C,MI
(D ).
MI
Note 2 to entry: The REFERENCE DISTANCE is specified by the MANUFACTURER.

– 14 – IEC 60601-2-41:2021 © IEC 2021

For D > D
MI Ref
For D < D
MI Ref
Figure 201.102 – Examples of different distance and illuminance terms
201.3.212
SHADOW DILUTION
ability of the ME EQUIPMENT to minimise the impact of shadows in the working area due to the
partial obstruction by the OPERATOR of the emitted light
201.3.213
SURGICAL LUMINAIRE
ME EQUIPMENT that emits a beam of light that can be aimed independently of other light beams
to provide illumination for surgery
Note 1 to entry: A SURGICAL LUMINAIRE may not be SINGLE FAULT SAFE by itself, but when used together with at least
one other SURGICAL LUMINAIRE, the resulting SURGICAL LUMINAIRE SYSTEM shall be SINGLE FAULT SAFE. See Table BB.1.
201.3.214
SURGICAL LUMINAIRE SYSTEM
combination of multiple SURGICAL LUMINAIRES that is SINGLE FAULT SAFE and intended to be used
during surgery to support treatment and diagnosis of the PATIENT

IEC 60601-2-41:2021 © IEC 2021 – 15 –
Note 1 to entry: A SURGICAL LUMINAIRE SYSTEM is SINGLE FAULT SAFE and provides adequate central illuminance to
locally illuminate the body of the PATIENT even in a single fault condition.
Note 2 to entry: A SURGICAL LUMINAIRE SYSTEM is not a system in the sense of Clause 16 of the general standard
(ME SYSTEMS).
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Addition:
The ESSENTIAL PERFORMANCE of a SURGICAL LUMINAIRE is the delivery of sufficient light to the
operating field, while limiting the delivery of radiant energy to the operating field and its
observers. This is achieved by providing the capability to deliver CENTRAL ILLUMINANCE of at
least 40 klx, while ensuring that the total irradiance at the LIGHT FIELD CENTRE at the MAXIMUM
ILLUMINANCE DISTANCE does not exceed 700 W/m .
NOTE 101 There is no ESSENTIAL PERFORMANCE for a LUMINAIRE FOR DIAGNOSIS since, by definition, its performance
can be interrupted without causing a HAZARDOUS SITUATION for the PATIENT (see 201.3.206).
NOTE 102 ESSENTIAL PERFORMANCE is maintained by restoring illumination within 1 s according to the requirements
of 201.13.1.101 in the event of a SINGLE FAULT CONDITION. If the RISK MANAGEMENT FILE identifies that the MAXIMUM
ILLUMINANCE DISTANCE does not change because of a SINGLE FAULT CONDITION, then it is acceptable to use the
MAXIMUM ILLUMINANCE DISTANCE prior to the SINGLE FAULT CONDITION to verify that ESSENTIAL PERFORMANCE has been
maintained.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.4 Other conditions
Additional items:
aa) In order to measure stabilised performance, measurements shall be made after an ageing
period not to exceed 1 000 h for which both the operating conditions and the duration are
specified by the MANUFACTURER.
bb) Measurements of the luminaire shall be made after a warm-up period such that
illuminance is changing less than 1 % in 30 min.
cc) All measurements shall be made with the beam axis of the luminaire directed vertically
down, unless indicated otherwise.
dd) Measurements shall be made with an illuminance due to the surrounding light (light not
produced by the ME EQUIPMENT) less than 500 lx.
ee) In the case of SURGICAL LUMINAIRE SYSTEMS with several different types of luminaires, all
measurements shall be made for each representative type of luminaire.
ff) All tests shall be performed without any additional user-initiated adjustments (such as
manual re-focusing) between testing of various quantities.
gg) Tests shall be performed with each user-selectable automated adjustment (technology
that senses and responds to the external environment without user interaction, if so
equipped) both enabled and disabled during the tests, if such adjustments affect
measured performance.
hh) If the light field and/or the illuminance are adjustable, they shall be set such that the
maximum illuminance is produced, unless indicated otherwise.

– 16 – IEC 60601-2-41:2021 © IEC 2021
ii) The errors of the illuminance meter, according to ISO/CIE 19476:2014, shall not exceed
the following values:
f’ : 3 %
u: 1 %
r: 1 %
f : 1 %
f : 0,5 %
jj) The diameter of the aperture of the meter shall not exceed
– 20 mm for photometric and radiometric measurements, and
– 30 mm for spectral measurements used to determine chromaticity and colour
rendering, unless photometric and radiometric quantities are calculated from these
spectral measurements, in which case the 20 mm limit for the diameter of the
sensitive area of the meter shall apply.
kk) The measurement of exposures related to photobiological risks shall be performed with a
measurement system adapted to a pupil size of 7 mm diameter.
NOTE See Annex CC for a method for correcting photometric and radiometric readings after restricting the
aperture of the meter.
ll) The spectral sensitivity of the meter shall include the entire range of wavelengths
associated with each specific exposure, or over the entire range of emission of the light
source, if it is less.
mm) Photometric quantities, such as illuminance, can be calculated from spectral irradiance
measurements weighted by the eye sensitivity curve, V . This method can provide
λ
improved accuracy over using different instruments to measure irradiance and illuminance
when determining the ratio of total irradiance, E , to MAXIMUM CENTRAL ILLUMINANCE,
Total
E (see 201.10.101.1.4).
C,MI
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
201.6.3 Protection against harmful ingress of water or particulate matter
Addition:
Reducing the ingress of dust and fluid particles into the lighthead will reduce the risk of
spreading infections due to airborne or liquid borne contaminants. This is not required for
LUMINAIRES FOR DIAGNOSIS.
Compliance is checked by exposing the lighthead, excluding the yoke, to water according to
the method corresponding to at least IPX2, as described in IEC 60529:1989,
IEC 60529:1989/AMD1:1999 and IEC 60529:1989/AMD2:2013, followed by drying the outside
of the lighthead and then inspection that there are no visible drops of water on the outside of
the luminaire or falling from the luminaire after the luminaire is oriented through its full range of
intended use for an observation period of 5 min. The area where the lighthead connects to the
yoke may be sealed during testing. This test shall be performed with the lighthead off.
NOTE 101 The lighthead is the enclosure of the light emitting portion of the ME EQUIPMENT.
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