SIST EN 60601-2-41:2010
(Main)Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis (IEC 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 (IEC 60601-2-41:2009)
This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICAL LUMINAIRES AND LUMINAIRES FOR DIAGNOSIS, hereafter referred to as ME EQUIPMENT. 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 UV lights for dermatological diagnosis, slit lamps for ophthalmology, lights for surgical microscopes and lights for surgical navigation systems; - lights connected to surgical instruments; - luminaires of an emergency lighting, which are covered by IEC 60598-2-22.
Medizinische elektrische Geräte - Teil 2-41: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Operationsleuchten und Untersuchungsleuchten (IEC 60601-2-41:2009)
Appareils électromédicaux - Partie 2-41: Exigences particulières pour la sécurité de base et les performances essentielles des éclairages chirurgicaux et des éclairages de diagnostic (CEI 60601-2-41:2009)
La CEI 60601-2-41:2009 s'applique à la sécurité de base et aux performances essentielles des éclairages chirurgicaux et des éclairages de diagnostic. Elle modifie et complète la CEI 60601-1 (troisième édition 2005), appelée norme générale dans la présente Norme. Cette deuxième édition annule et remplace la première édition publiée en 2000. Cette édition constitue une révision technique permettant l'alignement de la norme sur la troisième édition de la CEI 60601-1.
Medicinska električna oprema - 2-41. del: Posebne zahteve za osnovno varnost in bistvene lastnosti kirurških in diagnostičnih svetilk (IEC 60601-2-41:2009)
Ta poseben standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI KIRURŠKIH IN DIAGNOSTIČNIH SVETILK, v nadaljevanju ME OPREMA. Ta posebni standard ne velja za – naglavne svetilke, - endoskope, laparoskope in njihove svetlobne vire, ki so zajeti v IEC 60601-2-18, - svetilke, uporabljene v zobozdravstvu, ki so zajete v ISO 9680, - svetilke za splošno uporabo, ki so zajete v IEC 60598-2-1 in IEC 60598-2-4, - svetilke, namenjene za terapevtske namene; - svetila s posebnimi nameni z različnimi pogoji uporabe, kot na primer UV svetila za dermatološke diagnoze, špranjska svetila za oftalmologijo, svetila za kirurške mikroskope in svetila za kirurške navigacijske sisteme, - svetila priključena na kirurške inštrumente, - svetilke, uporabljene v zasilni razsvetljavi, ki so zajete v IEC 60598-2-22.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 60601-2-41:2010
01-marec-2010
1DGRPHãþD
SIST EN 60601-2-41:2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLNLUXUãNLKLQGLDJQRVWLþQLKVYHWLON ,(&
Medical electrical equipment - Part 2-41: Particular requirements for basic safety and
essential performance of surgical luminaires and luminaires for diagnosis (IEC 60601-2-
41:2009)Medizinische elektrische Geräte - Teil 2-41: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Operationsleuchten undUntersuchungsleuchten (IEC 60601-2-41:2009)
Appareils électromédicaux - Partie 2-41: Exigences particulières pour la sécurité de base
et les performances essentielles des éclairages chirurgicaux et des éclairages de
diagnostic (CEI 60601-2-41:2009)Ta slovenski standard je istoveten z: EN 60601-2-41:2009
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
29.140.40 Svetila Luminaires
SIST EN 60601-2-41:2010 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 60601-2-41:2010
EUROPEAN STANDARD
EN 60601-2-41
NORME EUROPÉENNE
December 2009
EUROPÄISCHE NORM
ICS 11.040.20; 11.040.55; 11.040.99 Supersedes EN 60601-2-41:2000
English version
Medical electrical equipment -
Part 2-41: Particular requirements for basic safety
and essential performance of surgical luminaires
and luminaires for diagnosis
(IEC 60601-2-41:2009)
Appareils électromédicaux - Medizinische elektrische Geräte -
Partie 2-41: Exigences particulières Teil 2-41: Besondere Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
des éclairages chirurgicaux von Operationsleuchten
et des éclairages de diagnostic und Untersuchungsleuchten
(CEI 60601-2-41:2009) (IEC 60601-2-41:2009)
This European Standard was approved by CENELEC on 2009-11-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: Avenue Marnix 17, B - 1000 Brussels
© 2009 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-41:2009 E---------------------- Page: 3 ----------------------
SIST EN 60601-2-41:2010
EN 60601-2-41:2009 - 2 -
Foreword
The text of document 62D/773/FDIS, future edition 2 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 was approved by CENELEC as EN 60601-2-41 on 2009-11-01.
This European Standard supersedes EN 60601-2-41:2000.EN 60601-2-41:2000 was revised to be consistent with EN 60601-1:2006.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2010-08-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2012-11-01
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive MDD (93/42/EEC). See Annex ZZ.In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of
tables is also in a smaller type.– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED:
SMALL CAPITALS.In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents, 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 standard are preceded by the term “Clause” followed by the clause
number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
of the conditions is true.The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb:− “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;− “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;− “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.---------------------- Page: 4 ----------------------
SIST EN 60601-2-41:2010
- 3 - EN 60601-2-41:2009
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-41:2009 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 60598-1 NOTE Harmonized as EN 60598-1:2008 (modified).IEC 60598-2-1 NOTE Harmonized as EN 60598-2-1:1989 (not modified).
IEC 60598-2-4 NOTE Harmonized as EN 60598-2-4:1997 (not modified).
IEC 60598-2-22 NOTE Harmonized as EN 60598-2-22:1998 (modified).
IEC 60598-2-25 NOTE Harmonized as EN 60598-2-25:1994 (not modified).
ISO 9680 NOTE Harmonized as EN ISO 9680:2007 (not modified)
__________
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SIST EN 60601-2-41:2010
EN 60601-2-41:2009 - 4 -
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following referenced documents are indispensable for the application 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 When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Addition:
IEC 60417 data- Graphical symbols for use on equipment - -
base
1) 2)
IEC 60598-2-9 - Luminaires - EN 60598-2-9 1989
Part 2: Particular requirements -
Section 9: Photo and film luminaires (non-
professional)
ISO 11664-1 - Colorimetry - - -
Part 1: CIE standard colorimetric observers
CIE 13.3 - Method of measuring and specifying colour - -
rendering of light sources
CIE 15 - Colorimetry - -
CIE 69 - Methods of characterizing illuminance meters - -
and luminance meters: Performance,
characteristics and specifications
Undated reference.
Valid edition at date of issue.
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SIST EN 60601-2-41:2010
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Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.___________
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SIST EN 60601-2-41:2010
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SIST EN 60601-2-41:2010
IEC 60601-2-41
Edition 2.0 2009-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-41: Particular requirements for the basic safety and essential
performance of surgical luminaires and luminaires for diagnosis
Appareils électromédicaux –
Partie 2-41: Exigences particulières pour la sécurité de base et les
performances essentielles des éclairages chirurgicaux et des éclairages de
diagnostic
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX
ICS 11.040.20; 11.040.55; 11.040.99 ISBN 2-8318-1054-4
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
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SIST EN 60601-2-41:2010
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CONTENTS
FOREWORD...........................................................................................................................4
INTRODUCTION.....................................................................................................................6
201.1 Scope, object and related standards..........................................................................7
201.2 Normative references ................................................................................................8
201.3 Terms and definitions ................................................................................................9
201.4 General requirements..............................................................................................12
201.5 General requirements for testing of ME EQUIPMENT ...................................................13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS ......................................................13
201.7 ME EQUIPMENT Identification, marking and documents...............................................14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT ........................................15
201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS ...............15
201.10 Protection against unwanted and excessive radiation HAZARDS ................................18
201.11 Protection against excessive temperatures and other HAZARDS ................................18
201.12 Accuracy of controls and instruments and protection against hazardousoutputs ....................................................................................................................19
201.13 HAZARDOUS SITUATIONS and fault conditions .............................................................33
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)................................................33
201.15 Construction of ME EQUIPMENT .................................................................................33
201.16 ME SYSTEMS .............................................................................................................33
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS..............................33
Annex AA (informative) Guidance and rationale for particular clauses and subclauses.........35
Bibliography..........................................................................................................................38
Index of defined terms ..........................................................................................................39
Figure 201.101 – Example of power supplies for SURGICAL LUMINAIRES ..................................10
Figure 201.102 – DETACHABLE HANDLE attachment and detachment tests...............................16
Figure 201.103 – Test for ease of motion..............................................................................17
Figure 201.104 – Light distribution........................................................................................22
Figure 201.105 – CENTRAL ILLUMINANCE measurement...........................................................24
Figure 201.106 – Measurements of LIGHT FIELD DIAMETER and diameter at 50 % ofCENTRAL ILLUMINANCE ............................................................................................................24
Figure 201.107 – Illuminance measurement with one mask...................................................25
Figure 201.108 – Illuminance measurement with two masks .................................................25
Figure 201.109 – Illuminance measurement with four different positions of the two
masks...................................................................................................................................26
Figure 201.110 – Tube for illuminance measurement ............................................................27
Figure 201.111 – Detail of the inner surface of the tube (example) .......................................27
Figure 201.112 – Illuminance measurement at the bottom of a cavity, with one mask ...........28
Figure 201.113 – Illuminance measurement at the bottom of a cavity, with two masks ..........29
Figure 201.114 – Illuminance measurement at the bottom of a cavity, with four different
positions of the two masks....................................................................................................30
Figure 201.115 – Measurement of DEPTH OF ILLUMINATION .....................................................31
Figure AA.1 – Changeover cycle to an emergency backup system ........................................36
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60601-2-41 © IEC:2009 – 3 –
Table 201.101 – Classification of SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS..........12
Table 201.102 – Distributed ESSENTIAL PERFORMANCE requirements ......................................13
Table 201.103 – Allowable maximum temperatures for ME EQUIPMENT parts that arelikely to be touched...............................................................................................................19
---------------------- Page: 11 ----------------------SIST EN 60601-2-41:2010
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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-41: Particular requirements for the basic safety and essential
performance of surgical luminaires and luminaires for diagnosis
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, and Guides (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to
technical committees; any IEC National Committee interested in the subject dealt with may participate in this
preparatory work. International, governmental and non-governmental organizations liaising with the IEC also
participate in this preparation. IEC collaborates closely with the International Organization for Standardization
(ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-41 has been prepared by subcommittee 62D:Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.This second edition cancels and replaces the first edition published in 2000. This edition
constitutes a technical revision to be consistent with the third edition of the IEC 60601-1.
The text of this particular standard is based on the following documents:FDIS Report on voting
62D/773/FDIS 62D/787/RVD
Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
---------------------- Page: 12 ----------------------SIST EN 60601-2-41:2010
60601-2-41 © IEC:2009 – 5 –
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
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 standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;– “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 publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed,• withdrawn,
• replaced by a revised edition, or
• amended.
---------------------- Page: 13 ----------------------
SIST EN 60601-2-41:2010
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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 (third Edition 2005), hereinafter referred to as the
general standard.The requirements of this particular standard take priority over those of the general standard,
entitled “Medical electrical equipment Part 1: General requirements for basic safety and
essential performance.---------------------- Page: 14 ----------------------
SIST EN 60601-2-41:2010
60601-2-41 © IEC:2009 – 7 –
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 particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICAL
LUMINAIRES AND LUMINAIRES FOR DIAGNOSIS, hereafter referred to as ME EQUIPMENT.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 UV lights for dermatological
diagnosis, slit lamps for ophthalmology, lights for surgical microscopes and lights for
surgical navigation systems;– lights connected to surgical instruments;
– luminaires of an emergency lighting, which are covered by IEC 60598-2-22.
NOTE See also 4.2 of the general standard.
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 asdefined in 201.3.
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 ESSENTIALPERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
—————————
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.---------------------- Page: 15 ----------------------
SIST EN 60601-2-41:2010
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For brevity, IEC 60601-1 is 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 standard 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 60601-1-2 collateral standard,
203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral
standard, etc.). The changes to the text of the general standard are specified by the use of
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, due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard 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 standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.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
Clause 2 of the general standard applies except as follows:
Addition:
IEC 60417, Graphical symbols for use on equipment
IEC 60598-2-9, Luminaires – Part 2: Particular requirements. Section Nine: Photo and film
luminaires (non-professional)ISO 11664-1, Colorimetry – Part 1: CIE standard colorimetric observers
CIE 13.3, Method of Measuring and Specifying Colour Rendering Properties of Light Sources
CIE 15, Colorimetry---------------------- Page: 16 ----------------------
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60601-2-41 © IEC:2009 – 9 –
CIE 69, Methods of characterizing illuminance meters and luminance meters: Performance,
characteristics and specifications201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
apply, except as follows:NOTE An index of defined terms is found beginning on page 39.
201.3.63
MEDICAL ELECTRICAL EQUIPMENT
Addition:
NOTE See Figure 201.101 as an example of possible POWER SUPPLIES for SURGICAL LUMINAIRES.
---------------------- Page: 17 ----------------------SIST EN 60601-2-41:2010
– 10 – 60601-2-41 © IEC:2009
B DC/AC
Key Lamp
B Battery
Transformer
M Mains
G Generator
DC/AC Direct current to alternative
current converter
Switch
IEC 1370/09
Figure 201.101 – Example of power supplies for SURGICAL LUMINAIRES
Addition:
201.3.101
CENTRAL ILLUMINANCE
illuminance at a 1 000 mm distance (or a measurement distance specified by the
MANUFACTURER if the specified working range does not include 1 000 mm) from the light-
emitting area of the ME EQUIPMENT in the LIGHT FIELD CENTRE without any obstruction of the
light beam---------------------- Page: 18 ----------------------
SIST EN 60601-2-41:2010
60601-2-41 © IEC:2009 – 11 –
201.3.102
DEPTH OF ILLUMINATION
working distance around the 1 000 mm distance (or a measurement distance specified by the
MANUFACTURER if the specified working range does not include 1 000 mm) below the emitting
surface of the ME EQUIPMENT, in which the illuminance reaches at least 60 % of CENTRAL
ILLUMINANCE (E )201.3.103
*FAIL SAFE
capability of an ME EQUIPMENT to pro
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