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
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Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2010
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SIST EN 60601-2-41:2002
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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 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)
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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.
- 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)
__________
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)
1)
ISO 11664-1 - Colorimetry - - -
Part 1: CIE standard colorimetric observers
1)
CIE 13.3 - Method of measuring and specifying colour - -
rendering of light sources
1)
CIE 15 - Colorimetry - -
1)
CIE 69 - Methods of characterizing illuminance meters - -
and luminance meters: Performance,
characteristics and specifications
1)
Undated reference.
2)
Valid edition at date of issue.
- 5 - EN 60601-2-41:2009
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.
___________
IEC 60601-2-41 ®
Edition 2.0 2009-08
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-41: Particular requirements for the basic safety and essential
performance of surgical luminaires and luminaires for diagnosis
Appareils électromédicaux –
Partie 2-41: Exigences particulières pour la sécurité de base et les
performances essentielles des éclairages chirurgicaux et des éclairages de
diagnostic
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
W
CODE PRIX
ICS 11.040.20; 11.040.55; 11.040.99 ISBN 2-8318-1054-4
– 2 – 60601-2-41 © IEC:2009
CONTENTS
FOREWORD.4
INTRODUCTION.6
201.1 Scope, object and related standards.7
201.2 Normative references .8
201.3 Terms and definitions .9
201.4 General requirements.12
201.5 General requirements for testing of ME EQUIPMENT .13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .13
201.7 ME EQUIPMENT Identification, marking and documents.14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT .15
201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS .15
201.10 Protection against unwanted and excessive radiation HAZARDS .18
201.11 Protection against excessive temperatures and other HAZARDS .18
201.12 Accuracy of controls and instruments and protection against hazardous
outputs .19
201.13 HAZARDOUS SITUATIONS and fault conditions .33
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).33
201.15 Construction of ME EQUIPMENT .33
201.16 ME SYSTEMS .33
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS.33
Annex AA (informative) Guidance and rationale for particular clauses and subclauses.35
Bibliography.38
Index of defined terms .39
Figure 201.101 – Example of power supplies for SURGICAL LUMINAIRES .10
Figure 201.102 – DETACHABLE HANDLE attachment and detachment tests.16
Figure 201.103 – Test for ease of motion.17
Figure 201.104 – Light distribution.22
Figure 201.105 – CENTRAL ILLUMINANCE measurement.24
Figure 201.106 – Measurements of LIGHT FIELD DIAMETER and diameter at 50 % of
CENTRAL ILLUMINANCE .24
Figure 201.107 – Illuminance measurement with one mask.25
Figure 201.108 – Illuminance measurement with two masks .25
Figure 201.109 – Illuminance measurement with four different positions of the two
masks.26
Figure 201.110 – Tube for illuminance measurement .27
Figure 201.111 – Detail of the inner surface of the tube (example) .27
Figure 201.112 – Illuminance measurement at the bottom of a cavity, with one mask .28
Figure 201.113 – Illuminance measurement at the bottom of a cavity, with two masks .29
Figure 201.114 – Illuminance measurement at the bottom of a cavity, with four different
positions o
...
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