IEC 60601-2-41:2000

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

Establishes particular requirements for the safety of surgical luminaires and luminaires for diagnosis.

General Information

• Status: Published
• Publication Date: 23-Feb-2000
• ICS: 11.040.30 - Surgical instruments and materials
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 12-Aug-2009

Relations

• Revised: IEC 60601-2-41:2009 - Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD
60601-2-41
First edition
2000-02
Medical electrical equipment –
Part 2-41:
Particular requirements for the safety of
surgical luminaires and luminaires for diagnosis
Appareils électromédicaux –
Partie 2-41:
Règles particulières de sécurité pour les éclairages
chirurgicaux et les éclairages de diagnostic

Reference number
Numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series.
Consolidated publications
Consolidated versions of some IEC publications including amendments are

available. For example, edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the
base publication, the base publication incorporating amendment 1 and the base

publication incorporating amendments 1 and 2.

Validity of this publication
The technical content of IEC publications is kept under constant review by the IEC,
thus ensuring that the content reflects current technology.
Information relating to the date of the reconfirmation of the publication is available
in the IEC catalogue.
Information on the subjects under consideration and work in progress undertaken
by the technical committee which has prepared this publication, as well as the list
of publications issued, is to be found at the following IEC sources:
• IEC web site*
•
Catalogue of IEC publications
Published yearly with regular updates
(On-line catalogue)*
• IEC Bulletin
Available both at the IEC web site* and as a printed periodical
Terminology, graphical and letter symbols
For general terminology, readers are referred to IEC 60050: International
Electrotechnical Vocabulary (IEV).
For graphical symbols, and letter symbols and signs approved by the IEC for
general use, readers are referred to publications IEC 60027: Letter symbols to be
used in electrical technology, IEC 60417: Graphical symbols for use on equipment.
Index, survey and compilation of the single sheets and IEC 60617: Graphical symbols
for diagrams.
* See web site address on title page.

INTERNATIONAL IEC
STANDARD
60601-2-41
First edition
2000-02
Medical electrical equipment –
Part 2-41:
Particular requirements for the safety of
surgical luminaires and luminaires for diagnosis
Appareils électromédicaux –
Partie 2-41:
Règles particulières de sécurité pour les éclairages
chirurgicaux et les éclairages de diagnostic

 IEC 2000  Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
W
International Electrotechnical Commission
For price, see current catalogue

– 2 – 60601-2-41 © IEC:2000(E)

CONTENTS
Page
FOREWORD . 4

INTRODUCTION .6

SECTION ONE – GENERAL
Clause
1 Scope and object . 7

2 Terminology and definitions . 8
4 General requirements for tests. 11
5 Classification . 11
6 Identification, marking and documents . 11
SECTION TWO – ENVIRONMENTAL CONDITIONS
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 Requirements related to classification .13
16 ENCLOSURES and PROTECTIVE COVERS .13
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
22 Moving parts.13
24 Stability in NORMAL USE .14
25 Expelled parts.14
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
34 Ultraviolet radiation.15
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures.15
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning,
sterilization and disinfection .15
49 Interruption of power supply .16
SECTION EIGHT – ACCURACY OF OPERATING DATA
AND PROTECTION AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data .16

60601-2-41 © IEC:2000(E) – 3 –

Page
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;

ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions .22

SECTION TEN – CONSTRUCTIONAL REQUIREMENTS

55 ENCLOSURES and covers .22

56 Components and general assembly .22
57 MAINS PARTS, components and layout .22
59 Construction and layout.23
Figures 101 to 115 . 24 – 34
Annex L References – Publications mentioned in this standard . 35
Annex AA (informative) Guidance and rationale for particular clauses and subclauses . 36

– 4 – 60601-2-41 © IEC:2000(E)

INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-41: Particular requirements for the safety of surgical luminaires

and luminaires for diagnosis
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the 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, the IEC publishes International Standards. 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. The 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 the 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 National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The 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.
The text of this standard is based on the following documents:
FDIS Report on voting
62D/344/FDIS 62D/352/RVD
Full information on the voting for the approval of this 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 3.
Annex AA is for information only.

60601-2-41 © IEC:2000(E) – 5 –

In this Particular Standard the following print types are used:

– requirements, compliance with which can be tested, and definitions: in roman type;

– notes, explanations, advice, introductions, general statements, exceptions and references: in smaller type;

– test specifications: in italic type;

– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD IEC 60601-1 OR THIS PARTICULAR
STANDARD: SMALL CAPITALS.
The committee has decided that this publication remains valid until 2005.

At this date, in accordance with the committee’s decision, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
A bilingual version of this standard may be issued at a later date.

– 6 – 60601-2-41 © IEC:2000(E)

INTRODUCTION
This Particular Standard concerns the safety of SURGICAL LUMINAIRES and LUMINAIRES FOR

DIAGNOSIS. It amends and supplements IEC 60601-1 (second edition 1988), 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 safety.”
A “Guidance and rationale” for the requirements of this Particular Standard is included in

annex AA.
It is considered that a knowledge of the reasons for these requirements will not only facilitate
the proper application of the standard but will, in due course, expedite any revision
necessitated by changes in clinical practice or as a result of developments in technology.
However, this annex does not form part of the requirements of this Standard.
An asterisk (*) inserted before a clause or subclause number indicates that some explanatory
notes are given in annex AA at the end of this Particular Standard.

60601-2-41 © IEC:2000(E) – 7 –

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-41: Particular requirements for the safety of surgical luminaires

and luminaires for diagnosis
SECTION ONE – GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows.
1 Scope and object
This clause of the General Standard applies except as follows:
*1.1 Scope
Addition:
This Particular Standard details the requirements to be applied to SURGICAL LUMINAIRES and
LUMINAIRES FOR DIAGNOSIS as defined in 2.101 to 2.105, hereinafter referred to as EQUIPMENT.
This 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 of an emergency lighting, which are covered by IEC 60598-2-22.
NOTE  Luminaires used in clinical areas of hospitals other than those defined in 2.101 to 2.105 are covered by
IEC 60598-2-25.
1.2 Object
Replacement:
The object of this Particular Standard is to establish particular requirements for the safety of
SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS.

1.3 Particular Standards
Addition:
This Particular Standard refers to IEC 60601-1 (1988): Medical electrical equipment – Part 1:
General requirements for safety, as amended by its amendment 1 (1991) and its
amendment 2 (1995).
For brevity, IEC 60601-1 is referred to in this Particular Standard either as the General
Standard or as the General Requirement(s).

– 8 – 60601-2-41 © IEC:2000(E)

The numbering of sections, clauses and subclauses of this Particular Standard corresponds to

that of the General Standard. 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 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.
“Amendment” means that the clause or subclause of the General Standard is amended as
indicated by the text of this Particular Standard.
“Modification” means that the clause or subclause of the General Standard is modified as
indicated by the text of this Particular Standard.
Subclauses or figures which are additional to those of the General Standard are numbered
starting from 101, additional annexes are lettered AA, BB, etc. and additional items aa), bb),
etc.
The term “this Standard” is used to make reference to the General Standard and this
Particular Standard taken together.
Where there is no corresponding section, clause or subclause in this Particular Standard, the
section, clause or subclause
...