IEC 60601-2-41:2009/AMD1:2013
(Amendment)Amendment 1 - Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
Amendment 1 - Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
Covers copper-clad Invar material of nominal thickness from 0,1 mm to 2,4 mm supplied in rolls or produced in sheets.
Amendement 1 - Appareils électromédicaux - Partie 2-41: Exigences particulières pour la sécurité de base et les performances essentielles des éclairages chirurgicaux et des éclairages de diagnostic
S'applique au matériau Invar recouvert de cuivre d'épaisseur nominale comprise entre 0,1 mm et 2,4 mm livré en rouleaux ou fabriqué en feuilles.
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IEC 60601-2-41 ®
Edition 2.0 2013-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
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
IEC 60601-2-41:2009/A1:2013
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IEC 60601-2-41 ®
Edition 2.0 2013-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
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 E
ICS 11.040.20; 11.040.55; 11.040.99 ISBN 978-2-8322-1153-3
– 2 – 60601-2-41 Amend.1 © IEC:2013
FOREWORD
This amendment has been prepared by subcommittee 62D: Electromedical equipment, of IEC
technical committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62D/1081/FDIS 62D/1097/RVD
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability 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.
_____________
INTRODUCTION TO THE AMENDMENT
The purpose of this amendment is to address comments received during the process of
harmonizing the standard in Europe, update defined terms, improve terminology usage and
expand the rationale for the Scope in Annex AA to take these changes into account
_____________
201.1 Scope
Replace the existing footnote 1 by the following:
1)
The general standard is IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance.
201.3 Terms and definitions
Replace the existing first sentence by the following:
For the purposes of this document, the terms and definitions given in IEC 60601-1 apply,
except as follows:
Renumber existing terms and definitions 201.3.101 to 201.3.112 as 201.3.201 to 201.3.212.
201.3.202 (previously 201.3.102)
DEPTH OF ILLUMINATION
Replace the existing term by the following:
60601-2-41 Amend.1 © IEC:2013 – 3 –
DEPTH OF ILLUMINATION ABOVE 60 %
Add the following new term and definition:
201.3.213
SINGLE SURGICAL LUMINAIRE
illumination device used for surgery that aims a light beam independently of other light beams
Table 201.101 Classification of SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS
Replace, in the second column of the row "FAIL SAFE", the existing reference to "201.3.103" by
the new reference "201.3.203".
Add, after the existing row “SHADOW DILUTION, the following new row:
e e
DEPTH OF ILLUMINATION 201.12.1.102.1.1 d) No requirement Specified Specified
ABOVE 60 %
Add, at the end of the table, the following new table footnote:
e
Working range where the illuminance reaches at least 60 % of the central illuminance.
201.5.4 Other conditions
Replace, in item aa), the word “pre-aging” with “aging” three times.
201.7.9.2 Instructions for use
201.7.9.2.1 General
Replace the existing second dashed item with the following:
– CENTRAL ILLUMINANCE E and the corresponding measurement distance and corresponding
c
correlated colour temperature;
Replace the existing sixth dashed item with the following:
– correlated colour temperature and corresponding general colour rendering index R and
a
the corresponding specific index R ;
201.12.1.102.1.1 General requirements
Replace, in item a), the defined term "single SURGICAL LUMINAIRE" with the same term entirely
in small caps: "SINGLE SURGICAL LUMINAIRE".
Replace, in point d), the existing text of the third and fourth paragraphs, (“The instructions for
use … expressed as percentages)“ by the following new text aligned with the left margin:
The information about LIGHT FIELD DIAMETER to be contained in the instructions for use
according to 201.7.9.2.1 shall indicate the values of
– LIGHT FIELD DIAMETER d ;
– diameter d where the illuminance reaches 50 % of CENTRAL ILLUMINANCE.
– 4 – 60601-2-41 Amend.1 © IEC:2013
The information about SHADOW DILUTION to be contained in the instructions for use according
to 201.7.9.2.1 shall indicate the values of
– remaining illuminance when the beam is obstructed by one mask,
– remaining illuminance when the beam is obstructed by two masks,
– remaining illuminance at the bottom of a standardized tube (inside),
– remaining illuminance at the bottom of a standardized tube when the beam is obstructed
by one mask,
– remaining illuminance at the bottom of a standardized tube when the beam is obstructed
by two masks
All values of remaining illuminance are relative to CENTRAL ILLUMINANCE without obstruction by
masks or tube and are expressed as percentages.
201.12.1.102.1.2 General conditions for tests
Replace, in the second sentence of the first paragraph, the reference to "4.5" of the general
standard with "5.3".
Add, after the first paragraph, the following new paragraph:
Measurements should be performed after the light has been operated at highest intensity for
at least one hour.
Add, after the existing fifth paragraph, the following new paragraph:
All tests shall be performed without any additional user-initiated adjustments (such as
re-focussing).
Annex AA – Guidance and rationale for particular clauses and subclauses
Subclause 201.1.1 SCOPE
Add, after the last paragraph, the following new text:
Surgical luminaires are intended to produce a high illumination in the visible range (400 nm –
780 nm). They are not intended to produce invisible and potentially harmful UV radiation.
However, in order not to lose too much of the visible blue light output, the cut-off filtering for
UV may allow some output in the longest wavelength range of the UVA close to the visible
blue boundary of 400 nm.
If measured with a radiometer that produces a flat wavelength response, a maximum
in the range from 300 nm – 400 nm therefore is
unweighted UV irradiance of 10 W/m
allowed.
Other IEC standards exist that also state maximum UV irradiance values. An example is
IEC 60601-2-50 that allows for a maximum effective UV irradiance of 0,1 mW/m . This value
is 5 orders of magnitude lower than the 10 W/m listed in IEC 60601-2-41. The difference lies
in the term effective irradiance. An effective UV irradiance or UV dose value indicates that
a spectral weighting function (like, e.g. the ICNIRP combined action spectrum for skin and
eyes) has been applied to the actual irradiance as measured by a radiometer with a flat
spectral response.
60601-2-41 Amend.1 © IEC:2013 – 5 –
Bibliography
Add the following new reference:
IEC 60601-2-50, Medical electrical equipment – Part 2-50: Particular requirements for the
basic safety and essential performance of infant phototherapy equipment
Index of defined terms
Replace the existing text of the Index with the following:
CENTRAL ILLUMINANCE . 201.3.201
DEPTH OF ILLUMINATION ABOVE 60% . 201.3.202
DETACHABLE HANDLE . 201.3. 210
FAIL SAFE . 201.3.203
LIGHT FIELD CENTRE . 201.3.204
LIGHT FIELD DIAMETER . 201.3.205
LUMINAIRE FOR DIAGNOSIS . 201.3.206
MAJOR SURGICAL LUMINAIRE . 201.3.207
MINOR SURGICAL LUMINAIRE (TREATMENT LUMINAIRE) . 201.3.208
SHADOW DILUTION . 201.3.209
SINGLE SURGICAL LUMINAIRE . 201.3.213
SURGICAL LUMINAIRE . 201.3.211
SURGICAL LUMINAIRE SYSTEM . 201.3.212
_____________
– 6 – 60601-2-41 Amend.1 © CEI:2013
AVANT-PROPOS
Le présent amendement a été établi par le sous-comité 62D: Appareils électromédicaux, du
Comité d’Etudes 62 de la CEI: Equipements électriques dans la pratique médicale.
Le texte de cet amendement est issu des documents suivants:
FDIS Rapport de vote
62D/1081/FDIS 62D/1097/RVD
Le rapport de vote indiqué dans le tableau ci-dessus donne toute information sur le vote ayant
abouti à l'approbation de cet am
...
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