SIST EN 60601-2-41:2010/A1:2015

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

2020-11-04-JO - lack of compliance. Refereince is made  CLC/TC 62 Decision 02/2019 in Oslo 2019 to decouple work items from MDD and AIMD for projects that do not yet have an Annex ZZ approved by the HAS consultant.. Following exchange with TC leadership and given that the transition of MDD ends in May 2021, the TC will rather focus on the citation of their standards under the MDR. The link to MDD and M/295  removed to the published standard

Medizinische elektrische Geräte - Teil 2-41: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Operationsleuchten und Untersuchungsleuchten

Appareils électromédicaux - Partie 2-41: Exigences particulières pour la sécurité de base et les performances essentielles des éclairages chirurgicaux et des éclairages de diagnostic

Medicinska električna oprema - 2-41. del: Posebne zahteve za osnovno varnost in bistvene lastnosti kirurških in diagnostičnih svetilk - Dopolnilo A1

General Information

• Status: Withdrawn
• Publication Date: 13-Aug-2015
• Withdrawal Date: 15-Oct-2024
• ICS: 11.040.30 - Surgical instruments and materials
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 29.140.40 - Luminaires
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 16-Oct-2024
• Due Date: 08-Nov-2024
• Completion Date: 16-Oct-2024
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN 60601-2-41:2009/A1:2015 - Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis

Relations

• Replaced By: SIST EN IEC 60601-2-41:2022 - 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)
• Effective Date: 07-Jun-2022
• Replaced By: SIST EN IEC 60601-2-41:2022 - 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)
• Effective Date: 21-Dec-2021
• Amends: SIST EN 60601-2-41:2010 - 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)
• Effective Date: 28-Jan-2023
• Amends: SIST EN 60601-2-41:2010 - 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)
• Effective Date: 07-Jun-2022
• Amends: SIST EN 60601-2-41:2010 - 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)
• Effective Date: 01-Sep-2015
• Revised: SIST EN IEC 60601-2-41:2022 - 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)
• Effective Date: 20-Mar-2018

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2015
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLNLUXUãNLKLQGLDJQRVWLþQLKVYHWLON'RSROQLOR$
Medical electrical equipment - Part 2-41: Particular requirements for basic safety and
essential performance of surgical luminaires and luminaires for diagnosis
Medizinische elektrische Geräte - Teil 2-41: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Operationsleuchten und
Untersuchungsleuchten
Appareils électromédicaux - Partie 2-41: Exigences particulières pour la sécurité de base
et les performances essentielles des éclairages chirurgicaux et des éclairages de
diagnostic
Ta slovenski standard je istoveten z: EN 60601-2-41:2009/A1:2015
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 60601-2-41:2009/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2015
ICS 11.040.20; 11.040.55; 11.040.99

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/A1:2013)
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 60601-2-41:2009/A1:2013) (IEC 60601-2-41:2009/A1:2013)
This amendment A1 modifies the European Standard EN 60601-2-41:2009; it was approved by CENELEC on 2015-04-14. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment 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 amendment 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-41:2009/A1:2015 E

Foreword
The text of document 62D/1081/FDIS, future IEC 60601-2-41:2009/A1, 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 60601-2-41:2009/A1:2015.
The following dates are fixed:
(dop) 2016-01-14
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2018-04-14
• latest date by which the national standards conflicting with
the document have to be withdrawn

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in
EN 60601-2-41:2009/A11:2011.
Endorsement notice
The text of the International Standard IEC 60601-2-41:2009/A1:2013 was approved by CENELEC as
a European Standard without any modification.
In the Bibliography of EN 60601-2-41:2009, the following note has to be added for the standard indicated:
IEC 60601-2-50 NOTE Harmonized as EN 60601-2-50:2009 (not modified).

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 Euro
...