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SIST EN 60601-2-41:2002

(Main)

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

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.

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

Appareils électromédicaux -- Partie 2-41: Règles particulières de sécurité pour les éclairages chirurgicaux et les éclairages de diagnostic

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

General Information

Status
Withdrawn
Publication Date
31-Jan-2002
Withdrawal Date
19-Jan-2010
ICS
11.040.30 - Surgical instruments and materials
11.040.55 - Diagnostic equipment
29.140.40 - Luminaires
Technical Committee
IEMO - Electrical equipment in medical practice
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
30-Dec-2009
Due Date
22-Jan-2010
Completion Date
20-Jan-2010
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
EN 60601-2-41:2000 - Medical electrical equipment - Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis

Relations

Replaced By
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
Revised
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
06-Nov-2012
Replaced By
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
Replaced By
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-Mar-2010

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EN 60601-2-41:2002
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Standards Content (Sample)

SLOVENSKI SIST EN 60601-2-41:2002
prva izdaja
STANDARD
februar 2002
Medical electrical equipment - Part 2-41: Particular requirements for the safety of
surgical luminaires and luminaires for diagnosis
ICS 11.040.30; 11.040.55; 29.140.40 Refere
...

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This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICAL
LUMINAIRES and LUMINAIRES FOR DIAGNOSIS, hereafter referred to as ME EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
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case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
This particular standard does not apply to
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– 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 light sources intended solely
for decontamination of air and surfaces, UV lights for dermatological diagnosis, slit lamps
for ophthalmology, lights for surgical microscopes and lights for surgical navigation systems;
– lights connected to surgical instruments, such as luminous retractors;
– luminaires for emergency lighting, which are covered by IEC 60598-2-22.
NOTE See also 4.2 of the general standard.
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This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICAL
LUMINAIRES and LUMINAIRES FOR DIAGNOSIS, hereafter referred to as ME EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
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;
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– special purpose lights with different conditions of use such as light sources intended solely
for decontamination of air and surfaces, UV lights for dermatological diagnosis, slit lamps
for ophthalmology, lights for surgical microscopes and lights for surgical navigation systems;
– lights connected to surgical instruments, such as luminous retractors;
– luminaires for emergency lighting, which are covered by IEC 60598-2-22.
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lighting equipment.

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