SIST EN 60601-2-41:2010/A11:2012

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

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

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

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

• Status: Withdrawn
• Publication Date: 22-Nov-2011
• 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/A11:2011 - 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: 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: 11-Oct-2011
• 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-januar-2012
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLNLUXUãNLKLQGLDJQRVWLþQLKVYHWLON
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/A11:2011
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/A11
NORME EUROPÉENNE
October 2011
EUROPÄISCHE NORM
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

Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-41: Exigences particulières pour Teil 2-41: Besondere Festlegungen für die
la sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles des éclairages chirurgicaux et Leistungsmerkmale von
des éclairages de diagnostic Operationsleuchten und
Untersuchungsleuchten
This amendment A11 modifies the European Standard EN 60601-2-41:2009; it was approved by CENELEC on
2011-10-01. 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 it
...