EN 60601-2-41:2009/A11:2011
(Amendment)Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis
Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis
D139/C149: BT approved the modified Annex ZZ for EN 60601-2-41:2009
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- Withdrawn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
- 13-Oct-2011
- Withdrawal Date
- 30-Sep-2014
- Technical Committee
- CLC/TC 62 - Electrical equipment in medical practice
- Drafting Committee
- CLC/TC 62 - Electrical equipment in medical practice
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 08-Oct-2024
- Completion Date
- 08-Oct-2024
Relations
- Effective Date
- 23-Jan-2023
- Effective Date
- 28-Jan-2023
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Frequently Asked Questions
EN 60601-2-41:2009/A11:2011 is a amendment published by CLC. Its full title is "Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis". This standard covers: D139/C149: BT approved the modified Annex ZZ for EN 60601-2-41:2009
D139/C149: BT approved the modified Annex ZZ for EN 60601-2-41:2009
EN 60601-2-41:2009/A11:2011 is classified under the following ICS (International Classification for Standards) categories: 11.040.20 - Transfusion, infusion and injection equipment; 11.040.55 - Diagnostic equipment; 11.040.99 - Other medical equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 60601-2-41:2009/A11:2011 has the following relationships with other standards: It is inter standard links to EN IEC 60601-2-41:2021, EN 60601-2-41:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 60601-2-41:2009/A11:2011 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 60601-2-41:2009/A11:2011 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2012
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQH]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
...
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