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MSZ EN IEC 60601-2-41:2022

Dokumentumazonosító

178871

Cím

Gyógyászati villamos készülékek. 2-41. rész: Sebészeti és diagnosztikai lámpatestek alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (IEC 60601-2-41:2021)

Angol cím

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)

Alkalmazási terület

Clause 1 of the general standard1 applies, except as follows: 201.1.1 * Scope Replacement: 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; – 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. SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS are medical devices and not general lighting equipment. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS as defined in 201.3. 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard. IEC 60601-1-3, IEC 60601-1-10, IEC 60601-1-11 and IEC 60601-1-12 do not apply. All other published collateral standards in the IEC 60601-1 series apply as published. Túl hosszú scope

ICS

11.040.20 Vérátömlesztő, infúziós és injekciós berendezések, eszközök

11.040.55 Diagnosztikai készülékek

11.040.99 Egyéb orvostechnikai berendezések

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2022-07-01

Forrás

idt EN IEC 60601-2-41:2021; idt IEC 60601-2-41:2021

Előd

MSZ EN 60601-2-41:2010, MSZ EN 60601-2-41:2009/A11:2012, MSZ EN 60601-2-41:2009/A1:2015

Utód

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