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IEC 60601-2-41-ed.3.0
Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
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STANDARD published on 3.9.2021
The information about the standard:
Designation standards: IEC 60601-2-41-ed.3.0
Publication date standards: 3.9.2021
SKU: NS-1034936
Approximate weight : 300 g (0.66 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Transfusion, infusion and injection equipmentDiagnostic equipmentOther medical equipment
Annotation of standard text IEC 60601-2-41-ed.3.0 :
IEC 60601-2-41:2021 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. SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS are medical devices and not general lighting equipment. IEC 60601-2-41:2021 cancels and replaces the second edition published in 2009 and Amendment 1:2013. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) revised the statement of essential performance; b) added exposure limits, test conditions, calculation methods and safety warnings related to photobiological hazards; c) removed the terms “MINOR SURGICAL LUMINAIRES” and “MAJOR SURGICAL LUMINAIRES”; d) added definitions of MAXIMUM ILLUMINANCE DISTANCE and REFERENCE DISTANCE and allowed MANUFACTURERS to measure some performance characteristics at the REFERENCE DISTANCE that they specify; e) replaced the region of acceptable chromaticity in (x,y) colour space with a requirement for Du,v; f) added a requirement for acceptable drift of the lighthead when attached to the suspension system; g) added a requirement for fluid ingress protection; h) revised Table 201.101 of IEC 60601-2-41:2009 and IEC 60601-2-41:2009/AMD1:2013 and moved it to Annex BB; i) specified a new device for measuring SHADOW DILUTION in a simulated cavity; j) specified test conditions for luminaires equipped with distance sensors. LIEC 60601-2-41:2021 s’applique a la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des ECLAIRAGES CHIRURGICAUX et des ECLAIRAGES DE DIAGNOSTIC, designes ci-apres sous le terme APPAREILS EM. Dans le cas ou un article ou un paragraphe est specifiquement prevu pour s’appliquer aux APPAREILS EM uniquement ou aux SYSTEMES EM uniquement, le titre et le contenu de cet article ou de ce paragraphe le mentionnent. Lorsque ce n’est pas le cas, l’article ou le paragraphe s’applique aux APPAREILS EM et aux SYSTEMES EM, le cas echeant. La presente norme particuliere ne s’applique pas aux – lampes frontales; – endoscopes, laparoscopes et a leurs sources de lumiere, qui sont couverts par l’IEC 60601-2-18; – eclairages utilises pour les soins dentaires, qui sont couverts par l’ISO 9680; – luminaires a usage general, qui sont couverts par l’IEC 60598-2-1 et l’IEC 60598-2-4; – eclairages a usage therapeutique; – lampes a usages speciaux avec differentes conditions d’utilisation comme les sources de lumiere destinees uniquement a la decontamination de l’air et des surfaces, lampes a ultraviolets pour diagnostic dermatologique, les lampes a fente pour l’ophtalmologie, les lampes pour microscopes chirurgicaux et les lampes pour systemes de navigation chirurgicale; – lampes montees sur des instruments chirurgicaux, tels que les ecarteurs lumineux; – luminaires pour eclairage de secours, qui sont couverts par l’IEC 60598-2-22. Les ECLAIRAGES CHIRURGICAUX et les ECLAIRAGES DE DIAGNOSTIC sont des dispositifs medicaux et non des appareils d’eclairage general. LIEC 60601-2-41:2021 annule et remplace la deuxieme edition parue en 2009 et lAmendement 1:2013. Cette edition constitue une revision technique. Cette edition inclut les modifications techniques majeures suivantes par rapport a ledition precedente: a) revision des enonces relatifs aux performances essentielles; b) ajout des limites d’exposition, des conditions d’essai, des methodes de calcul et des avertissements de securite relatifs aux dangers photobiologiques; c) suppression des termes "ECLAIRAGES CHIRURGICAUX MINEURS" et "ECLAIRAGES CHIRURGICAUX MAJEURS"; d) ajout des definitions des termes DISTANCE D’ECLAIREMENT MAXIMAL et DISTANCE DE REFERENCE et permission aux FABRICANTS de mesurer certaines caracteristiques de performance a la distance de reference qu’ils specifient; e) remplacement de la zone de chromaticite acceptable dans l’espace de couleur (x, y) par une exigence relative a Du,v; f) ajout d’une exigence relative a la derive acceptable du projecteur lorsque celui-ci est fixe au systeme de suspension; g) ajout d’une exigence relative a la protection contre la penetration d’un liquide; h) revision et deplacement a l’Annexe BB du Tableau 201.101 de l’IEC 60601-2-41:2009 et de l’IEC 60601-2-41:2009/AMD1:2013; i) specification d’un nouvel appareil de mesure de l’ATTENUATION DE L’OMBRE dans une cavite simulee; j) specification des conditions d’essai pour les eclairages equipes de capteurs de distance.
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