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IEC 60601-2-18-ed.3.0
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
STANDARD published on 12.8.2009
The information about the standard:
Designation standards: IEC 60601-2-18-ed.3.0
Publication date standards: 12.8.2009
SKU: NS-410701
The number of pages: 96
Approximate weight : 319 g (0.70 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Annotation of standard text IEC 60601-2-18-ed.3.0 :
IEC 60601-2-18:2009 establishes particular basic safety and essential performance requirements for endoscopic equipment. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of endoscopic equipment. IEC 60601-2-18:2009 amends and supplements IEC 60601-1:2005. This third edition cancels and replaces the second edition, published in 1996, and its Amendment 1 (2000). This edition constitutes a technical revision and has been aligned or harmonized with IEC 60601-1:2005. The main changes with respect to the previous edition include: - alignment of requirements with IEC 60601-1:2005; - inclusion of essential performance requirements; - the inclusion of energized endoscopes and energized endotherapy devices used through second and subsequent punctures within the scope of the standard; - reference to IEC 60601-2-2 for the dielectric strength testing of HF energized endotherapy devices, rather than defining different tests. La CEI 60601-2-18:2009 etablit les exigences particulieres pour la securite de base et les performances essentielles des appareils dendoscopie. Les exigences de securite minimales specifiees dans la presente norme particuliere fournissent un degre de securite pratique pour le fonctionnement des appareils dendoscopie. La CEI 60601-2-18:2009 modifie et complete la CEI 60601-1:2005. Cette troisieme edition annule et remplace la deuxieme edition, publiee en 1996 et son Amendement 1 (2000). Cette edition constitue une revision technique et est alignee ou harmonisee avec la CEI 60601-1:2005. Les modifications principales par rapport a ledition precedente sont les suivantes: - lalignement des exigences avec la CEI 60601-1-2005; - linclusion des exigences relatives aux performances essentielles; - linclusion des endoscopes alimentes et des appareils dendotherapie alimentes utilises pour des ponctions secondaires et ulterieures dans le cadre du domaine dapplication de la norme; - la reference a la CEI 60601-2-2 pour les essais de tension de tenue des appareils dendotherapie alimentes par courant HF, plutot que la definition dessais differents.
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