IEC 60601-2-18:2009

Title

Language: EN Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

Language: FR Appareils électromédicaux - Partie 2-18: Exigences particulières pour la sécurité de base et les performances essentielles des appareils d'endoscopie

Abstract

Language: EN 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.

Language(s)
Language: EN Language: FR
Edition
3.0
Date of issue
12.08.2009
TC 62/SC 62D
ICS Codes
11.040.50
Publication number
60601
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€ 218,20 (Download and hardcopy)
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Mandatory Standard according current regulation Mandatory Standard according current regulation

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