EN 60601-2-18:2015

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

Publication date:   Jan 18, 2016

General information

60.60 Standard published   Oct 23, 2015

CENELEC

CLC/TC 62 Electrical equipment in medical practice

European Norm

11.040.50   Radiographic equipment

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
EN 60601-2-18:1996/A1:2000

WITHDRAWN
EN 60601-2-18:1996

NOW

PUBLISHED
EN 60601-2-18:2015
60.60 Standard published
Oct 23, 2015

REVISED BY

IN_DEVELOPMENT
prEN IEC 60601-2-18

Relations

Adopted from IEC 60601-2-18:2009 IDENTICAL