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  • DS/EN 60601-2-18:2015

DS/EN 60601-2-18:2015

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


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 96.69
Legislation:

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.


Number of pages: 53

Published: 2016-09-08

Date of approval: 2016-08-25

International relationships : EN 60601-2-18:2015 IDT IEC 60601-2-18:2009 IDT

ICS: 11.040.50 - Radiographic equipment

Item number: M230369


Committees

Committee

  • CLC/TC 62

Danish committee

DS/S-562