IEC 60601-2-18:2009

IEC 60601-2-18:2009

IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

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Details

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.

Additional Info

Author International Electrotechnical Commission (IEC)
Committee TC 62/SC 62D
Published by IEC
Document type Standard
Edition 3.0
ICS 11.040.50 : Radiographic equipment
Number of pages 96
Cross references DIN EN 60601-2-18 (2016-10), IDT,ABNT NBR IEC 60601-2-18 (2014-04-01), IDT,BS EN 60601-2-18 (2015-11-30), IDT,EN 60601-2-18 (2015-10), IDT,NF C74-318 (2016-01-16), IDT,JIS T 0601-2-18 (2013-09-01), IDT,CAN/CSA-C22.2 No. 60601-2-18-11 (2011-07-01), IDT,OVE
Document history ,,,,
Keyword IEC60601-2-18,IEC 60601-2-18:2009,IEC 60601-2-18,TC 62/SC 62D
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