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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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Kehtiv alates 12.08.2009
Tegevusala (ICS grupid)
11.040.50 Radiograafiaseadmed
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puuduvad
Standardi ajalugu
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Kuupäev
Tüüp
Nimetus
12.08.2009
Põhitekst
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.
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ISO 8600-1:2015

Endoscopes -- Medical endoscopes and endotherapy devices -- Part 1: General requirements
Uusim versioon Kehtiv alates 09.10.2015
Põhitekst

IEC 60601-2-22:2007

Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Kehtetu alates 20.11.2019