Standard IEC standard · IEC 60601-2-18:2009

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

Status: Valid

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Standard IEC standard · 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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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.

Subjects

Radiographic equipment (11.040.50)


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Standard IEC standard · 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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Price: 3 640 SEK
standard ikon pdf

PDF

Price: 3 640 SEK
standard ikon

Paper

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Product information

Language: English French

Written by: IEC

International title:

Article no: STD-570097

Edition: 3

Approved: 8/12/2009

No of pages: 96

Replaces: IEC 60601-2-18:1996/AMD1:2000 , IEC 60601-2-18:1996