IEC 60601-2-18:2009
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
Appareils électromédicaux - Partie 2-18: Exigences particulières pour la sécurité de base et les performances essentielles des appareils d'endoscopie
| Označení normy: | IEC 60601-2-18:2009 |
| Vydáno: | 2009-08-12 |
| Edice: | 3 |
| ICS: | 11.040.50 |
| Počet stran (Anglicky/Francouzsky): | 96 |
| ISBN (Anglicky/Francouzsky): | 9782889102167 |
IEC 60601-2-18:2009
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.