HRN EN 60601-2-18:2015
Medicinska električna oprema -- Dio 2-18: Posebni zahtjevi za osnovnu sigurnost i bitne radne značajke uređaja za endoskopiju (IEC 60601-2-18:2009; EN 60601-2-18:2015)
Oznaka: | HRN EN 60601-2-18:2015 |
Naslov (HR): | Medicinska električna oprema -- Dio 2-18: Posebni zahtjevi za osnovnu sigurnost i bitne radne značajke uređaja za endoskopiju (IEC 60601-2-18:2009; EN 60601-2-18:2015) |
Naslov (EN): | Medical electrical equipment -- Part 2-18: Particular requirements for basic safety and essential performance of endoscopic equipment (IEC 60601-2-18:2009; EN 60601-2-18:2015) |
Područje primjene (EN): | 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. |
Izdanje: | 2 |
ICS: | 11.040.50 Radiografijska oprema |
Tehnički odbor/pododbor: | TO E62, Električna oprema u medicinskoj praksi |
Oznaka faze: | 60.60 - HRN dostupan |
Glasilo (rasprava): | HZN e-Glasilo 5/2015 () |
Glasilo (objava): | HZN e-Glasilo 6/2015 () |
Način prihvaćanja: | pr - prihvaćanje strane norme u izvorniku |
Cijena #1: | Cijena: 50,00 € | Jezik: en | Cjenovni razred: J | Broj stranica: 51 |
Izvornik: | EN 60601-2-18:2015 |
Zamjenjuje: | HRN EN 60601-2-18:1999 |
Direktiva/Uredba: | kandidat |
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