prBAS EN 60601-1/A13:2026

Medical electrical equipment - Part 1: General requirements for safety


Opšte informacije
Status:Projekt
Broj stranica:48
Metoda usvajanja:Proglašavanje
Jezik:engleski
Izdanje:1.
Datum realizacije:28.11.2025
Predviđeni datum naredne faze:20.02.2026
Tehnički komitet:BAS/TC 25, Zaštita zdravlja
Direktive:
2017/745, Uredba (EU) o medicinskim sredstvima
ICS:
11.040, Medicinska oprema

Apstrakt
Contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. The contents of the corrigenda of December 2006, of July 2007, the interpretation sheet 1 of April 2008, the interpretation sheet 2 of January 2009 and the interpretation sheet 2 of May 2013 have been included in this copy.

Životni ciklus
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Izvorni dokument i stepen usklađenosti
EN 60601-1:2006/A13:2024, identičan

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