prBAS EN 60601-1/A13:2026
Medical electrical equipment - Part 1: General requirements for safety
Opće informacije
Status:Projekt
Broj stranica:48
Metoda usvajanja:Proglašavanje
Jezik:engleski
Izdanje:1.
Nadnevak realizacije:28.11.2025
Predviđeni nadnevak naredne faze:20.02.2026
Tehnički komitet:BAS/TC 25, Zdravstvena skrb
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
...
Izvorni dokument i stepen usklađenosti
EN 60601-1:2006/A13:2024, identičan
Radni materijal
Samo članovi tehničkog komiteta imaju pristup radnom materijalu. Ukoliko ste član, molimo prijavite se sa vašim nalogom i dobićete pristup dokumentima. Пријавите се