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24 Nederlands
Elektromagnetische compatibiliteit
EN 60601-1-2: 2007 Medische elektrische toestellen: Deel 1-2: Algemene eisen voor
basisveiligheid en essentiële prestaties - Secundaire norm: Elektromagnetische
compatibiliteit - Eisen en beproevingen
Prestatie-eisen
EN ISO 81060-1: 2012 Niet-invasieve bloeddrukmeters - Deel 1: Eisen en
beproevingsmethoden voor niet-automatische type metingen
EN 1060-3: 1997+A2: 2009 Niet-invasieve bloeddrukmeters - Deel 3: Aanvullende eisen voor
elektromechanische bloeddrukmeetsystemen
Klinisch onderzoek
EN 1060-4: 2004 Niet-invasieve bloeddrukmeters - Deel 4: Beproevingsprocedures voor
totale nauwkeurigheidsbepaling van de automatische niet-invasieve bloeddrukmeters
Bruikbaarheid
EN 60601-1-6: 2010 Medische elektrische toestellen - Deel 1-6: Algemene eisen voor
basisveiligheid en essentiële prestaties - Secundaire norm: Bruikbaarheid
EN 62366: 2008 Medische apparatuur - Aanbrengen van bruikbaarheids-engineering aan
medische apparatuur
Processen in levenscyclus van
programmatuur
EN 62304: 2006+AC: 2008 Software voor medische hulpmiddelen - Processen in
levenscyclus van programmatuur
24


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