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Nederlands 23
Bedrijfsmodus Continue werking
Beschermingsklasse Toepassing type BF
Bescherming tegen binnendringend
water
IP21
Softwareversie V01
Apparaatclassificatie ME-apparaat met interne voeding
Lijst van nageleefde Europese normen
14
Risicomanagement
EN ISO 14971: 2012 Medische hulpmiddelen - Toepassing van risicomanagement voor
medische hulpmiddelen (ISO14971: 2007, gecorrigeerde versie 2007-10-01)
Etikettering EN 980: 2008 Symbolen voor gebruik bij het etiketteren van medische hulpmiddelen
Gebruikershandleiding EN 1041: 2008 Informatie die door de fabrikant bij medische hulpmiddelen wordt geleverd
Algemene veiligheidseisen
EN 60601-1: 2006+A1: 2013 Medische elektrische toestellen - Deel 1: Algemene eisen voor
basisveiligheid en essentiële prestaties
EN 60601-1-11: 2010 Medische elektrische toestellen - Deel 1-11: Algemene eisen voor
basisveiligheid en essentiële prestaties - Secundaire norm: Eisen voor medische elektrische
apparatuur en medische elektrische systemen die gebruikt worden voor de medische
verzorging in de thuissituatie
IEC/EN 80601-2-30: 2009 Medische elektrische toestellen - Deel 2-30: Speciale eisen voor
basisveiligheid en essentiële prestaties van niet-invasieve bloeddrukmeters
23


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