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12-5
Hebt u vragen? Zie pag. 10-10 voor instructies voor technische hulp.
Naleving van standaarden
Het Precision Xceed Pro systeem is op naleving van de volgende standaarden geëvalueerd:
UL 60601-1, 1e ed. Medische elektrische apparatuurdeel 1: algemene veiligheidseisen
CSA C22.2 No. 601.1-M90, Medische elektrische apparatuur – deel 1: algemene veiligheidseisen
EN 60601-1, 2e ed. Medische elektrische apparatuur – deel 1: algemene veiligheidseisen
CSA 22.2 No. 61010.1-4
EN 60601-1Medische elektrische apparatuur deel 1: algemene veiligheidseisen bevat erratum juli 1994; bevat de
amendementen A1: 1993, A11: 1993, A12: 1993, A2: 1995 en A13: 1996; IEC 601-1: 1988 + A1: 1991 + A2: 1995 + erratum 1995,
aangepast
IEC 61010-2-101 (2002-01) – Veiligheidseisen voor elektrische apparatuur voor meten, controle en laboratoriumgebruik deel
2-101: specieke eisen voor in-vitrodiagnostiek (IVD) medische apparatuur 1e editie
EN 60601-1-2 – 2001 klasse A – Medische elektrische apparatuur – deel 1-2: algemene veiligheidseisen – bijkomstige standaard:
elektromagnetische compatibiliteit – eisen en tests IEC 60601-1-2: 2001
IEC 60601-1 – Medische elektrische apparatuur – deel 1: algemene veiligheidseisen 2e editie
IEC 60601-1-1, 2e ed. Medische elektrische apparatuur — deel 1-1: algemene veiligheidseisen – bijkomstige standaard:
veiligheidseisen voor medische elektrische systemen
IEC 60601-1-2 (1993-04) – Medische elektrische apparatuur – deel 1: algemene veiligheidseisen 2. Bijkomstige standaard:
elektromagnetische compatibiliteit – eisen en tests eerste editie; (CENELEC EN 60601-1-2: 1993)
Precision Xceed Pro meter – Klasse II (APPARATUUR gevoed door een interne elektrische stroombron).
Dockingstation – Klasse II (APPARATUUR gevoed door een interne elektrische stroombron).
Hoofdstuk 12: Specificaties/beperkingen
85


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