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10. Reference to standards
Device standard:
Device corresponds to the requirements of
the European standard for non-invasive
blood- pressure monitor
EN1060-1 / 12:95
EN1060-3 / 09:97
DIN 58130, NIBP – clinical investigation
ANSI / AAMI SP10, NIBP – requirements
Electromagn.
compatibility:
Device fulfils the stipulations of the
European standard EN 60601-1-2
Clinical testing:
The clinical performance test was carried
out in Germany according to the
DIN 58130 / 1997 procedure N6
(sequential).
The stipulations of the EU-Guidelines 93/42/EWG for Medical
Products Class IIa have been fulfilled.
IB BP 3BU1-5 VarB 0702.qxd 13.08.2002 8:41 Uhr Seite 30
