Reference To Standards - Microlife BP 3BU1-5 Instruction Manual

10. Reference to standards

Device standard:
Electromagn.
compatibility:
Clinical testing:
The stipulations of the EU-Guidelines 93/42/EWG for Medical
Products Class IIa have been fulfilled.
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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
Device fulfils the stipulations of the
European standard EN 60601-1-2
The clinical performance test was carried
out in Germany according to the
DIN 58130 / 1997 procedure N6
(sequential).