Reference To Standards - aponorm Microlife Bedienungsanleitung

9. Reference to standards

9. Reference to standards 9. 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.
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