Reference To Standards - Welch Allyn OSZ5 Instrucciones De Uso

Directions For Use
instructions, or alterations made to the instrument by third
parties.

Reference to standards

Device standard:
Electromagnetic
compatibility:
Clinical testing:
The stipulations of the EU-Guidelines 93/42/EWG for Medical
Products Class IIa have been fulfilled.
Device corresponds to the requirements of the
European standard for non-invasive blood
pressure monitor
EN1060-1/12:95
EN 1 060-3/09:97
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).
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