Welch Allyn OSZ 5 - User Manual - Manual (Page 25)

Directions For Use 17
instructions, or alterations made to the instrument by third
parties.
Reference to standards
The stipulations of the EU-Guidelines 93/42/EWG for Medical
Products Class IIa have been fulfilled.
Device standard: 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
Electromagnetic
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).