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25
Rev
:A1
Reference Standard
• IEC 60601-1
:
2005 Medical electrical equipment-Part1:
General requirements for safety and essential performance.
• IEC 60601-1-2:2007 Medical electrical equipment – Part 1-2:
General requirements for basic safety and essential performance
– Collateral standard: Electromagnetic compatibility – Requirem
ents
and tests
• ANSI/AAMI/ISO 81060-2-2009 Non-invasive
sphygmomanometers-Part 2:Clinical validation of automated
measurement type.
Blood Pressure Measurement Chart
Date
Time
SYS/DIA
Pulse
Remark
Date
Time
SYS/DIA
Pulse
Remark
• IEC 80601-2-30:2009 Medical electrical equipment – Part
2-30: Particular requirements for the basic safety and essential
performance of automated non-invasive sphygmomanometers.