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Directions for use 51
Electromagnetic
compatibility
IEC/EN 60601-1-2 Medical
electrical equipment -
Part 1-2: General
requirements for basic
safety and essential
performance - Collateral
standard: Electromagnetic
compatibility -
Requirements and tests
Performance
requirements
and clinical
investigation
IEC 80601-2-30 Medical
electrical equipment- Part
2-30: Particular
requirements for the basic
safety and essential
performance of
automated non-invasive
sphygmomanometers
ISO81060-2:2013 Non-
invasive
sphygmomanometers —
Part 2: Clinical validation
of automated
measurement type
Software life-
cycle processes
IEC/EN 62304+AC:
Medical device software -
Software life cycle
processes
Item Standard

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