Citizen CH-618 Instruction Manual page 27

Note:
0197
Safety standard:
EN60601-1
EMC standard:
EN 60601-1-2 Medical electrical equipment Part 1-2: General requirements for
Performance standards:
EN 1060-1
EN 1060-3
EN 1060-4
EN ISO 81060-1 Non-invasive sphygmomanometers - Part 1: Requirements and
test methods for non-automated measurement type (partially applied)
IEC 80601-2-30 Medical electrical equipment - Part 2-30: Particular
requirements for the basic safety and essential performance of automated non-
invasive sphygmomanometers
Follow instructions for use.
This blood pressure monitor complies with the EC
Directive (93/42/EEC) and bears the CE mark. This
blood pressure monitor also complies with mainly
following standards,(included but not limited)
Medical electrical equipment Part 1: General requirements for
basic safety and essential performance
basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests
Non-invasive sphygmomanometers - Part 1: General
requirements
Non-invasive sphygmomanometers - Part 3: Supplementary
requirements for electro-mechanical blood pressure measuring
systems
Non-invasive sphygmomanometers - Part 4: Test procedures
to determine the overall system accuracy of automated non-
invasive sphygmomanometers
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