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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)
Safety standard:
EN 60601-1 Medical electrical equipment part 1: General requirements
for safety
EMC standard:
EN 60601-1-2 Medical electrical equipment part 1-2: General
requirements for safety- Collateral standard:
Electromagnetic compatibility- Requirements and tests
Performance standards:
EN 1060-1 Non-invasive sphygmomanometers - General requirements
EN 1060-3 Non-invasive sphygmomanometers - Supplementary
requirements for electromechanical blood pressure
measuring systems.
EN 1060-4 Non-invasive sphygmomanometers - Test procedures to
determine the overall system accuracy of automated non-
invasive sphygmomanometers.
Note:
Follow instructions for use.
0197
Safety standard:
EN60601-1
Medical electrical equipment Part 1: General requirements for
basic safety and essential performance
EMC standard:
EN 60601-1-2 Medical electrical equipment Part 1-2: General requirements for
basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests
Performance standards:
EN 1060-1
Non-invasive sphygmomanometers - Part 1: General
requirements
EN 1060-3
Non-invasive sphygmomanometers - Part 3: Supplementary
requirements for electro-mechanical blood pressure measuring
systems
EN 1060-4
Non-invasive sphygmomanometers - Part 4: Test procedures
to determine the overall system accuracy of automated non-
invasive sphygmomanometers
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
