Medline MDS1001U, Operation Manual, Page: 4 / 75

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The blood pressure measuring device bears the CE (conformity) label “CE0473”.
The quality of the device has been verified and conforms to the provisions of
the EC-Council directive 93/42/EEC as well as the EMC directive 89/336/EEC:
EN 1060-1
Non-invasive blood pressure measuring equipment. General requirements
EN 1060-3
Non-invasive blood pressure measuring equipment. Supplementary
requirements for electro-mechanical blood pressure measuring system
EN 60601-1
Safety requirements for medical electrical equipment
EN 60601-1-2
Electromagnetic compatibility and safety for medical electrical equipment
EN 14971
Risk analysis for medical devices in accord with requirement in section 21 of CMDR’S
MEASUREMENT ACCURACY