Topcom BD-4600 User Manual page 3

This Blood Pressure Monitor complies with the EC Directives and bears the CE Mark
"CE 0197".
This blood pressure monitor also complies with mainly following standards, 
(including but not limited).
Safety standards
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.
The declaration of conformity can be found on:
www.tristar.eu
Puede encontrarse la Declaración de conformidad en:
www.tristar.eu