– 57 –
NOTE
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 require
-
ments 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: Supplemen
-
tary requirements for electro-mechanical blood pressure measuring
systems.
EN 1060-4 Non-invasive sphygmomanometers - Part 4: Test proce
-
dures to determine the overall system accuracy of automated non-i
-
nvasive 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 auto
-
mated non-invasive sphygmomanometers
