Applicable standards
EN 980:
Symbols for use in the labelling of medical device
EN 60601-1:
Medical electrical equipment - Part 1: General
requirements for safety
EN 60601-1-2:
Medical electrical equipment - Part 1: General
requirements for safety. Collateral standard.
Electromagnetic compatibility
Operation
Temperature range +10° C to +40° C
Relative humidity 30 % to 75 %, non condensing
Air pressure 70 kPa to 106 kPa
During transportation
Temperature range -20° C to +60° C
Relative humidity 10 % to 90 %, non condensing
Air pressure 70 kPa to 106 kPa
Environmental conditions for use
11
10
13