Comen H3 - Appendix II Technical Specifications

II-1
Appendix II Technical Specifications
Safety
Standards
IEC60601-1
Medical Electrical
Equipment-Part 1: General
Requirements for Safety and
essential performance
IEC60601-2-25
Medical Electrical
Equipment-Part 2-25: Particular
requirements for the basic safety
and essential performance of
electrocardiographs
IEC 60601-1-2
Medical Electrical
Equipment-Part 1-2: General
requirements for basic safety and
essential performance - Collateral
standard: Electromagnetic
compatibility - Requirements and
tests
EC11
Diagnostic electrocardiographic
devices
Classification
Anti-electric-shock type
Class І with internal power supply
Anti-electric-shock degree
ECG: Type CF
Degree of safety of application
in the presence of flammable
gas
Equipment not suitable for use in the
presence of flammable gas