D-1
Annexe D Technical Specifications
D.1 Safety Specifications
Standards
MDD 93/42/EEC Medical Device Directive
IEC 60601-1:
2005+A1:2012
Medical electrical equipment - Part 1:
General requirements for basic safety
and essential performance
IEC 60601-2-25:
2011
Medical electrical equipment - Part 2-25:
Particular requirements for the basic
safety and essential performance of
electrocardiographs
IEC 60601-1-2:
2014
Medical electrical equipment - Part 1-2:
General requirements for basic safety
and essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
Classifications
Anti electric-
shock type:
Device: Class II with internal power
supply
Device equipped with recorder base:
Class I with internal power supply
Anti electric-
shock degree:
Defibrillation proof Type CF applied part
Degree of
protection against
harmful ingress of
water:
7” device: IPX2
10.1” device: IPX0
Installation and
use:
Portable, not permanent installation
device
Working mode: Continuous operation
EMC: Group I, Class B
Degree of safety
of application in
the presence of
flammable gas:
Equipment not suitable for use in the
presence of flammable gas
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