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