Ce directives and standards – Kontron Medi Client IIA 104 (EOL) User Manual
Page 46

9. Technical Data
Medi Client IIA - Instructions for use (Version 1.03)
9.4. CE Directives and Standards
CE Directives
Low Voltage Directive
(Electrical Safety)
2006/95/EC
EMC Directive
2004/108/EC
Medical Device Directive
93/42/EEC class 1 device
CE Marking
93/68/ECC
Electrical Safety
Standards
EUROPE
EN 60950-1: 2006
EN 60601-1 3
rd
Edition: 2006
USA / Canada
UL 60950-1:2006 cULus Listed
CB Scheme
CB Certification
EMC
Standards
EN 55022: 2006
Emission of Information technology equipment – Radio disturbance
characteristics – Limits and methods of measurement
EN 61000-3-2:2006
Limits - Limits for harmonic current emissions (equipment input current <=
16 A per phase)
EN 61000-3-3:2006
Limitation of voltage changes, voltage fluctuations and flicker in public low-
voltage supply systems, for equipment with rated current <=16 A per phase
and not subjected to conditional connection
EN 61000-6-4: 2007
Generic standards - Emission standard for industrial environments
EN 61000-6-3: 2007
Generic standards – Emission standard for residential, commercial and light-
industrial environments
EN 55024: 1998 + A1: 2001 +
A2: 2003
Information technology equipment – Immunity characteristics – Limits and
methods of measurement
EN 61000-6-2: 2005
Generic standards - Immunity for industrial environments (Immunity):
EN 55011: 2007
Industrial scientific and medical (ISM) radio-frequency equipment –
Electromagnetic disturbance characteristics – Limits and methods of
measurement
EN60601-1-2: 2007
Medical electrical equipment - General requirements for basic safety and
essential performance - Collateral standard: Electromagnetic compatibility -
Requirements and tests
U.S.A.
Canada
FCC 47 CFR Part 15, Class B
ICES-003
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