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

Page 46

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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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