Leica CM1950 Manuel D’Utilisation
We herewith declare, in exclusive responsibility, that the
Leica CM1950 Cryostat
was developed, designed and manufactured to conform with the
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Council Directive 2006/95/EC (Low Voltage),
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Council Directive 89/336/EEC, Appendix I (Electromagnetic Compatibility) and
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European council Directive 98/79/EC (IVD)
including their amendments up to the date mentioned below.
The following harmonized standards were applied:
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EN 61010-1: 2001
Safety requirements for electrical equipment for measurement, control and laboratory use -
Part 1: General requirements
Safety requirements for electrical equipment for measurement, control and laboratory use -
Part 1: General requirements
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EN 61010-2-101: 2002
Safety requirements for electrical equipment for measurement, control and laboratory use -
Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
Safety requirements for electrical equipment for measurement, control and laboratory use -
Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
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EN 591: 2001
Instruction for use for in vitro diagnostic instruments for professional use
Instruction for use for in vitro diagnostic instruments for professional use
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EN 61326-1: 2006
Electrical equipment for measurement, control and laboratory use - EMC requirements -
Part 1: General requirements
Electrical equipment for measurement, control and laboratory use - EMC requirements -
Part 1: General requirements
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EN 61326-2-6: 2006
Electrical equipment for measurement, control and laboratory use - EMC requirements
Electrical equipment for measurement, control and laboratory use - EMC requirements
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EN 61000-3-2: 2000
Electromagnetic compatibility (EMC)
Part 3-2: Limits - Limits for harmonic current emissions
Electromagnetic compatibility (EMC)
Part 3-2: Limits - Limits for harmonic current emissions
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EN 61000-3-3: 1995 + A1: 2001
Part 3: Limits -
Section 3: Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage
supply systems, for equipment with rated current
Part 3: Limits -
Section 3: Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage
supply systems, for equipment with rated current
≤ 16A per phase
Electromagnetic compatibility (EMC)
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EN 418: 1992
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EN 1037: 1995
Emergency stop equipment.
Safety of machinery.
Principles for design.
Prevention of unexpected start-up.
In addition, the following in-house standards were applied:
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DIN EN ISO 9001: 2000
Quality management system - requirements.
Quality management system - requirements.
EC Declaration of Conformity
14.
EC Declaration of Conformity
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Anne De Greef-Safft
President Biosystems Division
Leica Biosystems Nussloch GmbH
Postfach 1120
D-69222 Nussloch
Postfach 1120
D-69222 Nussloch
October 11, 2007