Leica RM2245 User Manual Page 68

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. . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dag Graupner
Managing Director
EC Declaration of Conformity
Leica Microsystems Nussloch GmbH
Postfach 1120
D-69222 Nussloch
January 12, 2004
10. EC Declaration of Conformity
We herewith declare, in exclusive responsibility, that the
Leica RM2245 – Rotary Microtome
was developed, designed and manufactured to conform with the
Council Directive 73/23/EEC, (Low Voltage),
Council Directive 89/336/EEC, Appendix I (Electromagnetic Compatibility) and
European council Directive 98/79/EC (IVD)
including their amendments up to the date mentioned below.
The following harmonized standards were applied:
EN 61010-1: 2001
Safety requirements for electrical equipment for measurement, control and laboratory use -
Part 1: General requirements
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
EN 61326-1: 1997 + A1: 1998 + A2: 2001 + A3: 2003
Electrical equipment for measurement, control and laboratory use -
EMC requirements -
Part 1: General requirements
EN 61000-3-2: 2000
Electromagnetic compatibility (EMC)
Part 3-2: Limits - Limits for harmonic current emissions
EN 61000-3-3:1995 + A1: 2001
Electromagnetic compatibility (EMC)
Part 3: Limits -
Section 3: Limitation of voltage fluctuations and flicker in low-voltage
supply systems for equipment with rated current 16 A
In addition, the following in-house standards were applied:
DIN EN ISO 9001: 2000.
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