Leica RM2245 EC Declaration of Conformity, We herewith declare, in exclusive responsibility, that

10.EC Declaration of Conformity

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.

Leica Microsystems Nussloch GmbH

Postfach 1120

D-69222 Nussloch

January 12, 2004

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Dag Graupner

Managing Director