Ec Declaration Of Conformity - Leica CM3050 S Instruction Manual

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Instruction manual (66 pages)

Instructions for use manual (86 pages)

Service manual (287 pages)

Table Of Contents

Table of Contents

We herewith declare, in exclusive responsibility, that the

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/EG (IVDD).

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

Part 3: Limits -

Section 3: Limitation of voltage fluctuations and flicker in low-voltage

supply systems for equipment with rated current £ 16 A

Electromagnetic compatibility (EMC)

• EN 418: 1992

Emergency stop equipment.

Principles for design.

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