Leica CM3050 S instruction manual EC Declaration of Conformity, Dag Graupner Managing Director

10. EC Declaration of Conformity

EC Declaration of Conformity

We herewith declare, in exclusive responsibility, that the

Leica CM3050S – Cryostat

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	• 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:

• 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