Leica CM1950 User Manual download pdf (Page 72)

We herewith declare, in exclusive responsibility, that the

Leica CM1950 Cryostat

was developed, designed and manufactured to conform with the

• Council Directive 2006/95/EC (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 591: 2001

Instruction for use for in vitro diagnostic instruments for professional use

• EN 61326-1: 2006

Electrical equipment for measurement, control and laboratory use - EMC requirements -

Part 1: General requirements

• EN 61326-2-6: 2006

Electrical equipment for measurement, control and laboratory use - EMC 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 changes, voltage fluctuations and flicker in public low-voltage

supply systems, for equipment with rated current

≤ 16 A per phase

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

Quality management system - requirements.

EC Declaration of Conformity

14. EC Declaration of Conformity

. . . . . . . . . . . . . . . . . . . . . . . . . . . .

Anne De Greef-Safft

President Biosystems Division

Leica Biosystems Nussloch GmbH

Postfach 1120

D-69222 Nussloch

October 11, 2007

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