Declaration Of Conformity; Anne De Greef-Safft President Biosystems Division - Leica CM1950 Manual De Instrucciones

We herewith declare, in exclusive responsibility, that the
was developed, designed and manufactured to conform with the
• Directive 2006/95/EC of the European Parliament and of the Council (Low Voltage)
• Directive 2004/108/EC of the European Parliament and of the Council (electromagnetic compatibility) and
• Directive 98/79/EC of the European Parliament and of the Council (in-vitro diagnostic medical devices)
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 61326: 2006
Electrical equipment for measurement, control and laboratory use - EMC requirements -
Part 1: General requirements
• DIN EN 61010-2-101: 2002
Safety requirement for electrical equipment for measurement, control and laboratory use
Part 2-101: Particular requirements for in vitro diagnostic (IVD)
• EN 14971: 2007
Medical devices - Application of risk management to medical devices
• EN 591: 2001
Instruction for use for in vitro diagnostic instruments for professional use
In addition, the following in-house standards were applied:
• DIN EN ISO 9001: 2000
Quality management system - requirements.
Leica Biosystems Nussloch GmbH
Str. 17-19
Heidelberger
D-69226 Nussloch
October 11, 2007
EC Declaration of Conformity
Leica CM1950 – Cryostat

14. Declaration of Conformity

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Anne De Greef-Safft
President Biosystems Division