Leica Biosystems ST4040 - Manual (Página 48)

48 Manual de instrucciones V1.4 – 06/2009
We herewith declare, in exclusive responsibility, that the
Leica ST4040
– Linear stainer
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)
• Directive 98/79/EC of the European Parliament and of the Council (in-vitro diagnostic medical devices)
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 systems - Requirements
EC Declaration of Conformity
10. EC Declaration of Conformity
Leica Biosystems Nussloch GmbH
Heidelberger Str. 17-19
D-69222 Nussloch
May 15, 2008
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Anne De Greef-Safft
President Biosystems Devision