Ec Declaration Of Conformity - Leica RM2125 Manual

EC Declaration of Conformity

EC Declaration of Conformity
We herewith declare, in exclusive responsibility, that the instrument
Leica RM2125/RM2125 RT –
was developed, designed and manufactured to conform with the
• Directive 98/79/EC of the European Parliament and of the Council (in-vitro diagnostic medical devices)
• Directive 2006/42/EC of the European Parliament and of the Council on machinery
including their amendments up to the date mentioned below.
The following harmonized standards were applied:
• DIN EN ISO 12100-1: 2003
Safety of machinery.
Basic concepts, general principles for design.
Part 1: Basic terminology, methodology.
• DIN EN ISO 12100-2: 2003
Safety of machinery.
Basic concepts, general principles for design.
Part 2: Technical principles and specifications.
In addition, the following in-house standards were applied:
• DIN EN ISO 9001: 2000.
Leica Biosystems Nussloch GmbH
Heidelberger Str. 17-19
D-69226 Nussloch
October 11, 2007
40
Rotary Microtome
. . . . . . . . . . . . . . . . . . . . . . . . . . . .
Anne De Greef-Safft
President Biosystems Division
Instruction manual V 2.3 – 02/2009