73
Leica RM2255
. . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dag Graupner
Managing Director
EC Declaration of Conformity
Leica Biosystems Nussloch GmbH
Postfach 1120
D-69222 Nussloch
January 12, 2004
10.
EC Declaration of Conformity
We herewith declare, in exclusive responsibility, that the
Leica RM2235 – Rotary Microtome
was developed, designed and manufactured to conform with the
•
Council Directive 98/37/EEC and
•
European council Directive 98/79/EG (IVDD).
The following harmonized standards were applied:
•
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.
•
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
•
EN 418: 1992
Emergency stop equipment.
Principles for design.
In addition, the following in-house standards were applied:
•
DIN EN ISO 9001: 2000.
