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We herewith declare, in exclusive responsibility, that the
was developed, designed and manufactured to conform with the:
• Directive 98/79/EC of the European Parliament and of the Council and
• Directive 2006/42/EG
including their amendments up to the date mentioned below.
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
•
EN 14971: 2007
Medical devices - Application of risk management to medical devices
•
EN 591: 2001
Instructions for use for in vitro diagnostic instruments
•
EN ISO 12100-1: 2003
Safety of machinery.
Basic concepts, general principles for design.
Part 1: Basic terminology, methodology
•
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 Straße 17 - 19
D-69226 Nussloch
March 13, 2008
Leica SM2010 R
EC Declaration of Conformity
Leica SM2010R – Sliding Microtom
10. EC-Declaration of Conformity
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Anne De Greef-Safft
President Biosystems Division
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