Ec Declaration Of Conformity - Leica RM2235 Manual De Instrucciones

We herewith declare, in exclusive responsibility, that the
was developed, designed and manufactured to conform with the
• Direktive 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
The following harmonized standards were applied:
• 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
• 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 14121-1: 2007
Safety of machinery
Risk assessment
Part 1: Principles
In addition, the following in-house standards were applied:
• DIN EN ISO 9001: 2000.
Quality management systems - Requirements
Leica Biosystems Nussloch GmbH
Postfach 1120
D-69222 Nussloch
May 15, 2008
Leica RM2235

EC Declaration of Conformity

Leica RM2235 – Manual Rotary Microtome
10. EC Declaration of Conformity
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Anne De Greef-Safft
President Biosystems Devision
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