Medite TES Valida - Page 2

User Manual Thermal Unit TES Valida
Page 2 Rev. 04(12/2013)
Medite GmbH
.
Wollenweberstr. 12
.
31303 Burgdorf
.
Germany
Phone +49 5136 88 84 0
.
Fax +49 5136 88 84 55
.
info@medite.de
.
www.medite.de
Certificate of Conformity
Type of instrument:
Thermal Unit – Tissue Embedding System
Model:
TES Valida™
Serial No.:
We do hereby certify that the above mentioned product meets the requirements set forth in the CE
Directives indicated below including all changes and addendums to date thereto. The above mentioned
product has been controlled and meets the following directives and standards:
 Directive 98/79/EWG In Vitro Diagnostic
 Directive 2004/108/EWG EMC
 Directive 2006/95/EWG Low Voltage
The following harmonized standards were applied:
 EN 61010-1:2001, EN 61010-2-010:2003, EN 61010-2-101:2002
Safety requirements for electrical equipment for measurement, control, and laboratory use –
Part 1: General requirements.
Part 2-010: Particular requirements for laboratory equipment for the heating of materials.
Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment.
 EN 61326-1:2006
Electrical equipment for measurement, control and laboratory use - EMC requirements -
Part 1: General requirements.
In addition, the following in-house standards were applied:
 DIN EN ISO 9001:2000
Quality management systems - Requirements.
Burgdorf, 10.12.2013 Michael Ott – Managing Director
figure 1
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