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Declaration of conformity, 8 declaration of conformity – Leica Biosystems RM CoolClamp User Manual

Page 19

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Declaration of Conformity

INHECO GmbH

19

8 Declaration of Conformity


INHECO GmbH
Fraunhoferstr. 11
82152 Martinsried
Germany

Confirms that the following product,

RM CoolClamp,

fulfills the essential requirements of the following directive(s) and their relevant
part(s) of the standards and their related documents of the European Union:

Standards and date of issue

EN 61010-1: 2004
UL 61010-1: 2004
CSA C22.2.61010.1: 2004

Safety requirements for electrical
equipment for measurement, control
and laboratory use - Part 1: General
requirements.

EN 61010-2-101: 2002

Safety requirements for in vitro
diagnostics instruments.

EN 60601-1-2: 2007

Electrical equipment for medical use.
EMC requirements.

EN 61326-1: 2006

Electrical equipment for measurement,
control and laboratory use. EMC
requirements.



This product fulfills the directives 98/79/EC for in vitro diagnostics medical
devices, 2002/96/EC WEEE, and 2002/95/EC RoHS.

City

Martinsried / Munich

Date

May, 2010

Signature

Name, position

Günter Tenzler, Managing Director