Ec Declaration Of Conformity - Miltenyi Biotec gentleMACS Manual Del Usuario

EC Declaration of conformity

This declaration of conformity is issued under the sole responsibility of the manufacturer:
Miltenyi Biotec B.V. & Co. KG
Friedrich-Ebert-Str. 68
51429 Bergisch Gladbach
Germany
This declaration relates exclusively to the machinery in the state in which it was placed on the market, and
excludes components which are added and/or operations carried out subsequently by the final user.
The declaration of conformity refers to the machinery identified as follows:
Description: Laboratory equipment
Model: gentleMACS™ Octo Dissociator with Heaters
The machinery complies with all essential requirements of the following directives:
2006/42/EC Machinery
2011/65/EU Restriction of the use of certain hazardous substances in electrical & electronic equipment
2014/30/EU Electromagnetic compatibility
The machinery is in conformity with the following harmonized standards:
EN 61010-1:2010
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EN 61010-2-010:2014
EN 61010-2-051:2015
EN 61326-1:2013
Person authorized to compile the relevant technical documentation:
Stefan Miltenyi
Miltenyi Biotec B.V. & Co. KG
Friedrich-Ebert-Str. 68
51429 Bergisch Gladbach
Germany
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