VETSCAN SA USER’S MANUAL
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1.1 SOFTWARE
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Declaration Of Conformity
Manufacturer:
Abaxis, Incorporated
3240 Whipple Road
Union City, CA 94587, USA
European Authorized Representative:
Achim Henkel
ABAXIS Europe, GmbH
Bunsenstr. 9-11
64347 Griesheim, Germany
The Directives covered by this Declaration
EU Machinery Directive 2006/42/EC
EU RoHS2 Directive 2011/65/EU
The Products Covered by this Declaration
VETSCAN SA sediment analyzer
The Basis on which Conformity is being declared
The manufacturer hereby declares under his sole responsibility that the products identified
above comply with the essential health and safety requirements of the Machinery directive
2006/42/EC.
The manufacturer has applied the following standards:
EN ISO 13485:2012
Medical devices-Quality Management systems- Requirements for
regulatory purposes
EN 61326-1
Electrical Equipment for Measurement, Control and Laboratory Use –
EMC Requirements – Part 1: General Requirements
IEC/EN 61010-1
Safety Requirements for Electrical Equipment for Measurement, Control
and Laboratory Use Part 1: General Requirements
IEC/EN 61010-2-081
Particular Requirements for Automatic and Semi-Automatic Laboratory
Equipment for Analysis and Other Purposes
The technical documentation required to demonstrate that the products meet the requirements
of the Machinery directive 2006/42/EC can be made available to relevant authorities within a
reasonable period of time.
