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Declaration of Conformity for Biochrom Manufactured Products
This is to certify that the following Biochrom manufactured products:-
EZ Read 2000 (80-4002-20)
Conform to the requirements of the following Directives:-
2006/95/EC
Low voltage directive (LVD)
2004/108/EC
Electromagnetic Compatibility (EMC) directive
2012/19/EU
Waste Electrical and Electronic Equipment directive recast (WEEE Recast)
2011/65/EU
Restriction on the use of certain hazardous substances (ROHS) directive
2006/42/EC
Machinery directive
98/79/EC
In Vitro medical devices directive (Annex I & III)
Standards, to which conformity is declared, are as follows:-
EN61010-1:2010
Safety requirements for electrical equipment for measurement, control and
laboratory use. General requirements
EN61010-2-101:2002
Safety requirements for electrical equipment for measurement, control and
laboratory use. Particular requirements for in vitro diagnostic (IVD) medical
equipment
EN61326-1:2006
Electrical equipment for measurement, control and laboratory use -EMC
Requirements*
EN ISO 12100:2010
Safety of machinery-General principles for design, risk assessment and risk
reduction
*This equipment has been tested and found to comply with the limits for a CLASS A digital device,
pursuant to part 15 of the FCC Rules.
For further information, including unpacking, positioning and installation of the products please refer to
the user manual.
Signed:
Dated: 07
th
May 2013
Sam Luke
Group Managing Director, Biochrom Ltd
