DECLARATION OF CONFORMITY
This is to certify that the following Biochrom manufactured products conform to the
requirements of the following Directives -:
Biochrom Libra S50 (80-7000-00, 80-7000-01, 80-7000-02, 80-7000-03, 80-7000-04)
Biochrom Libra S60 (80-7000-10, 80-7000-11, 80-7000-12, 80-7000-13, 80-7000-14)
Biochrom Libra S70 (80-7000-20, 80-7000-21, 80-7000-22, 80-7000-23, 80-7000-24)
Biochrom Libra S80 (80-7000-30, 80-7000-31, 80-7000-32, 80-7000-33, 80-7000-34)
2006/95/EC Low voltage equipment safety directive
98/79/EC In Vitro Diagnostic Medical Devices Directive
2004/108/EC EMC directive
2002/96/EC EC Directive on Waste Electrical and Electronic Equipment (WEEE)
2003/108/EC & 2008/34/EC
2002/95/EC Restrictions of the use of certain Hazardous Substances in Electrical
and Electronic Equipment (ROHS)
2006/42/EC Machinery directive
1999/5/EC Radio and Telecommunications Terminal Equipment Directive
(instruments fitted with Bluetooth accessory only)
Standards to which conformity is declared, where relevant, are as follows
EN61010-1:2001 Safety requirements for electrical equipment for measurement,
control and laboratory use. General requirements
EN61010-2-101:2002 Particular requirements for IVD medical equipment
EN61326-1:2006 Electromagnetic compatibility - generic emission standard
electrical equipment for measurement, control & laboratory use.
EN12100-1,2:2003(+A1:2009) Safety of machinery–Basic concepts, general principles for design
EN14121-1:2007 Safety of machinery, Risk assessment
For further information, including unpacking, positioning and installation of the products
please refer to the user manual.
Signed:
Brian Clarkstone
Technical Director
Biochrom Ltd
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