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Declaration of Conformity

AquaFlux Model AF200

Biox Systems Ltd declares that the above product complies with the essential requirements of the Low Voltage Directive 2006/95/EC and the Electromagnetic Compatibility (EMC) Directive 2004/108/EC.

Biox Systems Ltd further declares that the above product is in conformity with the requirements of the following specifications:

Document
Title Date of Issue
EN 61010-1
Safety requirements for electrical equipment for measurement, control, and laboratory use -- Part 1: General requirements.
2010
EN 61326-1
Electrical equipment for measurement, control and laboratory use - EMC requirements -- Part 1: General requirements.
2013
EN 61326-2-3 Electrical equipment for measurement, control and laboratory use - EMC requirements -- Part 2-3: Particular requirements - Test configuration, operational conditions and performance criteria for transducers with integrated or remote signal conditioning. 2012


Additional information:

1.
In addition to the above, the external power supply of the AquaFlux AF200 is UL94V-1 min compliant. It meets FCC Part-18 class B and CISPR-11 EN55011 class B emission limits and is designed to comply with UL/c-UL (UL 60601-1:2nd Edition), TUV/T-mark (EN 60601-1:2nd Edition) and new CE requirements for medical electrical equipment. However, Biox makes no representation that the AquaFlux Model AF200 is a clinically approved medical device.

2.
2. The AquaFlux AF200 is designed to comply with FCC Title 47 (Telecommunication), Part 15 (radio frequency devices) Subpart B (Unintentional Radiators) Class A (commercial and industrial environments) – 07 January 2015.


Click here to download a signed declaration in PDF format.
 
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