9 Appendix
9.1 Regulatory Status
9.1.1 CE Marking
We herewith declare that the Flow Control System Family PuraLev
®
iF100SU, in its various
configurations, is in conformity with the below mentioned European Directives.
Machinery Directive 2014/35/EC:
The machinery directive essentially has been followed by a risk analysis, according mitigation actions and a
user manual for safe operation. For the design and testing the following standards are used as a guideline:
EMC Directive 2014/30/EC:
The following standards of the EMC directive are tested and confirmed at a certified laboratory:
9.1.2 Biocompatibility
The wet materials of the DCP-200 pump heads and LFS-SU flow sensors, satisfy the following
biocompatibility specifications:
FDA 21 CFR
All wet raw materials used in the DCP-200 pump heads and flow sensors meet specifications according to
FDA 21 CFR (section 177.1520 for Olefin Polymers). This statement is based on a declaration provided by
our raw material supplier.
USP VI
The wet raw materials used in the DCP-200 pump heads and flow sensors meet the specifications of USP
Class VI. The statement is based on a declaration provided by our raw material supplier.
BSE/TSE and Animal Free
Based on declaration provided by our raw material supplier, we believe that the wet materials of the above
mentioned pump heads and flow sensors have been manufactured without coming into contact with animal
derived materials and that they do not contain potential spongiform or transmissible spongiform
encephalopathy (BSE/TSE) risk components.
9.1.3 Disposal of Equipment – WEEE Directive 2012/19/EU
Follow local legislation for disposal of equipment. In the European Union (EU) marked ( ) devices are governed by the
European WEEE Directive 2012/19/EU. Do not dispose with normal waste.
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