User Manual for PuraLev
®
iF30SU
www.levitronix.com
PL-4078-00, Rev00, DCO# 20-228
38
9
Appendix
9.1 Regulatory Status
9.1.1 CE Marking
We herewith declare that the
Flow Control System Family PuraLev
®
iF30SU
, 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:
EN809
Pumps for Fluids: basic requirements are followed.
EN12162
Procedure for hydrostatic pressure testing in fluid pumps: used for max. pressure testing of pump head.
ISO12100
Safety for machinery
– principles for risk assessments: used for system risk analysis.
EMC Directive 2014/30/EC:
The following standards of the EMC directive are tested and confirmed at a certified laboratory:
EN61000-6-2
Generic standards, Immunity for industrial environments
EN61000-6-4
Generic standards, Emission standard for industrial environments
9.1.2 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.
9.1.3 Biocompatibility
The wet materials of the
DCP-30
pump heads and the
LFS-SU
flow sensors satisfy the following
biocompatibility specifications:
FDA 21 CFR
All wet raw materials used in the single-use 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 single-use 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.
