User Manual for PuraLev
®
i100SU
www.levitronix.com
PL-4063-00, Rev03, DCO# 20-275
40
9
Appendix
9.1 Regulatory Status
9.1.1 CE Marking
We herewith declare that the
Centrifugal Pump System Family PuraLev
®
i100SU
, 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 ATEX / IECEx Certification and Marking
Specific pump drivers with pump heads of the
PuraLev
®
i100SU
pump system together with specific
accessories are in conformity with the requirements of the
Directive 2014/34EU
and the applicable IEC
standards. The following standards are tested and confirmed at a certified laboratory.
IEC / EN 60079-0
Explosive atmospheres - General requirements.
IEC / EN 60079-7
Explosive atmospheres -
Equipment protection by increased safety “e”
IEC / EN 60079-18
Explosive atmospheres -
Equipment protection by encapsulation “m”
IEC / EN 60079-31
Explosive atmospheres -
Equipment dust ignition protection by enclosure “t”
IEC / EN 80079-36
Explos. Atmosph. - Non-electr. equipment for explosive atmosph.
– Basic method and requirements
IEC / EN 80079-37
Explosive atmospheres - Non-electrical equipment for explosive atmospheres
– Non electrical type of
protection constructional safety “c”, control of ignition source “b”, liquid immersion “k”
The Levitronix Ex pump drivers are marked clearly and in accordance to the
ATEX
Directive and the relevant
IECEx
standards.
II 3G Ex ec h mc IIC T4 Gc
II 3D Ex h tc IIIC T90 °C Dc
Classification:
Category 3GD
(
Zone 2 for Gas
and
Zone 22 for Dust)
Thermal Classification:
Thermal classification of the driver is 120 °C (T4) (120 °C = 393 °F) for maximum full-load
operating temperature at a maximum liquid temperature of 70 °C / 158 °F.
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.
9.1.4 Biocompatibility
The wet materials of the
DCP-200
pump heads, satisfy the following biocompatibility specifications:
FDA 21 CFR
All wet raw materials used in the above mentioned pump heads 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 above mentioned pump heads 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 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.
