User Manual for PuraLev
®
200SU
www.levitronix.com
PL-4030-00, Rev06, DCO# 20-144
36
9.1.5 ATEX / IECEx Certification and Marking
Specific motors together with the pump head of the
PuraLev
®
200SU
pump system are in conformity with the
requirements of the
Directive 2014/34/EU
and the applicable
IEC
standards. The following standards are
tested and confirmed at a certified laboratory.
IEC / EN 60079-0
Electrical apparatus for explosive gas atmospheres. General requirements.
IEC / EN 60079-15
Electrical Apparatus for explosive gas atmospheres. Construction, test and marking of type of
protection, “n” electrical apparatus.
IEC / EN 60079-31
Explosive atmospheres
– Part 31: Equipment dust ignition protection by enclosure “t”.
IEC / EN 13463-1
Non-electrical equipment for use in potentially explosive atmospheres
– Part1: Basic method and
requirements.
IEC / EN 13463-5
Non-electrical equipment for use in potential explosive atmospheres
– Part5: Protection by
constructional safety “c”.
The Levitronix Ex motors are marked clearly and in accordance to the
ATEX
Directive and the relevant
IECEx
standards. The protection EX nA means non sparking electrical apparatus.
II 3G Ex nA IIC T5 Gc
II 3D Ex tc IIIC T100°C Dc
Classification:
Category 3GD (Zone 2 for Gas and Zone 22 for Dust)
Thermal Classification:
Thermal classification of motor is T5 (< 100
0
C = 212
0
F) for maximum full-load operating
temperature at a maximum liquid temperature of 90
0
C / 194
0
F.
9.1.6 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.
