User Manual for PuraLev
®
600SU
www.levitronix.com
PL-4032-00, Rev06, DCO# 20-144
9.1.5 ATEX / IECEx Certification and Marking
Specific motors together with the pump head of the PuraLev
®
600SU 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.
Electrical apparatus for explosive gas atmospheres. General requirements.
Electrical Apparatus for explosive gas atmospheres. Construction, test and marking of type of
Explosive atmospheres
Non-electrical equipment for use in potentially explosive atmospheres Part1: Basic method and
requirements.
Non-electrical equipment for use in potential explosive atmospheres Part5: Protection by
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 3D Ex tc IIIC T100°C Dc
Category 3GD (Zone 2 for Gas and Zone 22 for Dust)
Thermal classification of motor is 100°C (T5) (100°C) for maximum full-load operating temperature
at a maximum liquid temperature of 90°C / 194°F.
9.1.6 Biocompatibility
The wet materials of the DCP-600 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 declarations provided by our raw
material or component suppliers.
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 declarations provided by our raw material and component suppliers.
BSE/TSE and Animal Free
Based on declarations provided by our raw material and component suppliers, 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.