User Manual for PuraLev
®
600MU
www.levitronix.com
PL-4033-00, Rev09, DCO# 20-144
9.1.4 ATEX / IECEx Certification and Marking
Specific motors together with the pump head of the PuraLev
®
600MU 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 = 212 °F) for maximum full-load operating
temperature at a maximum liquid temperature of 90 °C / 194 °F.
9.1.5 Biocompatibility
We declare that the wet materials of the LPP-600 pump heads (made from PVDF and PFA), in the
configurations as listed below, satisfy the following biocompatibility specifications:
Table 15: Multi-Use pump heads with biocompatibility
FDA 21 CFR
All wet raw materials used in the pump heads mentioned above meet specifications according to FDA 21 CFR
(section 177.2510/177.1520 for PVDF, 177.1550 for PFA, 177.2600 for EPDM). This statement is based on
declarations provided by our raw material or component suppliers.
USP VI
The wet raw materials used in the pump heads mentioned above 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 pump heads mentioned above 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.
9.1.6 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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