User Manual for PuraLev
®
600MU
www.levitronix.com
PL-4033-00, Rev09, DCO# 20-144
9 Appendix
9.1 Regulatory Status
9.1.1 CE Marking
The Centrifugal Pump System PuraLev
®
600MU, in its various configurations as listed below, is in conformity
with the below mentioned European Directives.
Pump casing configurations consisting of variations concerning fittings,
O-Rings, biocompatible wet materials and performance. See separate
declaration for biocompatibility.
Impellers with various biocompatible
materials and performance variations.
See separate declarant. for biocompatibility.
Bearingless motors: LPM-600.x (x = various cable, connector and coating options)
Controllers with 48V DC / 600 W supply inputs:
LPC-600.x (x = various interfacing options, galvanic separated from high-voltage side)
Motor controller adaptor cables of various length, air cooling module and others
Machinery Directive 2006/42/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:
Pumps for Fluids: basic requirements are followed.
Procedure for hydrostatic pressure testing in fluid pumps: used for max. pressure testing of pump head.
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:
Generic standards, Immunity for industrial environments
Generic standards, Emission standard for industrial environments
9.1.2 IECEE CB Safety Certification
Specific motors with pump heads and controllers of the Centrifugal Pump System PuraLev
®
600MU are 3
rd
party tested and certified by Electrosuisse following the IECEE CB Scheme according to the following safety
standards:
Safety requirements for electrical equipment for measurement, control and laboratory use.
The CB certification number is CH-7696.
9.1.3 NRTL/ETL Safety Certification and Marking
Specific motors with pump heads and controllers of the Centrifugal Pump System PuraLev
®
600MU are
tested by the US national recognized laboratory (NRTL) Intertek according to the following safety standards:
Safety requirements for electrical equipment for measurement, control and laboratory (US Standard).
Safety requirements for electrical equipment for measurement, control and laboratory use (Canadian Standard).
Rotating Electrical Machines - General Requirements (US standard).
The ETL control number for the listing is 4010272.
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