User Manual for PuraLev
®
600SU
www.levitronix.com
PL-4032-00, Rev06, DCO# 20-144
39
9
Appendix
9.1 Regulatory Status
9.1.1 CE Marking
The
Centrifugal Pump System PuraLev
®
600SU
, in its various configurations as listed below, is in conformity with the
below mentioned
European Directives
.
Part Name
Description
DCP-600.x
Single-Use pump head with Biocompatible materials and variations of things like fittings. See separate
declaration for biocompatibility.
LPM-600.x
Bearingless motors:
LPM-600.x
(x = various cable, connector and coating options)
LPC-600.x-xx
Controllers with 48V DC / 600 W supply inputs:
LPC-600.x
(x = various interfacing options, galvanic separated from high-voltage side)
Accessories
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:
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 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.
9.1.3 IECEE CB Safety Certification
Specific motors with pump heads and controllers of the
Centrifugal Pump System PuraLev
®
600SU
are 3
rd
party tested and certified by
Electrosuisse
following the
IECEE CB Scheme
according to the following safety
standards:
IEC61010-1
Safety requirements for electrical equipment for measurement, control and laboratory use.
The CB certification number is
CH-7696
.
9.1.4 NRTL/ETL Safety Certification and Marking
Specific motors with pump heads and controllers of the
Centrifugal Pump System PuraLev
®
600SU
are
tested by the US national recognized laboratory (NRTL)
Intertek
according to the following safety standards:
UL61010-1
Safety requirements for electrical equipment for measurement, control and laboratory (US Standard).
CSA-C22.2
No. 61010-1-12
Safety requirements for electrical equipment for measurement, control and laboratory use (Canadian Standard).
UL1004-1
Rotating Electrical Machines - General Requirements (US standard).
The ETL control number for the listing is
4010272.