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User Manual for PuraLev
®
200MU
www.levitronix.com
PL-4031-00, Rev07, DCO# 20-144
35
9
Appendix
9.1 Regulatory Status
9.1.1 CE Marking
The
Centrifugal Pump System Family PuraLev
®
200MU
, in its configurations as listed below is in conformity with the
below mentioned
European Directives
. The pump system is thought to be used in hydraulic circuits of production
equipment of Life Science markets like Biotech and Pharmaceuticals.
Part Name
Description
Pump Heads LPP-200.x
Pump housing configurations consisting of variations
concerning fittings, O-Rings, wet materials (biocompatible) and
performance.
and impellers with various materials
(biocompatible) and performance variations
Motors BSM-1.x
Bearingless motors:
BSM-1.x
(x = various cable, connector and coating options)
Controllers LPC-200.x
Controllers with 24-48 VDC input:
LPC-200.x
(x = various interfacing options)
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
®
200MU
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-7695
.
9.1.4 NRTL/ETL Safety Certification and Marking
Specific motors with pump heads and controllers of the
Centrifugal Pump System PuraLev
®
200MU
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.