Standards and
Quality Management.
Our products and processes comply with the following standards and quality management criteria.
heliX biosensors
heliX® / heliXcyto
European CE Directives
2014/35/EU Low Voltage Directive
Tested according to the following standards
EN 61010-1:2010/AMD1:2016 Edition 3.0
EN 61010-2-081:2015
2014/30/EU Electromagnetic Compatibility Directive
Tested according to the following standards
EN 61326-1:2013
EN 61000-3-2:2014
EN 61000-3-3:2013
North America – NRTL
Tested according to the following standards
UL 61010-1, 3rd Ed.
CAN/CSA-C22.2 No. 61010-1-12, 3rd Ed.
FCC 47 CFR Part 15
ICES-003 Issue 6
DRX biosensors
DRX / DRX2
European CE Directives
2006/95/EC Low Voltage Directive
Tested according to standard EN 61010-1
2004/108/EC Electromagnetic Compatibility Directive
Tested according to the following standards
EN 61326-1: 2006
EN 61000-6-2: 2005
EN 61000-6-4: 2007 / A1: 2011
EN 61000-3-2: 2006 + A1 + A2
EN 61000-3-3: 2008
North America – NRTL
Tested according to the following standards
UL 61010-1, 3rd Ed.
CAN/CSA-C22.2 No. 61010-1-12, 3rd Ed.
proFIRE – purification system
proFIRE®
European CE Directives
EMC Directive 2014/30/EU
IEC 61000-3-2:2014
IEC 61326-1:2012
RoHS Directive 2011/65/EU
WEEE Directive 2012/19/EU
Low Voltage Directive 2014/35/EU
IEC 61010-1:2010
IEC 61010-2-081:2015
Certificates of Compliance
Tested according to the following standards
UL 61010-1, 3rd Ed.
CAN/CSA-C22.2 No. 61010-1-12, 3rd Ed.
Please contact us for more information and for assistance for 21 CFR Part 11 compliance.