Integra VIAFLO 96 - Page 2

Declaration of conformity
INTEGRA Biosciences AG – 7205 Zizers, Switzerland
declares on its own responsibility that the devices
comply with:
Zizers, June 19, 2017
Description Models
VIAFLO 96 6000, 6001
VIAFLO 384 6030, 6031
EU Directives (DoW: Date of Withdrawal) Before DoW DoW After DoW
Low Voltage Equipment 2006/95/EC 20.04.2016 2014/35/EU
Electromagnetic Compatibility 2004/108/EC 20.04.2016 2014/30/EU
Restriction of Hazardous Substances 2011/65/EU
Waste Electrical and Electronic Equipment 2012/19/EU
EU Regulations
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) 1907/2006
Standards for EU
Safety requirements for electrical equipment for measurement,
control and laboratory use - General requirements.
EN 61010-1: 2010
Particular requirements for automatic and semi-automatic
laboratory equipment for analysis and other purposes.
EN 61010-2-81: 2015
Electrical equipment for measurement, control and laboratory use
- EMC requirements.
EN 61326-1: 2013
Standards for Canada and USA
Safety requirements for electrical equipment for measurement,
control and laboratory use - General requirements
a
.
a
NRTL certificate number (TÜV Süd): U8 17 05 42035 007
CAN/CSA-C22.2
No. 61010-1
Safety requirements for electrical equipment for measurement,
control and laboratory use - General requirements
a
.
UL 61010-1
Particular requirements for automatic and semi-automatic laboratory
equipment for analysis and other purposes
a
.
UL 61010-2-81
Operation is subject to the following two conditions: (1) this device may not
cause harmful interference, and (2) this device must accept any interfer-
ence received, including interference that may cause undesired operation.
Part 15 of the
FCC Rules
Class A
Elmar Morscher
CEO
Thomas Neher
Quality Manager