Declaration of Conformity
INTEGRA Biosciences AG – 7205 Zizers, Switzerland
declares on its own responsibility that the devices
comply with:
EU Regulations
Standards for EU
Standards for Canada and USA:
Zizers, November 4, 2016
Description Models
MEDIAJET 103005, 103006
MEDIAJET vario 113000, 113001, 113002
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
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) 1907/2006
Safety requirements for electrical equipment for laboratory use EN 61010-1: 2010
Particular requirements for automatic and semi-automatic labora-
tory equipment for analysis and other purposes.
EN 61010-2-81: 2015
Electrical equipment for laboratory use - EMC requirements EN 61326-1: 2013
Safety requirements for electrical equipment for measurement,
control and laboratory use - General requirements
UL 61010-1
Operation is subject to the following two conditions:
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received, including
interference that may cause undesired operation.
Part 15 of the
FCC Rules
Class A
Elmar Morscher
CEO
Thomas Neher
Quality Manager
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