Declaration Of Conformity - Integra ASSIST Mode D'emploi

Declaration of conformity

INTEGRA Biosciences AG – 7205 Zizers, Switzerland
declares on its own responsibility that the device
Description
ASSIST
complies with:
EU Directives (DoW: Date of Withdrawal)
Low Voltage Equipment
Electromagnetic Compatibility
Restriction of Hazardous Substances
Waste Electrical and Electronic Equipment
Radio Equipment Directive
EU Regulations
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) 1907/2006
Ecodesign - Power supplies
Standards for EU
Safety requirements for electrical equipment for measurement,
control and laboratory use - General requirements.
Particular requirements for automatic and semi-automatic
laboratory equipment for analysis and other purposes.
Electrical equipment for measurement, control and laboratory
use - EMC requirements.
Standards for Canada and USA
Safety requirements for electrical equipment for measurement,
control and laboratory use - General requirements.
Safety requirements for electrical equipment for measurement,
control and laboratory use - General requirements.
Particular requirements for automatic and semi-automatic
laboratory equipment for analysis and other purposes.
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.
Zizers, April 13, 2018
Model
4500
Elmar Morscher
CEO
Before DoW DoW
2006/95/EC 20.04.2016
2004/108/EC 20.04.2016
2011/65/EU
2012/19/EU
1999/5/EC 13.06.2016
Thomas Neher
Quality Manager
After DoW
2014/35/EU
2014/30/EU
2014/53/EU
278/2009
EN 61010-1: 2010
EN 61010-2-81: 2015
EN 61326-1: 2013
CAN/CSA-C22.2
No. 61010-1
UL 61010-1
UL 61010-2-81
Part 15 of the
FCC Rules
Contains FCC ID:
PI4410B