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Integra ASSIST PLUS - Page 2

Integra ASSIST PLUS
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Declaration of conformity
INTEGRA Biosciences AG – 7205 Zizers, Switzerland
declares on its own responsibility that the ASSIST PLUS (Model 4505) complies with:
Zizers, October 7, 2019
EU Directives
Low Voltage Equipment 2014/35/EU
Electromagnetic Compatibility 2014/30/EU
Restriction of Hazardous Substances 2011/65/EU
Waste Electrical and Electronic Equipment 2012/19/EU
Radio Equipment Directive 2014/53/EU
EU Regulations
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
1907/2006
Ecodesign - Power supplies 278/2009
Standards for EU (titles shortened)
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
Radio equipment and services - Common requirements EN 301 489-1 V2.2.0
Specific conditions for Broadband Data Transmission Systems EN 301 489-17 V3.2.0
Wideband transmission systems - Access to radio spectrum EN 300 328 V2.2
Standards for Canada and USA
Safety requirements for electrical equipment for measurement,
control and laboratory use - General requirements.
CAN/CSA-C22.2
No. 61010-1
Safety requirements for electrical equipment for measurement,
control and laboratory use - General requirements.
UL 61010-1
Particular requirements for automatic and semi-automatic
laboratory equipment for analysis and other purposes.
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 interference received, including
interference that may cause undesired operation.
Part 15 of the
FCC Rules
Contains FCC ID:
PI4410B
Urs Hartmann
CEO
Thomas Neher
Quality Manager

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