Integra VACUSAFE - Page 2

Declaration of conformity
INTEGRA Biosciences AG – 7205 Zizers, Switzerland
declares on its own responsibility that the devices
comply with:
Zizers, November 4, 2016
Description Models
VACUSAFE 158300, 158310, 158320
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
Ecodesign - Power supplies 278/2009
Standards for EU
Safety requirements for electrical equipment for measurement,
control and laboratory use - General requirements.
EN 61010-1: 2010
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.
CAN/CSA-C22.2
No. 61010-1
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