Eu Declaration Of Conformity - Getinge Applikon my-Control Hardware Manual

SAFETY
1.3

EU DECLARATION OF CONFORMITY

The company Applikon Biotechnology B.V., residing in Delft, The Netherlands, hereby certifies that
the design of the instrument:
meets the requirements of the following Directive of the European Union:
✓ Directive 2006/42/EC on Machinery
✓ Directive 2014/30/EU on Electromagnetic Compatibility (EMC)
✓ Directive 2011/65/EU and 2015/863/EU on Restriction of Hazardous Substances (RoHS)
✓ Regulation (EC) No 1907/2006 on Restriction of Chemicals (REACH)
The compliance of the my-Control has been based on the following harmonized standards:
Directive
2006/42/EC (Machinery)
2014/35/EU (Low Voltage)*
2014/30/EU (EMC)
*
For the my-Control, the Machinery Directive includes the requirements of the Low Voltage Directive.
L. van Mierlo
Director QRC
Applikon Biotechnology B.V.
Heertjeslaan 2
2629 JG Delft
The Netherlands
8
my-Control
for MiniBio Reactors
(Z310210014)
Harmonized Standard
EN 60204-1:2018 / EN 12100:2010
EN 61010-1:2010 / EN 61010-2-010:2020 / EN 61010-2-051:2021 /
EN 62311:2020
EN 61326-1:2021 / EN 61000-3-2:2019 / EN 61000-3-3:2013
Digitally signed by
Lukas van Mierlo
Date: 2023.03.20
12:40:57 +01'00'
Tel. +31 (0)10 208 35 55
info.applikon@getinge.com
Delft,
The Netherlands
www.getinge.com
Hardware Manual my-Control MiniBio