Stiegelmeyer Deka - EC Declaration of Conformity

Appendix
EC Declaration of Conformity
Deka
115
18.5 EC Declaration of Conformity
EC Declaration of Conformity
We,
Stiegelmeyer GmbH & Co. KG
Ackerstrasse 42,
32051 Herford, Germany
hereby declare under sole responsibility as the manufacturer that the product model named below:
Product model:
Hospital Bed Series
Deka
in the version submitted complies with the regulations of the EC Directive 93/42/EEC Appendix VII
for Medical Devices, last amended by Directive 2007/47/EC dated 5 September 2007.
It is categorised as a Class I active medical device.
The relevant technical documentation is kept by the manufacturer’s safety representative.
To evaluate the conformity to the Directives, all applicable parts of the following standards were
referred to:
Harmonised Standards:
DIN EN ISO 14971: 2013-04
Application of Risk Management for Medical Devices
DIN EN 60601-1: 2007-07
Medical Electrical Equipment, Safety
DIN EN 60601-1-2: 2007-12
Electromagnetic Compatibility
DIN EN 60601-1-6: 2010-10
Medical Electrical Equipment - Suitability for intended use
DIN EN 60601-2-52: 2016-04
Particular requirements for the safety and essential performance of
medical beds
International Standards:
IEC 60601-2-52:2009-12 +AMD
1: 2015-03
Medical Electrical Equipment: Particular requirements for the basic
safety and essential performance of medical beds
IEC 62366:2007
Medical equipment: Usability
Herford, 2016-12-20
Hans-Peter Löw
(Management)
Ralf Wiedemann
(Management)