Instruction Manual for Sicurao pesa Hospital Bed
Page
86
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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 of the product model
named below:
Hospital Bed
Sicuro pesa
in the version submitted complies with the regulations of the EC Directive 93/42/EEC
Annex 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:
EN 14971: 2013-04
Risk analysis for medical devices
EN 60601-1: 2007-07
Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance
EN 60601-1-2: 2007-12
Electromagnetic compatibility
DIN EN 60601-1-6: 2010-10
Medical electrical equipment: Usability
DIN EN 60601-2-52: 2016-04
Medical electrical equipment:
Particular requirements for the basic 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, 2016-11-22
Georgios Kampisiulis Kemmler
(Management)
Hans-Peter Löw
(Management)