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w e,
Burmeier GmbH & Co. KG
Pivitsheider Strasse 270
32791 Lage / Lippe
Germany
hereby declare under sole responsibility as the manufacturer that the product model named below:
Nursing bed ALLURA II / ALLURA II 100 / ALLURA II 120
in the version submitted complies with the regulations of the ec directive 93/42/eec for Medical devices, last amended by direc tive 2007/47/ec
dated 5 September 2007. It is categorised as a class I active medical device.
The relefant 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:
complies with the regulations of ec Guidelines 93/42/ewG for medical products and fulfills all additional safety requirements by the highest State
Authority from May 22, 2001 for care beds.
Harmonised standards:
ó
eN 14971 : 2013-04
ó
eN 60601-1 : 2007-07
ó
eN 60601-1-2 : 2007-12
ó
dIN eN 60601-1-6 : 2010-10
ó
dIN eN 60601-1-1 1 : 2010-10
ó
dIN eN 60601-2-52 : 2010-12
International standards:
ó
Iec 60601-1-2-52 : 2009-12
Lage, 2015-05-28
54
EC-DECLARATION OF CONFORMITY
Risk analysis for medical devices
Safety for electromedical equipment
electromagnetic compatibility
Medical electrical equipment: with fitness for use
Medical electrical equipment – Requirements for medical electrical equipment and medical electrical systems
used in the home healthcare environment
Particular requirements for the safety and essential performance of medical beds
Medical electriacl equipment: Particular requirements for the basic safety and essential performance of
medical beds
G
e b RAUc h SANw e ISUNG
P
ALLURA II · I
f Le Ge b e TT
NSTRUc TIo N
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ALLURA II
ANUAL f o R
URSING
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