Product Safety / Extract From Applied Standards - wissner-bosserhoff Carisma Manual De Instrucciones

6.

PRODUCT SAFETY / EXTRACT FROM APPLIED STANDARDS

The product bears the
regulations to be applied to the product.
The product was developed and produced using DIN EN ISO 9001:2000 and DIN EN ISO
13485:2003.
Designation
EU directive
93/42/EEC
German Law on Medical
Devices
EN ISO 14971:2009
In accordance with DIN
EN 60601-1:2007-07
(relevant sections)
In accordance with
IEC 60601-2-52:2009
(relevant sections)
BfArM [German Federal
Institute for Drugs and
Medical Devices]
recommendation:
from 07-2000
DIN EN 60601-1-2:2007
Since a hospital bed in the standard is not equipped with a so-called equipo-
tential connection, a combination with other electro-medical appliances is not
permitted without further safety measures being taken. Get in touch with our
Technical Customer Service for further information. An equipotential connection
can be optionally provided, if required.
_______________________________
in assembled condition
2
mark and thus complies with the German and European safety
Comment
MDD (EU directive)
MPG (national implementation)
Risk management applied to
medical products
Medical electrical appliances
(medical beds)
Medical beds
Recommendations of German
Federal Institute for Drugs and
Medical Devices
EMC
electromagnetic compatibility
Designation
DIN 33402 Human body dimensions
DIN 50967 Nickel chrome and copper nickel
chrome coating
DIN 68861-1/ EN Furniture surfaces
12720
EN 60529 IP code (protection from
humidity)
In accordance with Castors for nursing home beds
EN 12530
(relevant sections)
EU directive Disposal of waste, old electrical
2002/96/EC and electronic equipment.
Mandatory identification since
August 13
Comment
, 2005
th
Page 69