Wissner-Bosserhoff Carisma - Product Safety and Applied Standards; Medical Device Compliance (MDD CE); Risk Management Standards; Electromagnetic Compatibility (EMC)

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T 08 9351 7500 E info@unicarehealth.com.au W www.unicarehealth.com.au
6. Product Safety / Extract From Applied Standards
The product bears the mark and thus complies with the German and European safety regulations
to be applied to the product.
Since a hospital bed in the standard is not equipped with a so-called equipotential
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.
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in assembled condition
Standard Comment Standard Comment
Medical product acc. to
93/42/EEC
MDD CE- Symbol DIN 33402 Body mass of people
Law on Medical
Devices
MPG DIN 50967 Nickel-chrome and
coppernickel-
chrome coating
EN ISO 14971 Risk management
applied to medical
products
DIN 68861-1/ EN
12720
Furniture surfaces
DIN EN12 182
- relevant sections
Technical aids for
handicapped people
EN 60529 IP code (protection
from humidity)
In compliance with EN
1970 :2004/A1
- relevant sections
Adjustable beds for
handicapped people
DIN EN 60601-1-2 EMV electromagnetic
compatibility
In compliance with DIN
EN 60601-1
- relevant sections
Medical electrical
appliances
In compliance with DIN
EN 60601-2-38:2000/
A1 - relevant sections
Medical electrical
appliances and
accessories
BfArM –
recommendation:
from 07-2000
Recommendations of
Fed. Institute for Drugs
and Medical Products
In compliance with EN
12530
Castors for hospital
beds
DIN EN 980 Graphical symbols
for marking medical
products