Technical Data; Classification - wissner-bosserhoff SafeSense Manual De Instrucciones

14. Technical data

Input voltage
Type of protection
Protection class
Relative humidity
Atmospheric pressure
Environment temperature
Manufacturer

15. Classification

According to Annex VIII, #13 of the Medical Device Directive (MDD) 2017/745, SafeSense
a Class I medical device. as an accessory for medical beds.
Designation
MDR 2017/745
Medical Device Law Implementation Act
Directive 2014/53/EU
DIN EN ISO 14971
DIN EN 60601-1
(relevant sections)
DIN EN 60601-2-52
(applicable sections)
BfArM [German Federal Institute for Drugs
and Medical Devices] recommendations
DIN EN 60529;
VDE 0470-1
DIN VDE 0834
24 – 30 V DC
IPX4
2
30% – 75%
800 hPa – 1060 hPa
+10°C – +40°C
wissner-bosserhoff GmbH
Hauptstraße 4 – 6
58739 Wickede (Ruhr)
GERMANY
Tel. +49 2377 784-0
Comment
EU regulation for medical devices
MPDG (national implementation)
RED (Radio Equipment Directive)
Risk management applied to medical products
Medical electrical appliances
Medical beds
Recommendations of German Federal Institute
for Drugs and Medical Devices
Type of protection by housing
IP code (protection from humidity)
Standard for nurse call systems in hospitals and
nursing homes
is
®
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