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ENGLISH
20. Classification and applied standards
According to Annex VIII, #13 of the Medical Device Directive (MDD) 2017/745, the sentida
low-set nursing home bed is a Class I medical device.
Designation
Comment
MDR 2017/745
EU regulation for medical devices
Medical Device Law Implementation Act
MPDG (national implementation)
DIN EN ISO 14971
Application of risk management to medical
devices
DIN EN 60601-1 (relevant sections)
Medical electrical equipment
DIN EN 60601-2-52 (relevant sections)
Medical beds
BfArM (German Federal Institute for Drugs and
Medical Devices) recommendations
Recommendations of the German Federal Insti-
tute for Drugs and Medical Devices
DIN 33402-2
Human body dimensions
DIN 68861-12011-01
DIN EN 12720
Furniture surfaces - Behaviour at chemical
influence
Assessment of surface resistance to cold liquids
DIN EN 60529
VDE 0470-1
Degrees of protection provided by enclosures
IP code (protection against moisture)
DIN EN 12530
(relevant sections)
Castors and wheels - Castors and wheels for
manually propelled institutional applications
EN 50419
Directive 2002/96/EC (WEEE)
Marking of electrical and electronic equipment
Data handsets
SafeControl
SD Handset
Electrical connection
24 V DC
24 V DC
Supply
14 - 38 V DC
14 - 38 V DC
Standby current
9 mA
14 mA
Application environment
3 und 5
3 und 5
Humidity
30 % - 75 %
30 % - 75 %
Ambient temperature
+ 10°C - 40°C
+ 10°C - 40°C
Protection rating
IPX7
IPX4
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