Wissner-Bosserhoff sentida - Classification and applied standards

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20. Classication 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
inuence
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