19. Classification and applied standards
According to Annex VIII, #13 of the Medical Device Directive (MDD) 2017/745, the movita
nursing home bed is a Class I medical device.
Designation
MDR 2017/745
Medical Device Law Implementation Act
DIN EN ISO 14971
DIN EN 60601-1 (relevant sections)
DIN EN 60601-2-52 (relevant sections)
BfArM (German Federal Institute for Drugs and
Medical Devices) recommendations
DIN 33402-2
DIN 68861-12011-01
DIN EN 12720
DIN EN 60529
VDE 0470-1
DIN EN 12530
(relevant sections)
EN 50419
Directive 2002/96/EC (WEEE)
134
Comment
EU regulation for medical devices
MPDG (national implementation)
Application of risk management to medical
devices
Medical electrical equipment
Medical beds
Recommendations of the German Federal Insti-
tute for Drugs and Medical Devices
Human body dimensions
Furniture surfaces - Behaviour at chemical
influence
Assessment of surface resistance to cold liquids
Degrees of protection provided by enclosures
IP code (protection against moisture)
Castors and wheels - Castors and wheels for
manually propelled institutional applications
Marking of electrical and electronic equipment