Technical Data; Classification And Applied Standards - wissner-bosserhoff SafeLift Manual De Instrucciones

11. Technical data

Input voltage
Transmission frequency
Max. transmitting power
Protection type
Protection class
Humidity
Atmospheric pressure
Environment temperature
Manufacturer

12. Classification and applied standards

According to Annex VIII, #13 of the Medical Device Directive (MDD) 2017/745, SafeLift is a
Class I medical device. as an accessory for medical beds.
Designation
MDR 2017/745
Medical Device Law Implementation Act
Directive 2014/53/EU
Directive 2002/96/EG (WEEE)
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 EN 60529;
VDE 0470-1
24–30 V DC
868.3 MHz
1.9 dBm
IPX4
2
30% – 75%
800 hPa to 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)
Directive on old electrical and electronic
equipment
Risk management applied to medical products
Medical electrical equipment
Medical beds
Recommendations of the German Federal
Institute for Drugs and Medical Devices
Type of protection by housing
IP code (protection from humidity)
47