Classification; Applied Standards - wissner-bosserhoff sentida 7-i Notice D'utilisation

Radio module RTM08
Frequency
Transmission power
Supply voltage
Standby current
Transmission current

13. Classification

The low nursing bed sentida 7-i is a medical product class Im (non-sterile with measuring
function) in accordance with appendix IX of the directive for medical devices 93/42 EEC and
amending directive 2007/47/EC.

13.1 Applied standards

Designation
Directive 93/42/EEC
German law on medical products
DIN EN ISO 14971:2013-04
DIN EN 60601-1:2006 + A1:2013
(applicable sections)
DIN EN 60601-2-52:2010 + A1:2015
(relevant sections)
BfArM [German Federal Institute for Drugs and
Medical Devices] recommendations
DIN 33402-2:2005-12 + amendment 1
DIN 68861-12011-01
DIN EN 12720:2009-07
DIN EN 60529;
VDE 0470-1:2000-09
DIN EN 12530:1999-05
(relevant sections)
EN 50419:2006/
directive 2002/96/EG (WEEE)
Directive
2014/31/EG
EN 45501 : 2015
EN ISO 15223-1
114
868,3 MHz
0,25 mW
5 V DC
max. 1,5 mA
max. 13 mA
Comment
Medical devices directive 93/42/EEC
German law on medical products (national imple-
mentation)
Risk management applied to medical products
Medical electrical appliances
Medical beds
Recommendations of German Federal Institute for
Drugs and Medical Devices
Human body dimensions
Furniture surfaces subjected to chemicals, resistan-
ce to cold liquids.
Type of protection by housing
IP code (protection from humidity)
Castors - equipment castors -
manually controlled castors
Labeling of electric and electronic equipment
Directive on non-automatic scales
Metrological aspects of non-automatic scales
Symbols to be used with medical device labels