page 56 of 99
cos105000_170-190_65, rev. 1.03
© 1988 - 2019 h/p/cosmos sports & medical gmbh
13.7 Technical and legal requirements
Description
Data
Stationary training equipment
ISO 20957-1, EN 957-6
Medical electrical equipment
IEC 60601-1
Electromagnetic compatibility
IEC 60601-1-2
Usability
IEC 60601-1-6, IEC 62366-1
Software
IEC 62304
Medical device directive
MDD 93/42/EEC
Machinery directive
MD 2006/42/EC
Legal requirements
German medical device act (MPG)
13.8 EMC tests
Description
Data
Electrostatic discharge immunity test
EN 61000-4-2
Radiated, radio-frequency, electromagnetic field
immunity test
EN 61000-4-3
Electrical fast transient immunity test
EN 61000-4-4
Surge immunity test
EN 61000-4-5
Immunity to conducted disturbances, induced by
radio-frequency fields
EN 61000-4-6
Power frequency magnetic field immunity test
EN 61000-4-8
Voltage dips, short interruptions and voltage
variations immunity tests
EN 61000-4-11
Testing of voltage changes, voltage fluctuations and
flicker in public low-voltage supply systems
EN 61000-3-3
Variation of mains frequency
DIN EN 60601-1
13.9 Classification
Description
Data
MDD 93/42/EEC Notified body
MDD 93/42/EEC Risk class
IIb
active therapeutic device and active diagnostic device
60601-1
Protection against electric
shock
Class I,
IEC 60601-1
Protection against harmful
ingress of water or particulate
matter
IP20
IEC 60601-1
Mode of operation
Continuous operation with intermittent loading
IEC 60601-1
Overvoltage category
II (2500 Vpeak mains transient voltage)
IEC 60601-1
Applied part
Type B (whole device)
IEC 60601-1
Pollution degree
Degree 2
ISO 20957-1
Usage class
S (Studio): professional and / commercial use
I (inclusive): professional and/or commercial use provided for inclusive use
for people with special needs
EN 957-6
Accuracy class
A
IEC 62304
Risk class
B
med
