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6
.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
Risk management
ISO 14971
Medical device regulation
MDR (EU) 2017/745
Machinery directive
2006/42/EC
German Medical Device Law Implementation Act
(MPDG – Medizinprodukterecht-Durchführungsgesetz)
Legal requirements
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6
.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
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6
.9 Classification
Description
Data
MDD 93/42/EEC Notified body
MDR (EU) 2017/745
MDD 93/42/EEC Risk class
MDR (EU) 2017/745
IIb
active therapeutic device and active diagnostic device
IEC 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/or 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
❚
170-190/65 MCU6
Copyrigth: h/p/cosmos sports & medical gmbh
operation manual: cos105000_170-190_65_en rev. 1.05 dated 22.09.2021
page 59 of 97