Technical And Legal Requirements; Emc Tests; Classification - h/p/cosmos 170-190/65 Series Original Instructions Manual

13.7 Technical and legal requirements

Description
Stationary training equipment
Medical electrical equipment
Electromagnetic compatibility
Usability
Software
Medical device directive
Machinery directive
Legal requirements

13.8 EMC tests

Description
Electrostatic discharge immunity test
Radiated, radio-frequency, electromagnetic field
immunity test
Electrical fast transient immunity test
Surge immunity test
Immunity to conducted disturbances, induced by
radio-frequency fields
Power frequency magnetic field immunity test
Voltage dips, short interruptions and voltage
variations immunity tests
Testing of voltage changes, voltage fluctuations and
flicker in public low-voltage supply systems
Variation of mains frequency

13.9 Classification

Description
MDD 93/42/EEC Notified body
MDD 93/42/EEC Risk class
60601-1 Protection against electric
shock
IEC 60601-1 Protection against harmful
ingress of water or particulate
matter
IEC 60601-1 Mode of operation
IEC 60601-1 Overvoltage category
IEC 60601-1 Applied part
IEC 60601-1 Pollution degree
ISO 20957-1 Usage class
EN 957-6 Accuracy class
IEC 62304 Risk class
© 1988 - 2019 h/p/cosmos sports & medical gmbh
Data
ISO 20957-1, EN 957-6
IEC 60601-1
IEC 60601-1-2
IEC 60601-1-6, IEC 62366-1
IEC 62304
MDD 93/42/EEC
MD 2006/42/EC
German medical device act (MPG)
Data
EN 61000-4-2
EN 61000-4-3
EN 61000-4-4
EN 61000-4-5
EN 61000-4-6
EN 61000-4-8
EN 61000-4-11
EN 61000-3-3
DIN EN 60601-1
Data
IIb
active therapeutic device and active diagnostic device
Class I,
IP20
Continuous operation with intermittent loading
II (2500 Vpeak mains transient voltage)
Type B (whole device)
Degree 2
S (Studio): professional and / commercial use
I (inclusive): professional and/or commercial use provided for inclusive use
for people with special needs
A
B
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