
page 57 of 90
cos105000_200-300_75-125, rev. 1.03
© 1988 - 2019 h/p/cosmos sports & medical gmbh
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
13.10 Certificates
Description
Data
MDD 93/42/EEC
CE declaration of conformity
MDD 93/42/EEC
EC certificate, quality assurance
MDD 93/42/EEC
Free sales certificate
EN ISO 13485
Certificate, quality management medical devices
IEC 60601-1
CB certificate
UL 60601-1
NRTL certificate
Certificates see accompanying documents and
https://www.hpcosmos.com/en/contact-support/media-downloads/certificates
med