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STANDARD COMPLIANCE
DescriptionReference number
EN ISO 10993-
1:2009/AC:2010
Biological evaluation of medical devices –
Part 1: Evaluation and testing within a risk
management process
EN ISO 14971:2012 Medical devices – Application of risk
management to medical devices
EN ISO 13485:2016 Medical devices – Quality management
systems – Requirements for regulatory
purposes
11.1 MANUFACTURER DECLARATION ON EMC
MESI mTABLET ABI is intended for use in the electromagnetic
environment specified below. The customer or the user of the
above listed models should assure that they are used in such an
environment.
Emissions test Compliance Electromagnetic
environment -
guidance
RF emissions
CISPR 11
Group 1 The above listed
models use RF energy
only for its internal
function. Therefore, its
RF emissions are very
low and are not likely to
cause any interference
in nearby electronic
equipment.
RF emissions
CISPR 11
Class B
MESI mTABLET ABI is
suitable for use in all
establishments, including
domestic establishments
and those directly
connected to the public
low-voltage power
supply network that
supplies buildings used
for domestic purposes.
Harmonic emissions
IEC 61000-3-2
N/A
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Complies
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