Emc Guidance - Samsung ARM BPM User Manual

EMC GUIDANCE

EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013 Medical
electrical equipment - Part 1-6: General requirements for basic safety
Usability and essential performance - Collateral standard: Usability
IEC 62366-1:2015 Medical devices - Part 1: Application of usability
engineering to medical devices
Software life-cycle
EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical
processes device software - Software life-cycle processes
ISO 10993-1:2009 Biological evaluation of medical devices- Part 1:
Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5:
Tests for in vitro cytotoxicity
Bio-compatibility
ISO 10993-10:2010 Biological evaluation of medical devices - Part
10: Tests for irritation and skin sensitization
EMC Guidance
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments
Warning：Don't near active HF surgical equipment and the RF shielded room of an ME system for magnetic
resonance imaging, where the intensity of EM disturbances is high.
Warning： Use of this equipment adjacent to or stacked with other equipment should be avoided because it
could result in improper operation. If such use is necessary, this equipment and the other equipment should be
observed to verify that they are operating normally.
Warning: Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation."
Warning：Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment
cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could
result.
Technical description：
1，all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to
electromagnetic disturbances for the excepted service life.
2，Guidance and manufacturer's declaration -electromagnetic emissions and Immunity
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Table 1
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Table 2
Immunity Test
Electrostatic
discharge (ESD)
IEC 61000-4-2
EI-B5000 , including
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC61000-4-5
Guidance and manufacturer's declaration - electromagnetic emissions
Compliance
Group 1
Class B
Not applicable
Not applicable
Guidance and manufacturer's declaration – electromagnetic Immunity
IEC 60601-1-2
Test level
±8 kV contact
±2 kV, ±4kV, ±8 kV, ±15 kV air
Not applicable
Not applicable
EMC GUIDANCE
Compliance level
±8 kV contact
±2 kV, ±4kV, ±8 kV, ±15 kV air
Not applicable
Not applicable
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