EMC GUIDANCE
EMC GUIDANCE
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Complied Standards List
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 PY-802-LTE, including 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
Table 3
Guidance and manufacturer’s declaration - electromagnetic emissions
Emissions
Compliance
RF emissions
CISPR 11
Group 1
RF emissions
CISPR 11
Class [ B ]
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Comply
Risk management
EN ISO 14971:2012 / ISO 14971:2007 Medical devices - Application of risk management
to medical devices
Labeling
EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used with
medical device labels, labelling and information to be supplied. Part 1 : General
requirements
User manual
EN 1041:2008 +A1:2013 Information supplied by the manufacturer of medical devices
General
Requirements
for Safety
EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012 Medical electrical equipment -
Part 1: General requirements for basic safety and essential performance
EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11:
General requirements for basic safety and essential performance - Collateral standard:
Requirements for medical electrical equipment and medical electrical systems used
in the home healthcare environment
Electromagnetic
compatibility
EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential performance - Collateral standard:
Electromagnetic disturbances - Requirements and tests
Performance
requirements
EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1: Requirements and
test methods for non-automated measurement type EN 1060-3:1997+A2:2009
Non-invasive sphygmomanometers - Part 3: Supplementary requirements for
electro-mechanical blood pressure measuring systems
IEC 80601-2-30:2018 Medical electrical equipment- Part 2-30: Particular requirements
for the basic safety and essential performance of automated non-invasive
sphygmomanometers
Clinical investi-
gation
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test procedures to
determine the overall system accuracy of automated non-invasive
sphygmomanometers
ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of
automated measurement type
Usability
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 and
essential performance - Collateral standard: Usability
IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to
medical devices
Software life-cycle
processes
EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical device software -
Software life-cycle processes
Bio-compatibility
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
ISO 10993-10:2010 Biological evaluation of medical devices -
Part 10: Tests for irritation and skin sensitization
