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COMPLIED EUROPEAN
STANDARDS LIST
Complied European Standards List
EMC Guidance
EMC GUIDANCE
Table 1 Guidance and MANUFACTURER’s declaration – ELECTROMAGNETIC
EMISSIONS- for all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic emissions
RF emissions
CISPR 11
Group 1
Class B
Not applicable
Not applicable
Compliance
The device is intended for use in the electromagnetic environment specified
below. The customer or the user of the device should assure that it is used in
such an environment.
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions IEC
61000-3-3
RF emissions
CISPR 11
Emissions test
Electromagnetic environment - guidance
The device uses 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.
Risk management
Labeling
User manual
General
Requirements for
Safety
Electromagnetic
compatibility
Performance
requirements
Clinical investigation
Usability
Software life-cycle
processes
EN ISO 14971:2012 Medical devices - Application of risk
management to medical devices
EN 980:2008 Symbols for use in the labelling of medical
devices
EN 1041:2008 Information supplied by the manufacturer of
medical devices
EN 60601-1:2006 Medical electrical equipment - Part 1:
General requirements for basic safety and essential
performance
EN 60601-1-11:2010 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
EN 60601-1-2:2007 Medical electrical equipment - Part
1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests
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
EN 1060-4:2004 Non-invasive sphygmomanometers - Part
4: Test procedures to determine the overall system accuracy
of automated non-invasive sphygmomanometers
EN 60601-1-6:2010 Medical electrical equipment - Part
1-6: General requirements for basic safety and essential
performance - Collateral standard: Usability
EN 62366:2008 Medical devices - Application of usability
engineering to medical devices
EN 62304:2006/AC: 2008 Medical device software -
Software life-cycle processes
