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EMC Guidance
1. The Blood Pressure Monitor needs special precautions
regarding EMC and needs to be installed and put into service
according to the EMC information provided in the
ACCOMPANYING DOCUMENTS
2. Wireless communications equipment such as wireless home
network devices, mobile phones, cordless telephones and their
base stations, walkie-talkies can affect this equipment and should
be kept at least a distance d = 3,3 m away from the equipment.
(Note. As indicated in Table 6 of IEC 60601-1-2:2007 for ME
EQUIPMENT, a typical cell phone with a maximum output power
of 2 W yields d = 3,3 m at an IMMUNITY LEVEL of 3 V/m)
Complied European Standards List
Risk management
Labeling
User manual
General Requirements
for Safety
Electromagnetic
compatibility
Performance
requirements
Clinical investigtion
Usability
Software life-cycle
processes
ISO/EN 14971:2012 Medical devices — Application of risk
management to medical devices
ISO/EN 15223-1:2012 Medical devices. Symbols to be used
with medical device labels, labelling and information to be
supplied. General requirements
EN 1041: 2008 Medical equipment manufacturers to provide
information
IEC/EN 60601-1: 2006+A1
：
2012 Medical electrical
equipment - Part 1: General requirements for basic safety and
essential performance
IEC/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
IEC/EN 80601-2-30:2009 Medical electrical equipment - Part
2-30: Particular requirements for the basic safety and
essential performance of automated noninvasive
sphygmomanometers
IIEC/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 1060-1:1995+A2:2009 Non-invasive blood pressure Part
1: General requirements
EN 1060-3:1997+A2:2009 Non-invasive blood pressure Part
3: Supplementary requirements for electromechanical blood
pressure measuring system
EN 1060-4: 2004 Automatic Blood Pressure Monitor overall
system Interventional accuracy of the testing process
IEC/EN 60601-1-6: 2010 Medical electrical equipment --
Part 1-6: General requirements for basic safety and essential
performance - Collateral Standard: Usability
IEC/EN 62366: 2007 Medical devices - Application of
usability engineering to medical devices
IEC/EN 62304:2006+AC: 2008 Medical device software -
Software life cycle processes
COMPLIED EUROPEAN
STANDARDS LIST
EMC GUIDANCE
