User's Manual

EMC Guidance
Complied Standards List
1) This equipment needs to be installed and put into service
in accordance with the information provided in the user
manual;
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=3,3m
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, 3m at an IMMUNITY LEVEL of
3V/m)
Risk management
Labeling
User manual
General Requirements
for Safety
Electromagnetic
compatibility
Performance
requirements and
Clinical investigation
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 60601-1: 2005+A1：2012 Medical electrical
equipment - Part 1: General requirements for basic safety
and essential performance
IEC 60601-1-11 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 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
IEC 80601-2-30:2009 Medical electrical equipment-
Part 2-30: Particular requirements for the basic safety
and essential performance of automated non-invasive
sphygmomanometers
IEC/EN 62304:2006+AC: 2008 Medical device
software - Software life cycle processes
Usability
IEC 62366 Medical devices - Application of usability
engineering to medical devices (IEC 62366:2007)
IEC 60601-1-6 Medical electrical equipment - Part 1
-6 : General requirements for basic safety and
essential performance - collateral standard : Usability
ANSI/AAMI SP10:2002/A2: 2008 Manual, electronic,
or automated sphygmomanometers
26
27
EMC GUIDANCECOMPLIED STANDARDS LIST