Risk
ISO/EN 14971:2012 Medical devices — Application of risk management to medical
management
devices
Labeling
ISO/EN 15223-1:2012 Medical devices. Symbols to be used with medical device
labels, labeling and information to be supplied. General requirements
User manual
EN 1041: 2008 Medical equipment manufacturers to provide information
General
IEC 60601-1: 2005+A1:2012 Medical electrical equipment - Part 1: General
Requirements
requirements for basic safety and essential performance
for Safety
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
Electromagnetic
IEC/EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements
compatibility
for basic safety and essential performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests
Performance
IEC 80601-2-30:2009 Medical electrical equipment- Part 2-30: Particular requirements
requirements
for the basic safety and essential performance of automated non-invasive
and Clinical
sphygmomanometers
investigation
ANSI/AAMI SP10:2002/A2: 2008 Manual, electronic, or automated sphygmomanometers
Software life-
IEC/EN 62304:2006+AC: 2008 Medical device software - Software life cycle
cycle processes
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
The following signs might be in the user manual, labeling or other component. They are the
requirement of standard and using.
Symbol for "THE OPERATION
GUIDE MUST BE READ"
Symbol for "MANUFACTURER"
Symbol for "SERIAL NUMBER"
Symbol for "MANUFACTURE DATE"
Caution: These notes must be observed
to prevent any damage to the device.
1. Blood Pressure Monitor (BPMA70)
2. Cuff (22-42cm)
(Type BF applied part)
3. 4 x AAA Batteries
4. Case
5. User Manual
4
All manuals and user guides at all-guides.com
Complied Standards List
Safety Information
List
Symbol for "TYPE BF APPLIED PARTS"
Symbol for "ENVIRONMENT PROTECTION
– Waste electrical products should not
be disposed of with household waste.
Please follow local guidelines. "
Symbol for "DIRECT CURRENT"