Levita BD-4603 ALB Manual De Usuario página 26

BD-4603 ALB/ALS
17 Complied European standards list
Risk management ISO/EN 14971:2012 Medical devices — Application of
Labeling
User manual
General
Requirements for
Safety
Electromagnetic
compatibility
Performance
requirements
Clinical
investigation
Usability
Software life-cycle
processes
26
risk management to medical devices
ISO/EN 15223-1:2012 Medical devices. Symbols to be
used with medical device labels, labeling and information to
be supplied. General requirements
EN 1041: 2008 Medical equipment manufacturers to
provide information
EN 60601-1: 2006+A1:2013 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
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
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