Table des Matières
Publicité
Complied European Standards List
Risk management
Labeling
User manual
General Requirements for Safety
Electromagnetic compatibility
Performance requirements
Clinical investigation
Usability
Software life-cycle processes
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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
EN 60601-1: 2006 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
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