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COMPLIED EUROPEAN STANDARDS LIST
Risk management
ISO/EN 14971:2012 Medical devices — Application of risk management to
medical devices
Labeling
ISO/EN 15223-1:2012 Medical devices. Symbols to be used with medical device
labels, labelling and information to be supplied. General requirements
User manual
EN 1041: 2008 Medical equipment manufacturers to provide information
General
Requirements for
Safety
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
Electromagnetic
compatibility
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
Performance
requirements
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
Clinical investigation
EN 1060-4: 2004 Automatic Blood Pressure Monitor
overall system Interventional accuracy of the testing process
Usability
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
Software life-cycle processes
IEC/EN 62304:2006+AC: 2008 Medical device software
- Software life cycle processes
