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USER GUIDE
Complied Standards List
Risk
management
EN ISO 14971:2012 / ISO 14971:2007 Medical devices – Application of risk management to
medical devices
Labeling
EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used with medical
device labels, labeling, and information to be supplied. Part 1: General requirements
User manual
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
General
requirements
for safety
EN 60601-1:2006+A1:2013+A12:2014/ IEC 60601-1:2005+A1:2012 Medical electrical
equipment - Part 1: General requirements for basic safety and essential performance
EN 60601-1-11:2015/ IEC 60601-1-11:2015 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
EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance – Collateral standard: Electromagnetic
disturbances – Requirements and tests
Performance
requirements
EN ISO 81060-1:2012 Non-invasive sphygmomanometers – Part 1: Requirements and test
methods for non-automated measurement type
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers – Part 3: Supplementary
requirements for electro-mechanical blood pressure measuring systems
