74
75
User manual
EN 1041:2008 Information supplied by the manufacturer of medical
devices
General
Requirements for
Safety
EN 60601-1:2006+A1:2013/ 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
IEC 80601-2-30:2009+A1:2013 Medical electrical equipment- Part
2-30: Particular requirements for the basic safety and essential
performance of automated non-invasive sphygmomanometers