48
STANDARD COMPLIANCE
STANDARD
COMPLIANCE
11
The provisions of the Council Directive 93/42/EEC concerning
medical devices were complied with. The standards in the table
below were complied with.
Description
Reference number
Medical electrical equipment - Part 1:
General requirements for basic safety and
essential performance
EN 60601-1:2006/
A1:2013
EN 60601-1-2:2015
Medical electrical equipment - Part 1-2:
General requirements for basic safety
and essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
EN 60601-1-6:2010/
A1:2015
Medical electrical equipment - Part 1-6:
General requirements for basic safety
and essential performance - Collateral
standard: Usability
EN 80601-2-
30:2010/A1:2015
Medical electrical equipment - Part 2-30:
Particular requirements for the basic safety
and essential performance of automated
non-invasive sphygmomanometers
EN 1060-
3:1997+A2:2009
Non-invasive sphygmomanometers.
Supplementary requirements for electro-
mechanical blood pressure measuring
systems
EN 1060-4:2004
Non-invasive sphygmomanometers. Test
procedures to determine the overall
system accuracy of automated non-
invasive sphygmomanometers
EN ISO 15223-
1:2016
Medical devices - Symbols to be used
with medical device labels, labelling and
information to be supplied - Part 1: General
requirements
EN 303 446-1:2017
Electromagnetic Compatibility (EMC)
standard for combined and/or integrated
radio and non-radio equipment; Part
1: Specific conditions for equipment in
residential locations.
EN 62366:2008
Medical devices - Application of usability
engineering to medical devices
EN 62304:2006/
A1:2015
Medical device software - Software life-
cycle processes