42
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.
DescriptionReference number
(ID:year)
Electrical medical equipment – Part 1: General
requirements for basic safety and essential
performance
EN 60601-
1:2006+A1:2013
EN 60601-1-
2:2015+A1:2021
Electrical medical equipment – Part 1-2: General
requirements for basic safety and essential
performance – Collateral standard: Electromagnetic
compatibility – 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
Electrical medical equipment – Part 2-30:
Requirements for the basic safety and essential
performance of automated non-invasive
sphygmomanometers
EN ISO 81060-1:2012 Non-invasive sphygmomanometers. Part 1: General
requirements
EN 1060-
3:2000+A2:2010
Non-invasive sphygmomanometers – Part 3:
Supplementary requirements for electromechanical
blood pressure measuring systems
EN 1060-4:2005 Non-invasive sphygmomanometers – Part
4: Test procedures to determine the overall
system accuracy of automated non- invasive
sphygmomanometers
EN ISO 14971:2012 Medical devices – Application of risk management
to medical devices
EN ISO 10993-1:2009
Biological evaluation of medical devices – Part 1:
Evaluation and testing within a risk management
process
ISO 15223-1:2021 Medical devices – Symbols to be used with infor-
mation to be supplied by the manufacturer – Part 1:
General requirements
EN ISO 13485:2016
Medical devices – Quality management systems
Requirements for regulatory purposes
EN
62304:2006+A1:2015
Medical device software – Software life cycle
processes
EN ISO 13485:2016 Medical devices – Part 1: Application of usability
engineering to medical devices
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