Complied standards list
Item Standard
Risk management ISO/EN 14971 Medical devices — Application of risk
management to medical devices
Labeling ISO/EN 15223-1 Medical devices. Symbols to be used with
medical device labels, labeling and information to be
supplied. General requirements
User manual EN 1041 Medical equipment manufacturers to provide
information
General Requirements for Safety
IEC 60601-1+A1 Medical electrical equipment - Part 1:
General requirements for basic safety and essential
performance
IEC 60601-1-11 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 Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests
Performance requirements and clinical investigation
IEC 80601-2-30 Medical electrical equipment- Part 2-30:
Particular requirements for the basic safety and essential
performance of automated non-invasive
sphygmomanometers
ISO81060-2:2013 Non-invasive sphygmomanometers —
Part 2: Clinical validation of automated measurement type
Software life-cycle processes
IEC/EN 62304+AC: Medical device software - Software life
cycle processes
Usability
IEC 62366 Medical devices - Application of usability
engineering to medical devices (IEC 62366)
IEC 60601-1-6 Medical electrical equipment - Part 1 -6:
General requirements for basic safety and essential
performance - collateral standard : Usability
24 Appendix Welch Allyn Remote Monitoring Blood Pressure Device RPM-BP100SBP
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