EchoNous KOSMOS - Safety; Electrical Safety; References

KOSMOS User Guide 83
CHAPTER 9 Safety
Electrical safety
References
IEC 60601-2-37: 2015 Medical electrical equipment – Part 2-37: Particular
requirements for the basic safety and essential performance of ultrasonic medical
diagnostic and monitoring equipment
ANSI AAMI ES 60601-1: 2012 Medical electrical equipment. Part 1: General
requirements for basic safety and essential performance – IEC 60601-1:2012, Edition
3.1
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
IEC 62304:2015 Medical device software - Software life-cycle processes
ISO 14971:2007/(R)2010 Medical devices - Application of risk management to
medical devices
10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process
ANSI AAMI EC53:2013 ECG Trunk Cables And Patient Leadwires