Electrical Safety

by | Sep 1, 2023 | Past Trainings

This training currently has no open sessions. If you would like to attend, please leave us a message, and we will inform you when a new date is planned.


Training Objectives:

  • Gain a general understanding of IEC 60601 standards (collateral and particular standards) 
  • Learn to interpret the clauses of IEC 60601 
  • Insights on electrical safety requirements of medical electrical equipment according to IEC 60601-1 3.2 Edition


Training Content:

By attending this training, you will receive in-depth knowledge on the following topics:

  • IEC 60601 internationally (market legislation and national differences) 
  • Explanation of Certification Body (CB) Scheme and Nationally Recognized Testing Laboratory (NRTL) 
  • Short introduction to Risk Management according to ISO 14971 3.0 Edition and Usability according to IEC 60601-1-6 3.2 Edition/ IEC 62366-1 1.1 Edition  
  • Apply IEC 60601-1 3.2 Edition requirements on medical electrical equipment 
  • Safety concept and single fault condition 
  • Focus on clause 8 protection against electrical hazards from medical electrical equipment  
  • Classification of medical electrical equipment 
  • Insulation diagram of medical electrical equipment (air clearance and creepage distances) 
  • Means Of Operator Protection (MOOP) vs. Means Of Patient Protection (MOPP) 
  • Examples of required tests (leakage current, touch current and dielectrically strength) 
  • Selection of components for the list of critical components 
  • Introduction to IEC 60601-1-2 4.1 Edition 


Training Format:

  • Presentation with interactive discussions
  • Exercises during the training
  • End of training assessment (participants will receive a training certificate)


Who Should Attend:

  • Managers and employees working in Quality Assurance or Regulatory Affairs departments of medical device manufacturing companies 
  • Managers and employees working in Research and Development departments of medical device manufacturing companies 
  • Technical medical device consultants and associates 
  • Auditors of medical devices