Electrical Safety

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