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