Speaker: Stefan Staltmayr
Training Objectives
- Gain general understanding of IEC 60601 standards (collateral and particular standards)
- Learn to interpret 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 list of critical components
- Introduction into IEC 60601-1-2 4.1 Edition
Training Format
- Presentation with interactive discussions
- Exercises during the training
- End of training assessment (participants will receive training certificate)
Group of Participants
- Manager and employees working in Quality Assurance or Regulatory Affairs department of medical device manufacturer
- Manager and employees working in Research and Development department of medical device manufacturer
- Technical medical device consultants and associates
- Auditors of medical devices
Price
EUR 775 including course material and certificate