IEC 60601 Electrical safety 24 & 26.09.2024

Duration: 8 hours |2x 8:00 – 12:00 AM US Eastern Standard Time | 2x 2:00 - 6:00 PM Central Europe Summer Time
Date: September 24th and 26th 2024, Online
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)

Target audience:
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 incl. course material and certificate