IEC 60601-1 for medical devices

About the training on safety and essential performance of medical devices according to IEC 60601-1

During the practical training on Basic Safety and Essential Performance of Medical Devices according to IEC 60601-1, you will learn how to select and apply all relevant standards in the development of medical devices. In addition to understanding the content of the standards, you will also learn to navigate practical aspects such as norm selection, interaction with external testing laboratories, and considerations for certification and smart documentation practices. Furthermore, the training provides insights into the relationships with other standards in areas like risk management, usability engineering, and software development.

This training is beneficial not only for medical device manufacturers but also for suppliers such as engineering firms and users of medical physics services.

During the basic safety and essential performance of medical devices training according to IEC 60601-1, the following topics will be covered:

• CE marking of medical devices and the use of standards
• Structure of the IEC 60601 series of standards (assurances, particulars) and national differences
• Selection of applicable standards
• Generic requirements from IEC 60601-1 and its relationship with risk management
• Key terms and definitions; Single Fault Condition (SFC), Essential Performance
• Electrical hazards (principles, insulation diagrams, insulation distances, test voltages, leakage currents)
• Mechanical hazards (moving parts, instability, support systems)
• Radiation hazards (laser, light, ionizing, electromagnetic)
  • Thermal and other hazards
  • Portable Emissions Measurement System (PEMS), relationship with IEC 62304 and ICT networks
  • Test reports and documenting the relationship with risk management
  • Pre-compliance testing and testing by an external testing laboratory