The fourth edition of IEC 60601-1-2 includes a number of dramatic changes, including more robust risk analysis requirements. FDA is recommending electromagnetic compatibility (EMC) testing to IEC 60601-1-2 4th Edition standards, requiring manufacturers to submit test plans and risk analysis documents before testing.

Intertek conducted two webinars, with speaker Nicholas Abbondante, Chief Engineer for EMC at Intertek, to gain a better understanding of:

IEC 60601-1-2 4th Edition: Understanding the Requirements

  • What it is? What are the changes? When does it matter?
  • Product configuration for testing and operating modes
  • Marking and information to user
  • Comparison with 3rd to 4th edition
  • Q&A

IEC 60601-1 4th Edition: Risk Management File Requirements

  • What is an RMF?
  • Basic Safety and Essential Performance
  • Specific Requirements for a 4th Edition RMF
  • Q&A

Please fill out the form below to gain access to both webinar recordings and the presentation slides.