EMC Training – Introduction to Medical EMC

IEC 60601-1-2: 2014 (4th Edition) & IEC TR 60601-4-2:2016 (1st Edition)

A 1 Day Course with Darryl Ray

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This is a full day intense training course. Participants will be encouraged to ask questions and engage in a interactive discussion of the issues presented. Upon completion of this course, the participants should leave with a understanding of how EMC compliance is achieved on medical devices.


The fourth edition of IEC 60601-1-2 will soon be mandatory in the US, Canada, The EU and other regions. The fourth edition will present dramatic changes for the medical device industry.  In addition, a new standard IEC TR 60601-4-2 (2016) may likely be required by the FDA as a way to demonstrate the devices effectiveness in the presence of various electromagnetic phenomena. Take this opportunity to get a deep in-site into the nuisances of Medical EMC. An outline of the course is shown below:

The course is geared towards:

  • EMC compliance engineers, technicians and project managers
  • Regulatory specialists
  • Quality system specialists
  • Any staff responsible for medical device EMC compliance

Course Outline

Medical EMC Requirements

  • IEC 60601-X Series of Standards Demystified
  • International Regulations
  • Complying with FDA Requirements
  • Standards vs. Regulations – What’s the Difference?
  • What is “Essential Performance”?
  • Labeling Requirements
  • Risk Management for EMC

Technical Issues

  • Analog Circuit Susceptibilities
  • Leakage Current Restrictions
  • Interference from Mobile Phones
  • Isolated I/O Ports
  • Acceptance Criteria for Immunity Testing
  • Sample Size & Design Margin Considerations
  • Modes of Operation During Testing

IEC 60601-1-2: 2014 (4th Edition)

  • Motivation
  • ESD Testing
  • Documentation Requirements
  • Emissions Requirements
  • Immunity Requirements
  • Timeframe for Compliance with the 4th Edition
  • Impact on Legacy Products
  • Things Learned Since Publication – Feedback from the Users
  • Changes Planned for Edition 4.1

IEC TR 60601-4-2:2016 (1st Edition)

  • Purpose of the Document
  • What is Efficacy?
  • ESD Testing
  • Comparison of Immunity Requirements with IEC 60601-1-2, 4th Edition
  • Simultaneous Testing with IEC 60601-1-2, 4th Edition
  • Regulatory Significance