EMC Training

EMC Training - Introduction to Medical EMC

IEC 60601-1-2: 2014 (4th Edition),

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

Objectives

This is a 1.5 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.

Background

Since 31 Dec 2018, the 4th edition of IEC 60601-1-2 is mandatory in the US, Canada, The EU and other regions. The 4th edition presents 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.

Instructor

Darryl Ray is the founder and Principal Consultant for Darryl Ray EMC Consulting, LLC. He has more than 35 years EMC experience working in the medical device, ITE and defense industries. Mr. Ray received a Bachelors of Engineering Technology degree from Wayne State University in Detroit, Michigan. He has performed EMC engineering on well over 100 products and has built 8 EMC complete EMC labs from scratch including several 10 meter semi-anechoic chambers. Darryl has authored several papers for past IEEE EMC symposiums. He is an iNarte Certified Master EMC Design Engineer. Mr. Ray is a Senior Member of the IEEE and former chair of the IEEE Santa Clara Valley EMC chapter. Darryl is an active member of IEC Technical Committee 62A, Maintenance Team 23 pertaining to the development of IEC 60601-1-2 and also a member of the US national committees for CISPR 11, 22, 24, 32 and 35.

Affiliations

  • iNarte Certified Master EMC Design Engineer
  • Senior member of the IEEE EMC Society
  • Active member of IEC Maintenance Team 23 Committee for IEC 60601-1-2
  • Active member of IEC USTAG Committees for CISPR 11, 22, 24 32, & 35

Technical Papers Published & Presented

  • "Introduction to Medical EMC and IEC 60601-1-2 4th Edition" - 2015 IEEE EMC & SI Symposium, Santa Clara, CA
  • "Introduction to Medical EMC" Tutorial - 2014 IEEE EMC Symposium, Raleigh, NC
  • “Remodeling a 10-meter Semi Anechoic Chamber – A Case History” – 2005 IEEE EMC Symposium, Chicago, IL
  • “Advance Design Techniques for Semi Anechoic Chambers” – 2002 IEEE EMC Symposium, Minneapolis, MN
  • “The Trials and Tribulation of Building a Modern EMC Facility” – 2000 IEEE EMC Symposium, Washington, D.C.

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
  • How to prepare an EMC Test Plan

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