IEC 60601 EMC Training Webinar

Introduction to Medical EMC

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, IEC TR 60601-4-2 (2016) is likely 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

  • Darryl Ray is the founder and Principal Consultant for Pacific EMC.

  • More than 35 years EMC experience working in the medical device, ITE and defense industries.

  • Bachelors of Engineering Technology degree from Wayne State University in Detroit, Michigan.

  • Performed EMC engineering on well over 100 products

  • Built 8 complete EMC labs from scratch including several 10 meter semi-anechoic chambers.

  • Active member of IEC Technical Committee 62A, Maintenance Team 23 pertaining to the Development of IEC 60601-1-2 and a former member of the US national committees for CISPR 11, 22, 24, 32 and 35.

More about Darryl Ray's affiliations, and technical papers

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

Training Course Outline

  • Relevant Regulations and Standards

  • Dates for compliance

  • Essential Performance and Basic Safety

  • IEC 60601-1-2:2014, Edition 4.0

  • IEC 60601-1-2:2014 + A1:2020, Edition 4.1

  • EMC Risk Management

  • Labelling Requirements

  • Design Considerations

  • Impact on Legacy Products

  • Medical Electrical Systems Connected to Non-Medical Equipment

  • EMC Requirements by Country

  • Medical Devices with Wireless Capabilities

  • Reference information

  • Summary and Q&A

Standards included

The course content includes an overview of these standards:

  • General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, IEC 60601-1-2: 2014 + A1:2020, ed 4.1

  • Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems, IEC TR 60601-4-2:2016, ed 1.0

Participant Details

The webinar will be held with Google Meet. You don't need a Google Account to participate in Meet video meetings. If you don't have a Google Account, our instructor will grant you access to the meeting.

All participants get the slides and speaker notes at the start of the webinar.

With full attendance, all participants receive a Certificate of Completion at the end of the webinar.

There are no course prerequisites, although some familiarity with quality management and risk management procedures is helpful.

Schedule

No live events are currently scheduled. If you have interest, let us know. We're considering a live event in the Boston or SF area, or it may be a live online event. To stay informed about future events, please join our mailing list.