Introduction to Medical EMC 

Objectives

This is a 1.5 day intense training course. 

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

Upon completion of this course, the participants should leave with an understanding of how EMC compliance is achieved on medical devices.  Participants are encouraged to ask questions and engage in a interactive discussion of the issues presented.

Instructor

Dates and Times

The 1.5 day seminar: 

• Thu, 9 May 2024 is an afternoon session, 13:00 to 16:30. 

• Fri, 10 May 2024 is a full day session, 8:30 to 16:30.

A large training room has been arranged for low density seating. Masks will be optional. We'll have a few Covid 19 test kits available, for anyone experiencing symptoms.

Your registration includes full catering for continental breakfast, morning break, lunch (on full days), and afternoon break.

There will be an optional tour of the TUV Rheinland EMC test facility, during one of the evenings.

Any needed travel and hotel accommodation are the responsibility of each participant.

For flight arrangements Boxboro is equi-distant between Boston Logan (BOS) and Manchester NH (MHT), although MHT can be faster depending on Boston traffic.

Here's a presentation prepared by TUV Rheinland providing information about the TUV training room and area hotels and restaurants, as well as other information of interest.

Course Outline

• EMC Testing Overview

• IEC 80601 Standards Demystified

• Medical EMC Requirements

• Dates for Compliance

• FDA Requirements

• Essential Performance and Basic Safety

• IEC 60601-1-2 Edition 4 and 4.1

• IEC TR 60601-4-2 Edition 1

• EMC Labelling and Risk Management

• Test Plans and Reports

• EMC Design – Quick Basics

• Impact on Legacy Products

• Medical Devices Attached to non-Medical Equipment

• Medical Devices with Wireless Capabilities

• Misc. Topics

• Reference Information

• Summary

• Q&A

Standards Included

The course content includes an overview of these product standards:

• IEC 60601-1-2:2014 + A1:2020, Ed. 4.1, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests

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

If you want to register 4 participants, separately register 2 participants twice. For 5 participants, separately register 2 participants, and then 3 participants.

You might also be interested in our Safety training during the same week.