IEC 60601 EMC Training Webinar
Introduction to Medical EMC
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.
The course is geared towards
EMC compliance engineers, technicians and project managers
Quality system specialists
Any staff responsible for medical device EMC compliance
Training Course Outline
Introductions & Questions/Problems to Solve
IEC 80601/60601 Standards Demystified
Medical EMC Regulations
Essential Performance and Basic Safety
IEC 60601-1-2 Edition 4 and 4.1
IEC TR 60601-4-2 Edition 1
Labelling and Risk Management for EMC
EMC Testing Overview
EMC Test Plan and Reports - How to create or review
Open Discussion/Problem Solving
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
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.
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.