EMC Compliance for Medical Devices

✔ New EMC testing standards and the impact on your compliance.

✔ Design for compliance techniques to help you meet the new challenges.

A 1 Day Course with Darryl P. Ray

Instructor Bio

Course Description

The fourth edition of IEC 60601-1-2 has been approved, and this means dramatic changes for the medical device industry. In addition, a new standard IEC/TR 60601-4-2 (2016) will likely be required very soon. Take this opportunity to get a deep in-site
into the nuisances of Medical EMC. An outline of the course is shown below:

Standards and Regulatory Changes

  • IEC 60601-X Series of Standards Demystified
  • International Regulations
  • Complying with FDA Requirements
  • What is “Essential Performance”?
  • Labeling Requirements

Design Challenges

  • Analog Circuit Susceptibilities
  • Leakage Current Restrictions
  • Interference from Mobile Phones
  • Isolated I/O Ports

Testing Issues

  • Acceptance Criteria for Immunity Testing
  • Sample Size ConsiderationsCapacitor resonance and Capacitors in parallel
  • Modes of Operation

Overview of IEC 60601-1-2 4th Edition (2014)

  • Motivation
  • Emissions Requirements
  • “Intended Use” vs. “Normal Use”
  • ESD Testing on Connectors
  • Documentation Requirements
  • When Do We Have to Comply with the 4th Edition?
  • Things Learned Since Publication – Feedback from the Users

Overview of the New IEC/TR 60601-4-2 1st Edition (2016)

  • Motivation
  • Immunity Requirements
  • ESD Testing on Connectors“Intended Use” vs. “Normal Use”
  • Regulatory Significance

Who Should Attend:

Technicians, engineers, managers, project managers etc involved with the design, testing and compliance of medical electrical equipment and systems will benefit from this seminar.

Schedule and Registration  |   Terms and Conditions