✔ 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
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
- Analog Circuit Susceptibilities
- Leakage Current Restrictions
- Interference from Mobile Phones
- Isolated I/O Ports
- 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)
- 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)
- 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.