In Cooperation with the EMC Standards Corporation and Washington Labs Academy
The Medical Device industry is expected to grow to $228B in 2015, with an annualized growth rate of 7% since 2010. Innovations in biological sensing, therapy and diagnostics are creating complex devices that must work without error or failure. Electromagnetic Compatibility is a critical requirement to assure safety and efficacy and forms a part of device evaluation and approval under the FDA and European Union Medical Device Directive regimens.
This one-hour webinar presents a detailed overview of IEC 60601-1-2:2014 (4th Edition), recently published. The 4th edition means dramatic changes for the medical electronics industry. Take this opportunity to get an insight into the 4th edition. An outline of the course is listed below:
- Relationship of IEC 60601-1-2 to Other Standards
- Motivation & Philosophy for the 4th Editon
- General Test Setup Conditions
- “Intended Use” vs. “Normal Use”
- Emissions & Immunity Requirements
- Labeling & Documentation Requirements
- Comparison of the 3rd & 4th Editions Emissions Limits and Immunity Levels
- Risk Analysis
- When Do We Have to Comply with the 4th Edition?
- Impact to Legacy Devices
- New Standard: IEC/TR 60601-4-2 for “EMC Performance”
Who Should Attend
Technicians, test engineers, design engineers, and project managers for medical electrical products and systems. In short, anyone tasked with the job of getting a medical product through EMC compliance will benefit from this seminar.
Darryl P. Ray is the founder and principal consultant for Darryl Ray EMC Consulting, LLC. He has more than 35 years EMC experience working in the medical device, ITE and defense industries. Darryl has performed EMC engineering duties on over 100 products. Mr. Ray received a Bachelors of Engineering Technology degree from Wayne State University in Detroit, Michigan. He is an iNarte Certified Master EMC Design Engineer. Darryl is a Senior Member of the IEEE, former chair of the IEEE Santa Clara Valley EMC chapter and has authored several papers for past IEEE EMC symposiums. He has designed and supervised the construction of 8 EMC labs including numerous anechoic chambers. Mr. Ray is an active member of IEC TC62A/Maintenance Team 23 pertaining to the development of IEC 60601-1-2 and also a member of the US national committees for CISPR 11, 22, 24, 32 and 35.
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