This course is an intense 3.5 day training course. There's presentation slides, frequent references to source standards, and skill implementation work group exercises. Participants are encouraged to ask questions about the safety requirements, and how they apply to products currently under development. Our course continues to evolve to stay up to date with latest standards, interpretations, regulatory guidance, and feedback from over 1400 past participants.
As an instructor Frank O'Brien is often credited with bringing a degree of fun to learning. He's been teaching IEC 60601-1 courses since 1996 for organizations including IEC, AAMI, UL, Quadtech, and OBCM.
Since 1996 Frank has been on IEC committees drafting IEC 60601 standards, including the new 3rd edition of IEC 60601-1, its Amendment 1, the in-process Amendment 2, the home care medical device collateral standard, IEC 60601-1-11, the light ion (e.g. proton) therapy equipment particular, IEC 60601-2-64, and the robotically assisted surgical equipment, IEC 60601-2-77.
From 2004 to 2017, Frank was the principal engineer at OBCM providing consulting and testing servcies for medical device manufacturers OBCM was a Partner Test Lab for TUV Rheinland. From 1980 to 2004, Frank was a Manager and Senior Staff Engineer at Underwriters Laboratories, where he evaluated medical devices. UL offices where Frank worked included Melville, NY; Offenbach, Germany (at VDE), Santa Clare, CA; and Chelmsford, MA.
Frank is a Professional Engineer in New York State. Frank has an MS degree from Stony Brook University in Technology Management, including MBA courses macro economics and financial accounting, and a BS degree from Clarkson University in Electrical and Computer Engineering. Frank and his wife Rita split their time between homes in Lowell, MA, USA, and Lisdoonvarna, County Clare, Ireland.
The course is 3.5 days. Course topics are weighted to emphasize risk management with about 20%, and electrical safety (insulation diagrams, etc), 40% The remaining topics are divided among the remaining 40% of time. Topics include the time for group exercises.
Not covered are details about EMC (Clause 17, IEC 60601-1-2, see separate EMC course), Sterility (clause 11.6.7), nor Biocompatibility (clause 11.7, ISO 10993).
This is the actual introduction to the IEC 60601 Safety Course. It reflects our yearly update of the course, based on past participant feedback and new amendments and versions to standards covered. The course update is a work in progress so minor details to the overview could change.