IEC 60601 with O'Brien Compliance Management
This 2 day training programme will give participants indepth knowledge on integrating the medical electrical equipment safety standard series, IEC 60601, into the design process.
Presentation slides will contain excerpts from the applicable safety standards, and frequent examples to illustrate how the safety requirements apply to typical medical device designs, and pitfalls to avoid. Participants are encouraged to ask questions about the safety requirements, and how they apply to their products currently under development.
Safety standards covered:
- Medical Electrical Equipment -- Basic safety and Essential performance (general), IEC 60601-1:2005 + C1:2006 + C2:2007 + A1:2012 + A1-C1:2014 + A2:2019 (draft), Ed 3.1 and 3.2 (draft), including the US, Can, and EU differences
- Alarms, IEC 60601-1-8:2006 + A1:2012 + A2:2017/CD (draft)
- Home healthcare, IEC 60601-1-11:2015
- Emergency medical services (pre-hospital), IEC 60601-1-12:2014
Any minimum experience requirements
The course is geared towards Technical design engineers, Compliance engineers, Regulatory/quality system specialists, Any staff responsible for medical device safety. There are no course prerequisites, although some familiarity with quality management and risk management procedures is helpful.
Your instructor is Frank O’Brien, who has over 35 years of experience testing medical devices. As an instructor, Frank 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 O’Brien Compliance Management (OBCM).
From 2004 to 2017, Frank was the principal engineer at OBCM, providing consulting and testing services 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 Clara, CA; and Chelmsford, MA. 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 equipment 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.
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 Lisdoonvarna, County Clare, Ireland; and Lowell, MA, USA.
* This training is supported by the Connected Heatlh Skillnet