Safety Training

Integrating medical device safety into the design process

IEC 60601, IEC/ISO 80601, Ed 3.1 Series

Objectives

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.

  • Practical application to typical medical device designs,
  • Avoiding safety pitfalls,
  • Supporting regulatory requirements,
  • Integrating risk management and usability engineering into the design process,
  • Documenting verification to IEC 60601-1 using IECEE CB formated test report forms
  • Applying new concepts in skill implementation work group exercises

Instructor

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 geared towards

  • Technical design engineers
  • Compliance engineers
  • Regulatory/quality system specialists
  • Any staff responsible for medical device safety

Standards covered include

  • 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), including US, Can, and EU differences, Ed 3.1 and 3.2 (draft)
  • Risk Management, ISO 14971:2007, including IECEE CB-OD 2044:2013, ed 2.2, and EU/EN Annex ZA:2012Usability engineering
  • Usability Engineering, IEC 60601-1-6:2006, IEC 62366:2007 + A1:2014, and IEC 62366-1:2015
  • Alarms, IEC 60601-1-6:2006, IEC 62366:2007 + A1:2014, and IEC 62366-1:2015
  • Programmable systems, Software, Clause 14, general standard; IEC 62304:2006 + A1:2015
  • Home healthcare, IEC 60601-1-11:2015
  • Emergency medical services (pre-hospital), IEC 60601-1-12:2014

Course topics and weighting

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. The pie chart shows the hours allocated to each topic. 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).

general 20%, risk 20%, risk 40%, mech-thermal 10%, software-systems 10%

Group exercises

Groups are assigned 1 of 3 typical medical devices; a patient monitor, an AED, or a CPR device. For your medical device, the following exercises are assigned. The class reviews the results:

  • Identify Applicable Safety Standards
  • Specify Device Classifications
  • Document Risk Assessment and Risk Controls (for given hazards and foreseeable sequence of events)
  • Categorize Accessible Parts for MOPP/MOOP insulation
  • Specify Insulation Diagram (for given circuit block diagram)
  • Specify Electrical Test Program
  • Specify Mechanical, Thermal Test Program
  • Specify System Testing (for orthopedic system cart)