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Safety Training

Integrating medical device safety into the design process

IEC 60601/ISO 80601, ed 3.1 and 2.2 families

Objectives

This course is an intense 3 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 1300 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

The course is geared towards:

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

Standards covered include:

Title Number:Publication Year 
Medical Electrical Equipment -- Basic safety and Essential performance (general) Ed 3.1: IEC 60601-1:2005 + C1:2006 + C2:2007 + A1:2012 + A1-C1:2014, including US, Can, and EU differences

Ed 2.2: IEC 60601-1:1988 + A1:1991 + A2:1995
Risk management ISO 14971:2007, including IECEE CB-OD 2044:2013, ed 2.2, and EU/EN Annex ZA:2012
Usability engineering IEC 60601-1-6:2006, IEC 62366:2007 + A1:2014, and IEC 62366-1:2015
Alarms  IEC 60601-1-8:2006 + A1:2012
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

Course topics are weighted to emphasize risk management and electrical safety (insulation diagrams, etc) with each topic getting 25% of time. The remaining topics are divided among the remaining 50% of time. The pie chart below shows the hours allocated to each topic, including time for group exercises.

agenda pie

Not covered are details about EMC (Clause 17, IEC 60601-1-2, see separate course module), Sterility (clause 11.6.7), nor Biocompatibility (clause 11.7, ISO 10993).

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: 

  1. Identify Applicable Safety Standards
  2. Specify Device Classifications
  3. Document Risk Assessment and Risk Controls (for given hazards and foreseeable sequence of events)
  4. Categorize Accessible Parts for MOPP/MOOP insulation
  5. Specify Insulation Diagram (for given circuit block diagram)
  6. Document Risk Results for Spill Test in Test Report Form
  7. Specify System Requirements (for orthopedic system)
  8. Specify Test Program.

Register

London England
17-19 April 2018
-- thanks to those who participated --
sf pyramid at dusk
San Francisco CA USA
22-24 May 2018
-- thanks to those who participated --
USA
16-18 Oct 2018