Safety Training

Integrating IEC 60601 into the design process

IEC 60601, IEC/ISO 80601, Ed 3.1 Series, Medical Electrical Equipment, Basic Safety & Essential Performance

This course is an intense 3.5 day training course. Presentation slides contain excerpts from the applicable safety standards, and frequent examples to illustrate how the safety requirements apply to typical medical device designs. Participants are broken into work groups where they put newly learned safety requirements into practice with assigned exercises. The groups review their answers with the class. The slides and a work book is given to each participant. After the class, the work book with answers is given to participants. Our course continues to evolve to stay up to date with latest standards, interpretations, regulatory guidance, and feedback from over 1400 past participants. Participants are encouraged to ask questions about the safety requirements, and how they apply to their products currently under development.

The goals of the course are:

  • Practical application of requirements to typical medical device designs,
  • Applying new concepts in skill implementation work group exercises,
  • Avoiding safety pitfalls,
  • Supporting regulatory requirements,
  • Integrating risk management, usability engineering, and test requirements into the design process,
  • Constructing insulation diagrams,
  • Identifying safety critical components and requirements, and
  • Documenting compliance to IEC 60601-1 using IECEE CB formatted test report forms.

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 + A2:2020, Ed 3.2, including US, Can, and EU differences
  • Risk Management, ISO 14971:2007, including IECEE CB-OD 2044:2013, ed 2.2, and EU/EN Annex ZA:2012; and ISO 14971:2019 and ISO TR 24971:2020
  • Usability Engineering, IEC 60601-1-6:2006 + A1:2013 + A2:2020, IEC 62366:2007 + A1:2014, and IEC 62366-1:2015 + C1:2016
  • Alarms, IEC 60601-1-8:2006 + A1:2012 + A2:2020
  • Programmable systems, Software, Clause 14, general standard; IEC 62304:2006 + A1:2015
  • Home healthcare, IEC 60601-1-11:2015 + A1:2020
  • Emergency medical services (pre-hospital), IEC 60601-1-12:2016 + A1:2020

Instructor

Frank O'Brien has

  • Evaluated 1000’s of MEE, worked with 100’s of manufacturers
  • 24 Years UL; Consulting since 2004
  • TC 62 committees since 1996, 1906 award recipient
  • MS Tech Mgt SUNY Stony Brook; PE NY; BS EE Clarkson College
  • Currently live in County Clare, previously Boston, San Jose, Frankfurt, Long Island NY

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.

Included in course fee

  • All presentation slides, (pdf),
  • Skill implementation work group exercise book (dgoc, docx), risk file form (gsheet, xlsx),
  • Answers to work group exercises (gdoc, docx; gsheet, xlsx),
  • Certificate of Participation for nn hours of instruction and exercises (nn=28 h for safety, =12 h for emc)
  • Continental breakfast, lunch, and break snacks (1.5 d EMC course includes 1 lunch; 3.5 d safety course includes 4 lunches)

Course modules

0 Introduction

1 Specify Intended Use, Markets

2 ID regulations, standards, about 601

3 ID safety characteristics

4 Risk, Usability, PMS

5.1 Essential Performance, Protection

5.2 Electrical, Protection

5.3 Mechanical, Protection

5.4 Thermal & Other, Protection

5.5 PEMS & Software, Protection

5.6 Systems, Protection

5.7 Alarms, Protection

6 Critical Components

7 Information for safety

8 Test plan, RM Results

9 Verifiation Testing

10 Wrapup

Not covered are details about EMC (Clause 17, IEC 60601-1-2, see separate EMC course), or Sterility.

Module organization over 3.5 days

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. Create Risk Mgt, characteristics related to safety, and document in Risk Mgt File Form
  4. Create Risk Mgt, for given hazards and foreseeable sequence of events, specify pre-Risk, any Risk Control, residual-Risk, and Verification tests, and document in Risk Mgt File Form
  5. Document clause 4.6 decision, Accessible parts subject to AP requirements except marking, or not AP
  6. Specify Insulation Diagram for given circuit block diagram, MOP, working voltage
  7. Specify insulation coordination environmental factors
  8. Specify Insulation Diagram for given circuit block diagram, specify insulation parameters, CR, CL, DS
  9. Specify System Test Plan for arthroscopic system cart
  10. Document Mfr's RM Procedures in Test Report Form, Table 4.2.2
  11. Document Mfr's RM Results from earlier RMF in Test Report Form
  12. Specify Mfr's Essential Performance from earlier RMF in Test Report Form
  13. Specify Electrical Test Plan
  14. Specify Mechanical, Thermal and other Test Plan

Course Overview

mod 0, IEC 60601 Integrating into Design

Sample training session, 30 minutes