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IEC 60601 Training Seminar

Designing to comply with IEC 60601-1, 2nd & 3rd Editions, Medical electrical equipment, Part 1: General requirements for basic safety and essential performance

What You Will Learn

This course is not an overview; it's an intense 2 day training course.  Gain practical knowledge you can directly apply to your new medical device designs.  Join OBCM for practical instruction on designing to new 3rd edition and current 2nd edition medical device safety requirements.  The emphasis will be on applying newly learned concepts to typical medical devices with skill implementation work group exercises.  Your instructor was one of those responsible for writing the new 3rd edition.  Over the last few years, we've taught over 500 participants; making us the world leader in 3rd edition training.  You will earn a certificate upon completion of 16 hours of instruction and exercises.

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Who Should Attend

The course is keyed to Electrical Medical Equipment:

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

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Background on IEC 60601-1, 2nd & 3rd Editions

The Part 1 general standard serves as the foundation for the international electrical medical equipment series of safety standards.  The series includes horizontal collateral standards, IEC 60601-1-xx, for specific equipment technologies or other general issues; and vertical particular standards, IEC 60601-2-xx, for specific types of medical equipment.  The series forms the basis for the consensus safety standards for most markets in the world, including, US, Europe, Japan, Canada, Australia, China, Korea, Brazil, and Argentina.

Currently medical devices are evaluated to the 2nd edition.  The new 3rd Edition, was published in December 2005.  National/regional versions aligned with the 3rd edition have been published by the US/AAMI, EU/CENELEC, and Canada/CSA.  The publication of these standards means they're official consensus standards, providing state of the art safety requirements for verifying acceptable risk.

Are you ready?

In Canada, the Therapeutic Product Directorate has announced that electrical medical devices must comply with 3rd edition by 1 June 2012.

Since November 2008, Europe has both the 2nd and 3rd editions on their Harmonized Standards List.  No cessation (withdrawal) date is published for the 2rd edition.  Either edition is considered harmonized to the essential requirements of Medical Device Directive, 93/42/EEC.  It's expected that the cessation of 2nd edition aligned particular standards will define the date by which particular medical equipment must comply with 3rd edition.  For example, for Ultrasound equipment, the effective date for when you must meet 3rd edition starts 1 Oct 2010, since that's the cessation date for the 2nd edition aligned EN 60601-2-37:2001 + A1:2005 + A2:2005 (IEC 60601-2-37:2001 + A1:2004 + A2:2005).  While the use of the 2nd edition remains possible, by including as Harmonized Standards, EN ISO 14971:2007, and EN 62366:2008 (ISO 14971:2007 and IEC 62366:2007), for risk management and usability engineering processes, respectively, the advantage of staying indefinitely with the 2nd edition is minimized.

FDA hasn't announced anything about 3rd edition yet. 

For Canada and Europe the cessation date for 2nd edition (effective date for 3rd edition) will apply to new products in development, as well as current products already in production, which will be shipped after the effective date.   While some of the world will be transitioning to the 3rd edition in the 2012 timeframe, it appears other parts of the world will be transitioning much slower.  During this transition, medical devices will need to comply with both the 2nd and 3rd edition.

What's New?

The 2nd edition is a Basic Safety standard, which provides verification tests for judging whether a medical device poses acceptable risk during normal use, reasonably foreseeable misuse, and single fault conditions.  Within this scope the 3rd edition is very similar.

The 3rd edition has some new verification tests, such as a reduced energy test for defib-proof equipment, and rough handling tests for mobile equipment.  The 3rd edition also has some areas where requirements are more relaxed, such as electrical insulation for operator protection, lower tensile safety factors for well defined support parts, and higher surface temperature limits for short durations.

The biggest impact with the 3rd edition is to expand on the scope of the 2nd edition to require, during the design process, Risk Management and Usability Engineering (Human Factors).  Reference standards that define minimum requirements for these processes are in ISO 14971 and IEC 62366 (or the older, IEC 60601-1-6).

The Risk Management process defines Essential Performance.  Essential Performance and Basic Safety are the broad spectrum of hazards which must be controlled to an acceptable risk.  Things like an enclosure thickness, flame rating of material, and separation of mains from operator accessible circuits are risk controls for the Basic Safety end of hazards.  Essential Performance will be at the other end, and normally associated with intended use/purpose of device (therapeutic, diagnostic, or monitoring function). You must ask, to what extend will loss or degradation of our device's intended use/purpose result in unacceptable risk?  Sometimes there will be no Essential Performance, as loss is obvious and results in acceptable delay in intended use/purpose.  Sometimes there will be a need for your device to check for errors and alarm errors, and when no error, to deliver min. acceptable performance/accuracy.  As with Basic Safety, Essential Performance must pose acceptable risk during normal use, reasonably foreseeable misuse, and single fault conditions.

The Risk Management process identifies surfaces that require Means of Patient Protection (MOPP), or Means of Operator Protection (MOOP).  MOPP is similar to 2nd edition insulation requirements.  MOOP is the same as that required for IT Equipment by IEC 60950-1.

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Course Overview

The training course focuses on the new 3rd edition.  The assumption is that unchanged requirements from the 2nd edition are also presented, as a refresher.  Areas where 3rd edition is more stringent or less stringent are highlighted.  The assumption is that designs will want to meet both 2nd & 3rd editions, with emphasis on the newer 3rd edition.

Emphasis is on:

• Practical application to typical medical device designs,
• Avoiding safety pitfalls,
• Supporting regulatory requirements,
• Integrating risk management and usability engineering into the design process,
• Learning how to apply practical risk-based superset of 2nd & 3rd editions to new designs,
• Leaning how to apply practical risk-based 3rd edition delta to existing designs already complying with 2nd edition,
• Documenting verification to IEC 60601-1 with both traditional test reports, and design process records for auditors.

After introducing new concepts, skill implementation work group exercises are included in most modules to allow small groups to apply newly acquired knowledge by performing design review and documentation activities on typical medical devices.  Groups are given 1 of 3 hypothetical devices, and asked to decide on best safety strategy, resolve safety critical issues, and provide safety feedback about possible areas of noncompliance or where additional info/testing will be needed.  After each work group exercise, groups report their finding to the full class. During all topics, staff is encouraged to ask questions about the safety requirements, and how they apply to products currently under development.  The training medium is PowerPoint slides, with frequent references to source standards.  Not covered: in-depth details about EMC requirements (Clause 17, IEC 60601-1-2) nor biocompatibility (Clause 11.7, ISO 10993).

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Course Agenda

Day 1

Registration 8:00 AM with Continental Breakfast - Start 8:15 AM - Ending 5:30 PM

Day 2

Start 8:00 AM with Continental Breakfast - Ending 5:30 PM

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Included in course registration fee are:

• Participant guide with all PowerPoint slides,
• Skill implementation exercise booklet, with support material, including templates for essential requirement matrix, risk table, and 3rd & 2nd Edition test report form. 
• Answer booklet
• Certificate of Participation for 16 hours of instruction and exercises
• Continental breakfast, lunch, and break snacks (both days)

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Participant requirements:

• Bring own copy of 3rd edition version of safety standard for hands-on reference.  Recommended is either AAMI ES 60601-1:2005, or EN 60601-1:2006.  This gives you generic IEC requirements, and national/regional differences.
• Optional are 2nd edition version, and free 2nd & 3rd edition mapping document, IEC TR 62348:2006.
• There are no course prerequisites, although some familiarity with quality management and risk management procedures is helpful
• Course registration including prepayment
• Any hotel, and travel arrangements (see below)

Standards can be purchased from many sources, including:

• http://www.AAMI.org (185 USD, ES 60601-1:2005); specific link for purchasing standards ES 60601-1, and IEC TIR62348, http://www.aami.org/publications/standards/60601.html)
• http://www.IHS.com (542 USD, BSI BS EN 60601-1:2006),
• http://www.BSI-global.com (252 GBP, (500 USD), BS EN 60601-1:2006)

IEC TR 62348:2006 is available as a free download from http://www.IEC.ch.

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Background on Instructor

Frank O'Brien is your instructor.  He has experience working with medical device manufacturers since 1980; evaluating medical devices.  He's been teaching IEC 60601-1 courses since 1996 for organizations including IEC, AAMI, UL, Quadtech, and OBCM. Frank is one of the committee members responsible for writing the new 3rd edition, and is currently on the committee drafting the new home healthcare collateral.  As an instructor he is often credited with bringing a degree of fun to learning otherwise serious topics.  For details about his background, see About Us Page.

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Participant Feedback on Past Seminars

We've provided public and private seminars on IEC 60601-1, 3rd edition to over 500 participants.  In 2008 public training occurred in San Diego, CA; Boston, MA; San Jose, CA; Auckland, NZ; Tokyo and Osaka, JP and London, UK.  In 2007, public training occured in Dublin, and Boston.  Private training has been provided to Medtronic, Covidien, Philips Healthcare, Gyrus, Zoll, Cytyc, Axya Medical, XP Power, Spacelabs, and Codman J&J.  Participant feedback for the course has been very positive.  In total, the average feedback score for "Would you recommend to others?" has been 4.6 out of 5.

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Cancellation Policy

Registrations can be cancelled anytime up to 6 weeks before Training Seminar date.  Refunded will be registration fee, less 2-3% credit card processing fee, and 10% cancellation fee.

Registrations cannot be cancelled within 6 weeks of Training Seminar date, due to logistical commitments made by OBCM.  No refund is available, however full credit is offered for a future workshop date.

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Dates, Locations, Registration

We hope you'll join us in 2009 for one of our practical IEC 60601-1 training seminars.

Credit card transactions are accepted using the secure servers of PayPal.  OBCM staff, or anyone else, does not see your credit card data; rather PayPal and Google keep this information secure.

To process a credit card transaction with PayPal, you don't need to be a PayPal registered user; you can enter credit card information directly.  If you are a register PayPal user, the transaction is easier as they'll automatically enter your billing information.  After completing the transaction, you'll receive a confirmation email, and you'll be returned to this website for final logistical details.

Alternatively, OBCM offers a discount for multiple attendees from the same company.  The following attendee discounts apply: two (2) = 10% per attendee, three (3) = 15% per attendee and four (4) or more = 20% per attendee.  Please contact us if you would like to register two or more employees from your organization.  OBCM will issue you a PayPal invoice to include the discount.  Payment can then be made by credit card through the PayPal system.

Please review our Cancellation Policy BEFORE registering.    You may also read our privacy policy.

Designing to comply with IEC 60601-1, 2nd & 3rd Editions, Medical electrical equipment, Part 1: General requirements for basic safety and essential performance			Registration
Dates	Location	Registration Fee	Make Payment with
10-11 Feb 2009	Orlando, FL, USA	Closed.  Thanks to those who attended!	Closed.
26-27 May 2009	Chelmsford, MA, USA	Closed.  Thanks to those who attended!	Closed.
9-10 Jun 2009	Galway, IRE	Closed.  Thanks to those who attended!	Closed.
15-16 Sep 2009	Minneapolis, MN, USA	Early bird price before 4 Aug, 895 USD; after 1,095 USD	Referred by: Google Search Google AdWords TUV Rheinland MECA (Biersach, Peck) Past Participant Other Participant's name, as appears on cert: Dietary restrictions:
3-4 Nov 2009	Berlin, DE (in English)	Early bird price before 22 Sep, 895 USD (approx 660 EUR); after 1,095 USD (approx 800 EUR)	Referred by: Google Search Google AdWords TUV Rheinland MECA (Biersach, Peck) Past Participant Other Participant's name, as appears on cert: Dietary restrictions:
1-2 Dec 2009	San Jose, CA, USA	Early bird price before 20 Oct, 895 USD; after 1,095 USD	Referred by: Google Search Google AdWords TUV Rheinland MECA (Biersach, Peck) Past Participant Other Participant's name, as appears on cert: Dietary restrictions:

Seminar locations being considered for 2010 include: Irvine, CA; New York Metro; Toronto, ON; Chicago, IL.  Dates and locations will be finalized and posted approximately 3 to 6 months prior.  Feedback is welcome.

Private seminars at your location can also be booked.  Please contact us for pricing and availability.

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Travel Arrangements

Other participation requirements are here.  For course agenda, see here.

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