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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

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.  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.

Are you ready?

The new 3rd Edition, was published in December 2005.  National/regional versions aligned with the 3rd edition have been published by the US/AAMI, and EC/CENELEC.  The publication of these standards means they're official consensus standards, providing state of the art safety requirements for verifying acceptable risk.

In Canada, the Therapeutic Product Directorate has announced that electrical medical devices must comply by December 2008.  If jurisdictional authorities such as FDA, and the EC Commission define transition dates based on dates published by CENELEC, compliance with the 2nd edition will no longer provide "reasonable assurance of safety and effectiveness", or allow "presumption of compliance with essential requirements" after 12 Sep 2009 for products which will have no particulars or collaterals, and after 12 Sep 2012(?) otherwise.  It's therefore advisable for new designs and changes to existing designs 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).  In addition to basic safety, Essential Performance must be defined and pose acceptable risk during normal use, reasonably foreseeable misuse, and single fault conditions.

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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 over 27 years experience working with medical device manufacturers; evaluating medical devices.  He's been teaching IEC 60601-1 courses for the last 10 years for organizations including IEC, AAMI, UL, and Quadtech. 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

From 2004 to 2008, both public and private seminars have been provided to over 250 participants.  The most recent seminars in 2008 occurred in San Jose, CA; Auckland, NZ; Tokyo and Osaka, JP and London, UK.  In 2007, 2 similar public training seminars were held.  One was in Dublin, one in Boston. Private training has been provided to Zoll, Cytyc, Axya Medical, XP Power, Spacelabs, and Codman J&J.  The course has been very well received.  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 2008 or 2009 for one of our practical IEC 60601-1 training seminars.

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

PayPal has advantages over Google Checkout in that you don't need to be a PayPal registered user; you can enter credit card information directly.  PayPal allows OBCM to receive data on course participants and company affiliation.

After completing the transaction, you'll receive a confirmation email, and you'll be returned to this website for final logistical details.  With Google, you'll be asked to provide participant name and company data later.  With PayPal, you'll also have opportunity to confirm participant name and company data later.

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
Tentative Date	Location	Registration Fee	Make Payment with	Make Payment with
21-22 Oct 2008	Chelmsford, MA, USA	Early Bird Price 895 USD when booked 6 weeks prior 1095 USD after 9-Sep-08	Participant Name(s), as appears on cert: Company Name:
18-19 Nov 2008	San Diego, CA	Early Bird Price 895 USD when booked 6 weeks prior 1095 USD after 7-Oct-08	Participant Name(s), as appears on cert: Company Name:
10-11 Feb 2009	Orlando, FL	Early Bird Price 895 USD when booked 6 weeks prior 1095 USD after 30-Dec08	Participant Name(s), as appears on cert: Company Name:

Successful seminars provided earlier this year (2008) included San Jose, CA and Auckland, NZ in April, Tokyo and Osaka, JP in May and London, UK in June.

Other seminar dates being considered for Spring, Summer and Fall of 2009 in New York Metro Area; San Jose, CA; 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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