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IEC 60601 Training SeminarDesigning to comply with IEC 60601-1, 2nd & 3rd Editions, Medical electrical equipment, Part 1: General requirements for basic safety and essential performanceWhat You Will Learn
[ Top ] [ Registration ] Who Should AttendThe course is keyed to Electrical Medical Equipment:
[ Top ] [ Registration ] Background on IEC 60601-1, 2nd & 3rd Editions
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?
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, although CENELEC is suggesting 1 June 2012. 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. In March 2010, FDA announced that they will be accepting the 3rd ed, including all its collaterals and particulars, starting in June 2010, with a transition ending June 2013. 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. For US, this will be for new device evaluations. 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. [ Top ] [ Registration ] Course OverviewThe 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:
[ Top ] [ Registration ] Course AgendaDay 1Registration 8:00 AM with Continental Breakfast - Start 8:15 AM - Ending 5:30 PM
Day 2Start 8:00 AM with Continental Breakfast - Ending 5:30 PM
[ Top ] [ Registration ] Included in course registration fee
are:
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Frank O'Brien 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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Ulrich Walz has over 16 years experience testing and certifying equipment to IEC 60601-1 for the VDE test and certificatoin institute. For the last 12 years he has been a Notified Body auditor for VDE and DQS. Since 2004, Mr. Walz has given a number of seminars on IEC 60601-1, 3rd edition. |
[ Top ] [ Registration ]
We've provided public and private seminars on IEC 60601-1, 3rd edition to over 500 participants. In 2009 public training occured in Orlando, FL; Boston, MA; Galway, IRE; and Minneapolis, MN. 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 Nonin, 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.
[ Top ] [ Registration ]
Registrations can be cancelled by you 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 by you 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.
In the unlikely event we need to postpone a training seminar due to illness or a similar event, we will reschedule the seminar on a date that's mutually agreeable to the majority of the group. Alternatively, a full refund will be promptly returned to any participant. We have never had to cancel an event due to too few registrations. In the unlikely event this might occur, a full refund will be promptly returned to all participants. Alternatively, at your request, we'll retain the registration for use at a future seminar date.
[ Top ] [ Registration ]
We hope you'll join us in 2009 for one of our practical IEC 60601-1 training seminars.
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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 |
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| 22-23 Jun 2010 | Boston, MA, USA See Travel Arrangements below for specific hotel location |
Thanks to all those who attended | |
| 20-21 Jul 2010 | London, UK See Travel Arrangements below for specific hotel location |
Thanks to all those who attended |
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| 15-16 Sep 2010 | Frankfurt am Main, DE (in English) See Travel Arrangements below for specific hotel location |
Discount price until 25 Aug is 805 EUR. Normal price is
845 EUR. Up to 20% discounts for multiple participants. This seminar will be taught in the ENGLISH language. All support material will be in the English language. There will be no formal simultaneous translation into German, but questions can be taken in German, and will be answered in enough German to provide understanding. |
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| 28-29 Sep 2010 | Orange County, CA, USA See Travel Arrangements below for specific hotel location |
Early bird price until 17 Aug is 955 USD. Normal price is 1195 USD. Up to 20% discounts for multiple participants. | |
| 9-10 Nov 2010 | Fort Lauderdale, FL, USA See Travel Arrangements below for specific hotel location |
Early bird price until 28 Sep is 955 USD. Normal price is 1195 USD. Up to 20% discounts for multiple participants. | |
We will consider locations in Philadelphia, Chicago, San Jose, Toronto, Bangalore, or Sydney, if there is sufficient interest. Private seminars at your location can also be booked. Please contact us for pricing and availability.
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| Location | Seminar Location and Hotel | Flight | Ground Transport |
|---|---|---|---|
| Boston |
Radisson Hotel and Suites Chelmsford-Lowell 10 Independence Drive, Chelmsford Massachusetts 01824, USA
Reservations: 1-800-395-7046 US/Canada Toll-free |
Fly into BOS (Logan) or MHT (Manchester, NH) each about 30 miles away. | Rent Car. See hotel for location address. |
| London |
K+K Hotel George
1-15 Templeton Place Tel: +44 20 7598 8700 |
Fly into LHT (Heathrow), or LGW (Gatwick). RyanAir has cheap flights into Stansted. | Short walk from Earl's Court underground tube stop (train); or Rent Car. |
| Frankfurt, 15-16 Sep 10 |
Le Méridien Parkhotel Frankfurt Wiesenhüttenplatz 28-38 Internet price from 320 EUR/night |
Fly into FRA (Frankfurt/Main). | Hotel is
easy walk from Frankfurt main train station (Hauptbahnhof). Driving directions. Parking is 27 EUR/day. |
| Orange County, 28-29 Sep 10 |
Shorebreak Hotel
500 Pacific Coast Hwy D: 714-965-4413 Internet prices from 219 USD/night |
Fly into SNA (John Wayne Airport), or LAX (Los Angeles. | Best to Rent Car. Hotel is beachside, downtown Huntington Beach |
| Fort Lauderdale, 9-10 Nov 10 | to be determined...(probably Marriot Courtyard at Federal Hwy and Commercial Blvd, but not finalized) | Fly into Fort Lauderdale or Miami | |
Other participation requirements are here. For course agenda, see here.