What's New

Considering on-line IEC 60601 training

21 Jul 2020 -- We're thinking about a 2 phase approach.

With phase 1 we'd like to post a free series of prerecorded 30 minute modules about integrating IEC 60601 into the medical device design process. We divided the training material into 20 modules, so about 10 hours of content. The modules will be prerecorded, and so can be taken at the viewer's own pace. Each module will be about 15 minutes of explaining theory, and 15 minutes applying the new concepts to a medical device example. The device will be a battery powered (internally powered) home-use thermometer. We expect to complete phase 1 in the Sep-Oct time frame. The 20 modules:

0. Overview of IEC 60601 integration process

1. Specify intended use, markets

2. ID regulations, standards, 601 overview

3. ID safety characteristics

4.a. Risk Mgt

4.b. Usability Eng

4.c. Post Market Surveillance data

5.1. Essential Performance

5.2.a. Electrical, 2 Golden rules

5.2.b. Electrical, Clause 4.6 MOOP/MOPP

5.2.c. Electrical, Insulation diagrams

5.3. Mechanical

5.4. Thermal, fire, liquids, radiation, enclosures

5.5. PEMS, Software

5.6. Systems

5.7. Alarms

6. Critical Components

7. Information for safety

8. Test plan, RM results

9. Verification testing

With phase 2, we'll consider expanding the material from 10 hours to 20 hours. This will allow a bit more depth in both covering the concepts as well as the examples. We're still working out details. These may be live with a defined schedule (probably 2 to 4 h each, with breaks), or prerecorded and can be taken at your own pace. With a prerecorded approach, we could do multiple device examples, showing different intended uses, e.g hospital physiological monitor, home care therapeutic, and emergency services therapeutic. Viewers could choose the example(s) most relevant to them. We could schedule live Q & A sessions. In either case, we'll probably do some kind of on-line tests after each module, so we can encourage engagement and provide certificate of completion. These will be available in the Oct-Nov time frame, and will be behind a paywall.

If you have feedback, let us know.

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Our Oct 2020 public training event is cancelled

21 Jul 2020 -- The Boston/Lowell hotel hosting our Safety and EMC training events has informed us that they are not hosting events or guests until 2021 per the governor’s order under phase four of reopening the state. We share the concerns the hotel and governor had about the Covid-19 transmission risk, and believe cancelling this event is prudent. Participants who had registered have received a full refund.

We have a YouTube Channel

14 May 2020 -- We now have a YouTube channel. We're starting small with a single 30 min how to video on insulation diagrams. We've found this to be the most frequently asked question about IEC 60601. We thought we'd provide an overview of the process. If feedback is positive, we'll do more.

Registrations now open for IEC 60601 Training in October 2020

3 Mar 2020, updated 31 Mar 2020 --

Boston -- Our Training Page is now accepting registrations to our IEC 60601 training event:

  • Boston/Lowell, UMass Lowell Convention Center & Inn
  • 5 to 9 Oct 2020
  • EMC 1.5 days,
  • Safety 3.5 days.

San Francisco -- We've suspended registrations to our San Francisco event, which was anticipated from 19 to 23 Oct 2020. With the covid19 virus controls in place, we're hoping to consolidate all training participation to our Boston/Lowell, MA event. If we'd like to see a training event in San Francisco, we'll be looking at this again in June. If you're interested you can Contact Us, or Sign Up for our Mailing List.

Dublin -- We're in discussions with Irish Medtech, Skillnet to support a Safety training event in Dublin, from 8 to 10 Sep, 2 or 3 days. You can contact Jennifer McCormack, with interest and any questions, jennifer.mccormack@ibec.ie, Tel +353 1 605 1537.

Frank O'Brien among recipients of IEC 1906 Award

4 Oct 2019 -- Frank O'Brien and wife, Rita, were on hand at AAMI headquarters in Arlington, VA, on 19 Sep, for this year's US National Committee meeting where they awarded the IEC 1906 Awards to "recognize exceptional current achievements of experts". Frank won the Award for his 23 years of donating his time and expertise to the TC 62 medical electrical equipment (MEE) committee, including groups developing the standards for: general MEE, home healthcare, light ion accelerators, and robotically assisted surgical equipment.

Frank wants to thank his wife Rita, for supporting his work and travel, and his mentors though the years, including Joe Murnane (UL), Steli Loznen (Israel Testing Labs), Chuck Sidebottom (Medtronic), Dave Osborn (Philips), and Martin Schneeberg (TUV Sud). Steli and Hae Choe (AAMI) deserve a special thank you for putting my name forward.

Battery Powered EM Disturbance Requirements for Medical Equipment

21 Aug 2019 -- We've added a Part II to our battery powered equipment series, Battery powered EM Disturbance information to our Resources. This was Part I to our series, Battery powered Safety information.

Irish Medtech Ibec, Skillnet offering an IEC 60601 training course

13 Aug 2019 -- Irish Medtech Ibec is offering an IEC 60601 training course, in Dublin, on 10-11 Sep 2019. Frank O'Brien, our founder, is the instructor. More information and booking offer can be found here (link removed).

Battery Powered Safety Requirements for Medical Equipment

12 Aug 2019 -- We've added Battery powered Safety information to our Resources

ME Equipment -- smaller, faster to market, less expensive, and safe -- Clause 4.6 demystified

14 May 2019 -- We've added Clause 4.6 information to our Resources.

Specifying power supplies for MEE

3 May 2019 -- We've added Power Supplies information to our Resources

IEC 62368-1 as option for MOOP

19 Apr 2019 -- We've added IEC 62368 information to our Resources

Medical EMC Latest News

25 Feb 2019 --

IEC 60601-1-2 Edition 4.1

IEC Technical Committee 62, subcommittee 62A, Maintenance Team 23 held a week long meeting in mid February 2019. The purpose of the meeting was to discuss comments from the latest committee draft circulated and to prepare for the first of two voting documents to be submitted before the final version of Edition 4.1 is published. The most significant changes will be the addition of low frequency magnetic field testing and clarification to the Risk Management requirements in Edition 4. The expected publication date for Edition 4.1 is summer 2020.

EMC Risk Management

Plans are underway to generate a new Technical Report within the IEC 60601 family to address the non-testable aspects of EMC to address Risk Management. No schedule has been set but an estimated publication date is sometime in 2021.

New Website Design

24 Feb 2019 -- We've redesigned our website with an eye towards display compatibility for phones and tablets as well as desktops, and getting training registrations up for 2019.

We haven't transferred older news items, which we felt had become dated. Resource information, which we retained, may have new URL paths. Until search engine crawling is up to date, searches will return older obcompman.com URL paths for search results. You might find the information desired by using the obcompman.com search in upper right hand corner, which may return the new URL path. If there's a news item you're missing, Contact Us and we'll provide by email.