What's New

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OBCM partnering with Skillnet for course, "Integrating IEC 60601 into the Design Process"

8 Jun 2023 -- OBCM is to be the instructor for an IEC 60601 course offered by Connected Health, Skillnet, tailored for Irish medical equipment manufacturers. 

The course is 3 days of content delivered on-line over 5 days.

The course is organized into 6 modules, which we'll cover over the 5 days:

The course covers the following safety standards:

These process standards are covered briefly:

Before the course, participants will receive a copy of slides with speaker notes, and a workbook with answers, which shows for 3 sample products how the requirements apply, and a test plan. After the course, participants will receive a certificate of participation.

Additional information and how to register is at Skillnet's site.

Updated Standards Related to FDA and EU MDR

19 Apr 2023

The Changes

In the last couple of years we've seen the following changes to key safety standards:

Effective Dates

These updates are included in FDA's recognized consensus standard database, and for the EU MDR begin to represent the required "generally acknowledged state of the art", as they're nearing 3 years old (in most cases the EN versions are dated 2021).

We've updated our Effective Dates guidance document to show the current effective dates for these standards. 

With the EU situation, we provide a summary and links to a number of EU Commission and MDCG documents that shed light on what your Notified Bodies will likely expect.

Impact

The changes to risk management and usability engineering will probably require some update to procedures, and records, including verification documents. 

The IEC 60601 updates generally have a minor impact on equipment design, but require updates to specified safety standards, and related test reports.

For a summary of the new EMC requirements and their impact, we have a new EMC guidance document.

What’s New for Medical EMC?

19 Apr 2023 -- We've posted a new guidance document to explain the impact of 

You can access the document here.

IEC 60601 Training Events for 2023

Gain an overview of the IEC 60601 & IEC/ISO 80601 safety standards, and their related Risk and Usability process standards. Knowledge that may help keep your medical equipment projects on track. You can get more information and register on our web pages.

The Boston EMC and Safety Boston seminars are held consecutively to facilitate attendance to both.

Register for our IEC 60601 Safety and EMC Training Webinars

17 Feb 2022 -- Based on the success of our on-line Safety Training Webinar in late 2021, we've scheduled an IEC 60601 Safety Training Webinar in May 2022. 

This training webinar is intended to help participants gain an overview of the IEC 60601 & IEC/ISO 80601 safety standards, and their related Risk and Usability process standards. Knowledge that may help keep your medical equipment projects on track.

Register for our IEC 60601 Webinar

24 Sep 2021 -- 6 sessions over 3 weeks, total 15 hours. 

Starts 30 Nov 2021, 2 pm GMT (9 am US East, 6 am US West).

Gain an overview of the IEC 60601/ISO 80601 safety standards, and their related Risk and Usability process standards. Knowledge that may help keep your medical equipment projects on track.

Presented by Frank O'Brien, who has evaluated 1000's of medical devices, participated on the TC62 committees who drafted the requirements, and has trained over 1,500 participants.

The agenda:

A. Standards & Test Reports (2 h)
B. General Philosophy (2 h)
C. Essential Performance & Alarms (3 h)
D. Electrical Basic Safety (3 h, Elec Part 1)
E. Mechanical, Thermal, Fire, Oxygen Rich Basic Safety (2 h, preceded by 1 h Elec Part 2 = 3 h)
F. Liquids, Radiation, Enclosures, Information for Safety (2 h)

Please visit our Register Now page for complete details. And pass along to any colleagues who may have interest.

IEC 60601 training videos on YouTube

10 Dec 2020 -- updated 1 May 2021

We'll be posting periodic IEC 60601 training videos on our YouTube channel. You can subscribe to our channel. Once we start, we'll be notifying those on our mailing list.

Our Oct 2020 public IEC 60601 training events are 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:

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.