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.
Dates: 19 to 23 Jun 2023
Time: 9:00 to 13:15 each day, with a 15 min break.
The course is organized into 6 modules, which we'll cover over the 5 days:
A Standards & Testing
B MEE & General Philosophy
C Essential Performance & Alarms
D1 Electrical, specifying insulation diagrams
D2 Electrical, verifying insulation
E. Mechanical, Software, Thermal, Fire, Oxygen Rich
F. Liquids, Radiation, Enclosures, Components, Information for Safety
The course covers the following safety standards:
IEC 60601-1 + A1:2012 + A2:2020, ed 3.2,
Related collateral standards, Alarms -1-8, Home care -1-11, EM services -1-12, and
EU, US, and Can differences,
These process standards are covered briefly:
Risk management, ISO 14971:2019, and
Usability engineering, IEC 62366-1:2015 + A1:2020
Software development life cycle, IEC 62304:2006 + A1:2015
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
In the last couple of years we've seen the following changes to key safety standards:
2019 Risk Management edition, ISO 14971.
2020 amendment to Usability Engineering, IEC 62366-1,
2020 amendments to the Medical Electrical Equipment standards, IEC 60601 series; general -1, emc -1-2, usability -1-6, alarms -1-8, home care -1-11, and emergency services -1-12, and
2021 revision to the standard for immunity from RFID Readers, AIM 7351731
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.
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
Amendment 1:2020 to IEC 60601-1-2:2014, the EMC safety standard for Medical Electrical Equipment (with the amendment, now Edition 4.1); and
FDA recognition of AIM 7351731, Revision 3, which outlines immunity testing for Medical Electrical Equipment, due to use in proximity with devices such as RFID Readers.
You can access the document here.
IEC 60601 Training Events for 2023
Public EMC seminar in Boston area, 22 to 23 May (1.5 days) -- closed
Public Safety seminar in Boston area, 23 to 26 May 2023 (3.5 days) -- closed
Live online Safety (webinar) for Asian-Pacific time zones, 18 to 20 Jul, & 25 to 27 Jul
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.
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
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:
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, email@example.com, 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
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
ME Equipment -- smaller, faster to market, less expensive, and safe -- Clause 4.6 demystified
Specifying power supplies for MEE
IEC 62368-1 as option for MOOP
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.