AAMI – Eisner Safety Consultants

Medical Device Compliance & Certification Summit – Why It Matters?

leoeisner — Tue, 23 Dec 2025 23:30:37 +0000

Medical Device Compliance & Certification Summit – Why It Matters?

Medical device and diagnostic compliance expectations are shifting earlier in the product lifecycle. IEC 60601 and related standards are no longer something teams can “handle at test.” Regulators increasingly expect standards interpretation, risk decisions, and test strategy to be visible and justified during design reviews and technical documentation development.

This shift is showing up in real ways – deeper design reviews, tougher pre-submission questions, and increased scrutiny of how standards were applied, not just whether a final test report exists.

To address this reality, Eisner Safety Consultants (ESC) is working with Nemko to deliver a three-day, in-person Medical Device Compliance & Certification Summit focused on how standards, testing, and regulator expectations intersect in real programs.

A focused, three-day program for engineering, regulatory, and compliance teams navigating IEC 60601, IEC 61010, EMC and RF requirements, certification strategy, and regulator guidance documents across FDA, EU, and other markets.

In-Person Training & Live Workshops

February 2–4, 2026
Carlsbad Inn Beach Resort, 3075 Carlsbad Blvd, Carlsbad, CA 92008

Designed for teams preparing new medical devices or diagnostics for market, working through recurring EMC or RF failures, or tightening FDA or EU MDR technical documentation ahead of submission or surveillance review.

Registration Summit Details

Who this summit is designed for

Electrical, EMC, RF, and systems engineers
Regulatory affairs and quality professionals
Product and compliance managers
Medical device and diagnostic startups preparing first submissions
Teams facing test failures, redesigns, or certification delays

What attendees will learn

How regulators evaluate standards application, not just test outcomes
Future impacts of IEC 60601-1, 4th edition concepts on design controls
Essential Performance and its role in risk management and review discussions
How EMC and RF strategies influence certification timelines
When IEC 61010 applies to diagnostic and laboratory equipment
Cybersecurity expectations under FDA and EU MDR
How guidance documents shape FDA and EU technical file expectations

How Eisner Safety Consultants Can Help

As regulatory expectations increase, delays are often caused by unclear standards interpretation, weak traceability between design decisions and requirements, and technical documentation that does not explain why choices were made.

Eisner Safety Consultants works with medical device, diagnostics, and combination device manufacturers every day to translate IEC 60601, IEC 61010, and related standards into practical design inputs, defensible test strategies, and documentation that aligns with FDA, EU, and other regulator guidance documents.

Registration Summit Details

From Engineer To “The IEC 60601 Guy” – Project MedTech Podcast

leoeisner — Sun, 19 Oct 2025 00:04:30 +0000

Podcast Feature

From engineer to “The IEC 60601 Guy” — my story and practical tips

I joined Duane Mancini on the Project Medtech Podcast to share how I became known for IEC 60601, why the series is a roadmap you can follow, and what 4th Edition changes mean for design, QMS, and documentation.

Episode 235

Listen on Web Open Spotify

A quick personal note

Nobody starts at the top as “The IEC 60601 Guy.” My path ran through early days at NASA, many years in test labs, and deep work in standards committees. What stuck with me is simple — stay curious, do the work, and show the work. That’s how we turn a dense standard into a practical plan.

Key takeaways from the episode

On the Project Medtech Podcast with Duane Mancini, M. Sc., I shared my genesis story of how I became known as The “IEC 60601 Guy”. Duane asked me to give listeners a 101 course on the IEC 60601 series, and I explained how I strive to “de-Greek” or demystify the standard series, and gave a preview of the big shifts coming in 4th Edition.

The “big picture” structure of the general standard, collateral standards, and particular standards

How lifecycle standards (risk management, usability, software) compare to type test standards in the 60601 family

Tangible changes to watch in the upcoming 4th Edition: clearer alarm requirements and impacts on design, QMS, & documentation

Why leaning on experts (internal or external) is key to getting this right for the impacts of 4th Edition

My goal is to “de-Greek” the process and show that IEC 60601 can be a roadmap , not a riddle

Whether you’re new to standards or a seasoned MedTech veteran, this episode shows how to approach IEC 60601 as a roadmap you can follow, instead of a riddle you can never quite solve.

What peers said

“If you want to know more about IEC 60601, Leo is the resource to go to … I recommend this episode to everybody working with medical electrical equipment.”

— Beat Keller

“Great to see how you became such an expert … I hope your story inspires young professionals to invest in becoming experts themselves.”

— Ronald Boumans

“It’s amazing that you covered the difference between process and test standards — there’s still a lot of confusion out there.”

— Tibor Zechmeister

Continue the discussion on this topic on LinkedIn

How We Can Help

If your team needs help with the IEC 60601 Series, or mapping the 4th Edition into your design controls, QMS, labeling, or testing strategy, my team at Eisner Safety Consultants and I are ready to support you.

Schedule a call with me, Leo, the IEC 601 Guy

Major changes to IEC 60601-1 are closer than you think

leoeisner — Fri, 15 Aug 2025 18:53:33 +0000

Once the 4th Edition is published, redesigns and QMS updates will be far more costly.

Direct insights from someone in the development of IEC 60601-1, 4th Edition

Get an insider’s view of the upcoming changes, their real-world impact, and how to prepare, from someone directly involved in developing the standard.

Event Recap – MLVx Friday In-Focus

On Friday, August 15, the MLVx Friday In-Focus with Sean Smith brought together Leonard (Leo) Eisner, The IEC 60601 Guy, and 110+ professionals from around the globe, including the UK, Romania, US, France, Switzerland, Germany, Finland, and Pakistan, representing medtech manufacturers, regulators, test houses, and standards developers.

We focused on the impact of IEC 60601-1, 4th Edition, the global standard that defines safety and essential performance for medical electrical equipment, and what’s coming that many companies are still not prepared for.

The highlight was an impromptu expert panel with leaders in risk management, software, cybersecurity, regulatory submissions, and combination devices. Together, we tackled questions from every angle, sharing real-world insights on design, testing, and compliance challenges. The discussion showed exactly what’s possible when top experts collaborate to help the industry prepare for disruptive change.

(Full presentation available for download at the bottom of this post.)

Unlock Your IEC 60601-1 Insider Advantage

Mitigate Risks: Spot disruptive changes early, prevent costly redesigns, and align documentation ahead of competitors
Accelerated Compliance: Seamlessly integrate evolving requirements into your development pipeline
Leadership Insight: The IEC 60601 Guy and our expert team track areas of interest for your organization based on draft documents
Behind Closed Doors: Access knowledge while it’s still being developed
Ready to Leap Ahead? Let’s turn this insider pipeline into your 4th Edition fast-track

+1-503-709-8328
EisnerSafety.com
Schedule a Free 30-Minute Web Meeting

If you missed the live session, this recap and presentation will help you understand what’s coming — and more importantly, how to prepare.

MLVx Impact of IEC 60601-1 4th Ed FINAL Vers 2025-08-15 compressed for website Download

Join me for an Interactive Workshop Identifying Standards, Guidances, & Turn Standards into Your Competitive Advantage @ 10X

leoeisner — Mon, 31 Mar 2025 22:50:00 +0000

Join me, Leo Eisner, The IEC 60601 Guy, as I lead an interactive and fun workshop at the 10X Medical Device Conference in Newport Beach, Ca on May 7 – 8, 2025. Turn Medical Device Standards into Your Competitive Advantage, and discover practical strategies to leverage standards, avoid costly errors, and accelerate your product development cycle.

Don’t make the 5 costly mistakes companies make with Medical Device Standards. Learn from the IEC 60601 Guy himself.:

Late Identification of Applicable Standards: Leads to expensive redesigns and delayed timelines
Ignoring Expert Standards Guidance: Results in regulatory rejections and costly resubmissions
Unprepared Risk Management File for Testing: Risks unnecessary costs due to lack of strategic planning for compliance.
Unprepared Regulatory Submissions: Leads to costly setbacks and market-entry delays
Underestimating Education and Training: Creates knowledge gaps, increasing errors and compliance risks.

I want to thank Sean Smith and his team from 10X for all his help and dedication for putting on this event. He is doing an amazing job and please contact him if you are interested.

Need help with standards?

We provide support for your design and development process for regulatory submissions.? Eisner Safety Consultants can help by

Assisting with strategic compliance planning for your medical electrical product lines,
Providing regulatory support when FDA or a regulator asks technical questions on your submission.
Identification of applicable standards, laws, regulations, guidances, and directives up front to support your design process effectively.
Design Documentation Reviews providing expert analysis supporting the design development process to avoid unnecessary design and development delays.
We provide EU, US, and other countries regulatory requirement reviews of standards, laws, directives, and guidance.
Providing support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs, and more.
Interfacing with test houses for medical safety, EMC and arrange other testing.

Feel free to schedule a web meeting with Leo or contact us.

The most valuable asset we each bring to the table is⁉️ Our unique experiences and innovation

leoeisner — Mon, 30 Sep 2024 06:46:00 +0000

Leo Eisner, The60601Guy will be visiting London in October. You have the chance to sit down with me, The60601Guy, have a cup a coffee or a beer and talk IEC60601, design for compliance, and standards that apply to your device. I have time slots open on 7, 8, and 11 of Oct. Or join me for a dinner on the 8 or 11 Oct.

Meet me in London – I want to hear from you the week of 7 Oct. These two hour slots are limited before they are gone, 𝗯𝗼𝗼𝗸 𝗻𝗼𝘄 𝗼𝗻 𝗺𝘆 𝘀𝗽𝗲𝗰𝗶𝗮𝗹 𝗰𝗮𝗹𝗲𝗻𝗱𝗮𝗿 for 𝗺𝘆 𝗟𝗼𝗻𝗱𝗼𝗻 𝘃𝗶𝘀𝗶𝘁. I’d love to chat!

Let’s connect, and explore how we can support your company with our international team of compliance & regulatory experts from Eisner Safety Consultants. I’m eager to learn what you’re working on and how you’re driving change and innovation in the industry, and how we can support you to get you to market faster.

Let’s meet up! 𝗕𝗼𝗼𝗸 𝘁𝗶𝗺𝗲 𝗼𝗻 𝗺𝘆 𝘀𝗽𝗲𝗰𝗶𝗮𝗹 𝗰𝗮𝗹𝗲𝗻𝗱𝗮𝗿 for 𝗺𝘆 𝗟𝗼𝗻𝗱𝗼𝗻 𝘃𝗶𝘀𝗶𝘁.

Leo Eisner the “IEC 60601 Guy” co-presenter in BSI Webinar

leoeisner — Thu, 30 May 2024 18:54:07 +0000

Webinar: Leveraging the CB Scheme: A Guide for North American Medical Device Manufacturers

When: Tuesday, June 25, 2024

Time: 11:00 a.m. – 12:00 p.m. EDT

About the Event: Join BSI & Leo Eisner for an insightful webinar that explores how North American medical device manufacturers can harness the power of the CB Scheme to enhance their global market access. Leo the “IEC 60601-1 Guy” will present the significant updates introduced in the latest edition of IEC 60601-1 Ed. 3.2, which will impact medical device manufacturers.

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; training to 3rd or 4th edition; strategic planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs.

We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

What’s The Relationship of Updated IMDRF N47 & N52 to IEC 60601-1, 4th ed?

leoeisner — Thu, 16 May 2024 01:22:22 +0000

𝗕𝗥𝗘𝗔𝗞𝗜𝗡𝗚 𝗡𝗘𝗪𝗦 𝗜𝗠𝗗𝗥𝗙 𝗡𝟰𝟳 & 𝗡𝟱𝟮 recently updated to 𝗘𝗱𝗶𝘁𝗶𝗼𝗻 𝟮 – 𝗪𝗵𝗮𝘁’𝘀 𝘁𝗵𝗲 𝗿𝗲𝗹𝗮𝘁𝗶𝗼𝗻𝘀𝗵𝗶𝗽 𝘁𝗼 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭-𝟭, 𝟰𝘁𝗵 𝗲𝗱

IMDRF N47 & N52 both have been updated which will support Regulatory Submissions and Compliance Testing for the future of the IEC 60601 series including IEC 60601-1, 4^th edition. 𝗜𝗠𝗗𝗥𝗙 𝗽𝘂𝗯𝗹𝗶𝘀𝗵𝗲𝗱 two Final documents on 𝟮𝟲 𝗔𝗽𝗿𝗶𝗹 𝟮𝟬𝟮𝟰, both to Version 2:
N47 Essential Principles of Safety and Performance of Medical Devices & IVD Medical Devices, and
N52 Principles of Labeling for Medical Devices and IVD Medical Devices

The 𝗽𝘂𝗿𝗽𝗼𝘀𝗲 𝗼𝗳 𝗡𝟰𝟳 𝗴𝘂𝗶𝗱𝗮𝗻𝗰𝗲 is to provide harmonized Essential Principles that should be fulfilled in the design & manufacturing of medical devices and in vitro diagnostic (IVD) medical devices to ensure that they are safe and perform as intended. The worldwide adoption of a common set of fundamental design and manufacturing requirements for medical devices that, when met, provide assurance the device is safe and performs as intended, offers significant benefits to, among others, manufacturers, users, patients/consumers, and to Regulatory Authorities. Reducing differences between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments.

While 𝗡𝟱𝟮 𝗹𝗲𝘃𝗲𝗿𝗮𝗴𝗲𝘀 𝗼𝗻 𝗡𝟰𝟳 𝗮𝘀 𝗶𝘁’𝘀 𝗽𝘂𝗿𝗽𝗼𝘀𝗲 states this guidance is to provide globally harmonized labeling principles for medical devices, including in vitro diagnostic (IVD) medical devices, and support N47. Specifically, this document provides guidance on the content of the label, instructions for use, and information intended for the patient in order to support the safe and effective use of medical devices and IVD medical devices by their intended users.

With the 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭-𝟭, 𝟰𝘁𝗵 𝗲𝗱𝗶𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗷𝗲𝗰𝘁 underway 𝗼𝗻𝗲 𝗼𝗳 𝘁𝗵𝗲 𝗗𝗲𝘀𝗶𝗴𝗻 𝗦𝗽𝗲𝗰𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 – 𝗚𝗼𝗮𝗹 𝟲 of the 𝗔𝗿𝗰𝗵𝗶𝘁𝗲𝗰𝘁𝘂𝗿𝗲 𝗦𝗽𝗲𝗰𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻:

“Establish a policy relating requirements of the IEC 60601 series to the IMDRF essential principles and labelling principles.”
𝗚𝗼𝗮𝗹 𝟲 𝗶𝘀 𝗱𝗶𝗿𝗲𝗰𝘁𝗹𝘆 𝗿𝗲𝗹𝗮𝘁𝗲𝗱 𝘁𝗼 𝘁𝗵𝗲 𝗜𝗠𝗗𝗥𝗙 𝗱𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝘀 𝗡𝟰𝟳 𝗮𝗻𝗱 𝗡𝟱𝟮 𝘄𝗵𝗶𝗰𝗵 𝘄𝗲𝗿𝗲 𝗿𝗲𝗰𝗲𝗻𝘁𝗹𝘆 𝘂𝗽𝗱𝗮𝘁𝗲𝗱 𝘁𝗼 𝗘𝗱𝗶𝘁𝗶𝗼𝗻 𝟮.

The Architecture Spec states:

“It is the 𝗽𝗼𝗹𝗶𝗰𝘆 𝗼𝗳 𝗜𝗘𝗖/𝗧𝗖 𝟲𝟮 𝘁𝗼 𝗶𝗻𝗰𝗹𝘂𝗱𝗲 𝗮𝗻 𝗶𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝘃𝗲 𝗮𝗻𝗻𝗲𝘅 𝗺𝗮𝗽𝗽𝗶𝗻𝗴 the 𝗿𝗲𝗹𝗮𝘁𝗶𝗼𝗻𝘀𝗵𝗶𝗽 𝘁𝗼 𝘁𝗵𝗲 𝗜𝗠𝗗𝗥𝗙 𝗘𝗦𝗦𝗘𝗡𝗧𝗜𝗔𝗟 𝗣𝗥𝗜𝗡𝗖𝗜𝗣𝗟𝗘𝗦 𝗮𝗻𝗱 𝗟𝗔𝗕𝗘𝗟𝗟𝗜𝗡𝗚 𝗣𝗥𝗜𝗡𝗖𝗜𝗣𝗟𝗘𝗦 in 𝗲𝗮𝗰𝗵 𝗼𝗳 𝘁𝗵𝗲 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 𝗼𝗳 𝘁𝗵𝗲 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭 𝗦𝗘𝗥𝗜𝗘𝗦.”
This is a goal of IEC/TC 62. For the IEC 60601-1, 4^th edition project all Working Groups (WG’s) are tasked to do this work in their WG’s. There are 12 WG’s split up by hazards. In the future all standards that are developed by IEC/TC 62 should also follow this goal.
Another part of Goal 6 from the Architecture Spec states:
“The 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 𝗶𝗻 𝗺𝗮𝗻𝘆 𝗼𝗳 𝘁𝗵𝗲 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭 𝗦𝗘𝗥𝗜𝗘𝗦 are 𝗶𝗻𝘁𝗲𝗻𝗱𝗲𝗱 𝘁𝗼 𝗳𝘂𝗹𝗳𝗶𝗹 𝘀𝗼𝗺𝗲 𝗼𝗳 𝘁𝗵𝗲 𝗽𝗿𝗶𝗻𝗰𝗶𝗽𝗹𝗲𝘀 set out 𝗶𝗻 𝘁𝗵𝗲 𝗜𝗠𝗗𝗥𝗙 𝗴𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗱𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝘀. To facilitate the usage of the documents in the IEC 60601 SERIES for conformity assessment purposes by the AUTHORITIES HAVING JURISDICTION, it is important to 𝗰𝗹𝗲𝗮𝗿𝗹𝘆 𝗶𝗻𝗱𝗶𝗰𝗮𝘁𝗲 𝘄𝗵𝗶𝗰𝗵 𝗜𝗠𝗗𝗥𝗙 𝗽𝗿𝗶𝗻𝗰𝗶𝗽𝗹𝗲𝘀 𝗮𝗿𝗲 𝗰𝗼𝘃𝗲𝗿𝗲𝗱 𝗯𝘆 𝘄𝗵𝗶𝗰𝗵 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 𝗶𝗻 𝗮 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱 𝗶𝗻 𝘁𝗵𝗲 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭 𝗦𝗘𝗥𝗜𝗘𝗦.”
This 𝗚𝗼𝗮𝗹 𝟲 𝘀𝘂𝗽𝗽𝗼𝗿𝘁𝘀 𝘁𝗵𝗲 𝗜𝗠𝗗𝗥𝗙’𝘀 𝗰𝗼𝗻𝗰𝗲𝗽𝘁 𝗼𝗳 𝗲𝗹𝗶𝗺𝗶𝗻𝗮𝘁𝗶𝗻𝗴 𝗱𝗶𝗳𝗳𝗲𝗿𝗲𝗻𝗰𝗲𝘀 𝗯𝗲𝘁𝘄𝗲𝗲𝗻 𝗷𝘂𝗿𝗶𝘀𝗱𝗶𝗰𝘁𝗶𝗼𝗻𝘀 which 𝗱𝗲𝗰𝗿𝗲𝗮𝘀𝗲𝘀 𝘁𝗵𝗲 𝗰𝗼𝘀𝘁 𝗼𝗳 𝗴𝗮𝗶𝗻𝗶𝗻𝗴 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 from the various AUTHORITIES HAVING JURISDICTION (AHJ) and allows 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀 𝗲𝗮𝗿𝗹𝗶𝗲𝗿 𝗮𝗰𝗰𝗲𝘀𝘀 𝘁𝗼 𝗻𝗲𝘄 𝘁𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝗶𝗲𝘀 𝗮𝗻𝗱 𝘁𝗿𝗲𝗮𝘁𝗺𝗲𝗻𝘁𝘀. This is a positive impact on patients and also makes for an easier process for the manufacturers and for the AHJ’s, as well.

When IEC TC 62/SC 62A/WG 39 met in Arlington, VA on 1- 2 May 2024 this was brought up during the meeting, as this is an important issue that needs to be addressed during the IEC 60601-1, 4^th edition project. One aspect WG 39 is dealing with is “Information to be supplied by the manufacturer” (i.e. Labeling). This is the IEC 60601-1, 4^th edition WG that I am a co-convener of. There are lots of changes happening in the standards and regulatory world around labeling and we are working hard to keep informed on all these changes that will impact this project. 𝗦𝘁𝗮𝘆 𝘁𝘂𝗻𝗲𝗱 𝗳𝗼𝗿 𝗺𝗼𝗿𝗲 𝘂𝗽𝗱𝗮𝘁𝗲𝘀

We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

IEC 60601-1 4th Ed Initial Launch: Positive Impacts Healthcare Standardization

leoeisner — Mon, 06 May 2024 04:46:53 +0000

Last week, 29 Apr – 3 May 2024, marked a significant milestone for the advancement in the world of patient safety and healthcare. The IEC TC 62/SC 62A convened its IEC 60601-1, 4th edition project kick-off meeting at AAMI in Arlington, Virginia. More than 200 experts from all corners of the globe attended in person, contributing to an inspiring and impactful week-long meeting.

The focus of this meeting was “level setting” all the parties on the development of requirements for the 4th edition of IEC 60601-1, which sets safety requirements for medical electrical equipment (also known as active medical devices). Twelve working groups (WGs) gathered to strategize their efforts, guided by the Design Specification for the 4th edition and the Architecture Specification. The first day was set with training to help all parties get an understanding of project requirements and ask questions based on the Design Specification and the Architecture Specification. The next 3 days focused on the 12 WGs working on their strategies for the start of the project and the plans to move forward. The last day was a wrap-up and getting feedback on how to improve the process with lots of great discussion from the week.

An Advisory Group (AG 50) is used to collaborate with all 12 WG co-convenors and secretaries, and IEC SC 62A officers ensuring the overall success of the project.

As a co-convenor for WG39, which addresses User Interfaces (Including information provided by the manufacturer, Alarm Systems and Usability Engineering Process), I am honored to be part of this excursion in the development of this standard for the support of the healthcare industry for the next edition. Alongside my co-convener, Martin Stangenberg, we led discussions and consensus-building within our WG. Our WG is comprised of amazing experts. We had over 30 experts in the room including regulators from 5 countries; test houses; usability, labeling, alarm systems, and robotics experts. We had over half of our experts from the whole WG in attendance at the meeting. Our responsibilities include coordinating with other experts to develop basic safety and essential performance requirements related to User Interface Aspects Hazards for our part of the standard. Each WG is working on a different set of hazards as described in the post “IEC 60601-1, 4th ed. — Where do we stand?“.

WG 39 Group Photo

As an expert on WG37, I also spent part of the week with WG 37 developing requirements related to general issues concerning underlying concepts including basic safety & essential performance, single fault safety, type testing. Correlation with processes relevant for IEC 60601-1 defined by other process standards (e.g., risk management) for IEC 60601-1, 4^th ed.

It was great to meet all the new people and see them get involved for the first time in the standardization process as well as work with familiar faces I have worked with for many years. It is a well-rounded group of individuals, supporting this next edition, with many different perspectives but with the mindset to provide the patient with a safe product.

Closing Meeting

I extend my appreciation to all who have made this happen — the officers, the design specification and architecture specification teams (a long road to get here), my mentors, and all the national committee experts for coming together in this massive effort. Now the real work of the experts in the WGs begins….

We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

Stop Waiting to Join New WGs for IEC 60601-1, 4th ed.

leoeisner — Sun, 14 Jan 2024 21:29:36 +0000

Stop waiting time – take action and join a Working Group for IEC 60601-1, 4th ed. project

This is a follow-up to IEC 60601-1, 4th Ed. – Time to Get Involved Is Now! and IEC 60601-1, 4th Edition Project – Where Do We Stand? – UPDATED 30 Nov 2023. 3 Weeks after the initial Nomination of experts and Co-conveners went out on 22 Dec 2023, the last 2 Working Group (WG) Q documents were released on 12 Jan 2024 for WG43 Mechanical Hazards and WG46 Ionizing Hazards. For WG43 & WG46 the Q document nomination period ends on 23 Feb 2024.

Having new people (young and old alike) interested in joining all the new WGs (12 in total) who have the technical experience and expertise for the WG subject matter (not all subjects within a WG but some and each National Committee (NC) decides on its selection process and criteria).

Some NCs may accept experts after the applicable Q documents close (no guarantee which countries) but if you wait too long you won’t be able to join the kickoff meeting for the IEC 60601-1, 4^th ed. project. The meeting will be held at AAMI in the US (Virginia) the week of 29 April – 3 May 2024. This is a closed meeting – you have to be nominated as an NC expert for a specific WG.

So, stop waiting to become an expert on 1 of the 12 WGs for IEC 60601-1, 4th ed. Now is the time to take action & contact your National Committee to get nominated as an expert.

I have updated the table in the IEC 60601-1, 4th Ed. – Time to Get Involved Is Now! post to include the two new WG Q documents (WG43 & WG46) just released so all in one place – below. The two previous posts discuss nominations of experts and considerations of being an expert. Please review before putting your name in for nomination.

4th Ed. WG	WG Title	WG Task/Description	Proposed Nomination of Co-Convenors	Call for Convenors & Experts Document
WG 37	General requirements	Develop requirements related to general issues with respect to underlying concepts (e.g., basic safety/essential performance, single fault safety, type testing), correlation with processes relevant for the IEC 60601-1 defined by other process standards (e.g., risk management) for the 4th edition of IEC 60601-1.	Mr. Richard Scott (UK) & Mr. Jos Van Vroonhoven (NL)	62A/1544/Q
WG 38	Physical environment hazards	Develop requirements to address safety issues due to specific environmental conditions, including power supply for the 4^th edition of IEC 60601-1.	Mr. Michel Brossoit (CA) & Mr. Brodie Pedersen (US)	62A/1545/Q
WG 39	User interface aspects (including all labelling and information to be provided)	Develop requirements to address safety issues related to user interfaces including marking, indications, accompanying information, alarm systems and usability for the 4th edition of IEC 60601-1.	Mr. Leo Eisner (US) & Mr. Martin Stangenberg (DE)	62A/1549/Q
WG 40	Materials hazards	Develop requirements to address safety issues related to interferences of materials of MEE/MES with users, patients, used substances, including cleaning, disinfection, sterilization for the 4th edition of IEC 60601-1.	No co-convenors nominated.	62A/1541/AC
WG 41	PEMS (e.g., SaMD (Software as a medical device), SiMD (Software in a medical device), firmware, software, apps, OS, drivers) related hazards	Develop requirements to address hazards related to software driven functionality of MEE/MES for the 4th edition of IEC 60601-1.	Mr. Jullian Goldman (US) & Ms. Patty Krantz-Zuppan (US)	62A/1550/Q
WG 42	Electrical hazards	Develop requirements to address safety issues related to electricity for the 4th edition of IEC 60601-1.	Mr. Alex Grob (US) & Mr. Martin Schneeberg (DE)	62A/1547/Q
WG 43	Mechanical hazards	Develop requirements to address safety issues related to mechanics, including acoustic and pneumatic energy and vibration energy for the 4th edition of IEC 60601-1.	Ms. Pamela Gwynn (US) & Mr. Roland Hans (DE)	62A/1552/Q
WG 44	Thermal and fire hazards	Develop requirements to address safety issues related to thermal effects caused by MEE/MES and to fire in MEE or MES for the 4th edition of IEC 60601-1.	Mr. Andreas Nilsson (NO) & Mr. Ayub Yancheshmeh (CA)	62A/1548/Q
WG 45	Optical radiation (visible, UV and IR) hazards	Develop requirements to address safety issues related to (visible radiation, UV and or IR) for the 4th edition of IEC 60601-1.	Mr. Winn Henderson (US) & Ms. Yaqing Liu (US)	62A/1546/Q
WG 46	Ionizing radiation hazards	Develop requirements to address safety issues related to ionizing radiation for the 4th edition of IEC 60601-1.	Mr. Jan Jans (NL) & Mr. Damien Kopyto (DE)	62A/1554/Q
WG 47	Electromagnetic exposure hazards (not optical or ionizing but including SAR)	Develop requirements to address safety issues related to radiation (not optical or ionizing radiation hazards but including SAR) for the 4th edition of IEC 60601-1.	No co-convenors nominated.	62A/1541/AC
WG 48	Electromagnetic disturbances hazards (including coexistence) hazards	Develop requirements to address safety issues related to electromagnetic emissions or electromagnetic immunity, (including wireless coexistence) for the 4th edition of IEC 60601-1.	Mr. Harald Buchwald (DE) & Mr. Curt Sponberg (US)	62A/1551/Q

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic compliance planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs.

We work with many test labs for Medical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

IEC 60601-1, 4th Ed. – Time to Get Involved Is Now!

leoeisner — Thu, 28 Dec 2023 05:19:45 +0000

We need young(er) and experienced professionals to join in the development of IEC 60601-1, 4th ed. for the future success of medical electrical equipment standards development.

This is a follow-up to the original post of IEC 60601-1, 4th Edition Project – Where Do We Stand? – UPDATED 30 November

As I said in a LinkedIn Post conversation with Beat Keller …we need bodies … younger bodies… but I would like to amend this that we also need experienced professionals to get involved in the development of the 4th edition of IEC 60601-1 as our whole Technical Committee 62 (IEC TC62), which is the “mothership” for all things IEC 60601-1 titled “Medical equipment, software, and systems”, is a …graying society this group of standards writers I would say (my personal opinion). To see the conversation thread see the links below (order of conversation):

The Q doc 62A/1528/Q closed on 8 Dec 2023 with all the P-member National Committees (NC’s) voting positively. A total of 35 NC’s voted and they were all positive votes, some provided feedback. All 27 P-members – participating NC’s voted. There were 15 O-members observing NCs that didn’t vote.

The big news is that for 10 of the 12 WG’s … multiple documents (were) released 22 Dec 2023 announcing a call for experts & a vote on nomination of convenors.

The big news is that for 10 of the 12 Working Groups (WG’s) noted in the Design Specification for the 4th ed. of IEC 60601-1 (free download) there were multiple documents released 22 Dec 2023 announcing a call for experts and a vote on the nomination of convenors. Below is a table with all the details. The end of the voting period for these documents is 2 Feb 2023. You’ll want to submit your name thru your National Committee (NC) to become an expert on a WG almost immediately as the voting period depending on your NC could end 1 week to several weeks prior to the close date of the vote. So, if you want to become an expert with one of the 10 WG’s get your name in through your NC. See the previous post, mentioned above, for more details. If you are a NC member please support my nomination for WG39 User interface aspects (including all labelling & info to be provided) as a Co-Convenor. There should be one or two more call for experts and nomination of convenors documents coming out soon (probably early 2024), with a 6 week voting period. This is also noted in the below table.

4th Ed. WG	WG Title	WG Task/Description	Proposed Nomination of Co-Convenors	Call for Convenors & Experts Document
WG 37	General requirements	Develop requirements related to general issues with respect to underlying concepts (e.g., basic safety/essential performance, single fault safety, type testing), correlation with processes relevant for the IEC 60601-1 defined by other process standards (e.g., risk management) for the 4th edition of IEC 60601-1.	Mr. Richard Scott (UK) & Mr. Jos Van Vroonhoven (NL)	62A/1544/Q
WG 38	Physical environment hazards	Develop requirements to address safety issues due to specific environmental conditions, including power supply for the 4^th edition of IEC 60601-1.	Mr. Michel Brossoit (CA) & Mr. Brodie Pedersen (US)	62A/1545/Q
WG 39	User interface aspects (including all labelling and information to be provided)	Develop requirements to address safety issues related to user interfaces including marking, indications, accompanying information, alarm systems and usability for the 4th edition of IEC 60601-1.	Mr. Leo Eisner (US) & Mr. Martin Stangenberg (DE)	62A/1549/Q
WG 40	Materials hazards	Develop requirements to address safety issues related to interferences of materials of MEE/MES with users, patients, used substances, including cleaning, disinfection, sterilization for the 4th edition of IEC 60601-1.	No co-convenors nominated.	62A/1541/AC
WG 41	PEMS (e.g., SaMD (Software as a medical device), SiMD (Software in a medical device), firmware, software, apps, OS, drivers) related hazards	Develop requirements to address hazards related to software driven functionality of MEE/MES for the 4th edition of IEC 60601-1.	Mr. Jullian Goldman (US) & Ms. Patty Krantz-Zuppan (US)	62A/1550/Q
WG 42	Electrical hazards	Develop requirements to address safety issues related to electricity for the 4th edition of IEC 60601-1.	Mr. Alex Grob (US) & Mr. Martin Schneeberg (DE)	62A/1547/Q
WG 43	Mechanical hazards	Develop requirements to address safety issues related to mechanics, including acoustic and pneumatic energy and vibration energy for the 4th edition of IEC 60601-1.	No Call for experts or nomination of co-convenors sent yet. Expect by sometime early Jan 2024.	Not issued yet
WG 44	Thermal and fire hazards	Develop requirements to address safety issues related to thermal effects caused by MEE/MES and to fire in MEE or MES for the 4th edition of IEC 60601-1.	Mr. Andreas Nilsson (NO) & Mr. Ayub Yancheshmeh (CA)	62A/1548/Q
WG 45	Optical radiation (visible, UV and IR) hazards	Develop requirements to address safety issues related to (visible radiation, UV and or IR) for the 4th edition of IEC 60601-1.	Mr. Winn Henderson (US) & Ms. Yaqing Liu (US)	62A/1546/Q
WG 46	Ionizing radiation hazards	Develop requirements to address safety issues related to ionizing radiation for the 4th edition of IEC 60601-1.	No Call for experts or nomination of co-convenors sent yet. Expect by sometime early Jan 2024.	Not issued yet
WG 47	Electromagnetic exposure hazards (not optical or ionizing but including SAR)	Develop requirements to address safety issues related to radiation (not optical or ionizing radiation hazards but including SAR) for the 4th edition of IEC 60601-1.	No co-convenors nominated.	62A/1541/AC
WG 48	Electromagnetic disturbances hazards (including coexistence) hazards	Develop requirements to address safety issues related to electromagnetic emissions or electromagnetic immunity, (including wireless coexistence) for the 4th edition of IEC 60601-1.	Mr. Harald Buchwald (DE) & Mr. Curt Sponberg (US)	62A/1551/Q

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs.

We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.