Single Fault Condition – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Sun, 19 Oct 2025 00:04:30 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png Single Fault Condition – Eisner Safety Consultants https://eisnersafety.com 32 32 From Engineer To “The IEC 60601 Guy” – Project MedTech Podcast https://eisnersafety.com/2025/10/19/from-engineer-to-the-iec-60601-guy-project-medtech-podcast/?utm_source=rss&utm_medium=rss&utm_campaign=from-engineer-to-the-iec-60601-guy-project-medtech-podcast Sun, 19 Oct 2025 00:04:30 +0000 https://eisnersafety.com/?p=8354
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

Project Medtech Podcast Episode 235 – Leo Eisner
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

]]> 🎥 IEC 60601-1 4th Edition: Design Controls And QMS Impacts You Need To Know 📣📣 https://eisnersafety.com/2025/08/25/%f0%9f%8e%a5-iec-60601-1-4th-edition-design-controls-and-qms-impacts-you-need-to-know-%f0%9f%93%a3%f0%9f%93%a3/?utm_source=rss&utm_medium=rss&utm_campaign=%25f0%259f%258e%25a5-iec-60601-1-4th-edition-design-controls-and-qms-impacts-you-need-to-know-%25f0%259f%2593%25a3%25f0%259f%2593%25a3 Mon, 25 Aug 2025 09:31:00 +0000 https://eisnersafety.com/?p=7868

Impacts on IEC 60601-1, 4th Ed. – Webinar Recap and Industry Reactions

Insights from 110+ MedTech professionals on the upcoming 4th Edition and its impact on design controls, QMS, and labeling.

On August 15, 2025, I had the privilege of presenting the Impacts on IEC 60601-1, 4th Edition webinar as part of MLVx Friday In-Focus. The turnout was incredible, with more than 110 MedTech professionals from around the world joining. Startups, SMEs, large manufacturers, test labs, and regulators were all represented.

We unpacked the drivers and major changes in the upcoming 4th Edition, and the discussion didn’t stop when the webinar ended. Some of the most valuable insights came afterward in the LinkedIn conversations that followed.

👉 See the replay post and comments here on LinkedIn
👉 And the prior post: Major changes to IEC 60601-1, 4th Ed. are closer than you think

What the Industry Is Talking About

From the comments and follow-up conversations, four major themes stood out:

  • SME vs Large Corp Burden – Smaller companies worry the 4th Edition requirements could hit them harder than large corporations with more resources.
  • National & International Committee Involvement – Many are realizing that participating in standards development, even at the national level, gives manufacturers a seat at the table. Being involved internationally is even more powerful if you can swing it.
  • Rationale Behind Requirements – The Design Specification requires a rationale for each requirement of the standard. This is not fully addressed in Ed. 3.2, so the change should help improve industry understanding of the standard going forward.
  • Impacts on Design Controls, QMS, and Labeling – These changes are not just “paper exercises.” They will reshape how manufacturers approach design controls, QMS integration, and labeling processes across the entire product lifecycle.

Replay Video

If you missed the live session or want to revisit the details, here’s the full webinar replay:

👉 Download the slides here

Why This Matters

As the IEC 601 Guy, I’ve been deeply involved in the development of IEC 60601-1, not just for this edition but also for the previous edition. The 4th Edition is shaping up to be one of the most impactful yet, especially in how it connects to design controls, supplier oversight, and QMS processes.

Conversations like these are important because they highlight the real-world concerns of manufacturers, regulators, and test labs. They help ensure implementation of the standard is proactive, not reactive.

How We Can Help

If your team needs help mapping these 4th Edition changes into your design controls, QMS, or testing strategy, my team at Eisner Safety Consultants and I are here to support you.

🔗 Schedule a call with me, Leo, the IEC 601 Guy. My team & I are here to support your needs.

Keep the Conversation Going

Standards only evolve when industry voices are active. I encourage you to:

Together, we can make sure these changes lead to safer devices, smoother regulatory pathways, and stronger compliance strategies.

]]> 🎩 Get your reviewer’s hat on – IEC 60601-1, 4th Edition Draft Fragments Have Dropped‼️ 🚀 https://eisnersafety.com/2025/06/28/%f0%9f%8e%a9-get-your-reviewers-hat-on-iec-60601-1-4th-edition-draft-fragments-have-dropped%e2%80%bc%ef%b8%8f-%f0%9f%9a%80/?utm_source=rss&utm_medium=rss&utm_campaign=%25f0%259f%258e%25a9-get-your-reviewers-hat-on-iec-60601-1-4th-edition-draft-fragments-have-dropped%25e2%2580%25bc%25ef%25b8%258f-%25f0%259f%259a%2580 Sat, 28 Jun 2025 01:09:39 +0000 https://eisnersafety.com/?p=7826


Posted on LinkedIn June 19, 2025. Updated with extra blog content June 25, 2025.

Over the last two weeks – and with a Friday night (6/20/25 Geneva time – late) finale still to come – we’ve seen CD1s and CD2 (WG 47 ONLY) fly out for Fragments 5, 6, 7, 8, 10, 11, and 12 from WG 41 through WG 48, but for WG 45.

This is not just standards spring cleaning – these are foundational changes to the IEC 60601-1 General Standard, folding the Collateral standards into the core. If you have medical electrical equipment, medical electrical systems or software SaMD or SiMD you need to be aware of these changes. If you’re a manufacturer, test lab, trade association, Notified Body, Regulator or other interested party who owns a risk file… you need to review this.

These fragments cover hazards related to: • Electrical, mechanical, thermal, and fire • Software & PEMS (SaMD, SiMD, firmware, OS…) • EM Disturbance, wireless coexistence, ionizing radiation, and electromagnetic exposure (EMF)

🕐 The International comment deadlines start closing August 29th, with more due by September 12th. National deadlines close much sooner (does your summer holiday schedule conflict?🍹🏝)

📎 Don’t wait for the FDIS – get involved now or get caught off guard later.


👉 Read the full breakdown of all Working Groups, due dates, and what you should do now:

Here’s the who’s who of the Working Groups behind the fragments with CD1 to issue 20 July:

• WG 41 – PEMS (e.g., SaMD (Software as a medical device), SiMD (Software in a medical device), firmware, software, apps, OS, drivers) related hazards 🔗 WG 41 link

• WG 42 – Electrical hazards 🔗 WG 42 link

• WG 43 – Mechanical hazards 🔗 WG 43 link

• WG 44 – Thermal and fire hazards 🔗 WG 44 link

Other Fragments CD1s & CD2 have recently published – clock ticking 🕰 to get your comments in:

• Fragment 11 – WG 47: Electromagnetic exposure hazards (not optical or ionizing but including SAR) 🔗 WG 47 link CD2, closes 29 August

• Fragment 10 – WG 46: Ionizing radiation hazards 🔗 WG 46 link CD1, closes 5 September

• Fragment 12 – WG 48: Electromagnetic disturbances (including wireless coexistence) 🔗 WG 48 link CD1, closes 5 September

The early pack of CD1 Fragments released late last year

Fragments 1–4 and 11 from WG 37–40 & WG 47 were released as CD1 back on December 6, 2024, with comments closing February 28, 2025. You can still access them if you’re a National Committee member for SC62A or a WG participant. If not, consider joining — this is a major transformation, and early awareness = better preparation. 🔗 Access link

Here’s a handy summary table of the IEC 60601 Fragments, their WG #s, their titles, the issue & close dates & more.

Who Should Be Reviewing

  • Design and Systems engineers
  • Risk management experts/leaders
  • Electrical & mechanical designers
  • Software designers (SaMD/SiMD, firmware, OS)
  • EMC/EMF compliance leads
  • Compliance engineers
  • Regulatory and quality teams
  • Usability & human factors engineers
  • Test labs
  • Trade Associations
  • Regulators
  • Notified Bodies
  • Other Interested Parties

✅ What You Need to Do

  1. Review the Drafts & the 4th ed. Design & Architecture Specs Now • Assign key experts by hazard/WG • Map against your design controls: Design Spec • Understand the architecture spec: Architecture Spec
  2. Track IEV Part 880 Terms • Stay aligned with the evolving definitions: Terms & Definitions
  3. Analyze Impact to Products • Run gap assessments • Identify implications for design, testing, and documentation
  4. Submit Comments • Through your National Committees (ANSI, BSI, DIN, etc.) • Clear, technically sound feedback = meaningful influence
  5. Update Design & Risk Inputs • Don’t wait for the final version to start aligning
  6. Integrate Into Product Roadmaps • Work with R&D, QA/RA, and exec sponsors • Flag projects needing early adaptation
  7. Engage the Right Experts • Join WGs or partner with someone who’s inside (👋) • Stay active – your input now shapes what becomes final
  8. Invest in Training • Get smart now to avoid surprises later

📎 Don’t wait for the FDIS – get involved now or get caught off guard later.

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.

]]> Join me for an Interactive Workshop Identifying Standards, Guidances, & Turn Standards into Your Competitive Advantage @ 10X https://eisnersafety.com/2025/03/31/join-me-for-an-interactive-workshop-identifying-standards-guidances-turn-standards-into-your-competitive-advantage-10x/?utm_source=rss&utm_medium=rss&utm_campaign=join-me-for-an-interactive-workshop-identifying-standards-guidances-turn-standards-into-your-competitive-advantage-10x Mon, 31 Mar 2025 22:50:00 +0000 https://eisnersafety.com/?p=7796

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 https://eisnersafety.com/2024/09/30/the-most-valuable-asset-we-each-bring-to-the-table-is%e2%81%89%ef%b8%8f-our-unique-experiences-and-innovation/?utm_source=rss&utm_medium=rss&utm_campaign=the-most-valuable-asset-we-each-bring-to-the-table-is%25e2%2581%2589%25ef%25b8%258f-our-unique-experiences-and-innovation Mon, 30 Sep 2024 06:46:00 +0000 https://eisnersafety.com/?p=7706

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.

]]> Time and Regulators Wait for No One – Free Presentation https://eisnersafety.com/2024/09/28/time-and-regulators-wait-for-no-one-free-presentation/?utm_source=rss&utm_medium=rss&utm_campaign=time-and-regulators-wait-for-no-one-free-presentation Sat, 28 Sep 2024 13:03:00 +0000 https://eisnersafety.com/?p=7700

Free presentation in London 🇬🇧🎡🏰 — With Leo Eisner, The60601Guy, & Ian Sealey

𝗪𝗵𝗮𝘁’𝘀 𝗼𝗻 𝘁𝗵𝗲 𝗺𝗲𝗻𝘂🍰?

• Some 𝗳𝘂𝘁𝘂𝗿𝗲 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 of IEC60601-1 , 4th being considered you 𝙢𝙖𝙮 𝙣𝙤𝙩 𝙚𝙭𝙥𝙚𝙘𝙩:
Gas Pathways,
Cleaning,
Disinfection,
AI/ML,
Voice Input/Output,
Adhesives for Applied Parts,
PPE,
and so much more….

• IEC60601-1 , 4th Ed.
• Applicable Standards
• Future Proofing Test Plans

IEC 60601-1, 4th edition is currently in development and there are some SIGNIFICANT changes underway.

Ian Sealey, Michael Kipping, James Pink and I, Leonard (Leo) Eisner, The60601Guy, will be discussing the changes, indicative timescales, and how to plan for them.

𝗪𝗵𝗲𝗻, 𝘄𝗵𝗲𝗿𝗲, 𝗵𝗼𝘄:
7 𝘖𝘤𝘵𝘰𝘣𝘦𝘳 2024
𝘊𝘭𝘢𝘺𝘵𝘰𝘯 𝘏𝘰𝘵𝘦𝘭 𝘊𝘩𝘪𝘴𝘸𝘪𝘤𝘬
𝘈𝘳𝘳𝘪𝘷𝘢𝘭 𝘧𝘳𝘰𝘮 𝟱:𝟬𝟬𝙥𝙢
𝘚𝘵𝘢𝘳𝘵 𝟱:𝟯𝟬𝙥𝙢
𝘌𝘯𝘥 𝟴:𝟰𝟱𝙥𝙢
𝙉𝙚𝙩𝙬𝙤𝙧𝙠𝙞𝙣𝙜 𝙖𝙣𝙙 𝙙𝙧𝙞𝙣𝙠𝙨 🍺 afterwards

TICK TOCK ⏰ 🧨 – Time is starting to run out for signing up for this event. If you wait too long there won’t be room so sign up now before we fill up. Don’t wait tooooooo long and miss this great opportunity to learn from experts.

Register by using our Contact form, send Leo an email (go to bottom of page) or send Leo a LinkedIn message via his profile.

Join the conversation on the LinkedIn Post and leave a comment.

]]> Join Leo Eisner In The Next Let’s Talk Risk Episode https://eisnersafety.com/2024/08/30/join-leo-eisner-in-the-next-lets-talk-risk-episode/?utm_source=rss&utm_medium=rss&utm_campaign=join-leo-eisner-in-the-next-lets-talk-risk-episode Fri, 30 Aug 2024 21:34:03 +0000 https://eisnersafety.com/?p=7674

I'm excited to be joining this event with Naveen Agarwal, Ph.D. on the next Let's Talk Risk episode on Sept 6, 11:00 -11:30AM EDT our discussions I'm sure will be interesting talking about my work in the development of 4th ed of IEC 60601-1 and so much more.

Naveen likes to talk about Guest Speaker's career's and how they got to where they are. So, it is possible this topic may come up. You can see much of my career information by going to Leo Eisner's LinkedIn Profile.

]]>

I’m excited to be joining this event with Naveen Agarwal, Ph.D. on the next Let’s Talk Risk episode on Sept 6, 11:00 -11:30AM EDT our discussions I’m sure will be interesting talking about my work in the development of 4th ed of IEC 60601-1 and so much more.

Naveen likes to talk about Guest Speaker’s career’s and how they got to where they are. So, it is possible this topic may come up. You can see much of my career information by going to Leo Eisner’s LinkedIn Profile.

Need help with 60601 series standards 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. Eisner Safety Consultants team of experts also provides support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs and more. He team includes experts on additional standards committees and we all talk to the regulators regularly. We’re here 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 web meeting with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

]]> Free Presentation in London Oct 7 On IEC 60601-1, 4th Ed. and Meet with Leo Eisner in London https://eisnersafety.com/2024/08/29/free-presentation-in-london-oct-7-on-iec-60601-1-4th-ed-and-more-with-leo-eisner-and-ian-sealey/?utm_source=rss&utm_medium=rss&utm_campaign=free-presentation-in-london-oct-7-on-iec-60601-1-4th-ed-and-more-with-leo-eisner-and-ian-sealey Thu, 29 Aug 2024 16:47:52 +0000 https://eisnersafety.com/?p=7641

What’s on the menu🍰?

Where are we headed with 4th Ed.?
Structure changes;
Project timeline: and
Critical documents

Leo Eisner, the “IEC 60601 Guy”, of Eisner Safety Consultants will be your guide

What to do in the meantime?
Select applicable and normative standards for testing; and
How to set up a solid future-proof test plan

Ian Sealey of Vertexian will explain it

Clayton Hotel Chiswick
Arrive 5:15 PM
Starts 5:30 PM sharp
Ends 8:45 PM

Networking and meet for drinks afterwards

]]>

What’s on the menu🍰?

Where are we headed with 4th Ed.?
Structure changes;
Project timeline: and
Critical documents

Leo Eisner, the “IEC 60601 Guy”, of Eisner Safety Consultants will be your guide

What to do in the meantime?
Select applicable and normative standards for testing; and
How to set up a solid future-proof test plan

Ian Sealey of Vertexian will explain it

When, Where, How:

7 October 2024

Clayton Hotel Chiswick
Arrive 5:00 PM
Starts 5:30 PM
Ends 8:45 PM

Networking and meet for drinks afterwards

Register by either using our Contact form or send Leo a LinkedIn message via his profile.

If you would like to meet with Leo during the week of 7 Oct in London please contact him to schedule this rare opportunity.

Presenters Background:

Leo is the founder and principal compliance and regulatory consultant of Eisner Safety Consultants (ESC), ESC provides the medical device industry (from SME’s to Fortune 500’s) with product safety compliance & regulatory support focused on:

  • design for compliance to IEC 60601 series of standards;
  • design reviews against applicable requirements;
  • identification of applicable standards, laws, regulations, directives and guidances;
  • labeling reviews;
  • support with test labs;
  • training

Leo’s leadership and commitment in the standards development process runs deep and over many years including his involvement in numerous IEC, ISO, and AAMI working groups, committees, and maintenance teams over the last 20 years. 
His IEC 60601-1, 4th edition involvement:

To see a more detailed list go to Leo’s LinkedIn Profile.

Ian Sealey is the founder of Vertexian and is a medical device regulatory and quality consultant, with over 25 years’ experience. Vertexian provides the medtech industry with support in the following areas:

  • electromedical devices;
  • risk management;
  • pre-compliance testing;
  • training;
  • UKCA marking; and
  • manufacture of IEC test equipment

He was Assistant Secretary to the Board of the Department of Health (DH), a Medical Device Specialist at the Medicines and Healthcare products Regulatory Agency (MHRA), and a principal Medical Engineer in the National Health Service (NHS). He is a director of a health-related charity and a visiting university lecturer.






Need help with 60601 series standards 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. Eisner Safety Consultants team of experts also provides support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs and more. He team includes experts on additional standards committees and we all talk to the regulators regularly. We’re here 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.

]]>
					
		
		
			
		
		Leo Eisner the “IEC 60601 Guy” co-presenter in BSI Webinar
		https://eisnersafety.com/2024/05/30/leo-eisner-the-iec-60601-guy-co-presenter-in-bsi-webinar/?utm_source=rss&utm_medium=rss&utm_campaign=leo-eisner-the-iec-60601-guy-co-presenter-in-bsi-webinar
		
		
		Thu, 30 May 2024 18:54:07 +0000
				
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		https://eisnersafety.com/?p=7559

					
										




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.





Sign up for this webinar 





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.

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		IEC 60601-1 4th Ed Initial Launch: Positive Impacts Healthcare Standardization
		https://eisnersafety.com/2024/05/06/iec-60601-1-4th-ed-initial-launch-positive-impacts-healthcare-standardization/?utm_source=rss&utm_medium=rss&utm_campaign=iec-60601-1-4th-ed-initial-launch-positive-impacts-healthcare-standardization
		
		
		Mon, 06 May 2024 04:46:53 +0000
				
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		
		https://eisnersafety.com/?p=7532

					
										




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, 4th 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….





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.





 

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