The IEC 60601-1 4th edition is organized by hazard, not by clause. That is not a cosmetic change, and it decides how you read every draft that follows.

Edition 3.2 of IEC 60601-1 is organized by clause. You want leakage current, you go to Clause 8. You want mechanical hazards, you go to Clause 9. You want excessive temperatures, you go to Clause 11.

The 4th edition is not built that way, and the difference is not cosmetic. It changes what you look up, how you scope your project, and what a gap analysis against it actually has to do.

Here is what sits underneath the change, why it was made, and how to read the drafts without getting lost in them.

The two documents almost nobody reads

There are two public specifications behind the 4th edition. Both are publicly available; both have been sitting on the IEC servers for years, and almost nobody outside the working groups has opened them.

The Architecture Specification (V3.0) was approved on 5 May 2020, and it sets the philosophy for the 4th edition. Sharpen the focus on basic safety and essential performance. Clarify the concepts. Give a rationale for every requirement. Push the standard toward discrete, atomic, design-ready requirements written in consistent terminology (IEV 60050-880), rather than prose that has to be interpreted before it can be applied. It aligns the standard with the IMDRF Essential Principles (N47 and N52) so that it is regulatory-ready. And it looks past publication to a machine-readable database version of the standard.

I wrote about where all of this came from, including the 2015 SC 62A decision in Kobe that started it, in a LinkedIn post on 20 July 2026.

The Design Specification Outline followed on 30 November 2023. It is the road map that implements the architecture: which parts of the 3rd edition map to which working group, what other standards feed in, what is new, and what is being removed. It is the document that actually carves the work into the twelve hazard concepts. It also merges the collateral standards into the general standard, and that merge is a large part of why roughly 500 pages becomes more than 1,000.

Both specifications are on the IEC servers and free to download:

• Architecture Specification (2020)
• Design Specification Outline (2023)

The Design Specification has evolved since these documents were released, shaped by AG 50 editing team feedback. They are still the best available window into why the edition is shaped the way it is. If you are going to read one thing before you read a fragment, read the Design Specification Outline.

Why hazard, and not clause

A clause-organized standard answers the question what does this clause require? A hazard-organized standard answers a different question: what can hurt someone, and what do we do about it?

That matters for three practical reasons.

It matches how risk management already works. IEC 60601-1 has been built on ISO 14971 since Edition 3.0. That is not new in the 4th edition, and anyone telling you the risk-management foundation is the change has it wrong. What is new is that the structure of the document now follows the same hazard logic your risk file already uses. The standard stops making you translate between two organizing principles.

It stops the same hazard being addressed in multiple places. In Edition 3.2, thermal considerations show up in the enclosure clause (13.1.2), in the single-fault clause (13), in the applicable components clauses, and so on. Grouping by hazard forces the working groups to write each hazard once and to keep cross-references few and deliberate. The Architecture Specification asks for exactly that: limited cross-referencing, used on purpose rather than by accident. The move runs the other way too. Construction and ME systems (MES) are clauses of their own in Edition 3.2, Clauses 15 and 16. In the 4th edition they are not clauses at all. Those requirements are distributed across the standard, into the hazard fragments wherever they apply.

It makes the requirements addressable. A requirement written as a discrete, traceable statement can be tagged, filtered and pulled into a requirements database. A requirement buried in a paragraph of qualified prose cannot. That is the quiet ambition of the architecture, and it is the reason the drafts read differently from Edition 3.2 the moment you open one.

The map: twelve fragments, twelve working groups

The mapping is mechanical. Fragment N is written by Working Group 36 + N.

For current draft status of each fragment, see the fragment table in the 4th-edition hub, which is kept up to date as drafts circulate.

One reader described the map as a table of contents for the future standard. That is close to right, with one caveat worth holding onto: it is a table of contents for twelve documents that do not yet read as one. Making them read as one is the job of the merge, and of AG 50.

AG 50, and the problem of twelve authors

Twelve working groups drafting in parallel produce twelve dialects. One group writes “verify basic safety.” Another writes out the specific tests. One uses a term the way its own sector uses it; another uses the same term to mean something adjacent. Left alone, you get a standard that contradicts itself in the seams.

AG 50 is the editing team that stops that. It is made up of the leadership of all twelve working groups plus the project leadership, and it meets weekly. Its output is consistency: shared terminology, a shared style guide (the Design Specification, with a great deal more added), agreement on where a requirement belongs when two groups both have a claim on it, and a set of drafting rules that keep the fragments compatible before anyone tries to merge them. That work can reach into the starting concepts behind requirements, not only the words used to express them.

That is unglamorous work, and it is the reason the edition is slow. It is also the reason the merged document will be readable at all.

What CD1, CD2 and CD3 actually mean when you are reading a draft

This is the practical part, and it is where most people reading fragment drafts go wrong.

A committee draft is a snapshot, and it is frozen the day it is circulated. Nothing is edited into it afterwards. Here is the sequence, because it is the part that catches people.

It runs in five stages, and Fragment 1 makes a clean worked example because every document in the sequence exists.

1. The CD is circulated to the National Committees. Fragment 1’s first committee draft went out as 62A/1628/CD.
2. The comments are compiled into a CC. The national committees and their experts read the draft and file comments, and the comments are gathered up and circulated back as a compilation of comments. For Fragment 1 that was 62A/1656/CC.
3. The working group resolves them. Accepting some, partially accepting others, editing others, and rejecting others, often over several months or more. Nothing circulates while that is going on.
4. The resolutions are issued as a revised CC. In this case 62A/1656A/CC, carrying the full resolution of every comment, and it goes to the National Committees.
5. The next CD circulates with the resolved text in it. For Fragment 1 that was 62A/1759/CD, the CD2 that is open for comment until 16 October 2026. It is built from 62A/1628/CD and 62A/1656A/CC together: the previous draft, plus what the working group decided to do about every comment on it. 16 October is the IEC date, not yours: see the comment windows are the part people miss.

Two things follow from that sequence, and they pull in different directions.

The resolutions are not secret. The revised CC goes to the National Committees, so if you are active in yours, or you ask someone who is, you can find out what happened to a comment without waiting a year for the next draft. Note what that means: none of these documents sit on the open web. Every one of them, the CDs included, reaches you through your National Committee. That is a good reason to be connected to yours rather than watching from outside.

But the draft itself never changes. So there is still a long stretch where the newest circulated draft (CD, CDV or FDIS) is at the same time the most current draft available to you and materially out of date. A requirement you read in it may already have been resolved into something else. That is not a failure of process. It is how consensus standards development works, and it is why the draft in your hands has to be read as a direction of travel rather than as the answer.

That describes what circulates. The work itself lives somewhere else. Drafting happens in the OSD, the IEC’s online standards development database, and it is there from the start of a project through to publication of the standard. This is the database-driven way standards are now developed: the text is written and revised in the OSD, and the comments and the edits made in response to them are tracked in it as the project moves. So there is a continuous record of how a requirement got to where it is. Committee members can see it. If you are not on a working group you cannot, so the practical thing you can do is keep track of which stage has actually been circulated for each fragment, CD, CDV or FDIS, and read whatever you are holding knowing the work has carried on since it was frozen.

So when you read a fragment:

• CD1 is a first pass. Treat the direction as real and the specifics as provisional. Do not build a design decision on CD1 wording.
• CD2 has been through a full round of National Committee comment and resolution, so the thinking is more settled than CD1. It is still a committee draft.
• CD3 is unusual. Fragment 4 is on CD3 and will probably be the only one in the IEC 60601-1 4th edition project to run a CD3. For most fragments the intent is to publish a CD2, take the comments and move on toward the merge CDVs, which will be AG 50’s responsibility.

The thing that surprises people about the page count

Edition 3.2 runs about 500 pages. The 4th edition is heading past 1,000, and the number gets quoted as though the requirements have doubled.

They have not, quite. Two things inflate it.

First, Clause 3, terms and definitions, repeats in every fragment. Each fragment has to stand alone as a readable draft, so each carries its own definitions. That duplication disappears at the merge.

Second, the edition carries far more supporting material than Edition 3.2 ever did. The Architecture Specification requires each requirement to be accompanied by guidance, rationale, and an explanation of what changed from Edition 3.2. The old IEC TR 62348, which was a standalone document explaining the changes, is now built into an annex per subclause. That is genuinely useful to a reader, and it is a lot of pages.

It is also the single biggest reason the project takes as long as it does. Rationale was never written for every subclause of Edition 3.2, and writing a differences explanation for every subclause of a thousand-page standard is a very heavy lift.

How to actually read this thing

Seven steps, in order. Part of this came from a mentor of mine, and the sequence he drilled into me has held up ever since. Read the terms and definitions first, because you have to understand the language of the standard before anything else in it makes sense. Then read the rationale, because that is where the background and the context sit, and the more of it you carry up front, the easier the implementation gets later. Then go back and reread the terms and definitions, which land differently once the rationale has given them weight. Only then get your hands dirty in the requirements themselves.

1. Start with the Scope. Understand the scope of the standard and how it applies to your products: what is in scope and what is not. More products have been brought into scope under the broader scope that has been written, including SaMD. Do not assume that because the current edition did not reach your product, the 4th edition will not either.
2. Read the terms and definitions. Clause 3 of Fragment 1. Check them against the current IEC 60050-880 and any amendments, including the latest drafts where a published version has not caught up. Fragment 1’s terms should sync with 60050-880, but depending on which copies (Frag 1 and IEC 60050-880) you can get hold of they may not, so work from the most recent versions available to you.
3. Read the rationale annexes. This is where your gap analysis should start. The committee’s own “what changed and why” statements are a better source for it than reconstructing the diff yourself, and they are the closest thing the 4th edition has to the old IEC TR 62348, which is now built into an annex per subclause.
4. Reread the terms and definitions. Now that the rationale has given them context. This is the step people skip, and it is the one that makes the rest of the reading go faster.
5. Then Fragment 1, the general requirements. These decide what applies to you at all. Use specification drives what is in scope. Categorization points you to the requirements that apply and lets you set the rest aside. Nothing downstream is scopeable until this is done. This is also the point to start putting your conformity evaluation plan together, and you can do that today rather than waiting for the 4th edition: see what part of Fragment 1 is critical to start early.
6. Then read the fragments your device clearly touches. For most devices that is most of them, to differing degrees. Only ionizing radiation is genuinely device-specific.
7. Reread the rationale annexes. A second pass, now against the requirements that apply to your product(s).

What part of Fragment 1 is critical to start early: the plan and the file

Start with Frag 1 and you arrive, fairly quickly, at Clause 8 of Frag 1. It is called Conformity evaluation, and it is a clause in its own right, sitting after use specification and categorization. This is the part of the 4th edition that changes how you work rather than what you build, and it is the part you can start on today.

Two documents sit at the centre of it, and one contains the other.

The conformity evaluation plan is where you decide, in advance and in writing, what compliant means for your device: which requirements apply, what evidence shows each one is met, and who owns that evidence. The conformity evaluation file holds the plan and it holds the results. That is the whole shape of it:

The planning side is where the work sits. The plan pins down how your device is categorized, what your use specification says, which clauses you are evaluating and which you are not, what samples you will use and the worst-case test scenarios, and what order the evaluations run in. That is not a small job. It is also the job that decides whether everything downstream holds together, because a scope nobody agreed at the start is a scope everyone inherits later.

The record side is a chain, and the chain is the point:

Pull any link and the next one should be right there. That is what a reviewer is checking for when they ask the question you did not prepare for.

Two things surprise people about this.

None of it has to live in a new set of binders. The draft is explicit that the records forming the file may form part of other documents and files you already keep, and it names the risk management file and the usability engineering file as examples. Most organizations already produce or contract most of this evidence: safety and EMC reports, risk analysis, usability, software, design reviews, labeling assessments. What is usually missing is the plan that ties them to requirements.

It is not an invention of this committee. The Fragment 1 draft cites the FDA ASCA programme, the Accreditation Scheme for Conformity Assessment, in its bibliography, and attributes part of the specific-plan requirements to it directly. If ASCA is familiar to you, a good deal of this will be too. ISO/IEC 17025 is cited alongside it for third-party evaluating organizations.

And nothing in Edition 3.2 stops you working this way today. Edition 3.2 has no explicit requirement for a conformity evaluation plan, which is a different thing from prohibiting one. The teams already working this way have an easier time on every test project submission, and they will not be building this from nothing in the year they are trying to launch against the new edition.

The short version of this section ran on LinkedIn on 25 August 2026, where the discussion in the comments is worth reading on its own.

The comment windows are the part people miss

Every one of these drafts is open for a defined period, and then it is not. If you are not one of the experts writing the document, the comment window is your route into the text.

Two IEC dates worth having on a calendar as of 31 August 2026: Fragments 2, 4 and 10 close on 25 September 2026, and Fragment 1 closes on 16 October 2026.

The current status of every fragment, and the deadlines as they change, live on the 4th-edition hub.

Almost nobody reads a thousand-page draft cover to cover. So here is one place to get oriented, then go deep only where it touches your device.

You have heard the headline: the IEC 60601-1 4th edition is coming, and it is big. Edition 3.2 is around 500 pages. The 4th edition is heading past 1,000, written across twelve hazard-based working groups.

The headline is not the useful part. The useful part is the question underneath it: where do you start, and what do you actually need to read? Almost nobody reads a thousand-page draft cover to cover, and nobody should have to. So this is a hub. It is one place to get oriented and then go deep only where it touches your device, as your device likely will not touch every corner of the standard.

1. The structure: twelve hazard-based fragments

Edition 3.2 is organized by clause. You find a requirement by its number. The 4th edition is currently organized by hazard, split across fragment working groups that will later be merged into one document. Each hazard concept is a fragment, and each fragment has its own working group. Here is the whole map, and where each fragment stands today:

Draft status, committee-draft stage, as of 31 August 2026. “CD” = committee draft; higher numbers are later rounds. Treat all fragment content as current draft, not final.

That structure is not arbitrary, and you do not have to take my word for it. Behind it sits the Architectural Specification (approved 5 May 2020), which sets the direction for the edition, sharpening the focus of basic safety and essential performance and pushing toward discrete, design-ready requirements. The Design Specification Outline (30 November 2023) then implements that architecture, laying out how the work is grouped into the twelve hazard concepts above. An editing team, AG 50, the leadership of all twelve working groups, keeps twelve fragments reading as one standard.

Most people never look at this layer. The original concepts have evolved since these specs were written, based on the experts and National Committee feedback, but they remain the best window into why the 4th edition is shaped the way it is.

2. Where the drafts stand, and the timeline

You do not have to track every document to stay oriented. Every one of the twelve fragments now has at least a first committee draft. Several are on their second draft, and Fragment 4 is furthest along at CD3. It will probably be the only CD3: for most fragments the intent is to publish a CD2, get comments from the National Committees, and move on. A third CD made sense only for WG 40, which has the time and bandwidth in its group to complete one before the project needs to move into the CDV1 phase.

Three recent fragment drafts dropped on 3 July 2026: Physical environment (Frag 2), Materials (Frag 4) and Ionizing radiation (Frag 10). All three are open for comment until 25 September 2026.

The IEC date is not your date. National Committees need your comments well before the IEC deadline so they can process them and submit to Geneva, and their national deadlines land earlier, sometimes much earlier. As of 31 August 2026 the US national window for Fragments 2, 4 and 10 has already closed, even though the IEC deadline is still weeks away.

If you have missed a national deadline, do not assume you are out. Contact your National Committee, in the US case that is AAMI, and ask to submit late, or approach the National Committee secretary yourself. In most cases committees would rather receive a good comment late than not receive it. Ask your National Committee rather than reading the IEC date and assuming you have time.

And the map just moved again: Fragment 1 (General requirements) issued its next committee draft on 24 July 2026 (62A/1759), with comments open to 16 October 2026. Fragment 12 (electromagnetic disturbances) is the one still to come. WG 48 did not publish the Fragment 12 CD2 over the weekend of 1–2 August 2026, so it is not expected until after the Hamburg meeting in mid November 2026.

Treat the dates as goals; these schedules are likely to shift again. The point is the opposite of “relax, it is years away.” The text that becomes the 2031 standard is being written and commented on right now, and if you or your organization are not directly involved in writing the document (not one of the experts on the WG committees), the comment windows are the best way to provide your feedback.

3. Where to go deeper (the shelf)

You do not need to read everything, but you do need to start preparing now and understand the impact on your device designs, your test plans, your QMS, your document control, and your supply chain. Here is a starter kit to map to your device, plus a couple of orientation pieces:

• The TÜV Rheinland 4th-edition seminar, presented by Leo Eisner, Caitlin Brady and Elizabeth Casey. Working-group material from the people writing the drafts.
• The EU MDR / EN 60601-1 harmonisation cheat sheet on how the current standard lines up with the MDR, Annex ZZ, and state of the art.
• The 4th-edition one-page cheat sheet: IEC 60601-1, 4th Edition: Strategic Changes and Preparation Strategy.
• The LinkedIn series this hub grew from: the opening post lays out the three running series. The full, updated index of every post is below.

4. The series index: every post, by track

Three series run in parallel. This index is kept current as posts publish, so it is the one place to find them all. Each post is listed once, under the series it was written for; where it also touches another track, the description says so.

Start here

• The opener: 500 pages to 1,000+, and the three running series — what the whole thing is and how it is organised.

Series 1: the CEP and CEF, start now

The conformity evaluation plan and the conformity evaluation file: what the 4th edition expects of them, and how to start putting them to work under Edition 3.2 now.

• The CEP and the CEF: start now, under Edition 3.2 — what the plan and the file actually hold, the traceability chain, and why nothing in Edition 3.2 stops you working this way today.

Series 2: the 4th edition, fragment by fragment

How the edition is structured, and what is changing in each hazard working group.

• Where the structure came from: the Architecture and Design Specifications, and AG 50 — also touches the CEP.
• The twelve fragments, and where each draft stands today
• Your EMC/EMD test plan is yours to write, not the test house’s — the plans you already owe today, and how Fragment 12 raises the bar in the 4th edition.
• How much of the 4th edition actually applies to your device — almost every hazard fragment reaches almost every device, to differing degrees; only optical and ionizing radiation are genuinely device-specific.
• How to Read the IEC 60601-1 4th Edition: 12 Fragments, Not Clauses : the long form on the blog. Why the edition is built by hazard, what CD1, CD2 and CD3 actually mean, a seven-step reading order, and where Fragment 1 leads: the conformity evaluation plan and file.

Series 3: Standards Watch

New and draft standards as they land, inside the 60601 family and beyond it, with the comment windows that decide the final text.

• The updated 4th-edition timeline and the July committee drafts — the schedule out to about 2031, and the three fragment drafts that opened for comment.
• Combination products: ISO TS 24971-3, and where the risk lives — a device plus a drug or biological product, and the risks that only appear once they are combined.
• EMF exposure assessment: IEC TS 63738 enters comment — the technical specification feeding the Fragment 11 electromagnetic exposure work.
• IEC 60601-1 and IEC 62304 as Group Safety Publications — SC 62A’s application for horizontal status, and why it names two editions that do not exist yet. National Committee responses close 11 September 2026.

5. Strategic readiness: your action items

You do not need the final text to start. Here is the readiness list I walk teams through:

• Map your design controls against the draft working-group requirements now, rather than waiting for the next draft.
• Run a full QMS gap analysis: risk management file, conformity evaluation file, and the EMF and biocompatibility assessment reports.
• Pull R&D, RA/QA, software, labeling, supplier quality and manufacturing into your readiness reviews. This is not a regulatory-only exercise.
• Embed cybersecurity, AI/ML and PEMS design inputs early in the pipeline, not at verification.
• Update labeling, symbols, packaging and IFU against ISO 20417 and the working-group requirements.
• Engage suppliers now for SBOM, spacing changes, power cords and component impacts. Supplier lead time is where these programs slip.

That list is the orientation. Turning it into a real gap analysis and a plan for your specific device is the part that takes experienced hands. Day to day, my team supports manufacturers, test labs, and regulators with exactly this: strategic readiness, CEP/CEF development, and training teams up on the 4th edition. It does not have to be a heavy engagement, either. One client took a four-hour CEP/CEF workshop and had the concept working in their process the next week.

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

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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.

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.

Join us for the fifteenth 10x Medical Device Conference on May 7 to 8, 2025 – Hyatt Regency Newport Beach, CA

What’s 10x 2025 about you ask?

• The focus is on building meaningful relationships and tackling real challenges
• Move through key stages of the MedTech lifecycle. Each workshop station focuses on critical topics such as:
  • Regulatory Pathways
  • Cybersecurity
  • Engineering
  • Product Development
  • Market Access
  • Reimbursement
  • Commercialization

Join experts Carrie Britton, Matthias Fink, Sean Smith, Jan Gates, Angelina Lisandrelli, Jose Bohorquez, and others experts for a journey through the MedTech lifecycle – from ideation to marketed product. Each workshop represents a stage of this journey, offering opportunities to collaborate, ask questions, and exchange expertise.

Thank you, Sean for including me on this impressive list of experts for 10x this year!

Looking forward to seeing you in Newport Beach, CA. – Seats are limited

Join us for this very personalized experience and Joe Hage‘s Ice Cream Social

This is an amazing resource that MedTech Leading Voice has put together and is free to download.

‘This isn’t a “best of” list – it’s a guide to people worth following …

 It’s a guide to 100 individuals worth following on LinkedIn—people who are sharing unique insights, actionable advice, and thought-provoking content.’ – Sean Smith, MedTech Leading Voice

• So, what now?
  Browse through to find leaders you want to follow – lots of different categories and interests
  Explore their insights
  Share your favorites in Leo Eisner’s LinkedIn Post comments for the MLV100

Now for my story of how I made it onto the MLV100 Yearbook list – Thank you Sean, Mike and many others in the MedTech community

My credo: “I like to support my clients and the MedTech industry in understanding standards, regulations, laws, and guidance. This is one of our cornerstones to support our clients from the  beginning of the design and development process.”

My journey began, straight out of college, in 1985 at Underwriters Laboratories, where I gained experience in various product and component test standards, including UL and NFPA.

I joined TÜV SÜD in 1994, starting my medical career. I worked with medical electrical standards UL 601-1, UL 544, and IEC 60601-1, 2nd ed. and became an MDD auditor.

Moved into an industry role for a couple years and then decided to start up my consulting company in 1998 full time.

I have been fortunate to be involved in standards development over the past 20+ years to benefit my clients and industry. This helps me stay updated and assist my clients in product design and development.

My focus has been IEC 60601-1. I am one of the conveners for the 4th ed. of IEC 60601-1 which is under development currently. But I am also involved in a lot more standards than just IEC 60601-1.  Check out my LinkedIn profile.

I have always been happy to share my knowledge via blog posts, articles, webinars, and podcasts.

It’s an honor to be included with this amazing listing of MedTech experts, Regulators, entrepreneurs, and influencers.

Thank you, Sean and MedTech Leading Voice, for including me on this impressive and very unique list. You’ve built a collaborative community that enhances skills and knowledge in the MedTech community!

Need Help?

Need help with 60601 series standards including EMC? Eisner Safety Consultants can assist with strategic compliance planning for your medical electrical product lines, provide support when FDA or a regulator asks questions for a submission. We deal with EU, US, and other country regulatory requirements, standards, laws, directives, and guidances. Our team also provides support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs, and more. We work with many test labs for medical safety, EMC and can arrange other testing, as well. Feel free to schedule a web meeting with Leo or contact us.

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.

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.

𝗪𝗵𝗮𝘁 𝗦𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 𝗔𝗽𝗽𝗹𝘆 𝘁𝗼 𝗠𝘆 𝗗𝗲𝘃𝗶𝗰𝗲? Podcast with one of the best MedTech podcasters Etienne Nichols – Greenlight Guru‘s very own

𝗞𝗲𝘆 𝗧𝗼𝗽𝗶𝗰𝘀:
• Why standards like IEC60601 are crucial for medical device development
• Steps for identifying proper standards for your product
• How to integrate standards into your design process
• Mistakes & consequences of ignoring standards
• Tools for staying updated on changing standards & regulations
• How startups can navigate standards with limited resources

If you have any thoughts and comments on the podcast I’d would like to hear from you Comment on the LinkedIn post about the Podcast

If you found this interesting or helpful, consider Reposting on LinkedIn; follow me, Leonard (Leo) Eisner, the60601Guy and click the so you don’t miss future content.

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. His 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.