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

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, 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.

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Leo Eisner, founder of Eisner Safety Consultants and a leading voice in IEC 60601 standards development.

We unpack the upcoming revisions to IEC 60601, 4th ed., focusing on the rationale behind these changes, their impact on medical device design, and how MedTech professionals can prepare for the future.

Leo provides insights into the intricate process of updating global standards, shares practical advice for compliance, and discusses the role of risk management in ensuring safer, more effective medical devices.

Key Points:

1. New Modular Approach:
   • The updated standard adopts a modular approach (12 working groups focused on specific hazard areas).
   • Simplifies updates by consolidating Collateral Standards into the General Standard.
   • Aligns better with global regulations.
2. IEC 60601-1 4th Edition:
   • Focuses on addressing various hazards including:
     • physical environment,
     • electrical,
     • thermal and fire,
     • mechanical,
     • user interface (usability, alarms, information supplied by the manufacturer & user interface aspects),
     • materials,
     • optical radiation, and
     • electromagnetic exposure hazards.
3. New Requirements:
   • Introduces new international requirements for wireless coexistence and other cutting-edge technologies (e.g., gas pathways, user interface aspects).
4. Consolidation of Standards:
   • Collateral standards are being consolidated to improve consistency and reduce the update cycle time for the 60601 series.
5. Timeline and Publication Dates:
   • Expected timeline for the fourth edition is 2029-2030.
   • Companies need to plan now, though the actual timeline may slip depending on various factors.
6. Benefits of Proactive Planning:
   • Proactive planning and test preparation are essential for regulatory success.
   • Staying informed and embracing continuous learning in MedTech are key factors for success.
7. Practical Advice for Compliance:
   • Begin designing for new standards early, even before they are finalized. MedTech design cycles are long.
   • Engage with industry groups and standards organizations.
   • Use test planning to streamline development and meet regulatory expectations efficiently.
8. Engaging in the Standards Development Process:
   • Manufacturers are encouraged to engage in the standards development process and submit comments.
   • This proactive approach can help shape the standards and ensure they are practical and achievable.

These updates aim to enhance safety and performance while keeping pace with technological advancements. Manufacturers need to stay informed and prepare for the impact these changes will have on their product lines and quality systems.

Resources:

Design specification Outline for the fourth edition of IEC 60601-1

Architectural Specification For Safety Standards of Medical Electrical Equipment, Medical Electrical Systems, and Software Used in Healthcare

Only 5 of the 12 Fragments went out for CD on 6 Dec 2024, which were Working Groups (WGs) WG37, 38, 39, 40 & 47 (Fragments 1, 2, 3, 4, & 11 respectively). The status of each of these Fragments is noted below:

• Fragment 1 (WG37) Status
• Fragment 2 (WG38) Status
• Fragment 3 (WG39) Status
• Fragment 4 (WG40) Status
• Fragment 11 (WG47) Status

The other 7 fragments will go out for CD approximately May ’25 (estimated schedule is my best intelligence). Fragments 5 – 10 & 12. You can look at the SC 62A Work Programme and find the Fragment number in the descriptions for each project on the first 12 projects of the Work Programme to find the status of each Fragment.

If you are a National Committee (NC) member and want to comment on the Fragment depending on your NC rules you may be placing your comments directly into the Online Standards Development (OSD) Platform for the Fragment. Other NCs are collecting the comments and then the NC Secretariat (or similar role) will be responsible for placing all the comments into OSD. Please check with your NC for your specific rules. Details about the OSD platform, How to use OSD, OSD resources (various training and other resources)

New terms and definitions which IEC 60601-1, 4th Ed. will be based on but other Technical Committees will adopt across the Healthcare sector to increase consistency – “International Electrotechnical Vocabulary (IEV) – Part 880: Electrical equipment, electrical systems and software used in healthcare” – IEC Website that has the schedule, list of draft documents. The CDV was released on 13 Dec 2024. If you are a National Committee Member of TC 1, TC 62, SC 62A, SC 62B, SC 62C, SC 62D, TC 65, TC 66, TC 76, TC 87, or SyC AAL you should be able to get access to this document and be able to comment on this document. This document is also being distributed for comment to ISO TC 210 and some additional ISO TCs .

Engage with the Podcast on the LinkedIn Post we’d like to hear from you

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?

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, and more. We deal with EU, US, and other country regulatory requirements, standards, laws, directives, and more. 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 and 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.

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.

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, 4^th edition involvement:

• Co-Convener of IEC/TC 62/SC 62A/WG39 – User interface aspects
• Advisory group member of IEC/TC 62/SC 62A/AG 50 – IEC 60601-1 Ed. 4.0 editing & leadership team
• Committee member IEC/SC 62A/WG37 – General requirements

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.

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?“.

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.

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.