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 24 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.

Most National Committees need your comments about two weeks before the IEC deadline so they can process them and submit to Geneva. Submit your comments with that buffer in mind, or check with your National Committee for its national deadline, so you do not miss the window.

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.

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.

Before you scroll: I write a newsletter for MedTech teams who do not want to be surprised by IEC 60601-1, 4th edition. Plain-language updates on the fragments, the working groups, and what each change means for design, QMS, labeling, and testing. Subscribe here and get the next update in your inbox.

This was a week of learning I will not forget, and one that reminded me why I do this work. Strip away the standard numbers, the acronyms, the requirements, and the test reports, and the whole event came back to a core concept: keep the patient at the center and keep them safe. That is the thread I want to pull through this longer recap, the one that did not fit in a single LinkedIn post.

A quick note on format. On LinkedIn I kept this tight. Here on the blog I have room to go deeper, so this version adds more on the structure of 4th edition, more on how I think about the Conformity Evaluation Plan and File, and a closing section on what I am personally carrying back to the standards committees. If you only have two minutes, the LinkedIn version covers the highlights. If you want the real detail, you are in the right place.

Why I keep saying “get ahead of 4th edition”

Let me set the stage, because it is the backbone of almost everything I presented this week. IEC 60601-1, 4th edition is not a distant, someday concern. It is being actively drafted right now, fragment by fragment, across a set of working groups (broadly WG 37 through WG 48), and all of those fragments have already circulated Committee Drafts (CD1s, and some have done CD2s). The collateral standards many of us have treated as separate documents are being folded into the core of 60601-1. The structure is moving toward clearer, more “atomic” requirements, each one distinct and design-ready, with rationale attached and tighter alignment to the IMDRF Essential Principles. The scope is broadening to span lay users and professional users, home and EMS and professional environments, and patients of every age, human and animal.

Here is why that matters to you, not just to standards people like me. When this edition lands, the gap between a product designed against 3rd edition assumptions and one designed with 4th edition in mind will show up as redesign, retesting, and documentation rework. That is the expensive way to meet a standard. The inexpensive way is to read the direction of travel now and bake it into your design inputs, your risk management file, your labeling, and your test strategy while you still have design freedom. That is the whole argument in one breath: plan now, avoid the fire drills later.

It started Monday in Boxborough: TÜV Rheinland and IEC 60601-1, 4th Edition

The week kicked off in Boxborough, Massachusetts, with TÜV Rheinland North America’s first IEC 60601-1, 4th Edition seminar, held at their Northeast Technology and Innovation Center. I shared the stage with Caitlin Brady and Elizabeth Casey, and for the Q&A we pulled in two additional local experts from our Working Groups, Ashleigh McNaboe and Jenna Smolko-Jaser. Dr. Nicholas T. Kirkland kindly introduced me that morning and even worked my Star Trek podcast into the introduction, which set a warm and slightly playful tone for a deep technical day. You can listen to the podcast here.

That left me as the only man on the panel, standing alongside four exceptional women in STEM, and I could not have been prouder to be there. These are not token seats. On the standards committees I work with, women like these are among the strongest, most technically capable people in the room, the ones I lean on and learn from. Our field is finally heading in the right direction on this, and it needs to keep going. When I started more than 40 years ago, engineering and the technical fields were a hard place for women. It is better now, I see real progress even in my son’s college, though equity is still a work in progress. Panels and committees stacked with talent like this are how we close the gap, and being outnumbered by minds that sharp is an honor every single time.

If you could not join live, the recording and the slide deck are available here.

A deeper look at the CEF and CEP, and why “Bridge, not wait”

At IMSC26 I ran a 4-hour workshop, “Building and Using an IEC 60601 Conformity Evaluation File for Today and Tomorrow,” with a group of about 20. Without reproducing the workshop materials, here is the thinking, because it is useful even if you were not in the room.

The problem the CEF and CEP solve is fragmentation. Today, evidence tends to live in silos: test reports here, design reviews there, the risk management file somewhere else, the usability engineering file in its own world. Different formats, different levels of detail, and a reviewer at a test lab or Notified Body who has to hunt to piece it together. A Conformity Evaluation Plan flips that. You plan, up front, how each applicable requirement will be evaluated, then the Conformity Evaluation File becomes the executed plan with the evidence attached and traceable from requirement to hazard to test method to acceptance criteria to result. It is the difference between a complete file and a usable one, a distinction that came up in other sessions this week as well.

The line I kept coming back to was “Bridge, not wait.” 3rd edition does not require a formal CEP, but nothing stops you from adopting the mindset now. Teams that build this muscle today will transition into 4th edition smoothly, and they will hand reviewers a cleaner package in the meantime. If you want the practical version of this for your own projects, that is exactly the kind of thing I help clients set up, and the kind of thing I write about in the newsletter.

Quick break: If this level of detail is useful, it is a sample of what I send out. Subscribe to the newsletter for plain-language 4th edition updates and practical compliance tips you can actually use.

I also delivered a 45-minute session, “The Impact of IEC 60601-1, 4th Edition on RA/QA, Design, Document Control, Test, Supply Chain, and Management,” to a room of close to 100 with more online, and even a few of my own clients in the seats. The point of that talk was to take the drivers behind the next edition and trace them into the real work across functions, because a standard change is never just an engineering change. It ripples into your QMS procedures, your document control, your supplier and test planning, and your management reviews.

A quick note on why this is my lane: I co-convene IEC/TC 62/SC 62A/WG 39 (user interface for IEC 60601-1, 4th edition), am a member of IEC/TC 62/SC 62A/WG 37 (general requirements) and IEC/TC 62/SC 62A/AG 50 (the editing team leading the 4th edition of IEC 60601-1), serve as US co-chair of AAMI TAG 62D on electromedical equipment, and sit on ISO/TC 210/WG 2. A lot of what I shared comes straight from inside the rooms where this edition is being written.

It also meant a lot to hear Jean-Yves Pairet, Quality Assurance Director at CLEIO, write that the workshop “made a clear case for preparing for IEC 60601-1 4th edition now, rather than waiting four years for it to roll out,” and that he left “with a practical, immediately usable approach CLEIO can already apply to current projects.” Practical and immediately usable is exactly what I am going for.

The talks that stuck with me

Michelle Tarver, MD, PhD, Director of FDA’s CDRH, delivered a keynote that was simply outstanding, with patient safety running clearly through the entire keynote. She covered the Case for Quality programs (the Voluntary Improvement Program and the Achieving Quality Excellence Collaborative Community), the Accreditation Scheme for Conformity Assessment (ASCA), supply chain resilience including the very real PFAS challenge, and QMSR, now in effect and incorporating ISO 13485:2016. The common thread, and the reason it ties to my own message, is that every one of those rewards teams who prepare early instead of scrambling at a deadline.

James Pink gave a talk I, and many of us, will be thinking about for a long time: “When You Become the Patient: A Safety Professional on the Other Side of the Decision.” He laid out what the formal risk model does well (sets the safety assessment scope, identifies hazards and hazardous situations, defines controls and acceptable residual risk, supports surveillance and signal detection) and what lies outside its boundary: cross-device effects over time, the psychological burden between appointments, the cumulative impact of “acceptable” events, and the lived experience across encounters.

His concept of “bound risk” has stuck with me. The manufacturer owns the chain up to the device-level event, but the path from a hazardous situation to actual patient harm gets distributed to the health institutions that control the diagnostic and therapeutic pathway. His example: an MRI down in a radiology suite. Nobody is crushed or burned, the file says no harm, and meanwhile patients sit stalled on the diagnostic pathway with a clock ticking inside them. That is harm. It just is not the kind our current files capture. He also made the uncomfortable point that adverse events are among the weakest signals we will ever get, because the system often needs someone to be seriously injured before anyone investigates properly.

James and I have known each other for about five years and have worked through plenty of medical device and IEC 60601-1 questions together, so this one lands close to home. During the Q&A I told him I would be thrilled to have him speak to the IEC TC 62, SC 62A, and the 4th Edition IEC 60601-1 teams writing the standard. Here is why. We still do not focus enough on the patient. We focus on the engineering and the technology, and those matter, but technology and standards are only one piece of the puzzle. The patient pathway is just as critical, and arguably more. A device can pass every clause we write and still leave a patient stalled, anxious, and unsafe somewhere along their journey. The people writing the standards need to hear this clearly, and hearing it from someone directly impacted who also understands the risk management perspective drives the point home far better than I could on my own.

Susan Neadle presented on “Streamlined” Risk Management for Drug-Device Combination Products, touching on the draft Technical Specification ISO TS 24971-3 (guidance on applying ISO 14971 to combination products) and the integration path with AAMI TIR 105. The problem she names is one anyone working at the intersection of device, drug, and user knows in their bones: multiple frameworks (ISO 14971 for the device, ICH Q9(R1) for the drug) overlap, execution is siloed, and the result is inconsistent terminology, traceability gaps, and interaction risks that go under-assessed, especially the drug-device interactions and the way a user actually handles the combined system. Streamlined does not mean lighter. It means connected, consistent, and decision-driving. David Cronin of Cognition followed with a strong session on minimizing patient risk at the intersection of drug and device risks. Meeting David in person was a real highlight. He carries deep knowledge across medtech, pharma, and combination products, and he and Susan go way back, which showed in how naturally their two talks complemented each other.

A personal highlight: Susan and I were initially scheduled at the same time, and she asked Bijan to reschedule so she could watch my presentation. That kind of attention to detail from Bijan is part of what makes this conference special, and it honestly blew me away. I have had huge respect for Susan for many years as the combination products expert, and she knows me, as many do, as the IEC 60601 Guy. There is a lot of mutual respect in this conference and a huge amount of knowledge and decades of experience to tap into.

Friday panels: what do we really mean by “risk,” and how mature is it?

Friday brought panels, a new addition this year, and they delivered. One of the liveliest was “What Do We Really Mean by ‘Risk’? US vs EU Perspectives,” a genuinely useful debate about how the same word carries different weight on different sides of the Atlantic. It sounds academic until it shows up in your submission strategy and your acceptable-risk arguments.

Fubin Wu’s panel introduced his Risk Management Maturity Model (RM3), and I am very glad I sat through it. It is a first-principles effort to answer a question we rarely measure well: what does good, and great, risk management actually look like, and how do you grow toward it? The panel brought together FDA voices including co-chairs Keisha Thomas and Melissa Burns alongside industry core-team members. As Fubin puts it, RM3 pushes past “did we follow the process?” to a deeper question: “are we making decisions with confidence that fulfill the intent of the process to serve patients?” With QMSR now in force, that shift from better documentation to better decision-making is the real work.

AI, human factors, and more sessions worth your time

My associates at Prodct Studio, Christie Johnson and Devon C. Campbell, ran a fantastic Tuesday workshop, “The AI-Powered MedTech Professional.” They also know how to host. I may have “dragged” a few TÜV Rheinland friends to their Monday-night party. Great hosts, every time.

I did not catch all of Shannon Hoste’s usability sessions, and I wanted to. Her work asks a question our whole field needs to sit with: are human factors processes ready for AI in medical devices? The risks she maps (automation bias, loss of situational awareness, and function allocation between human and AI) are real use-related hazards, and the comfortable assumptions, like “the clinician will catch it,” do not hold up. Her two-part HFE workshop with Jonathan Kendler, on factoring human factors data into your risk file and safety case, is exactly the kind of practical, on-the-ground content I look for.

One session I did sit through and keep thinking about was Steve Gompertz and Jean Blom’s “Hidden Influences: How Risk Management Can Go Wrong.” It gave us a phrase worth posting in every quality department: “dysfunctional compliance,” where the process is followed precisely but the results still are not acceptable, because the focus drifts to how the work gets done instead of the value it is meant to produce. Risk management is done by humans, and the human factors of decision-making belong inside our risk process.

The fun version: standards are star maps

If you want the more playful version of the philosophy underneath all of this, enjoy The Podcast episode where I joined Faisal Kamal, “The Star Map to the Future.” The core idea: IEC 60601 is not a rulebook, it is a star map built from decades of engineering mistakes, test data, regulatory learning, and field experience. We even used the Star Trek tricorder as an analogy for the electronic devices now used in homes and EMS environments, the noisy, unpredictable, RF-filled spaces that 4th edition deliberately pushes us to design for. There is also a companion write-up, What’s NASA & Star Trek have to do with IEC 60601?

What I am carrying back to the committees

Conferences like this are not just about what you present, they are about what you take home to the work. Three things are coming back with me into the standards rooms. First, the patient pathway belongs in our thinking, not just the device-level event, and James Pink made that case better than anyone. Second, maturity matters more than compliance, and RM3 gives us a vocabulary for it. Third, the human side of risk, the biases and blind spots Gompertz and Blom mapped, deserves a seat at the table inside our risk process, not as an afterthought. If we hold those three together while we write 4th edition, we end up with a standard that protects real people in real environments, which is the entire point.

Resources to get ahead of IEC 60601-1, 4th Edition

If this left you wanting a head start, here is where I would point you first:

• IEC 60601, 4th Edition: What’s Changing and How to Prepare — my strategic-shifts overview and companion to the Easy Medical Device podcast episode.
• IEC 60601-1, 4th Edition Survival Guide: Why It Matters for MedTech
• IEC 60601-1, 4th Edition: Design Controls and QMS Impacts You Need to Know
• Get Your Reviewer’s Hat On: 4th Edition Draft Fragments Have Dropped
• From Engineer to “The IEC 60601 Guy” (Project Medtech Podcast)

The part that matters most

The theme of the whole week was patient safety and risk management, but the human side stuck with me just as much. I finally met people in person whom I have worked with for years, in some cases for decades. Voices and email signatures became handshakes and hugs. That never gets old. I had great conversations with Fubin Wu and David Bonnett on the risk maturity work, time with Susan Neadle, James Pink, David Cronin, Steve Gompertz, and Jean Blom, and real face time with Bijan Elahi himself. There were genuinely too many good people to name them all here, and that is a wonderful problem to have. A small backstory I am proud of: Caitlin Brady and Elizabeth Casey of TÜV Rheinland were at IMSC26 because I suggested they sponsor, and they grabbed the very last sponsor spot. Sometimes a nudge at the right moment is all it takes.

A heartfelt thank you to Bijan Elahi, Jamie D. Selby and the entire volunteer team, to my TÜV Rheinland North America colleagues, and to Christie Johnson, Devon C. Campbell, and the Prodct Studio crew. IMSC alternates between the US and Europe so attendees on both sides of the Atlantic get a fair shot, and IMSC27 heads to Europe, with Ireland, Belgium, and Portugal in serious consideration.

Onward. And if you are writing standards or developing products, keep the patient at the center.

Live long and prosper, and keep your patients safe, in every environment, be it on earth or in space , on every device. To infinity and beyond, we can design for patient safety, in all its forms, if we really set our minds to it, with such a dedicated set of great minds as this group.

Do not let the next 4th edition update pass you by.

I send practical, plain-language guidance on IEC 60601-1, 4th edition and the broader 60601 and 61010 world, written for the people who actually have to design, test, document, and certify these products. No fluff, just what helps you get ahead of the curve.

Subscribe to the newsletter

Schedule a call with Leo Learn more about our work

Leonard “Leo” Eisner · The IEC 60601 Guy · Eisner Safety Consultants

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.

ISO TC 210 WG2 met in Tokyo, Japan on 4 – 5 March 2025.

WG2 meeting focused primarily on resolving the National Committees (NCs) comments received on the ISO/DIS 20417, 2^nd ed.

• Thx to the hard work of our fearless Project Leader, doing a huge amount of prep work just prior to the WG meeting.
• WG was able to review and resolve all the comments.
• Next step will be to circulate for FDIS ballot ISO/FDIS 20417, 2^nd ed., that the NCs will vote on.

Changes proposed:

Add reference to transport and storage symbols for environmental conditions for packaging to distinguish between transport and storage environmental conditions.

• Updated sub-cl 6.5.3 a) new sub items 2) & 3) with symbols for transport and storage – Special Section not included in LinkedIn Post
• These symbols for transport is Symbol 3869 from ISO 14617-14:2004 (link goes to the ISO online browsing platform) and for storage is Symbol 2066 from ISO 14617-7:2002
• This has been something I have been developing for more than a year with TC 210/ WG3 and also IEC 60601-1, 4^th ed., IEC TC 62/SC 62A/WG38 with a small team. At the Tokyo meeting TC210 / WG3 we have set up a task team to look at the proposed symbols for transport, storage and operation (operation was not included in ISO 20417 as no comment was provided). WG3 task team has not met yet so unable to share the proposed symbols from WG3 perspective at this time.
  
  IEC TC 62/SC 62A/WG38, Fragment 2, (IEC 60601-1, 4th ed. – learn more about it) 62A/1630/CD was issued Dec 6 2024 and was closed for comments on Feb 28 2025. We are meeting in Arlington, Virginia at the AAMI offices to work on the comments March 30 – April 4, 2025. The two symbols above are part of the symbols that are in the CD and there are additional ones including one for operating IEC 60417‑6090:2012 and transient IEC 60417-5184:2002 environmental conditions, and indoor use IEC 60417-5957:2004. Some combination of the environmental conditions such as temperature, humdity, and atmospheric pressure will need to be combined as applicable to operation, storage and transport. Trainsient is a special condition. Please refer to the CD to understand the usage of the symbols.

Deleted 6.1.2 d) 1) (Change from “EC Rep” to “XX Rep”)

• Align with update of ISO 15223-1:2021/A1:2025 published March 3, 2025 with “EC Rep” changed to “XX Rep” (5.1.2).
• 6.1.2 d) 1) previously stated: “When using symbol 5.1.2 from ISO 15223-1:—, the ‘EC’ may be replaced by the 2-letter or 3-letter country code given in ISO 3166-1.”

 Added concept of “applicable policy”

• New 3.3 definition.
• Aligns with 1/2634/CDV of IEC 60050-880, 1^st ed, term 880-17-02) & about 20 additions in the normative text to “applicable policy” making those requirements based on what the authority having jurisdiction requires so more flexible.

Changed from “production control” to “production control identifier”

• Make clearer the definitions of lot number, lot code, batch code, batch number, serial number, & other options noted in 5.9 of ISO 20417, 1^st ed. (will be 5.8 ISO 20417, 2^nd ed.)

The requirements related to commercial product name were deleted as they were duplicative of the catalogue number requirements.

Deleted 4 b)

• The previous 4 b) roughly says: Normatively referenced edition of a standard in ISO 20417, ed., the manufacturer may substitute with a more current version provided by the manufacturer provided they can demonstrate the residual risk remains acceptable and is comparable to the residual risk that results from applying the normatively referenced document.
• The normative referenced standards in the new draft FDIS are undated or dated.  Undated references are required to be the most recent copy of the standard and the dated ones are required to be the dated version.  ISO 15223-1 is the only dated normative referenced standard and references ISO 15223-1:2021 and ISO 15223-1:2021/AMD 1:2025 (ISO format requirements) in the draft FDIS.

HAS Consultant comments received late, added to collated comments, and resolved. JTC3 will prepare updated Annex Zs for addition to the FDIS

updated the normative references

• Informative referenced standards (“should ” or “see standards” statement) were moved to the bibliography
• Dropped ISO 16142-1 & -2 standards as both were withdrawn

Delete former informative Annexes D, F, G and H;

• Annex D – Cross reference between the document and the requirements considered
• Annex F – Reference to the essential principles (ISO 16142-1:2016 & ISO 16142-2:2017 – both withdrawn)
• Annex G – Reference to the general safety and performance requirements for medical devices (Was previous corresponding list of GSPRs to the EU MDR list but will be replaced by Annex ZA^#)
• Annex H – Reference to the general safety and performance requirements for IVD medical devices (Was previous corresponding list of GSPRs to the EU IVDR list but will be replaced by Annex ZB^#)
• ^# Annex ZA & ZB The FDIS will include Annex ZA & ZB prepared by JTC3 but not the final ISO publication.

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.

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