leoeisner – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Sun, 01 Mar 2026 09:36:37 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png leoeisner – Eisner Safety Consultants https://eisnersafety.com 32 32 IEC 60601, 4th Edition: What’s Changing and How to Prepare https://eisnersafety.com/2026/02/28/iec-60601-4th-edition-whats-changing-and-how-to-prepare/?utm_source=rss&utm_medium=rss&utm_campaign=iec-60601-4th-edition-whats-changing-and-how-to-prepare Sat, 28 Feb 2026 21:33:00 +0000 https://eisnersafety.com/?p=8486
IEC 60601-1, 4th Edition
Strategic Shifts and How to Prepare

Companion post to my Easy Medical Device podcast episode on IEC 60601-1, 4th Ed., focused on what is shifting across the Working Groups and what RA/QA, Design, Test, and Management teams should do now.

Most organizations will feel the impact long before any formal transition date. The practical shift is that evidence expectations are tightening, scope is becoming clearer, and the standard’s direction is being shaped now through Working Group outputs. Teams that treat this as a design input and planning topic today will avoid late-cycle surprises in test strategy, labeling, and documentation tomorrow.

IEC 60601-1, 4th Edition Resource Kit One-Pager

Translate 4th Edition Direction into Organizational Action

Quick to read and easy to share across RA/QA, Design, Documentation, Supply Chain, Test, and Management. Use it to brief teams and kick off impact planning for IEC 60601-1, 4th Edition.

Your 4-Part Resource Kit
Listen to Podcast Episode Watch YouTube Interview EMD Magazine #2 Feature 4th ed. Survival Guide
Download One-Pager PDF

Use this one-page briefing handout to kick off internal alignment across RA/QA, Design, Test, Documentation, Supply Chain, and Management.

Read High-Level Overview

This newsletter provides a high-level overview of 4th Edition preparation themes, including transition timing, regulatory positioning, and early planning actions. For deeper technical shifts that drive design inputs and evidence expectations, use the podcast and the one-pager as the primary briefing baseline.

Why this matters for MedTech

The architecture is structured around 12 hazard-based Working Groups, with a much expanded and clearer scope. There are stronger expectations for intended use, user environments, software and PEMS, wireless coexistence, and emerging EMF exposure concepts. These changes will flow into design inputs, QMS documentation, labeling and IFUs, verification and validation evidence, and test strategy.

Across the Working Groups, changes are focused on

  • Scope and Essential Performance
  • User environments and intended use
  • Software and PEMS
  • International wireless coexistence expectations
  • EMF exposure concepts
  • Hazard-based structure

How to use this kit

  1. Brief leadership using the podcast as the shared baseline.
  2. Revisit your intended use, user environments, and understand the changing scope of the standard now.
  3. Assign owners to track the Working Groups most relevant to your product and markets.
  4. Track areas likely to affect:
    • QMS documentation
    • Labeling and IFUs
    • Test strategy and test planning
    • Design impacts
    • Impact register – track what impact your company expects and what decisions you are making now

Related resources from my earlier Survival Guide

If you want the broader 4th Edition transition kit from my Survival Guide, it includes the MLVx one-pager, my MLVx webinar replay, a summary article, and the slide deck.

Want deeper analysis beyond LinkedIn?

My newsletter is where I publish longer-form breakdowns and structured updates that are not always fully posted on LinkedIn.

Subscribe to the ESC Newsletter Schedule a Call

If your team needs help mapping 4th Edition direction into design controls, QMS, labeling, or test strategy, my team at Eisner Safety Consultants can support you.

]]> Dec 22, 2025: FDA Updated Its Recognized Consensus Standards db 100+ New Or Updated Standards https://eisnersafety.com/2026/01/04/dec-22-2025-fda-updated-its-recognized-consensus-standards-db-100-new-or-updated-standards/?utm_source=rss&utm_medium=rss&utm_campaign=dec-22-2025-fda-updated-its-recognized-consensus-standards-db-100-new-or-updated-standards Sun, 04 Jan 2026 11:15:53 +0000 https://eisnersafety.com/?p=8406 FDA Updated Its Recognized Consensus Standards db FDA Recognized Consensus Standards Update

Key themes: IEC 60601/80601, IEC 61326-2-6, ISO 15223-1 A1:25, & ASCA considerations

In late December 2025, the FDA expanded its Recognized Consensus Standards Database, adding more than 100 new or updated standards. Some are eligible for use under the ASCA Program, while others carry important implications for design, testing, labeling, and overall regulatory strategy.

Regulatory expectations around standards are shifting earlier in the product lifecycle. Standards are no longer something teams can simply “handle at test.” Reviewers increasingly expect standards interpretation, risk decisions, and test strategies to be visible and justified during design reviews and technical documentation development. This reinforces why understanding not just which standards are recognized, but how they are recognized and applied, matters more than ever.

What the latest FDA update included

The scope of this database expansion spans a wide range of medical device technologies, including medical electrical equipment, IVDs, software-driven devices, imaging systems, interoperability standards, and labeling-related standards.

Beyond simply identifying newly recognized standards, the changes highlight how recognition status, ASCA eligibility, and extent of recognition can materially affect how conformity is demonstrated, how evidence is presented, and how submissions are reviewed.

Over the past year, I’ve been sharing what I’m seeing based on feedback gathered from many sources, including my Eisner Safety Consultants experts and discussions across the community with regulators, standards developers, test labs, and manufacturers. The goal is practical clarity: what changed, what it means, and what teams should do next as they navigate evolving standards expectations and regulatory requirements.

IEC 60601 / 80601 standards in the update

For manufacturers of medical electrical equipment, the December 22, 2025 update includes several standards from the IEC 60601 and 80601 series. These standards remain central to demonstrating basic safety and essential performance for medical electrical equipment. However, recognition alone does not mean every clause or requirement is fully accepted without qualification.

Standards called out in the December 22, 2025 update
(from the FDA database extract)

Standard Title (abbreviated) FDA Recognition No. Extent of Recognition
IEC 80601-2-70:2025 Sleep apnoea breathing therapy equipment 1-199 Complete
IEC 60601-2-31:2020 External cardiac pacemakers 3-201 Complete
IEC 60601-2-34:2024 Invasive blood pressure monitoring 3-202 Complete
IEC 80601-2-49:2024 Multifunction patient monitoring equipment 3-203 Partial*

* Partial recognition. The following part(s) of the standard is (are) not recognized:
Subclause 202.8.101 “IMMUNITY test setup” – Reference to table height (>= 0,4 m) for IMMUNITY testing in Figure 202.101.
Refer to Rationale for Recognition for explanation of partial recognition.

EMC context within the IEC 60601 / 80601 framework

IEC 60601-1-2 remains the primary EMC standard within the IEC 60601 series. However, other IEC 60601 standards can and do include EMC-related requirements. Applicability must be assessed standard by standard, based on the specific requirements of each applicable document.

This context becomes especially important when considering how EMC expectations are addressed across different standard families, including IVD-specific EMC requirements discussed next.

IVD EMC and IEC 61326-2-6

A notable change reflected in the FDA Recognized Consensus Standards Database is the inclusion of IEC 61326-2-6 Edition 4 as a Recognized Consensus Standard, with ASCA eligibility under the ASCA Program, effective July 28, 2025.

This is significant because IEC 61326-2-6 is the primary EMC standard used to demonstrate electromagnetic compatibility for IVD medical equipment, and its inclusion under ASCA directly affects how EMC conformity evidence may be presented in FDA submissions.

However, ASCA eligibility alone does not guarantee streamlined review.

For manufacturers intending to rely on ASCA pathways for IVD EMC:

  • Test lab scope must be verified as active for the specific standards and applicable editions being claimed.
  • If a standard or edition is not within a laboratory’s ASCA-accredited scope, manufacturers cannot rely on an ASCA Summary Test Report for that standard.
    • In those cases, full EMC test reports remain necessary, and FDA review timelines are typically longer.

As of early January 2026, there are no ASCA-accredited laboratories that reflect IEC 61326-2-6 Edition 4 within their active scope. This creates a practical timing and planning consideration for manufacturers preparing IVD submissions that intend to leverage ASCA.

This gap does not change the applicability of IEC 61326-2-6 itself, but it does affect how conformity evidence can be packaged and reviewed until laboratory scopes are updated.

ISO 15223-1 Amendment 1:2025 and labeling implications

Authorized Representative symbol changes and labeling impact

ISO 15223-1 Amendment 1:2025 introduces a substantive correction to the requirements for the Authorized Representative symbol that has direct regulatory and labeling implications across multiple markets.

This change is implemented through a revision to Clause 5.1.2, which governs how the Authorized Representative symbol is applied.

Clause 5.1.2 – prior to Amendment 1:2025

“This symbol shall be accompanied by the name and address of the authorized representative, adjacent to the symbol.”

Under this wording:

  • The symbol itself did not explicitly encode the jurisdiction
  • The convention of using “EC REP” persisted in practice, even after the transition from the MDD & IVDD to EU MDR and IVDR
  • This created ambiguity for non-EU markets and for products marketed globally under different regulatory frameworks

Clause 5.1.2 – after Amendment 1:2025

“The [XX] text of the symbol shall be replaced by either the two-letter country code or the three-letter country code defined in ISO 3166-1 or other text required by the authority having jurisdiction.

This symbol shall be accompanied by the name and address of the authorized representative adjacent to the symbol.”

Key changes introduced by this amendment:

  • The Authorized Representative symbol must identify the jurisdiction represented
  • The jurisdiction identifier is no longer implicit or assumed
  • Country-specific representation is now explicitly required using ISO 3166-1 codes or authority-mandated text

This change aligns the symbol requirements with:

  • EU MDR and IVDR expectations for EU Countries
  • Non-EU regulatory frameworks that require local authorized representation
  • Global labeling clarity for multi-market products

Practical application of the revised requirement

International example

Used for countries outside the EU, such as Switzerland or the United Kingdom.

Examples:

  • CH REP for Switzerland
  • UK REP for the United Kingdom

Convert from EC Rep to International two-letter country code Authorized Representative Symbol

EC REP to XX REP symbol example

EU example

Used for EU Member States.

Convert from EC Rep to EU Rep Authorized Representative Symbol

EC REP to EU REP symbol example

Labeling and change-control implications

Symbol changes cascade into artwork, IFUs, packaging, and labeling change control. This affects and has significant impact on:

  • Device labels
  • IFUs
  • Packaging artwork
  • Labeling control procedures

These changes must be assessed and implemented through formal labeling change processes, not treated as isolated graphic updates.

Need help turning standards updates into practical actions?

My team & I at Eisner Safety Consultants supports medical device, diagnostic, and combination product manufacturers by translating standards into practical design inputs, test strategies, and documentation approaches aligned with FDA and other market expectations.

Keep the conversation going on LinkedIn

Add your perspective to the discussion on the December FDA standards update, including ASCA, IEC 60601/80601, IVD EMC,
ISO 15223-1 A1 & how these changes play out in practice.

Dec 22, 25 FDA db update (includes info on AAMI CR515:2025)

Recent FDA Recognized Consensus Standards Update
What Medical Device Manufacturers Should Know

Related technical discussion

High-engagement discussion on IVD EMC & ASCA implications:
IEC 61326-2-6 (IVD EMC) | 55+ comments

Reference materials

FDA Recognized Consensus Standards Database:
December 22, 2025 (all 100+ standards)

ASCA Eligible Standards List: December 22, 2025

]]> Medical Device Compliance & Certification Summit – Why It Matters? https://eisnersafety.com/2025/12/23/medical-device-compliance-certification-summit-why-it-matters/?utm_source=rss&utm_medium=rss&utm_campaign=medical-device-compliance-certification-summit-why-it-matters Tue, 23 Dec 2025 23:30:37 +0000 https://eisnersafety.com/?p=8390 /* Wrapper */ .esc-wrap{max-width:980px;margin:0 auto;font-family:inherit} /* Title + intro */ .esc-hero h1{font-size:44px;line-height:1.15;margin:0 0 14px} .esc-hero p{font-size:18px;line-height:1.65;margin:0 0 14px} /* Main image under title */ .esc-mainimg{margin:18px 0 28px} .esc-mainimg img{ display:block; width:100%; max-width:100%; height:auto; border-radius:18px; } /* Super hero info box */ .esc-callout{ background:#EAF3FF; border:1px solid #CFE2FF; border-radius:22px; padding:28px; margin:32px 0 42px; } .esc-callout h3{font-size:26px;line-height:1.2;margin:0 0 10px} .esc-callout p{font-size:18px;line-height:1.65;margin:0 0 12px} /* Buttons */ .esc-btnrow{ display:flex; gap:12px; width:100%; margin-top:14px; } .esc-btn{ flex:1 1 0; display:inline-flex; align-items:center; justify-content:center; padding:14px 16px; border-radius:14px; text-decoration:none; font-weight:700; color:#fff !important; background:#1F3B76; white-space:nowrap; box-sizing:border-box; } .esc-btn.secondary{background:#0F2E63} /* Headings */ .esc-h2{font-size:32px;line-height:1.2;margin:38px 0 14px} /* CTA block */ .esc-cta{ background:#EAF3FF; border:1px solid #CFE2FF; border-radius:22px; padding:36px; margin:44px 0; } .esc-cta h3{font-size:30px;line-height:1.2;margin:0 0 10px;color:#0F2E63} .esc-cta p{font-size:18px;line-height:1.6;margin:0 0 12px;color:#111} /* Mobile */ @media (max-width:860px){ .esc-btnrow{flex-direction:column} .esc-btn{width:100%} }

Medical Device Compliance & Certification Summit – Why It Matters?

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

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

Operating room with C-arm imaging system and surgical robot – medical device compliance context

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

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

In-Person Training & Live Workshops

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

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

Registration Summit Details

Who this summit is designed for

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

What attendees will learn

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

How Eisner Safety Consultants Can Help

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

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

Registration Summit Details

]]> What’s NASA & Star Trek have to do with IEC 60601? https://eisnersafety.com/2025/11/29/whats-nasa-star-trek-have-to-do-with-iec-60601/?utm_source=rss&utm_medium=rss&utm_campaign=whats-nasa-star-trek-have-to-do-with-iec-60601 Sat, 29 Nov 2025 05:19:05 +0000 https://eisnersafety.com/?p=8368
From NASA to IEC 60601 – A Lifelong Trek for Safer Devices hero image
Jump to the article Listen to the episode

When I was in high school, I had no idea a simple work study opportunity would redirect my entire future. That is exactly what happened when I was beamed over to NASA for the first time. That early exposure to real world engineering lit a spark that has stayed with me ever since. A curiosity for science, safety, and how technology can genuinely serve people.

All these decades later, that same curiosity still energizes my work with IEC 60601, patient safety, and supporting the MedTech industry. So when I joined Faisal Kamal on The ⭕ Podcast, it felt like a perfect chance to bring all these threads together. Star Trek. NASA. Standards. Innovation. Human factors. EMS & Home use environments.. And above all, patient safety.

Judging by the conversation that unfolded across LinkedIn afterward, I was not the only one who felt the episode combined heart, humor, and hard won lessons in a very different way.

Standards Are Not Rulebooks. They Are Star Maps.

One of the core themes Faisal and I explored on the podcast was the idea that IEC 60601 is not just a set of rules. It is a star map.

A star map built from decades of engineering mistakes, test data, regulatory learning, and field experience.

Many people see standards as obstacles. In reality, standards like the IEC 60601 series are a knowledge base created to unlock innovation safely, not shut it down.

Several people who reacted to the episode picked up on that idea. They commented on how the format allowed serious topics like risk, essential performance, and compliance to feel more approachable. That mix of education and entertainment was exactly what we were hoping for.

Why Star Trek Got So Much Right

A fun part of the episode, and something listeners responded to strongly, was connecting Star Trek’s fictional tools to real world design challenges.

Take the tricorder. It is a great analogy for electronic medical devices used in the home and in EMS environments. These are unpredictable spaces filled with:

  • noise
  • chaotic motion
  • temperature shifts
  • RF interference
  • unexpected stress

The 4th edition of IEC 60601 intentionally integrates these concepts. It pushes engineers and manufacturers to design for the environments where devices actually get used, not just for clean lab conditions.

The underlying idea is simple and powerful. Reliability under stress is at the heart of essential performance and patient safety.

The Human Side Of Standards Work

Another meaningful thread that came out in the comments was the human side of the story.

People commented that the journey from NASA to MedTech felt inspiring and very real. Hearing that from respected peers in the MedTech community meant a lot to me personally.

IEC 60601 discussions rarely highlight the human side of standards work. The early influences. The mentors. The choices that move someone from pure engineering into safety and compliance. Those pieces matter.

As Faisal noted, learning about the path from NASA to medical device safety helped make the technical content more relatable and more human.

Building The Next Generation Of Standards Developers

A theme that resonated with several colleagues, including Beat Keller and others who shared or commented, was the hope that this episode reaches the “Next Generation” of engineers and standards enthusiasts.

Right now, more experts are aging out of standards development than new people are joining. The future of safe medical device design depends on bringing younger professionals into the process.

If even a handful of listeners feel curious enough to explore standards work after hearing this episode, that is a tremendous win not only for me personally but for the whole MedTech industry as a whole. We desperately need “new blood” to come into standards development.

A Community Effort

Many colleagues across LinkedIn reposted, amplified, and commented on the podcast. I am grateful for every one of them.

From Trekkie references to technical reflections to notes from people who simply enjoyed the story

the engagement showed how enthusiastic and thoughtful the MedTech safety community really is.

Where To Listen

If you have not listened yet, I welcome you to take the journey.

“The Star Map to the Future with Leo Eisner The IEC 60601 Guy” on The ⭕ Podcast.

It mixes sci fi, standards, storytelling, and safety into a format that is both fun and unexpectedly educational to make it edu-tainment.

You can listen to the full episode through The ⭕ Podcast and through the episode links shared on my LinkedIn post and on Faisal’s page.

Closing Thoughts

Thank you to everyone who listened, commented, shared, or supported the conversation.

Here is to curiosity, creativity, and keeping patients safe in every environment on every device across every generation whatever race you are where ever you are in the galaxy

Live Long and Prosper my Friends one and all
🖖🚀

Leonard “Leo” Eisner
The IEC 60601 Guy

A quick snapshot of how we help

This one-page overview summarizes our core focus areas in product safety, EMC, risk management, labeling, and training.

Eisner Safety Consultants – Services Summary

You are welcome to read, share, or save this summary if it is helpful for your team.

Download services summary (PDF)
Ready to turn your own “star map” into a safer device?
If this journey from NASA to IEC 60601 resonated with you and you are working on a device that needs to be safe in every environment it touches, my team and I would be honored to help.
Schedule a call with Leo Learn more about our work

]]> From Engineer To “The IEC 60601 Guy” – Project MedTech Podcast https://eisnersafety.com/2025/10/19/from-engineer-to-the-iec-60601-guy-project-medtech-podcast/?utm_source=rss&utm_medium=rss&utm_campaign=from-engineer-to-the-iec-60601-guy-project-medtech-podcast Sun, 19 Oct 2025 00:04:30 +0000 https://eisnersafety.com/?p=8354
Podcast Feature

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

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

Episode 235

Project Medtech Podcast Episode 235 – Leo Eisner
Listen on Web Open Spotify

A quick personal note

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

Key takeaways from the episode

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

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

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

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

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

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

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

What peers said

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

— Beat Keller

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

— Ronald Boumans

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

— Tibor Zechmeister

Continue the discussion on this topic on LinkedIn

How We Can Help

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

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

]]> IEC 60601-1, 4th Edition Survival Guide – Why It Matters For MedTech https://eisnersafety.com/2025/09/30/iec-60601-1-4th-edition-survival-guide-why-it-matters-for-medtech/?utm_source=rss&utm_medium=rss&utm_campaign=iec-60601-1-4th-edition-survival-guide-why-it-matters-for-medtech Tue, 30 Sep 2025 09:23:00 +0000 https://eisnersafety.com/?p=8326

IEC 60601-1, 4th Edition Survival Guide – Why It Matters For MedTech

The 4th Edition of IEC 60601-1 is no longer a future concern. Eleven of the twelve hazard fragments (WGs 37–48) have circulated Committee Drafts (CDs). All fragments have issued first CDs (WG 47 is at CD2), except WG 45 (Optical Radiation Hazards).

That means manufacturers, design houses, trade associations, test houses, and regulators must follow the working group outputs closely. If you cannot stay directly engaged in National or International (IEC) committees, you will need trusted expert guidance. These changes will impact design, QMS, labeling and IFUs, documentation, and test strategies.

One-Pager: 9 Things RA/QA Leaders Must Know

Download the One-Pager: 9 Things RA/QA Leaders Must Know

Quick to read and easy to share with RA/QA, Design, Documentation, Supply Chain, Test, and Management. Use it to brief teams and kick off transition planning for IEC 60601-1, 4th Edition.

📌 WG Status at a Glance

First-round CD comment periods are closed; the Compilation of Comments (CC) now drives edits in each WG. Expect a first wave of CD2s planned for early Dec 2025 after the Nov 2025 Milan work week, and a second wave following the Apr 2026 Shanghai meetings around Jun 2026. Stay current with CDs and CCs — or engage experts — because changes here will flow into design inputs, QMS, labeling/IFUs, V&V, and documentation.

Working Group Key Document CD Status CD Comment Period Compilation of Comments / Next Milestone
WG 37 – General requirements62A/1628/CD1st CD circulated Dec 2024closed Feb 28, 202562A/1656/CC resolve by Dec ’25; iss CD2
WG 38 – Environmental & electromagnetic environments62A/1630/CD1st CD circulated Dec 2024closed Feb 28, 202562A/1658/CC resolve by Dec ’25; iss CD2
WG 39 – User interface & alarm hazards62A/1631/CD1st CD circulated Dec 2024closed Feb 28, 202562A/1659/CC resolve by Dec ’25; iss CD2
WG 40 – Materials hazards62A/1632/CD1st CD circulated Dec 2024closed Feb 28, 202562A/1660/CC resolve by Dec ’25; iss CD2
WG 41 – Programmable electrical medical systems62A/1675/CD1st CD circulated Jun 2025closed Sep 12, 202562A/1695/CC resolve by Jun ’26; iss CD2
WG 42 – Electrical hazards62A/1676/CD1st CD circulated Jun 2025closed Sep 12, 202562A/1696/CC resolve by Jun ’26; iss CD2
WG 43 – Mechanical hazards62A/1677/CD1st CD circulated Jun 2025closed Sep 12, 202562A/1697/CC resolve by Jun ’26; iss CD2
WG 44 – Thermal & mechanical energy hazards62A/1673/CD1st CD circulated Jun 2025closed Sep 12, 202562A/1698/CC resolve by Jun ’26; iss CD2
WG 45 – Optical radiation hazards—No CD circulated yetNext: issue CD1: TBDResolve by: TBD; Next milestone: compile CC after CD1
WG 46 – Ionizing radiation hazards62A/1671/CD1st CD circulated Jun 2025closed Sep 5, 202562A/1693/CC resolve by Jun ’26; iss CD2
WG 47 – Electromagnetic exposure hazards62A/1666/CD (CD2)2nd CD circulated Jun 2025closed Aug 29, 202562A/1689/CC discuss @ next mtg 2025-11-03
WG 48 – Electromagnetic disturbances hazards62A/1672/CD1st CD circulated Jun 2025closed Sep 5, 202562A/1694/CC resolve by Jun ’26; iss CD2

9 things RA/QA leaders must know

📄 One-Pager

Sean Smith captured nine essentials from the webinar (timestamps included):

  1. Scope & Essential Performance; the boundaries for design, testing and compliance
  2. Use Environments & Users; usability files and IFUs must match
  3. Software Requirements Expanded; PEMS, SaMD, SIMD now covered
  4. Collaterals Integrated; 1,000+ pages, one-stop standard
  5. QMS Impact Areas; labeling, ISO 20417 reliance
  6. EMC & Wireless Coexistence; higher RF fields, coexistence testing
  7. Regulator Participation & Timeline; April 2030 + transition window
  8. Hardware & Documentation Updates; alarms, usability, labeling, V&V
  9. Immediate Actions; build an impact register, update labeling, begin EMC testing

The webinar replay

▶ Watch Webinar

The replay provides the why — why regulators are focusing on scope and user environments, how expanded software/PEMS requirements shift the burden of evidence, and why wireless coexistence is no longer optional outside the US.

The summary article

📝 Summary Article

This article organizes the hour-long webinar into a reference that RA/QA leaders and design managers can use to pinpoint pain points to focus on to avoid the fire drills of last-minute planning.

How to use this survival kit

  1. Kick off a cross-functional session using the one-pager as the agenda
  2. Watch replay segments together (software, EMC, labeling, etc.)
  3. Assign owners for each of the 12 hazard Working Groups across RA/QA, Design, Test
  4. Use the article as a quick reference to keep momentum
  5. Track WG outputs and rely on your internal or external experts

one-pager for overview, the replay for context, the article for detail, and the slide deck for depth give your team a GPS starting point for 4th Edition readiness.

How We Can Help

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

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

Keep the Conversation Going

]]> What IVD Manufacturers Need To Know About IEC 61326-2-6:2025 https://eisnersafety.com/2025/08/31/what-ivd-manufacturers-need-to-know-about-iec-61326-2-62025/?utm_source=rss&utm_medium=rss&utm_campaign=what-ivd-manufacturers-need-to-know-about-iec-61326-2-62025 Sun, 31 Aug 2025 21:28:00 +0000 https://eisnersafety.com/?p=8039

IVD EMC and IEC 61326-2-6:2025
FDA Recognition & the Tougher Road Ahead

FDA fully recognized IEC 61326-2-6:2025 and included it in ASCA on July 28, 2025. Here’s what changes and how IVD manufacturers should respond.

Lab technician working with chemistry analyzer in a modern IVD lab

Bottom line: many will assume this removes the burden of IEC 60601-1-2 compliance. The reality is more nuanced. Parts of 60601-1-2 were incorporated into the updated 61326-2-6, and Essential Performance and risk management remain critical. The FDA 2022 EMC Guidance still applies.

The technical reality – 4 key takeaways

The technical reality – 4 key takeaways for IEC 61326-2-6:2025

Global implications

IEC 61326-2-6:2025 applies internationally, not just in the United States. Update your compliance strategy across markets, not only for FDA submissions.

Global compliance concept

What manufacturers should do now

If your EMC test plans, risk analysis, or labeling still reference IEC 60601-1-2 or IEC 61326-2-6:2020 for IVDs, it’s time to recheck your EMC strategy ✔

Checklist – What manufacturers should do now for IEC 61326-2-6:2025
  • Refresh your risk management file and test plans to align with 61326-2-6:2025.
  • Train teams on how Essential Performance still factors into acceptance criteria and test objectives.
  • Anticipate ripple effects from CISPR 11:2024 when 61326-1 updates land.

Keep the Conversation Going

Continue the discussion on LinkedIn:

Useful references

At Eisner Safety Consultants, we have multiple EMC experts ready to support you. If you’d like to schedule a free 30-minute meeting with me, Leo, The IEC 601 Guy, to discuss your needs, I’d be glad to help.

Explore more insights on my blog: Standards Updates or see my previous Podcasts.

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

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

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

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

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

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

What the Industry Is Talking About

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

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

Replay Video

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

👉 Download the slides here

Why This Matters

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

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

How We Can Help

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

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

Keep the Conversation Going

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

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

]]> Major changes to IEC 60601-1 are closer than you think https://eisnersafety.com/2025/08/15/major-changes-to-iec-60601-1-are-closer-than-you-think/?utm_source=rss&utm_medium=rss&utm_campaign=major-changes-to-iec-60601-1-are-closer-than-you-think Fri, 15 Aug 2025 18:53:33 +0000 https://eisnersafety.com/?p=7854

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

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

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

Event Recap – MLVx Friday In-Focus

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

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

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

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

Unlock Your IEC 60601-1 Insider Advantage

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

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

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

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

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


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

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

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

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

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

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


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

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

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

• WG 42 – Electrical hazards 🔗 WG 42 link

• WG 43 – Mechanical hazards 🔗 WG 43 link

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

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

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

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

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

The early pack of CD1 Fragments released late last year

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

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

Who Should Be Reviewing

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

✅ What You Need to Do

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

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

Need help with standards?

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

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

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

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