Recognized Consensus Standards – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Sat, 17 Jan 2026 00:47:11 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png Recognized Consensus Standards – Eisner Safety Consultants https://eisnersafety.com 32 32 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

]]> 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.

]]> 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

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

Join me, Leo Eisner, The IEC 60601 Guy, as I lead an interactive and fun workshop at the 10X Medical Device Conference in Newport Beach, Ca on May 7 – 8, 2025. Turn Medical Device Standards into Your Competitive Advantage, and discover practical strategies to leverage standards, avoid costly errors, and accelerate your product development cycle.

Don’t make the 5 costly mistakes companies make with Medical Device Standards. Learn from the IEC 60601 Guy himself.:

  • Late Identification of Applicable Standards: Leads to expensive redesigns and delayed timelines
  • Ignoring Expert Standards Guidance: Results in regulatory rejections and costly resubmissions
  • Unprepared Risk Management File for Testing: Risks unnecessary costs due to lack of strategic planning for compliance.
  • Unprepared Regulatory Submissions: Leads to costly setbacks and market-entry delays
  • Underestimating Education and Training: Creates knowledge gaps, increasing errors and compliance risks.

I want to thank Sean Smith and his team from 10X for all his help and dedication for putting on this event. He is doing an amazing job and please contact him if you are interested.

Need help with standards?

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

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

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

]]> ISO 20417, 2nd DIS Breaking News from Tokyo Meeting 📣📣 https://eisnersafety.com/2025/03/25/iso-20417-2nd-dis-breaking-news-from-tokyo-meeting-%f0%9f%93%a3%f0%9f%93%a3/?utm_source=rss&utm_medium=rss&utm_campaign=iso-20417-2nd-dis-breaking-news-from-tokyo-meeting-%25f0%259f%2593%25a3%25f0%259f%2593%25a3 Tue, 25 Mar 2025 20:38:12 +0000 https://eisnersafety.com/?p=7774
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👉 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, 2nd 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, 2nd 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, 4th 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, 1st 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, 1st ed. (will be 5.8 ISO 20417, 2nd 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.

]]> 10x Humanizing MedTech: Breaking The Mould For Conferences https://eisnersafety.com/2025/02/11/10x-humanizing-medtech-breaking-the-mould-for-conferences/?utm_source=rss&utm_medium=rss&utm_campaign=10x-humanizing-medtech-breaking-the-mould-for-conferences Tue, 11 Feb 2025 06:39:03 +0000 https://eisnersafety.com/?p=7760

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

]]> IEC 60601 Updates: What MedTech Need to Know for 2025 and Beyond Podcast https://eisnersafety.com/2024/12/12/iec-60601-updates-what-medtech-need-to-know-for-2025-and-beyond-podcast/?utm_source=rss&utm_medium=rss&utm_campaign=iec-60601-updates-what-medtech-need-to-know-for-2025-and-beyond-podcast Thu, 12 Dec 2024 21:46:24 +0000 https://eisnersafety.com/?p=7713

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:

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.

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