ISH1 – 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 ISH1 – Eisner Safety Consultants https://eisnersafety.com 32 32 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

]]> 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

]]> 🎩 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.

]]> 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.

]]> The most valuable asset we each bring to the table is⁉️ Our unique experiences and innovation https://eisnersafety.com/2024/09/30/the-most-valuable-asset-we-each-bring-to-the-table-is%e2%81%89%ef%b8%8f-our-unique-experiences-and-innovation/?utm_source=rss&utm_medium=rss&utm_campaign=the-most-valuable-asset-we-each-bring-to-the-table-is%25e2%2581%2589%25ef%25b8%258f-our-unique-experiences-and-innovation Mon, 30 Sep 2024 06:46:00 +0000 https://eisnersafety.com/?p=7706

Leo Eisner, The60601Guy will be visiting London 🇬🇧🎡🏰 in October. You have the chance to sit down with me, The60601Guy, have a cup a coffee or a beer and talk IEC60601, design for compliance, and standards that apply to your device. I have time slots open on 7, 8, and 11 of Oct. Or join me for a dinner on the 8 or 11 Oct.

Meet me in London – I want to hear from you the week of 7 Oct. These two hour slots are limited before they are gone, 𝗯𝗼𝗼𝗸 𝗻𝗼𝘄 𝗼𝗻 𝗺𝘆 𝘀𝗽𝗲𝗰𝗶𝗮𝗹 𝗰𝗮𝗹𝗲𝗻𝗱𝗮𝗿 for 𝗺𝘆 𝗟𝗼𝗻𝗱𝗼𝗻 𝘃𝗶𝘀𝗶𝘁. I’d love to chat!

Let’s connect, and explore how we can support your company with our international team of compliance & regulatory experts from Eisner Safety Consultants. I’m eager to learn what you’re working on and how you’re driving change and innovation in the industry, and how we can support you to get you to market faster.

Let’s meet up! 𝗕𝗼𝗼𝗸 𝘁𝗶𝗺𝗲 𝗼𝗻 𝗺𝘆 𝘀𝗽𝗲𝗰𝗶𝗮𝗹 𝗰𝗮𝗹𝗲𝗻𝗱𝗮𝗿 for 𝗺𝘆 𝗟𝗼𝗻𝗱𝗼𝗻 𝘃𝗶𝘀𝗶𝘁.

]]> How to ID Applicable Standards – Combinate Podcast https://eisnersafety.com/2024/08/07/how-to-id-applicable-standards-combinate-podcast/?utm_source=rss&utm_medium=rss&utm_campaign=how-to-id-applicable-standards-combinate-podcast Wed, 07 Aug 2024 21:08:23 +0000 https://eisnersafety.com/?p=7632  

Join me, Leonard (Leo) Eisner, the “IEC 60601 Guy”,

in a conversation with Subhi Saadeh of Combinate Podcast

as we look at how to assess applicable standards for medical and combination devices and a few highlights on IEC 60601-1, 4th ed. in Combinate Podcast 148 https://bit.ly/LIPostCombinatePodcast148LeoEisner

He really does his research and is a great interviewer. I always find it fun and intriguing to have a conversation with Subhi as I too learn from our conversations.

We discuss:
☞ complexities in assessing applicable standards
☞ understanding the impact of product environment, intended use, & applicable markets
☞ challenges and strategies for documenting standards assessments
☞ leveraging existing standards to avoid unnecessary development
☞ tips for small and large companies
☞ significance of early research
☞ essential stakeholders involved in standards assessment
☞ and more….

Join us 🫵 in the conversation on LinkedIn and leave your comments so we can continue this discussion.

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic compliance planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs.

We work with many test labs for Medical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

]]> Watch Free Webinar IEC 60601 Amendments & CB Scheme https://eisnersafety.com/2024/06/28/watch-free-webinar-iec-60601-amendments-cb-scheme/?utm_source=rss&utm_medium=rss&utm_campaign=watch-free-webinar-iec-60601-amendments-cb-scheme Fri, 28 Jun 2024 07:18:13 +0000 https://eisnersafety.com/?p=7606

Learn from an 𝗶𝗻𝘀𝗶𝗱𝗲𝗿 𝗰𝗼𝗺𝗺𝗶𝘁𝘁𝗲𝗲 𝗺𝗲𝗺𝗯𝗲𝗿 that wrote portions of 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭-𝟭, 𝗲𝗱 𝟯.𝟮 𝗔𝗺𝗲𝗻𝗱𝗺𝗲𝗻𝘁𝘀 and is involved in the development of the Fourth Edition of IEC 60601-1. If you want to learn about these updates to the standard and the IEC 60601 Amendments Project – You’re in luck – Leonard (Leo) Eisner the “𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭 𝗚𝘂𝘆” from Eisner Safety Consultants partnered with Holly Rossington of BSI to present the webinar “Leveraging the CB Scheme: A Guide for North American Medical Device Manufacturers”

We answered some of the most pressing questions, such as:
• How North American medical device manufacturers can leverage the CB scheme and its benefits.
• Examples of medical devices BSI can certify.
• Key changes introduced in the latest edition of IEC 60601-1 (Ed. 3.2):
o Clause 7, Identification and marking.
o Clause 8, Protection against electrical hazards.
o Clause 13, Hazardous situations and fault conditions.
And lots more.

Watch to the end to get other valuable resources too!!! 💥🎉🥳👍✈

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; training to 3rd or 4th edition; strategic planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs.

We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

Feel free to schedule a meeting Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

]]> Leo Eisner the “IEC 60601 Guy” co-presenter in BSI Webinar https://eisnersafety.com/2024/05/30/leo-eisner-the-iec-60601-guy-co-presenter-in-bsi-webinar/?utm_source=rss&utm_medium=rss&utm_campaign=leo-eisner-the-iec-60601-guy-co-presenter-in-bsi-webinar Thu, 30 May 2024 18:54:07 +0000 https://eisnersafety.com/?p=7559

Webinar: Leveraging the CB Scheme: A Guide for North American Medical Device Manufacturers

When: Tuesday, June 25, 2024  

Time: 11:00 a.m. – 12:00 p.m. EDT 

About the Event: Join BSI & Leo Eisner for an insightful webinar that explores how North American medical device manufacturers can harness the power of the CB Scheme to enhance their global market access. Leo the “IEC 60601-1 Guy” will present the significant updates introduced in the latest edition of IEC 60601-1 Ed. 3.2, which will impact medical device manufacturers.

Sign up for this webinar

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; training to 3rd or 4th edition; strategic planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs.

We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

]]> IEC 60601-1 4th Ed Initial Launch: Positive Impacts Healthcare Standardization https://eisnersafety.com/2024/05/06/iec-60601-1-4th-ed-initial-launch-positive-impacts-healthcare-standardization/?utm_source=rss&utm_medium=rss&utm_campaign=iec-60601-1-4th-ed-initial-launch-positive-impacts-healthcare-standardization Mon, 06 May 2024 04:46:53 +0000 https://eisnersafety.com/?p=7532

Last week, 29 Apr – 3 May 2024, marked a significant milestone for the advancement in the world of patient safety and healthcare. The IEC TC 62/SC 62A convened its IEC 60601-1, 4th edition project kick-off meeting at AAMI in Arlington, Virginia. More than 200 experts from all corners of the globe attended in person, contributing to an inspiring and impactful week-long meeting.

The focus of this meeting was “level setting” all the parties on the development of requirements for the 4th edition of IEC 60601-1, which sets safety requirements for medical electrical equipment (also known as active medical devices). Twelve working groups (WGs) gathered to strategize their efforts, guided by the Design Specification for the 4th edition and the Architecture Specification.  The first day was set with training to help all parties get an understanding of project requirements and ask questions based on the Design Specification and the Architecture Specification. The next 3 days focused on the 12 WGs working on their strategies for the start of the project and the plans to move forward. The last day was a wrap-up and getting feedback on how to improve the process with lots of great discussion from the week. 

An Advisory Group (AG 50) is used to collaborate with all 12 WG co-convenors and secretaries, and IEC SC 62A officers ensuring the overall success of the project.

As a co-convenor for WG39, which addresses User Interfaces (Including information provided by the manufacturer, Alarm Systems and Usability Engineering Process), I am honored to be part of this excursion in the development of this standard for the support of the healthcare industry for the next edition. Alongside my co-convener, Martin Stangenberg, we led discussions and consensus-building within our WG. Our WG is comprised of amazing experts.  We had over 30 experts in the room including regulators from 5 countries; test houses; usability, labeling, alarm systems, and robotics experts. We had over half of our experts from the whole WG in attendance at the meeting. Our responsibilities include coordinating with other experts to develop basic safety and essential performance requirements related to User Interface Aspects Hazards for our part of the standard. Each WG is working on a different set of hazards as described in the post “IEC 60601-1, 4th ed. — Where do we stand?“.

WG 39 Group Photo

As an expert on WG37, I also spent part of the week with WG 37 developing requirements related to general issues concerning underlying concepts including basic safety & essential performance, single fault safety, type testing.  Correlation with processes relevant for IEC 60601-1 defined by other process standards (e.g., risk management) for IEC 60601-1, 4th ed.

It was great to meet all the new people and see them get involved for the first time in the standardization process as well as work with familiar faces I have worked with for many years. It is a well-rounded group of individuals, supporting this next edition, with many different perspectives but with the mindset to provide the patient with a safe product.

Closing Meeting

I extend my appreciation to all who have made this happen — the officers, the design specification and architecture specification teams (a long road to get here), my mentors, and all the national committee experts for coming together in this massive effort. Now the real work of the experts in the WGs begins….

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; training to 3rd or 4th edition; strategic planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs.

We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

]]> FDA Recognizes IEC 60601-1 Edition 3.2 https://eisnersafety.com/2023/04/10/fda-recognizes-iec-60601-1-edition-3-2/?utm_source=rss&utm_medium=rss&utm_campaign=fda-recognizes-iec-60601-1-edition-3-2 Mon, 10 Apr 2023 18:14:20 +0000 https://eisnersafety.com/?p=7333

On April 3, 2023 FDA added IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment – Part 1: General requirements for basic safety and essential performance to their list of Recognized Consensus Standards as Recognition # 19-49 in Recognition List # 060. A reminder that Recognized Consensus standards are considered voluntary by the FDA for premarket submissions but they are what the majority of manufacturers use to facilitate & streamline the premarket process.

Relevant FDA Guidance and/or Supportive Publications*

US national differences:

1. (Recognition Number: 19-46) ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]

2. Attachment Form No.: US_ND_IEC60601_1U ATTACHMENT TO TEST REPORT IEC 60601-1: US NATIONAL DIFFERENCES – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
(https://documents.iecee.org/ords/f?p=702:558:::::P558_DOCUMENT_FILE_ID:2955038)

Note from Leo: This is a US National Difference Test Report Form issued by the CB Scheme for CB scheme reports.

You have 3 options
1 expires after December 17, 2023
The first 2 are acceptable now & going forward.

1) Use IEC 60601-1 Edition 3.2 (Recognition # 19-49) from now onward making sure to use References #1 AND #2.
Note: This first option is the best of the three. Test to the IEC standard as that way you can prepare your product for the US domestic and international markets at the same time. If you pass the testing you’ll meet most if not all requirements and then you can deal with the few US National Differences by applying the US National Differences which are also in item 2) of this list anyway. This is less restrictive for your product than if you test your product to the US version of the standard (ANSI AAMI – Item 2 of this list) and then try to go to the international market which most countries will require IEC testing anyway.

2) Use ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] (Recognition Number: 19-46) from now onward.
Note: This SIS is an older Recognized Consensus Standard but by inference, one would be wise to make sure that you also get the US National Difference Test Report mentioned above for the IEC 60601-1, ed. 3.2 which is based on the ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] (Recognition Number: 19-46)

3) During the transition period FDA will accept a declaration of conformity in support of premarket submissions to the older ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) (Recognition Number: 19-4) but it will be superseded by recognition of ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) [Including Amendment 2 (2021)] (Recognition Number: 19-46) after December 17, 2023.
Note: The SIS says that Recognition Number: 19-4 (ANSI/AAMI ES60601-1, edition 3.1) by Recognition Number: 19-46 (ANSI/AAMI ES60601-1, edition 3.2) but if you are smart I would switch to Recognition Number 19-49 (IEC 60601-1, edition 3.2). FDA should accept this Recognized Consensus standard for your premarket submission as long as your submission includes the US national differences References #1 & #2.

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs. Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.

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