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.

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.

This is an amazing resource that MedTech Leading Voice has put together and is free to download.

‘This isn’t a “best of” list – it’s a guide to people worth following …

 It’s a guide to 100 individuals worth following on LinkedIn—people who are sharing unique insights, actionable advice, and thought-provoking content.’ – Sean Smith, MedTech Leading Voice

• So, what now?
  Browse through to find leaders you want to follow – lots of different categories and interests
  Explore their insights
  Share your favorites in Leo Eisner’s LinkedIn Post comments for the MLV100

Now for my story of how I made it onto the MLV100 Yearbook list – Thank you Sean, Mike and many others in the MedTech community

My credo: “I like to support my clients and the MedTech industry in understanding standards, regulations, laws, and guidance. This is one of our cornerstones to support our clients from the  beginning of the design and development process.”

My journey began, straight out of college, in 1985 at Underwriters Laboratories, where I gained experience in various product and component test standards, including UL and NFPA.

I joined TÜV SÜD in 1994, starting my medical career. I worked with medical electrical standards UL 601-1, UL 544, and IEC 60601-1, 2nd ed. and became an MDD auditor.

Moved into an industry role for a couple years and then decided to start up my consulting company in 1998 full time.

I have been fortunate to be involved in standards development over the past 20+ years to benefit my clients and industry. This helps me stay updated and assist my clients in product design and development.

My focus has been IEC 60601-1. I am one of the conveners for the 4th ed. of IEC 60601-1 which is under development currently. But I am also involved in a lot more standards than just IEC 60601-1.  Check out my LinkedIn profile.

I have always been happy to share my knowledge via blog posts, articles, webinars, and podcasts.

It’s an honor to be included with this amazing listing of MedTech experts, Regulators, entrepreneurs, and influencers.

Thank you, Sean and MedTech Leading Voice, for including me on this impressive and very unique list. You’ve built a collaborative community that enhances skills and knowledge in the MedTech community!

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.

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

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

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

Key Points:

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

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

Resources:

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

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

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

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

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

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

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

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

If you found this interesting or helpful, consider reposting on LinkedIn; follow me, Leonard (Leo) Eisner, the60601Guy and click the so you don’t miss future content.

Need Help?

Need help with 60601 series standards including EMC? Eisner Safety Consultants can assist with strategic compliance planning for your medical electrical product lines, provide support when FDA or a regulator asks questions for a submission, and more. We deal with EU, US, and other country regulatory requirements, standards, laws, directives, and more. Our team also provides support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs, and more. We work with many test labs for medical safety and EMC and can arrange other testing as well. Feel free to schedule a web meeting with Leo or contact us.

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

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

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

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

Free presentation in London — With Leo Eisner, The60601Guy, & Ian Sealey

𝗪𝗵𝗮𝘁’𝘀 𝗼𝗻 𝘁𝗵𝗲 𝗺𝗲𝗻𝘂?

• Some 𝗳𝘂𝘁𝘂𝗿𝗲 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 of IEC60601-1 , 4th being considered you 𝙢𝙖𝙮 𝙣𝙤𝙩 𝙚𝙭𝙥𝙚𝙘𝙩:
Gas Pathways,
Cleaning,
Disinfection,
AI/ML,
Voice Input/Output,
Adhesives for Applied Parts,
PPE,
and so much more….

• IEC60601-1 , 4th Ed.
• Applicable Standards
• Future Proofing Test Plans

IEC 60601-1, 4th edition is currently in development and there are some SIGNIFICANT changes underway.

Ian Sealey, Michael Kipping, James Pink and I, Leonard (Leo) Eisner, The60601Guy, will be discussing the changes, indicative timescales, and how to plan for them.

𝗪𝗵𝗲𝗻, 𝘄𝗵𝗲𝗿𝗲, 𝗵𝗼𝘄:
7 𝘖𝘤𝘵𝘰𝘣𝘦𝘳 2024
𝘊𝘭𝘢𝘺𝘵𝘰𝘯 𝘏𝘰𝘵𝘦𝘭 𝘊𝘩𝘪𝘴𝘸𝘪𝘤𝘬
𝘈𝘳𝘳𝘪𝘷𝘢𝘭 𝘧𝘳𝘰𝘮 𝟱:𝟬𝟬𝙥𝙢
𝘚𝘵𝘢𝘳𝘵 𝟱:𝟯𝟬𝙥𝙢
𝘌𝘯𝘥 𝟴:𝟰𝟱𝙥𝙢
𝙉𝙚𝙩𝙬𝙤𝙧𝙠𝙞𝙣𝙜 𝙖𝙣𝙙 𝙙𝙧𝙞𝙣𝙠𝙨 afterwards

TICK TOCK – Time is starting to run out for signing up for this event. If you wait too long there won’t be room so sign up now before we fill up. Don’t wait tooooooo long and miss this great opportunity to learn from experts.

Register by using our Contact form, send Leo an email (go to bottom of page) or send Leo a LinkedIn message via his profile.

Join the conversation on the LinkedIn Post and leave a comment.

𝗪𝗵𝗮𝘁 𝗦𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 𝗔𝗽𝗽𝗹𝘆 𝘁𝗼 𝗠𝘆 𝗗𝗲𝘃𝗶𝗰𝗲? Podcast with one of the best MedTech podcasters Etienne Nichols – Greenlight Guru‘s very own

𝗞𝗲𝘆 𝗧𝗼𝗽𝗶𝗰𝘀:
• Why standards like IEC60601 are crucial for medical device development
• Steps for identifying proper standards for your product
• How to integrate standards into your design process
• Mistakes & consequences of ignoring standards
• Tools for staying updated on changing standards & regulations
• How startups can navigate standards with limited resources

If you have any thoughts and comments on the podcast I’d would like to hear from you Comment on the LinkedIn post about the Podcast

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 with 60601 series standards including EMC; strategic compliance planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Eisner Safety Consultants team of experts also provides support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs and more. His team includes experts on additional standards committees and we all talk to the regulators regularly. We’re here to support your needs.

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

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

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.