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’s on the menu?

Where are we headed with 4th Ed.?
Structure changes;
Project timeline: and
Critical documents

Leo Eisner, the “IEC 60601 Guy”, of Eisner Safety Consultants will be your guide

What to do in the meantime?
Select applicable and normative standards for testing; and
How to set up a solid future-proof test plan

Ian Sealey of Vertexian will explain it

When, Where, How:

7 October 2024

Clayton Hotel Chiswick
Arrive 5:00 PM
Starts 5:30 PM
Ends 8:45 PM

Networking and meet for drinks afterwards

Register by either using our Contact form or send Leo a LinkedIn message via his profile.

If you would like to meet with Leo during the week of 7 Oct in London please contact him to schedule this rare opportunity.

Presenters Background:

Leo is the founder and principal compliance and regulatory consultant of Eisner Safety Consultants (ESC), ESC provides the medical device industry (from SME’s to Fortune 500’s) with product safety compliance & regulatory support focused on:

• design for compliance to IEC 60601 series of standards;
• design reviews against applicable requirements;
• identification of applicable standards, laws, regulations, directives and guidances;
• labeling reviews;
• support with test labs;
• training

Leo’s leadership and commitment in the standards development process runs deep and over many years including his involvement in numerous IEC, ISO, and AAMI working groups, committees, and maintenance teams over the last 20 years. 
His IEC 60601-1, 4^th edition involvement:

• Co-Convener of IEC/TC 62/SC 62A/WG39 – User interface aspects
• Advisory group member of IEC/TC 62/SC 62A/AG 50 – IEC 60601-1 Ed. 4.0 editing & leadership team
• Committee member IEC/SC 62A/WG37 – General requirements

To see a more detailed list go to Leo’s LinkedIn Profile.

Ian Sealey is the founder of Vertexian and is a medical device regulatory and quality consultant, with over 25 years’ experience. Vertexian provides the medtech industry with support in the following areas:

• electromedical devices;
• risk management;
• pre-compliance testing;
• training;
• UKCA marking; and
• manufacture of IEC test equipment

He was Assistant Secretary to the Board of the Department of Health (DH), a Medical Device Specialist at the Medicines and Healthcare products Regulatory Agency (MHRA), and a principal Medical Engineer in the National Health Service (NHS). He is a director of a health-related charity and a visiting university lecturer.

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. He 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 call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.