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.

They unpack the upcoming revisions to the fourth edition of IEC 60601, 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 Timestamps

• [02:30] – Introducing Leo Eisner and his expertise in IEC 60601 and global standards.
• [06:45] – The complexities of updating IEC 60601 and its 12 working groups.
• [12:20] – Expected timeline for the fourth edition (2029-2030) and why companies need to plan now.
• [18:50] – Overview of the most significant upcoming changes, including wireless coexistence and integration of collateral standards.
• [27:00] – Practical advice for navigating new standards during product development.
• [36:15] – How to engage in the standards development process and submit comments.
• [48:30] – Benefits of proactive planning and test preparation for regulatory success.
• [53:45] – The importance of staying informed and embracing continuous learning in MedTech.

Top Quotes from the Episode

1. "The biggest mistake you can make is waiting too long to plan for changes. Compliance is about foresight." – Leo Eisner
2. "IEC 60601 is often thought of as just an electrical standard, but it’s so much more—it’s about mitigating risks across all aspects of a device." – Leo Eisner
3. "Standards aren’t just rules; they’re lessons learned from history, guiding us to safer, better devices." – Etienne Nichols

Key Takeaways

Latest Trends in MedTech Standards

1. The modular approach in the new IEC 60601 simplifies updates and aligns better with global regulations.
2. Wireless coexistence and other cutting-edge technologies will soon become international requirements.
3. Consolidating collateral standards improves consistency and reduces redundancies.

Practical Tips for Compliance

1. Begin designing for new standards early, even before they are finalized.
2. Stay informed by engaging with industry groups and standards organizations.
3. Use test planning to streamline development and meet regulatory expectations efficiently.

Questions to Ponder for the Future

1. How will integrating advanced hazard mitigation strategies impact device innovation?
2. What role will emerging technologies like AI and IoT play in future standards revisions?
3. How can smaller MedTech companies effectively adapt to these significant changes?

MedTech 101: Understanding IEC 60601

For new listeners, IEC 60601 is a global standard that ensures the safety and effectiveness of medical electrical equipment. It encompasses requirements for design, labeling, testing, and risk management. With updates spanning usability, wireless technologies, and biocompatibility, it’s essential for any MedTech company working with electrical devices.

References and Resources

• Greenlight Guru – The QMS software designed exclusively for MedTech: Learn more
• Connect with Leo Eisner – Founder of Eisner Safety Consultants and leading expert on IEC 60601: Visit Eisner Safety Consultants
• Etienne Nichols’ LinkedIn – Connect here
• Submit comments to standards – Contact your national committee or regulatory body for IEC SC62A involvement.

Audience Poll: What aspect of the IEC 60601 update concerns you most—testing, design changes, or regulatory approval?

Share your thoughts by emailing us at podcast@greenlight.guru.

Sponsor Segment

This episode is brought to you by Greenlight Guru, the leading QMS software for the MedTech industry. Simplify compliance and accelerate innovation with tools tailored to your needs. Visit www.greenlight.guru to schedule a demo today and start your journey toward easier compliance!

Feedback and Reviews

Love the podcast? Leave us a review on iTunes! It helps others find us and improves our content. For feedback or topic suggestions, email us at podcast@greenlight.guru.

Stay ahead of MedTech changes by tuning in to the Global Medical Device Podcast. See you next time!

Leo Eisner: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge.

Etienne Nichols: Direct from some of the world's leading medical device experts and companies.

Are you ready to take your medical device development to the next level? Greenlight Guru is the leading QMS software built exclusively for the medtech industry. With Greenlight Guru, you'll stay compliant with global regulations while accelerating innovation and time to market.

No more paper trails or complex spreadsheets, just a single source of truth to manage your entire product lifecycle. Join the growing list of medtech professionals who've made compliance easier and faster with Greenlight Guru.

Learn more at www.greenlight.guru.

And I know he's working hard on the next edition as well, which is what we kind of want to talk about today. So before we get into all that, Leo, how are you doing today?

Leo Eisner: Doing great. We're getting back from the UK after a month. I'm sort of getting adjusted back to US time, I guess.

Etienne Nichols: I understand that. I don't think it's been a while since I've spent a month overseas, but just spending a few weeks, it could mess you up. So I can only imagine what you're going through right now.

Leo Eisner: Yeah. Spent a week in London at BSI in Chiswick and week at the general meeting in Scotland, which was a great place to be.

That's where I caught Covid for a week and lost Vacation time with my wife and daughter, which was a bummer but they got to meet family, which was nice.

Etienne Nichols: Yeah. Wow. I'm sorry that you had to experience that, but I glad you were able to get some work done. I suppose sometimes we wish. Well I wish I'd rather spend time on the vacation than work.

But let's talk about the work that you did.

Leo Eisner: Well, we're plugging along. There's 12 different groups or working groups which are the fragments that are currently being put together.

And it spans a large array of different expertise from physical environments to user interfaces. Which includes. Which is the working group I'm in charge of with another expert or code convener.

And we're dealing with alarms, usability information supplied by the manufacturer or labeling as some people are used to calling it, or marking and labeling.

And also we have another subgroup or subsection called user interface aspects which deals with visual alarm, visual displays. And I can't even think of all the groups, controls, voice output, reset controls in the verdant operation, voice input, gesture input.

And we haven't set all that up yet because that's an area that's still new that we're working on. So there's a lot of TBDs in that section.

Then there's material hazards is another group which includes biocompatibility, gas pathways.

What else is in that group? There's.

Etienne Nichols: Well, I might stop you for just a second because I'm curious.

It takes a long time for a standard to get updated to go through one of these revisions.

When do you anticipate this coming out? And I know that's probably a moving target, but maybe a follow up question to that would be why do people need to be thinking about this now?

I don't think we're going to quite hit the target based on what's happening right now. And I'll get into that a little later I think would be better than talking about it right now.

The reason to start thinking about it now instead of waiting is planning and understanding what's going to happen will affect your design and development cycle.

Your timing is important because some products have a very long development cycle like MRIs, gamma infusion pumps all have very long development cycles.

Some other products might have shorter development cycles.

But you want to start planning to understand.

One of the very first steps I always push on all my clients, I shouldn't say push but encourage is knowing what are the current standards out there or even new standards that are being developed so they can design their products to current or state of the art standards.

Think about Europe is always pushing for state of the art.

Etienne Nichols: Yeah.

Leo Eisner: And in the US they're pretty good with the FDA about keeping up with state of the art standards even if they don't call them state of the art standards.

They have a very big group in the standards and conformity assessment group of fda.

There's 64 people in my working group. Wow.

Etienne Nichols: Wow.

Leo Eisner: Some of the working groups have only 20 to 30 people.

Others have, I think there's one or two group working groups that have more than our size, but most of them are smaller than 64. And our group keeps going up and down a little bit.

And it's really. You touched on the development cycle. So if you have a medical device that you're working on right now, you're getting started or maybe you're in the middle of it with a few years down the line, how does that affect you as you get, as you near the completion of this standard, you also may be near the completion of your product.

Is there a.

What do you recommend as a, as a consultant and just a, as a professional in the industry when new standards come out, as you near your submission timelines as a medical device company.

Leo Eisner: So there's always some type of adoption period, but you want to always be ahead of the curve to know what's coming. So you're not surprised because that adoption period may be shorter than you expect.

And so knowing what's coming is better than being thrown to the walls that you have to meet it and you've already designed it and you're not ready for it. So knowing what's coming and you could adopt to, okay, I see this coming.

I know these changes that I have to adopt to start designing to it now with the knowledge that yeah, there may be some changes, but I see it coming.

So when it gets to the later cdvs and I'll explain that in a minute. So there's the CD is the committee draft. So that's the first round. Then there's committee draft for vote and then there's the FDIs final draft international standard, which is just before publication.

Then it's an IS international standard. So final draft international standard might have some minor typos or other things that get corrected before it's published. But or they usually they don't do any technical changes between an FDIS and a publication.

They'll do technical changes for CD or they'll take comments and do technical changes between a CD to CDV and CDV to NEFTAs, but not an FDIS.

Etienne Nichols: Okay. Okay. And you had also mentioned so just as you're mentioning those comments, what are the kind of comments that you look for from the audience? What would you request from those listening?

Leo Eisner: So if there's something that doesn't make sense because physically you can't design a product because the requirement doesn't make sense for whatever reason, the comment needs to be cohesive enough though that they give a reason and give a recommended change that will work as well.

Not just that this is junk. You have to give a recommend. You have to give a proposal that's reasonable as well. If you just say I don't like this, it's going to get ignored.

So you need to give a proposal that's substantial and reasonable or give maybe two options might work as well, or look at a risk mitigation process. Potentially we're trying to go away from risk analysis or risk mitigation out of this version of the standard and go more towards prescription testing is one of the architecture requirements from the architecture document.

So we have two guiding documents that is running this project, the architecture specification and the design specification that started this project.

Etienne Nichols: What would you say are some of the biggest changes or biggest challenges that may come from implementing some of the changes? Either one. However you want to tackle that, I'd be interested to hear any specifics.

Leo Eisner: Well, some are going to be that there's some totally new concepts I think that are going to come into play.

Some are new tests that like one is wireless coexistence has been a US requirement but has not been anything internationally that's getting adopted into this version of the standard that would be then become internationally a requirement.

There's some things I think in the what's called PAMZER programmable Electromedical System section, which they're looking at software as medical device software in a medical device firmware software Apps OS related.

I couldn't tell you. It's not a project that I've ever been involved in. It's not my space at all, not my expertise.

So one of the aspects of the 4th edition is all the collateral standards, the 1 dash X standard, so 12 the EMC, 1 6, the usability 18 the alarms, 110 the physiological closed loop controllers, 111 the emergency medical systems or environment standard and 112 the home healthcare environment standards.

All of those are getting rolled into the general standard instead of being all separate and that way it'll help us do maintenance of the standards better. Because when in the third edition, as we updated the general standard, then we had to update the collaterals, then we had to update the particulars.

Etienne Nichols: Gotcha.

Leo Eisner: And that's a problem.

Etienne Nichols: Yeah.

Leo Eisner: And it's messy. So with the collaterals being all in one standard now that's the concept, they'll make it easier to maintain when we do one rev of the fourth edition. Once that happens, then all the particulars can rev right after that and you don't have like this rolling issue that is harder to maintain.

So that's one of the concepts.

Etienne Nichols: Gotcha. Where do people go to see what is going on as far as so that they can make those comments or make those suggestions.

Leo Eisner: So right now there's none of the fragments are out quite yet that's going to happen. So the first probably three fragments it looks like I actually talked to the project leader maybe an hour ago.

I texted him and asked talk to him about this specific question because I wasn't sure fragments were going to go out and I think it's just the first three. So working group 37, 38 and 39.

So the general requirements which are going to cover what everyone knows as classification, but we're going to call them categorization now, which are what categories of device. So like Class 1 or Class 2, which is power source, not like Class 1 of FDA or Class 2 of FBA, or.

I'll pull up categorization here on my screen. Where do I have that?

I'll pull it up in a minute. Oh, I know where I have it. It's on the screen. Here it is.

Or if it's internally powered, being battery operated, or if it's what type of applied parts. So those are things that people already know. But another one that's newer in the list.

Let's find one that's new. Oh, is it single or multiple use?

Another one, let's see, another one that's new that we're gonna have is mobility we're looking at. So is it stationary, is it fixed, is it not fixed?

Is it transportable, is it portable, handheld, stationary, et cetera?

And there's others. I'm not going to go through them all. So that's one of them.

Then. Let's see. Let's go back to the list of groups.

So 37 general requirements. Also includes essential performance, risk analysis and other things. And it's not gonna. We're not. With the cd. We're not gonna have all the requirements set out.

It's gonna be, as Brody would say, it's a fragment of fragments. Yeah, at this point. So it's gonna be a partial.

Look at where we're at at this point.

For 38 physical environmental hazards, we're looking at operating temperatures, humidity, vibrations, or. Let's see, in vibration, all that stuff. So the stuff that's typical in 1 11, 112 temperature.

There's one other, and I'm just totally blanking.

Oh, here it is.

Looking at transport, storage operation, temperature, humidity and atmospheric pressure. That's what it is. Yeah.

Etienne Nichols: Okay, makes sense.

Leo Eisner: Going back to physical, earthquake, physical security, battery management systems, ingress protection.

What other things are hiding in this group?

Those are some of the things. They're not going to have everything in that. I don't know that battery management system is going to be in there at this point. Or earthquake protection.

I know some of the environmental stuff.

More the temperature and transport storage operations stuff is going to be in there probably at this point. What do you mean?

Etienne Nichols: I'm curious what's driving a lot of the change. So is it primarily organizational or there are. Do you anticipate this changing how medical devices are designed in the future?

Leo Eisner: I'm not quite sure I understood the question or the driver. The question, yeah.

Etienne Nichols: Yeah. So the revision of the standard, my understanding is a lot of it is you're organiz. Organizing things a little bit differently to be a little bit more of a. Almost like a modular approach.

And maybe I'm misunderstanding that.

Will the content change how devices are made in the future? Aside from. Obviously there's going to be additional testing that will be done and there'll be different ways to interpret the standard.

What if I'm designing. You mentioned an infusion pump earlier in some of the timelines. If I'm. If I am designing an infusion pump today with the existing standard and I'm going to design.

Well, I'm going to look at this standard three, four, five years from now. How will I change my design, do you think?

Are there any things like that?

Leo Eisner: So I.

Etienne Nichols: That didn't make any sense, did it?

Leo Eisner: Not totally. Let's remove the infusion pump from the question more. Let's make it more broad and say it. Let's look at a medical electrical piece of equipment.

One of the reasons the standards being updated is we're looking at the risks and seeing that there's additional risks or hazards that we haven't identified previously that now we've identified through this process and over time we've identified more risks or hazards that we need to mitigate.

And so through this design document that we've developed over time, which there was a group of people that had been working on this, which I was not involved in, but I've commented on it significantly and that was noticed is how it was pointed out to me at one point recently.

In a good way, not a bad way. Yeah, that's guided how we've put this project together.

And so the 12 fragments are basically separated in different hazard groups.

So physical environmental hazards, material hazards, software hazards or pems, electrical hazards, mechanical hazards, thermal and fire hazards, optical radiation hazards, ionizing radiation hazards. These are all the working groups. I'm just telling you the titles.

The one that. Well, there's two that don't say it in the title. General requirements, but there's still hazards in there.

It's just not in the title.

My working group's called User Interface Aspects. But there's hazards around user interfaces, including all labeling and information to be provided. While those are mitigations, the lowest level of mitigation But Right, okay.

So they're all grouped in different types of hazards.

Etienne Nichols: Okay. I'm always curious about how we've reached the. We reached the conclusion to do this versus that, especially in regulations or standards. Go ahead.

Leo Eisner: So over time we've learned more. Right. And from that knowledge we've adding that information into the standard because we've learned how to mitigate those hazards.

Etienne Nichols: Yeah.

Leo Eisner: So we're putting that knowledge base into the standard is what we're trying to do.

Etienne Nichols: Yeah, I get that. I guess what I was saying, what I was trying to say is sometimes people talk to me about regula regulations. They're like, oh, regulations can be so boring.

But the things that lead up to putting that into the regulation is seldom boring. It's usually a big historical thing, you know.

Leo Eisner: Well, I put it this way, it's usually shocking, right?

Leo Eisner: Well, the problem is everyone thinks it's electrical only and this standard is anything but just electrical.

Etienne Nichols: Right.

Leo Eisner: That's where people get way astray on this standard. And one of the recommendations one of my business partners and I posed was this standard should also be for orphan devices that are non electrical.

That are non electrical.

Etienne Nichols: Yeah.

Etienne Nichols: Yeah, yeah, we have to talk about that at some point.

Leo Eisner: Yeah, that's a good standard.

Etienne Nichols: Any other things that you think people really need to know about this upcoming change?

Leo Eisner: There's lots of things to. Yeah, need to know.

Etienne Nichols: What can we get across in the podcast and maybe point people to the detail later so that they can make those comments.

Leo Eisner: So there's going to be a.

Another document. It's called. Let me pull it up.

Here it is.

Here's the name to it. Okay, so there's going to be a committee draft for vote coming out mid December is the schedule, if it comes out on time, for the international electrotechnical vocabulary.

So IEV part 880, electrical equipment, electrical systems and software used in healthcare. And it's the vocabulary we're using for the fourth edition.

But it's also going to be distributed to.

I thought it was going to TC210 as well, which is the more what I would call quality system and management and the symbols group which I'm involved in.

So some of the. There's 21 sections in it. It's massive. There's 400ish definitions in it.

So it's a big document.

The main sections are alarm systems, circular economy classifications which I think they're going to change into categorizations would be my suggestion since that's what we're going to call it in 601.

But maybe not, I don't know, Cleaning, disinfection, sterilization, which is not something that's directly a 601 thing. Obviously connections which I'd have to look at to understand what they mean by that.

Exactly. Electrical hazards. That's a very 601 based concept I would think.

EMC Electromagnetic Compatibility Environment which I'm sure gets into some of the hospital environment and the shoes, equipment and its parts and accessories.

What are all those different types of definitions?

General generic definitions.

Mechanical hazards, organizations, people and roles.

Physiological closed loop control.

I suspect without looking at it closely. I don't know every one of these sections inside out obviously. Yeah.

Protection against hazards.

That sounds like 14,971 to me. I hope, I would hope it better be security.

Okay.

I'm not sure I looked at that yet. Software usability.

So my work group that deals with user interface aspects, we deal with a lot of these areas. The primary ones are alarms, usability.

Where's the other one?

Information supplied by the manufacturer. Those are the three biggies for migrate.

Etienne Nichols: Nice.

Leo Eisner: We have a lot of impact on all of those.

So one of the questions you asked are which are the ones which are the fragments that are going to come out to be viewed and commented on first, which are 37, 38 and 39.

So the general requirements, physical environments and user interface aspects including labeling and information to be provided. So probably about the end of this month, early in December, it'll get published as a cd.

So if you're a national committee member through Amy in the US or a national committee member through whatever country you're a member of, you'll have access if you're a member of 62A, which is IEC SC62A.

If you want to get to the nitty part outside of that, then you'll be able to see it through what's called the online standards development tool, which is a new database system.

And as of January, all IEC and ISO standards are going to get developed through that is any new projects. I think there's other requirements that were outside our the scope that I don't know the details.

It's going to be a huge lift, I think.

Etienne Nichols: And if you send me that link, we can put that in the show notes. Maybe people can easily find that so that they can.

Leo Eisner: Well, I can give you a link to the training for the online standards development tool, but there's no direct access to seeing a standard through OSD unless you're a member body.

Etienne Nichols: Gotcha.

Leo Eisner: For the specific standards committee. And once it's published, then you get a link to that specific document.

Etienne Nichols: I see.

Leo Eisner: So once it's published, you'll get that link, then you can see and depending on your role, you'll see the document based on that role. So I'm a leader for Working Group 39, but for all the other working groups, I can't actually access the other working groups OSD documents at all.

I can't see any other working groups documents.

Even as a convener within fourth edition, I don't see any other working groups documents currently because right now all 12 working groups are working independently.

Once we get further along at some point in the process. Right now the schedule is after.

Is it the second cdv?

I think at the second CDV is when we're planning to switch to a merge document from the fragments.

But when I was talking to the project leader this morning, he said because the schedule may shift, we're not sure when we're going to merge at this point. Point.

Etienne Nichols: Yeah.

Leo Eisner: So that may change.

Etienne Nichols: Okay. Well, it sounds like a lot of changes are coming. What are you most excited about?

Leo Eisner: Well, I call this my retirement package.

Just keeping people informed. And that is such a new set of big changes that. Just keeping people informed and trying to keep everyone excited about it. Yeah, it is a lot.

And I'm learning a lot as I go to and being involved. I'm spending a huge amount of time on this.

I don't get paid for it, but I get to talk to a lot of people about it. And I'm learning a lot. I'm learning huge amounts because every time I'm in meetings there's Something new.

I learn all the time.

That's one thing I like, is always learning something new every day. Otherwise, I don't feel like I'm living.

Etienne Nichols: It's important to keep living. That's good.

Leo Eisner: Yeah. Yes.

Etienne Nichols: Keep living as long as you're alive.

Leo Eisner: Well, yeah, that's important.

Etienne Nichols: It's sad that the number of people who aren't and are. So, anyway, not to get into the philosophical side of things, but.

Leo Eisner: Oh, you're sounding like Subie now.

Etienne Nichols: You know, I do hang out with him sometimes.

Leo Eisner: Oh.

Etienne Nichols: He and I recommend the same books. It's so funny.

Leo Eisner: Yes. Anyway.

Etienne Nichols: Yeah. Subi Sede, for those who aren't familiar with the the Combinate podcast. I don't know, there's something about. Maybe. Maybe there's something about what draws someone to be a podcaster.

Some more set of interests. I'm not sure what it is.

Leo Eisner: Well, you look like you're in a basement right now. Just sort of like Subi's setup.

Etienne Nichols: It's not a base, it's actually an in. It's kind of an industrial part of town. So there's just an empty part of a factory that someone written it to me as an office.

So it's. It's worked out, but. Oh, yeah, it's a strange place to be for sure, but very cool. I am excited to see what is coming and how this is going to change some of the things in the industry.

Any last piece of advice you want to give the audience before we close it out? We'll put links in the show, notes later for people to check things out. But any last pieces of advice?

Leo Eisner: Well, just keep updated and ask questions. And if you have any concerns about how things are going, let the leadership of 62A, or what's called AG50, which is the leadership of the fourth edition, which I'm part of, know what's going on and we'll feed it back up to the right people.

And we're happy to. You know, we're trying to be as transparent as possible.

Etienne Nichols: Yeah. Yeah, I think that's something.

Leo Eisner: We want to make this good.

Etienne Nichols: Yeah.

Leo Eisner: And. And usable. Not, like, hard to use.

Etienne Nichols: It's not change for the sake of change, which I think some people in the industry get a little bit pessimistic sometimes, thinking, oh, they're changing it again. But the goal is for improvement and to cover additional risks that may not have been covered in the first one.

So I think what you're doing is great and I hope people will offer.

Leo Eisner: Support, even though it's not a requirement it's to support making it easy, easier to get through the regulatory process, too, because a lot of what's coming through this is meeting the regulatory requirements, like GAS pathways is part of something that comes up through, like the ventilator standards, but it applies to other things outside of that.

And so bringing it up brings up that you need to think about it for other things, or we're talking about having. Doing test planning, which is something regulators expect you to do.

And so that was the meeting I was in before this podcast.

And doing that upfront is going to benefit you in the long run for a lot of reasons. Or make going to the test lab or doing your own internal testing better because you'll have thought about it properly and scheduled it in a way that you will know the way you're headed and you'll know what devices, what accessories, what software.

So you have your plan set up instead of going in chaotically.

Etienne Nichols: Yeah, yeah.

Leo Eisner: So I think it'll be to your benefit in the long run.

Etienne Nichols: Yeah.

Leo Eisner: Short run, you might complain, why am I doing this extra work? I hear that all the time, especially from those small customers.

Etienne Nichols: Yeah.

If it keeps the product on the market longer and keeps it safer, it's definitely worth it. Long run. So have to. Have to keep the long run in the mind.

Play the long game. So, yeah.

Very cool. Thank you so much for being on the podcast today, Leo. It's always good to talk to you and share your. Or learn from your expertise. We're going to have to.

There's a few other standards. I know.

I think I always bring this up. 15, 2, 23. That was one of the first webinars I ever moderated that. You did. Yeah.

Leo Eisner: It blew up your system. I think it did a little bit.

Etienne Nichols: Which might be part of why I remember it so well.

Leo Eisner: And it was a purse.

Etienne Nichols: Yeah, it was one of my first. But it was also one of the most technologically difficult ones.

But good memories. So.

But thank you so much for being on the. On the podcast. Look forward to seeing when the standard comes out and all your work coming to fruition. So wish you the best and thank you so much.

Those for you when listening. Thank you so much for listening. We will see you all next time. Take care.

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