Impact of Updates to IEC 60601-1 (4th ed) Leo Eisner

Thanks, Sean. So… as Sean knows, and a lot of you guys know, but not all. I am what is called the IEC60601 guy, and I'm going to talk about 4th edition. If my mouse is gonna agree with me, that is, of course. So, just to give you a little bit about me, I'm Leo Eisner. I've been around for a long time, as you can tell by my gray hair. So, I'm called the IEZ60601 guy, and if Paul D'Souza's on the line, he will tell you, hi, Carrie, that… at 10X, he went and looked online and found might leave by looking up IEC601 guy. I've been around in the medical device field for about 30 years, product safety testing even longer, and 20 years plus.

developing standards, and that's what I'm gonna… Talk to you about today. My mouse will cooperate. We won't go on, maybe. My company, my consulting firm, has been around for about 28 years now, and we do a lot of things around Product safety standards, and if you want to talk about that, we can talk offline. So the standard that we're talking about is about medical electrical equipment and systems. That's the first bullet. And that's in the existing standard, and also going to be in the future standard. It specifies general requirements for basic safety and essential performance. That's the core of the standard, those two bullets. Anything in yellow and red is the future standard, and it's really important because

In the first Yellow section here. We're talking about a definition that the manufacturer gets to do to specify the users. And the specific environments of use as specified in the instructions for use. Now… That the manufacturer gets to find that is obvious. But now having it defined in the scope is great. The first thing I do when I look at a standard is always look at the scope. Is it a standard that applies to me or not? If it doesn't. Most of the time, I ignore it, but not always. Most of the time. I always look to the scope, first thing I always do. The next bullet is a new big deal.

add software into the standard as in the scope. It really highlights that software is a critical thing. Software is a huge addition into the standard now. And there's a huge, big area on software and PEMS now, much bigger than it was. There's going to be a huge amount of comments in this section. So it applies to software integrated into medical electrical equipment, so SIMD, a new term. SAMD. Everyone's heard about SAMD by now, probably. Software as a medical device. But a key point is it needs to contribute to the basic safety or essential performance of the device, otherwise it's not…

SAMD in the eyes of 601. So, what's that mean? So, if you have an infusion pump, that's a medical electrical equipment, because it's a single device. So that would be SIMD, because it's one device. But an SAMD would be, say, you have an app on a phone controlling that infusion device, that would be an SAMD, the app. Now, what's an MES? An MES would be, like, a surgical robotic system where you have multiple systems or components in the system, like a computer controlling the robot, let's say, just as an example. So this image here next to my logo.

Adding definitions about sub-assemblies, that's all new. The Does Not Apply section has not changed at all. It's totally the same, so I'm not going to get into that. So, the series of standards and the formatting is going to change significantly in the fourth edition. So, we, in third edition series. 3.0, 3.1, 3.2, we had all these collateral standards here, the horizontal standards that apply pretty much across the board. the EMC standard 1-2, the usability 1-6, the 1-8 for alarms.

And then there's other standards and collaterals that may or may not apply. So those are all going to get shrunk down and shoved into the general standard, so right in here. So this general standard, instead of being 400 or 500 pages. let's say it's gonna be a thousand pages or more. It's gonna blow up. Significant. The particular standards, so the technology-based standards that are vertical. So, like, high frequency surgical for 2-2, and I know I'm talking a little gibberish for some people, but I'm going fast because there's a lot of material to cover. So if you have questions, we'll talk about them sort of at the end, trying to

you know, getting the pace through. The 2-77 surgical robots is another technology-based standard that adds to the general, basically. So, all the changes that, filtered into the general standard that existed in the third edition. the details are described here. I'm not gonna have a chance to discuss them here, but there are notes here talking about the different working groups, and what's happening for the different, like, … 62366, the usability, the system requirements being distributed into the general standard, the software and PEMS, what's happening, and the risk management. There's two things.

Is there a hand up? I guess not. I thought I heard a hand up. Then the technical reports and technical specifications, they're just going along on the side. at normal pace. The only other point I'm going to say is that the particular standards will get updated on their own schedule after the general standards updated. Versus before, first, the general standard would get updated, then the collaterals would get updated, which would take 2 or 3 years, and then the particulars would get updated, which would take another good 3 years or so. now… You get rid of all the collaterals being updated, so you're saving 3 years in the cycle. So you're speeding up the update cycle, which is great.

And I was very involved in that process. Since I'm the 62D co-chair for the U.S. Which is involved in a lot of the particular standards. Some of the drivers behind the next edition. New technologies, obviously, and changes to some existing technologies. So, AI, machine learning, no surprise there. software as a medical device and a medical device, we just talked about that a little bit. Robotics, surgical robots. So defibrillation, the voltages for those devices have changed, and that's impacting some of the testing, and that's still under discussion. User interface aspects is one of the working groups. That happens to be the working group that I'm a co-convener on.

New requirements. Most of these that are not old did, we're going to be talking about in slides to come. And there are more validation reports than what was a requirement in 3rd edition. Addressing safety gaps, we're going to close as many of them as we can, hopefully all of them that exist in third edition. Believe it or not, there are some gaps, because as technology changes and things move, we realize, oh, we missed some gaps. Look at the mod reports that come out of FDA. You'll realize there are gaps out there. Standards evolved since 3rd edition. 20417 didn't exist when 3rd Edition came out. That's information supplied by the manufacturer. Or Gas Pathways, the 18562.

Batteries have developed significantly in the last 5 or 10 years. Robotics have advanced hugely in that time period. A normative standard or a normative reference is a requirement in the standard versus informative, which is more guidance, basically. So those standards being updated impact the requirements into the standard itself, being the fourth edition. So, CISPR 11 Has updated since the publication of 3rd Edition Amendment 2, and that's going to have a huge impact, which I'll talk about later in the presentation. there's more international regulatory interest than there were… was on 3rd Edition Amendment 2, which I was heavily involved in that development. And in the room in the first meeting for Working Group 39, which is the working group I'm involved in.

There were 5 regulators in the room, and I think there were 8 people from those regulators. out of maybe 35 or 39 people total in the meeting. That's significant interest. The other point is there's 18 people from FDA involved in the total project of 200, 220 people. So that's significant. That's almost 10% of the people involved is FDA. That's huge. So regulators are definitely signaling they're interested in adopting this standard. Your impact, planning now, is going to avoid redesign and QMS fire drills. Hold on.

Oops, I always want to move it that way. If you see an underline in the presentation, it's a hyperlink. So when I pass off the slides for those interested, you can access those documents. So, the architecture specification is one of the guiding documents for this project. just like the design specification in the next slide. So it's something that was written by the… either the technical committee or the subcommittee, I always forget which one, which is our, … leadership. for the 6 of 1 series of standards. So, they give us guidance, and it's a massive document, a brilliantly written document, for the whole series of standards, actually more than just the 601 series of standards, I believe. And Edwin probably could tell me that, because he was probably involved in it, knowing him.

To sharpen the focus on basic safety and essential performance. Which is the core concept of 60601. To clarify the scope of the patient types much more clearly. And animals have always been involved in the scope of 601. which a lot of people argue about. We are still getting comments about that, and that comes back to the first edition of 601, which goes back to the early 70s, which was before I was ever involved in this standard. I go back to the second edition, but not the first. Also, clarifying what the medical environment is, and we're working on definitions

and terminology, to really clarify that really well. And there's this dictionary, I would call it, of definitions and terms, IEV60050880, which has a huge, like, it's been a 3-year project at this point, I'd call it. … And I'd go insane if I was working on that group. I sat in for 3 days in a meeting in San Francisco way back when, and I would not survive that group. But they're doing an awesome job, and they're setting it up to work on … having it work for the whole of the medical device industry, not just medical electrical equipment. So they're really trying to make it work across the board for all the technical committees, including TC210, 1988, all the different technical committees.

That are involved in many different aspects of the industry, not just the electrical devices. Having atomic requirements so they're distinct and design-ready, so you can write design specs. align with IMDRF, So you have essential principles, so you can have us, Subcluse that matches the essential principle, so you can use it for regulatory requirements, and be regulatory ready, and have a, … database that you can use to pop out and have a design requirement come right out of it. That's still 5 or 10 years out. we, … complain about the OSD all the time, or online standards development tool.

The design specification is our roadmap to how to write the standard. So, how to implement the architecture spec that I just talked about, what areas we're taking from the third edition, what subclauses apply to what section or working group, what other standards, the particulars, the collateral standards, other standards that apply, what are new requirements? There's lots of them. What sections are being deleted out of 3rd edition and other standards? And then it's 12 working groups that are all hazard-related, which is the next slide. And that's your cheat sheet when I keep talking about working groups. I'm going to try my best to say the names.

So, refer back to that. And the project timeline. I'm gonna go through this pretty quick. So the project officially started April of 24. … We've published the first CDs for 11 of the 12 working groups, and I'll talk about the other working group when I get to that slide. The second committee draft, hopefully, will be published by June of 26th. Then we have Two committee draft for votes to come. June 2027, and I don't know how we're gonna do it by December 2027 for the second CDV. I think Brody's smoking something, to be honest. Don't say I said Brody is smoking something. I'll get in trouble for that.

And then we have to merge all the fragments, so every working group is working individually and generating their own document, basically, or separate text. They're not merged into one standard yet. It's all separate, still. So, the CDV… once it's merged will be one document, so that year between December 27th to 28th. is… … Gonna be a really intense year. And then we move on to having the final draft international standard, and then publishing it Several months later.

So we hopefully will have it published April 2030, which is, I think, 6 months or a year slippage from the original project plan, which we updated the plan in June of this year. So that's an important date for people to be aware of, obviously. So, major changes. This is a very important slide to be aware of. And I have it coded based on the working groups, or that it applies to all or most working groups. So these… this is my diagram. Actually, it's my associate's diagram of the design control process. So you have your design inputs. Over on the left side, design outputs on the right upper corner, and VNV on the right-hand bottom side.

And it's obviously a summary. So, if you look, you have your user needs and user specification, use error analysis. That's all usability-based items. That would be Working Group 39, or User Interface Aspects, which is all usability-based. That's what… one of the three major things we work on. Also, label requirements, IFU requirements, specs, that's all part of Working Group 39 requirements. The other thing that's working Group 39 is usability, formative. and user interface aspects, which is part of design output. So, things are going to flow through from design inputs into design outputs. It's going to impact all these documents, so it's going to impact your QMS and your design control process, obviously.

So that's the point. It's going to impact your whole QMS process. That you're gonna have to… Be aware that it's… it's going to have a huge rollout through your system. I'm not gonna go through the whole diagram, but software is across here. Your SRS, software requirements spec, software hardware analysis, cybersecurity risk analysis, that's all working group 41, which is PEMS and software-based type items. The name for it is really long, and it's also going to go into your VNV, obviously, too. So it's a big hit, that… that one slide.

So, now I'm getting into the working groups, and I'm only going to touch really lightly on each slide, because there's just so much information with 12 working groups, and I am doing a super light touch. Because of just how much time there is. … So, working group 37 is general requirements, but everything's hazard-based, but this is on the high-level stuff. So, categorization, we changed the name from classifications. Which is what was in the third edition, and first and second edition, too, to categorization, because the classification sort of is a terminology that's more a regulatory term, and we wanted to get away from that. That was the reason for the change.

It's a tagging system, so when we have the database. the standard setup. We can make it that all the requirements fall out, that any NAs disappear, and you can end up with a design document, basically, that you have all your requirements that come out, and then you have your design spec, basically, of all your requirements that are for 601. And if you have a particular standard, once we get to that point, you'll be able to merge them together and just have your specific requirements for your product. That's the ultimate goal. Hopefully it's not a pipe dream, we'll see. Alarm systems. This is something so many of my small clients, especially, but some even big clients, keep avoiding. They say, I have a buzzer, and it notifies

And so there's no alarm. Well, a buzzer doesn't meet 601-1-8, the alarm system requirements. And… but they have a hazard situation, so yes, you do need to meet 1-8. It's in the standard, but people are so scared of that standard, they don't need to be. That they just ignore things. the requirements are going to be really written clearly. We've been banging our heads to write it clearly. So, E4 orange. Hello?

Hey, it's Sean.

Yeah. We….

Can we take a couple questions?

Yeah, sure.

Jose had a question. And Michelle had a question? Jose, do you want to come in and ask your question?

Sorry, I lost the window that had the mute button. Yeah, Leo, just curious, you know, given that you're incorporating so many different topics, like, you know, software requirements specifications I saw on the previous page, makes me think, how aligned is that going to be with 62304? Or with the cybersecurity, how aligned is that going to be with SW96? Because one of the big challenges you end up facing is. you know, if you're having to follow multiple standards for the same documentation or the same process, it just becomes very confusing and conflicting. So, just curious if… what that's looking like.

So, remember that a lot of people that are involved in those requirements Are involved in the development of that, … section of the standard. So the people that are involved in 62304 are involved in the PEMS working group. So, I'm sure they're quite aware that's not an area that I'm an expert in. I'll get to that slide, so I'll be able to give you at least a smattering And we can talk offline about that a little more. I am definitely not an expert in that area, so….

No, I think that the more general question is, like, when you're covering with, you know, it's gonna be a 1,000-page document, as you mentioned. You're covering different topics that are covered in other standards, so part of me wonders.

One thing they did say, Jose, is they are monitoring… so, 62304 is being developed at the same time, and second edition is what's being developed, as you know pretty well, I'm sure. So, they're monitoring it, and they wrote a box note specifically saying they are monitoring the development, and they're not going to overlap what's going on with 62304. So there is a box note talking about that, specifically, that they've addressed that, or they're trying to address that issue.

Okay, thank you.

Sure. Michelle? I think was next, you said, Sean?

Yeah.

Hi, yes, hi, Leo, … Because we are moving all our devices to… MDR, alcohol does a Class 2As, and then, Obviously, some of our product Again, 3.2, but some of them are not. So, … Because now the fourth edition coming out. and for the Class 2A, particularly ours, you know, we're working on MDR, but it doesn't have to be till December 2028. And as the time goes on, do you think they will change, the requirements? Say, okay, if you want to be certified under MDR, then you will have to have forced addition for your 6060-1 as well. Would that happen?

So that's an interesting question, because now you're sort of talking, I think, about state-of-the-art versus harmonization. And… I can hear my own thought person in the background, sorry. It's a little distracting. So… Maybe Bayak can chime in a little bit on this one.

Yeah, sure. So… You started earlier with the harmonization, which is currently due to the different chord decisions a little bit in stock. And the latest when it once would be… should be, harmonized, then I'm sure the notified bodies will ask for it. At the moment where the harmization is a little bit stuck. It's more or less up to the notified body when he will ask. And I know there are notified bodies, they at least want to see a plan. Quite some days after publication, all the notified bodies If… wait a little bit longer until they ask. Or, for a plan?

But they will, for sure, when the fourth edition is out, ask when will it be implemented. So, once all the devices on the European market need to be compliant with the fourth edition, as this will once be seen as a state of the art by the authorities and the notified bodies.

Which is gonna be missing. And this, this happened very similarly with 3rd Edition, too. Not as….

Not the same will be with the second edition of the IC62304 software standard.

Yep.

Which will be out a little bit earlier, probably.

That's the hope.

That's the hope.

Any other questions, Sean, or should I….

Nellie asks if you're going to share the presentation.

Yeah, I will. I think I see another hand with, Edward.

Hi, Leo. I'm based in the UK. We've got a medical device that doesn't right now have any electronics in it, and everything you've just described is exactly why I'm happy we don't. We are, however, thinking about developing a sensor to incorporate. It would be a separate standalone device. Could you tell… because I do not want to learn all this expertise that you have. Can you tell me what should I be looking for in the design consultants that we might work with to make sure they know all this stuff that you know? Or, you know… you know, I'm sure we could talk to you as well if you were interested in working with a tiny little UK company.

I'm more than happy to work with little companies. I work with all size companies. Why don't… I have a slide at the very end that we can do a 30-minute call and talk about that also. I think would be better than taking everyone's time right now, if that's fair with you.

Absolutely.

Okay. Sure. Thank you. Shall I go on, Sean?

Yeah, and memo to everybody, if you would like to contact Leo about working with him, or having him come in and educate your team on this, please do so. Just reach out to him directly.

Okay, so I'm gonna skip over one of the bullets that I highlighted here, just to save a little time. Ingress protection, which is dust and liquid tests. in short summary, minimum IP22 is a significant change from where it was, because it would be IPX1 previously, so that's a design change. That's an impact on design. battery management systems, the requirements, this list is huge, these changes they're considering. So you're talking design, test, labeling, etc. User interface aspects. You're talking labeling, usability, and alarms.

It's a massive section, and thank God I have two really good co-partners to work with. Dave Osborne, my mentor, saves my butt all the time. And Martin Stangenberg is just amazing. They are great partners to work with. If I didn't have them, this group wouldn't be where we are. So information provided by the manufacturer, ISO 20417, something you're gonna have to get to know, because we are going to be relying on that significantly. It's a newer standard, it's in first edition. We have already worked on the development of second edition, which I am on the committee for that, and it should be publishing near the end of this year.

If… that… If there's specific hazards that are addressed in 601, we'll do the hazards out of 601. There is a pretty significant section in the standard that we're developing, some that came out of 3rd Edition Amendment 2, but we've added to that list. Then there's also installation requirements that we've developed, which I was on the sub-team that worked on that, and that's a fairly extensive list, but it's only going to be Specific to your device, you're gonna pick from a list and add apply what applies to your device. And you may add to that. This is just sort of a suggestion list.

User interface clause. Totally new concept, really. And we're looking at, you know, graphical displays, touch sensors, textual displays, auditory, so human factors type things, tone, speech, voice, gesture, autonomy. Autonomy, I have only noted in this one slide, but it's going to affect several other working groups as well, like the PEM software, obviously, and a couple others, but I didn't note it here. Distributed interfaces. So. If you have a device where it's distributed across several parts of the device, where you have your interface. Or it could be across the world.

We're addressing that. Oops. Material hazards. This working group deals with a lot of different substances, coatings, adhesives, and biocompatibility and processing requirements. So the biocompatibility and processing requirements this is where you're going to have some validation reports and biocompatibility assessment report requirements. So, this is… some of the validation reports I was talking about. So, 10993 is biocompatibility. 18562 is the gas pathway requirements. 7405 is dentistry biocompatibility.

the 176… Fixed 4 is the processing of healthcare products. Not a standard I'm very familiar with, even though it's in a standard that I'm a convener of. I'm not an expert in any of those standards, by any stretch of the mind. like… Edward said, there's so much to be an expert in, you can't be an expert in all of this stuff. This is Jose's slide. I saw a smile there. I had to get his attention. There is so much information in this section. One of the co-combiners on Wednesday morning when we had the U.S. National Committee meeting to discuss the comments for this section was shocked there were not as many comments on this section from the U.S. National Committee.

She's expecting, as she's one of the co-conveners internationally for this group, she's expecting over a thousand comments on this section. I saw Jose's face almost drop. That's… that's what she said, and I believe her. There is a lot of material in this section. Huge amount. Artificial intelligence. … to me, how I'm reading it, it's talking about clinical and preclinical data. That sounds like validation data to me, if I'm reading it right. I'm not an expert. I would like other people to look at it and tell me if that's correct.

Cybersecurity. this is stuff that FDA is hugely involved in this area. I think there's 2 or 3 people involved in this working group. they have their paws all over it. And Jose's written a lot about FDA and cybersecurity in the last many months. He knows what's going on there much better than I do. ….

Henry, why is this being included in 6601 when it's being covered in other standards?

I… Couldn't tell you that. To be honest. This is just not my expertise, so, ….

I mean, even at a higher level, like, why is the 6601 document including content that's just generally, you know, so thoroughly covered in other standards?

So, one comment that came up on Wednesday, and I don't remember if it's in cybersecurity or artificial intelligence, and this comes from a really big manufacturer. They said some of this material should not be requirements, and should become… go into the rationale. Rationale is informative, which is not requirement. So, as guidance, basically. Now, one thing I'd say about guidance, some regulators make that. what's guidance for the FDA? It's still a requirement. Right? You know that really well.

Jan Gates (Semi-retired): Jose. I want to say, Jose? Jan Gates (Semi-retired): I want to say, Leo, too, a lot of times these ISO committees don't know about the other standards, so they put the stuff in because they know it. They need people like you on the committee to make sure they know about it, so they don't, contradict the Vienna Agreement and rewrite things that shouldn't be rewritten.

Comment, why would you put this in there? It's moving so darn fast. By the time in 2030 it's being published, this stuff's gonna be obsolete. That, too.

Standards are always obsolete, but.

I know, I mean, it's… Dumb, in my humble.

problems.

I'll go back on that now. Okay.

Edwin "Bills: Just as an example, Leo, we're working on the guidance in 14971 for machine learning. Edwin "Bills: And, last year, Pat, the leader of that group, found out that there were 80 standards under development on AI.

Least. At this point, there's probably 120 or 150.

Edwin "Bills: Yeah, by now, yeah.

Optically, yeah.

That's where the FDA puts guidance, because they can change it on a On a shoestring, you know? Publish a standard that takes 50 years to get it done, and then it's obsolete. Done. Dropbox.

Jan Gates (Semi-retired): I'm just going to follow the normal stuff, where it takes… a year after it's published, ISO, the, Europe adopts it, but it's, required immediately for the FDA. Jan Gates (Semi-retired): When it's published, and they get it on their docket.

FDA, most likely, my guess, because it's a major change, my assumption then this is what happened with, I believe, 3rd edition, and even 3.2 was a 3-year transition period. It might be 2 years, but I think it'll be 3. This is really significant. I think industry might push even for 5 years if they push hard enough.

They refused .1, Leo, so….

Say again?

The FDA refused to accept 3.1.

I don't remember that.

Yeah, they didn't like that. Because it didn't have all the electrical safety stuff, so….

Loki has a question, I believe. If I'm saying his name right.

I think it's Luke.

Luke.

Yeah, just a moment, I have to start my video. I have a zillion ques… I have a zillion questions for you, and I'm….

What we do.

Yeah, cheers to you.

Outside with the beer.

5 o'clock? ….

Yeah, of course, it's Friday afternoon here. No, I have a question for you, like, if we design something that has to be on the market for at least 5 years, and you wanted to have it because the development time is so long. It's… it's best to, to use automotive parts, because they are… they will be on the market for such a long time, because medical and even aerospace is not… the industry is not… big enough to have an incentive for the manufacturers to keep them on the market so long. So, is there any… how do you say it? Synchronization with the automatic, automotive…

standards, like safety integrity level, that at least the standards to test the parts to are equal to the medical parts, because sometimes I want to design something, and I have the perfect part for it. But just one tiny bit is not up to the medical standards, and then we're not allowed to use it. So if there was a little bit more synchronization between automotive parts and medical parts, then we would be much easier to use those automotive parts for medical appliance. Can you… can you elaborate a little bit more on that?

Well, there's… what we call… and I don't know how we're approaching that yet. There's, in 3.2, what I call the escape clause, or the Michael Schmidt Clause, for those that know Mike.

Edwin "Bills: That's up. Edwin "Bills: My gosh, man.

Yeah, in his honor at this point, because he passed away quite a few years ago at this point. … Where you can show equivalence, but the equivalence is a high bar for most test labs. That's the only way I can think of, unless you can think of anything else, Edwin.

Edwin "Bills: No, I'm… that's not in my daily work.

That's really the only way. Martin?

So… Standards are supposed to… to communicate best practice. And we have a standard here, which is trying to put everything in one bucket. Which everybody would… everybody would say is not best practice.

I'm not disagreeing, I'm just trying to communicate what's coming down the line at this point. I have a problem with what's coming, too, and I'm in leadership. But I… I'm not, you know, at the top of the chain. I'm sort of in the middle. I'm in middle management, let's say.

Right.

Or lower middle management, maybe. I don't know. Yeah, I don't disagree. There are some aspects, and this section especially is, like, total overkill, I think. Some of the other areas did need updates for reasons of technology change, safety aspects that really did need to be… there were gaps that were needed. Making it atomic, I think, made it… is going to make it easier to read based on that. When you had… like, in the EMC standard, the clauses run on for pages long, and you don't know what the requirement is, so it's hard to read. Now it's gonna hopefully be

easier to read and understand the requirement. So there, you're going towards a better outcome. So that's worth it. To change it to make it readable and understandable. That's… the right direction. But when you're adding requirements to add requirements. Is that a benefit or not? if there's overlap, like Jose asked. Does that add any benefit? No. So… Where's the balance? It's a good question. So… having a voice. you don't have to be on the standards committee to make comments to the national committees. You do have to be a member of your national committee to make comments, though, or through someone on your, …

company… That's on the National Committee. Which could be any country. Doesn't have to be the country that you're in. So I'm gonna continue on. for a few more minutes till, Sean kicks me off. And I think I might skip a couple slides here, just because… I want to get to… Temperature limits is a good one. This is gonna impact quite a few new areas. Non-skin contact applied parts. That would be, like, ultrasound, transferring energy. Energy transfer generates power, Power generates temperature. Delivered gases, that's a new concept for temperature. Infused liquids having temperature. That's something being discussed, asking

Is that something we want to look at for temperature? So those are fair questions to ask. Looking at phantom testing. Using the FDA guidance as a partial Concept to look at. So this is the working group that the committee draft hasn't been released, and there's been disagreements how information's being dealt with between a different technical committee that's in charge of a lot of the standards that's within the optical radiation section. And there's a whole bunch of standards involved in this section. The ionizing radiation is X-ray equipment, and so it's replacing the existing 1-3 standard, the X-ray standard, basically.

Emf, electromagnetic fields, so it's expanded the frequency and scope of the section, to 0Hz to 300 GHz, so it's expanding it significantly, and it's going from To include unintentional radiators and intentional radiators. And this section, I think they did a really good job of doing a very tiered assessment process. And… The structure of the assessment report is there's no specific structure. You can do any way you want to do it. As well, as long as you do it based on a risk management follow, you know, per ISO 14971.

Everyone goes back to ISO 14971, at least in the medical field. That's the main concept. Other than in 2nd Edition for a 62304, you don't have to use 14971. At least that's the concept currently. For some people, they don't think that's the right solution, so they do.

Edwin "Bills: However, risks from software need to be in the overall residual risk analysis in 14971. So, they may not use it, but it has to be in 14971.

Yeah, it's… it's an interesting balance. I don't know how that's all gonna fall. Good point, Edwin. That is a very good point. Fair point. So what I like is that they've tiered this assessment going from the lowest unintentional radiator. … did I say that right? Yeah, radiator, to… … Stepping… so you want to start from the very lowest, and the requirements get harder and harder as you go. up the food chain. So, try to be as low of an intentional radiator as possible, because as you go up, your requirements get harder, your design requirements get harder, too, obviously. And so there's a whole list of standards that apply, or requirements. So the lower, the better.

And then the PC resistance is the EMC requirements are going to be significant changes. CISPER 11, I had one of my three EMC, maybe 4 EMC experts in my group, or my team, look at this. And he told me… He sat down and looked at the changes. It says for 11 in the 1-2 standard that exists currently, Edition 4.1. is based on a 2021 edition of 1-2, so CISPR-11 is… before 2024, which is on the slide here. So, the requirements

will change when it gets pulled into the Working Group 48 electromagnetic Disturbances section. So the 1-2 requirements are going to update, which is going to pull in these 2024 requirements, and they're major technical changes. So that means it's going to drive New emissions testing. Most likely gonna be design changes is the implication, and you're going to have risk management follow-up dates. So it's pretty significant. Radio Frequency Wireless Fields. Table 3 within the Working Group 48 section. FAME standard, which FDA loves and was pushing years ago, and I think it was 4th edition of 1-2 of the MC standard.

The levels have increased significantly. … basically doubling. That's huge. It's very impactful, and it's gonna kill some devices off the market. That's how significant it is. Also, this new ham radio frequency is significant enough in itself that it can also have significant impact. So you're going to want to do mitigation testing, early mitigation testing, to figure out, is your product owns 5? Are you going to have to do some mitigation, changes to hopefully Get through this gauntlet.

How are they considering all those devices in the ER? It's not going to survive ER devices. Okay.

I'm guaranteeing you this comes from FDA, because AIM7351731, FDA was pushing years ago, and years ago, FDA required this in submissions.

They're not considering sirens.

From ambulances, because that… So… so… there's… An area that wasn't really clearly….

HVAC.

Wonderful.

Or… helicopters, or anything else that lands in the ER.

So….

Okay. That makes everything else fail for these devices when they raise this level.

That's the problem, is….

Okay. Just bringing that back, since you're in mid-level management in the committee.

Indian Note.

Okay.

it's getting comments in on time. Right now, we're, like, in the middle of commenting. It's… Almost too late to put the comments in. For this round. Next round. But, yeah, send me a comment, and that would be helpful. Wireless coexistence, that's an FDA requirement currently. only in the U.S. If it gets placed into the standard, which it is placed in the draft. It's going to be an international requirement. That's the change in design, because now you're talking country frequencies as well, that you need to deal with. So… Really, one more slide. So, if you want support, we're here to help.

mitigate your risks. spot disruptive changes. We've talked about a whole bunch of them. Prevent costly redesigns, align documentation ahead of competitors, accelerate compliance, integrate evolving requirements seamlessly into your development pipeline. Work with Carrie and I. and with Edwin. And with Jose. We can work as a team. And Bayot. Bayot is part of my team. And I have quite a few other people on my team. Leadership insight, as part of the standards development. 601 guy, and my support team of experts can track areas of interest. That your group's interested in. Behind closed doors, access to knowledge that's being developed still.

Ready to leap ahead? Let's turn this into your insider pipeline, into 4th edition. Fast track. And if you want to contact me, Here's my… Info. Schedule a 30-minute contact, meeting, web meeting. Back to you, Sean.

That was awesome. Thank you so much. You know, this standard is gonna have a huge impact, as Leo and I discussed offline, you know, particularly for the largest manufacturers. you know, the top 250 MedTech manufacturers with multiple product lines. multiple products that fall under this standard are gonna be facing seismic changes to their QMS, and… other… processes. So, you know, plan early and often, as they say. And … get ahold… get ahold of Leo. I wanted to do the AI Minute. I had put something on, …

LinkedIn, and Martin and I were playing with it earlier this morning. We're trying to get, … a prompt together for medtech experts to just put in, I'm an expert at this, and to pump out a marketing statement that doesn't sound like absolute rubbish. And so that was… I put the link in the chat. Interested in… You know, I mean, a lot of times you see the things where it's like, I help companies, and as soon as I see I help companies at the beginning of something… somebody's LinkedIn thing, I hit delete. Like, delete, do not accept, do not accept. It's like, you know, poisonous language that comes from marketing. So, if you're trying to frame what you do and bottle and sell your expertise.

Start thinking about how you talk about yourself, what you share, how you share it. And because so much information right now is being filtered through the LLMs themselves, that is really the discussions that take place in this room, in this environment, on this call, and the voice of the expert that's gonna distinguish you from the next consultant. So, I would like you to think about that as you move forward. what can you tell me about what you do that no one else can tell me? Tell me something I don't know. Today, Leo told us a lot of stuff we don't know. And that's why I love working with experts. I think it's amazing. I think that what you guys do is incredible, and I hope that you will become an active member of this community.

Lastly, I'd like to say, if you can put in the chat, or you can put, in the email to me, or a LinkedIn message to me today, something that you learned from Leo today, we will put it in the, in the group, article that we're gonna put together about today's session. So get your name in print. And, I hope everybody has a great week. Next week, we're gonna have… who are we gonna have? Tiana Benson from LeanRAQA. I want all the regulatory people to show up and have a big, nasty fight next week about, working with the FDA.

It's gonna be a lot of fun, and … and let's… let's rip each other's wigs off, okay? Goodbye, everyone. Leo, do you want to say goodbye to everyone? Thank you.

Yeah, thank you so much, everyone. I really appreciate all the comments and questions and support.

Edwin "Bills: Great information, Leo.

Thanks, Edwin. No problem. Always good seeing everyone.

Awesome job. Thank you.

Leo.

Buh-bye.

Thank you, bye.

Thank you, bye-bye.

Thank you.