第235集 | Leo Eisner，Eisner安全咨询公司创始人兼首席合规与监管顾问 | 引领医疗技术创新的IEC 60601合规之路

大家好。我是林赛·德尼恩，Project MedTech的市场与参与总监，欢迎收听Project MedTech播客的又一期节目。如果您有任何需求或想推荐未来的嘉宾，可以发送邮件至info@projectmedtech.com联系我们。若喜欢本播客，请订阅并留下评论。欲了解更多关于Project MedTech的信息并注册我们的月度通讯，请访问我们的网站projectmedtech.com，并在LinkedIn上关注我们。

Everybody. I'm Lindsay Deneen, director of marketing and engagement at Project MedTech, and welcome to another episode of the Project MedTech Podcast. If you need anything from us or would like to suggest a future guest, you can email us at info@projectmedtech.com. If you enjoy this podcast, please subscribe and leave a review. For more information on project med tech and to sign up for our monthly newsletter, visit our website projectmedtech.com and follow us on LinkedIn.

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本期节目中，杜安·曼西尼将与医疗设备安全与合规领域的资深专家利奥·艾斯纳对话，分享他关于IEC 60601标准的丰富经验和知识。拥有四十余年职业生涯的利奥将谈及他在NASA的起步经历、参与医疗安全标准制定的角色，以及合规性测试的复杂性。探索IEC 60601更新的难点、保持信息更新的重要性，并为医疗设备制造商提供实用建议。让我们开始收听。

In this episode, Duane Mancini sits down with Leo Eisner, a seasoned expert in medical device safety and compliance, as he shares his extensive experience and knowledge on the IUC 60,601 standards. With a career spanning over forty years, Leo talks about his beginnings at NASA, his role in the development of medical safety standards, and the intricacies of compliance testing. Discover the complexities of the IEC 60,601 updates, the importance of staying informed, and practical advice for medical device manufacturers. Let's tune in.

好的，利奥，欢迎来到播客节目。

Okay, Leo, welcome to the podcast.

谢谢，很荣幸。很高兴认识你。

Thanks, I appreciate it. Good meeting you.

没错，确实如此。最好的播客往往是我们初次交流就直接在节目中进行的。那么利奥，请介绍一下你的背景和你所从事的工作吧。

Yeah, that's right. Yeah, are always the best podcasts anyways is the first time we get a chance to talk is just being on the podcast. So Leo, introduction into your background and what you do would be great.

当然，我在医疗领域已有约三十年经验，从事产品安全合规测试约四十年，参与标准制定二十年。因此我被称作'IEC 60601先生'——那是医疗电气安全标准。简而言之，我曾为三家公告机构和两家检测实验室工作。全球范围内，我被公认为产品安全合规与标准制定专家，这是最精简的自我介绍。截至本月，我从事咨询工作已满二十八年，哇哦，可以说相当久了。

Sure, so I've been in the med field about thirty years, been doing product safety compliance testing for about forty years and doing standards development for twenty years. So I'm called the IEC six zero one guy, which is the medical electrical safety standard. I've worked for three notified bodies and two test labs is the short short bio. So I'm known as a global safety expert in product safety, compliance and standards development is the really brief bio. I've been consulting for now twenty eight years as of this month, so woo hoo, you could say.

历经这些年风雨起伏，我和团队帮助医疗器械公司通过产品安全测试、电磁兼容（虽然我绝非EMC专家）、软件生命周期管理、风险管理、标签标识、大量文档工作（如DHF技术档案）、全球合规事务、标准战略制定等。我还参与多个标准委员会工作。

I've survived that many years doing this, with lots of ups and downs, helping medical device companies getting through product safety testing, EMC with my team, because I'm not an EMC expert by any stretch of the mind, software lifecycle, risk management, labeling, lots of documentation, DHF, tech file, around the world type stuff, standard strategy and lots of other stuff, and I'm on lots of standards committees.

明白了，非常厉害。在我们深入探讨60700标准及其对医疗器械创新者、制造商的意义之前，我对您的背景很好奇——为什么选择医疗技术领域？您入行的契机是什么？更让我惊讶的是，如您所言，您已深耕四十年，是什么让您坚持这么久？

Okay, very cool. So, yeah, I mean, before we dive into 60700, and what that means for medical device innovators, manufacturers, I guess, I am curious about your background and curious to why med tech? I guess that story of why you got in the industry, but then, like you just said, you've been in it for forty years. So why'd you stay for forty years?

其实四十年要从更早说起。高中时我非常幸运能在NASA实习。哇哦。那时我就接触了大型主机，学习了Fortran、BASIC和汇编语言，简直酷毙了。

Well, the forty years starts way before then. Because in high school, I was really fortunate to actually work at NASA in high school. Woah. So I got to play with a big fricking mainframe in high school, and I got to learn Fortran, basic and assembly, which was pretty fricking cool.

您就读于哪所高中？是在哪个NASA基地参与的？具体在哪里？

Where'd you go to high school? Where where where what NASA base were you at? Or did you get to do this at?

NASA艾姆斯研究中心。位于森尼维尔的莫菲特场。

NASA Ames. Okay. So Moffett Field in Sunnyvale.

明白了。

Okay.

所以硅谷在真正成为硅谷之前，那里几乎是一片田野。

So Silicon Valley before it really was almost Silicon Valley. It was fields.

是啊。

Yeah.

那时那里是果园。桑尼维尔当时真的有果园。所以这是很久以前的事了。

This was orchards out there. There were real orchards in Sunnyvale back then. So this is a time ago.

好的，对于所有不在美国的听众——我们40%的听众来自海外——来说，我们正在谈论的是加利福尼亚，对吧？这是个相当酷的机会，不过请继续。

Okay, so for all the listeners who are not, 40% of our listening base is not US based, international. For those listening in, we're talking about California, right? And so pretty cool opportunity here, but keep going.

我确实很幸运。我的高中老师基本上问我，你想在NASA工作吗？我说，当然，不在乎有没有报酬。我就去了，毫不犹豫。

I was pretty fortunate, definitely. I mean, my high school teacher basically said, Do you wanna work at NASA? It's like, Sure, I don't care if I get paid or not. I'm like, I'm there. I am there.

另外，我为之工作的那个人非常酷。他的斯坦福论文就是他的实验室，这太棒了。他的论文是关于视频压缩和向卫星发送信号的。所以我学会了视频压缩和向卫星发送信号，这也非常酷。我因此掌握了视频压缩和数字信号处理。

The other thing, and my, the guy that I worked for, he was very cool. He it was his Stanford thesis was his lab, which was awesome. And his thesis was to, do video compression and send signals up to satellites. So I got to learn video compression and send signals up to satellites, which was also very cool. So I learned video compression and digital signal processing.

所以我大部分的电子学知识是在工作中学到的，而不是在学校，而且我在上大学前就学会了这些。因此，我在大学一年级就当上了Fortran课程的助教，这几乎是闻所未闻的。这样我挣得比在学院食堂打工多，这也不是坏事。

So I learned a lot of my electronics in work experience instead of at school, and I got to learn it before I got to go college. So I was a Fortran TA my freshman year of college, which was pretty much unheard of. So I got paid better than working at the cafeteria in college, which was also not a bad thing.

没错，没错。

That's right, that's right.

所以这确实在某种程度上塑造了我，并为我的工程职业生涯铺就了一条好路。

So it definitely sort of formed me a little bit and it made a good career path into engineering.

嗯。好的。那么你先是进入工程领域，之后又从那里转到了医疗技术领域？

Yeah. Okay. So so you went into engineering and then from there, you kind of got into the med tech arena after that?

九年之后。因为最初是UL公司，那是我大学毕业时的机会之一，当时有四个职位可选，其中之一就是UL。他们正在为伯根消防集团寻找人选，而他们选中我的唯一原因是我毕业设计的项目是一个会说话的伯根火灾报警器。那些你永远不知道会通向何方的小机会。

Nine years after. Because first was UL and UL was one of my opportunities out of college was there were four positions and one of them was UL and they were looking for someone for the Bergen Fire Group. And the only reason they picked me as my senior project was a Bergen Fire alarm that spoke. Small opportunities that you never know where they're gonna lead.

确实。

Sure.

对吧？

Right?

是的。

Yeah.

最终在UL，在我第三次尝试离开UL之后——因为我已经厌倦了那里——但UL对我来说是一个极好的跳板，因为我学到了大量关于标准、组件、不同类别以及整个认证流程的知识，而这正是六零一标准的核心所在，即产品认证。因此，我在UL接触了各种产品类别：伯格与防火设备、计算机设备、家用娱乐机器、微波炉。我几乎什么都做过，包括塑料制品和印刷线路板。

And at the end of UL, after my third attempt to leave UL, because I was getting tired of UL, but it was a great stepping stone for me because I learned a lot about standards, a lot about components, a lot about different categories and the whole process of certification, which was part of what six zero one is all about, is certification of products. So learning about all these different product categories that I dealt with at UL, Berg and fire, computer equipment, household amusement machines, microwave ovens. I did everything. I did, plastics. I did print wiring boards.

我在那里涉猎广泛。学习所有这些知识为我打下了非常扎实的基础，这是毋庸置疑的。

I did a little of everything there. But learning all that, it was a good good background. There's no question about it.

嗯，好的。那么当你离开UL时，你是直接转型成为六零一标准专家，还是...能否告诉我这期间发生了什么？我想通过这些铺垫让听众理解：什么是60601标准？为什么现在的听众需要关注它？

Mhmm. Okay. Alright. So so when you leave UL, I mean, do you kinda jump right into being the six zero six zero one guy or or or tell me what transpires there? And all of this I wanna lead up to what is 60601 and why does a listener right now care about it?

不过，是的，也请详细说说这个转变过程是如何发生的。

But, yeah, kinda walk me through how that that transpires as well. So

我并非立刻成为六零一标准专家。显然，我自己也需要接受培训。离开UL后，我开始四处求职。我已厌倦为UL工作，正在寻找新的机会。

I don't become the six zeros six zero one guy right away. I mean, I have to train up to it myself, obviously. So after UL, I'm looking around to get a job. I'm tired of working for UL. I'm looking for opportunities.

我去了德克萨斯州拜访朋友，心想或许能在当地找工作。但运气不佳。后来遇到一位猎头，他问：'想不想去圣地亚哥？'我说：'当然。'

I go to Texas, visit a friend, and I thought, oh, I'll look for a job in Texas. No luck. I hit this headhunter. He says, would you like to live in San Diego? I said, sure.

这听起来是个好机会。我开始与圣地亚哥的TUV南德公司接触——这是一家公告机构。当时他们正根据MDD（对不了解的人解释：医疗器械指令，这是现行医疗器械法规MDR的前身）启动新业务。那时他们非常需要具备认证背景但未必熟悉六零一标准的人才。

Sounds like a good opportunity. I start talking to this company in San Diego, TUV sued, which is a notified body. And they're just starting up under what's called the MDD for those that don't know what that is, Medical Device Directive. That's the predecessor to the Medical Device Regulation, which is the current status now of where we're at for Europe. So at that point, they were very interested in someone that had certification background, but maybe didn't have six zero one background.

所以我非常符合他们的要求。于是他们联系了我，几周后安排我过去面试。实际上我记得是隔周就去了，他们花了一整天时间面试我。那天面试结束时我问他们，你们什么时候能出结果？

And so I fit the bill pretty well. And so they talked to me. They had me down a couple weeks later and interviewed me. Actually, I think it was the next week And they spent the whole day with me. And I asked at the end of the interview that day, when will you know?

其实他们当天就决定了。他们说：好的，你什么时候能入职？两周后可以吗？我说当然可以，然后就去了。

They already made up their mind that day. It's like, okay, when do you want me? Oh, can you be here in two weeks? I said, yeah, sure. I was there.

是啊，没错没错。

Yeah, right, right.

那是个绝佳的机会。我在UL待了九年后实在受够了，当时就想：我受够了，必须离开这儿。幸运的是，我在Nemco有位挚友兼导师，他现在是公司副总裁，正是他培养了我。

It was a great opportunity. I was so done with UL after nine years. I was like, I'm done, I am like out of here. So it was, and I had some really great mentors, someone I'm really good friends with that works at Nemco. He's a VP of Nemco, trained me.

那时他还在CSA工作，经常过来指导我。后来他去了TUV工作一年左右，接着就加入了NEMCO。这些都是认证检测机构，只是名称不同。所以我学到了很多关于601标准的知识。

He was at CSA at the time. He kept coming down and he was training me. Then he actually joined TUV for a year or so, then he joined NEMCO. And these are all certification test houses, just different names. So I learned a lot about six zero one.

我还去了慕尼黑——TUV的总部所在地，接受601标准创始团队成员的培训。第一版标准诞生于七十年代初，不过我从未见过初版，我受训的是第二版。现在我们用的是第三版，而我目前正在参与第四版的制定工作。不仅是第四版领导团队成员，还负责其中一个工作组，同时参与另一个工作组。第三版的修订我也贡献过力量。

I went to Munich, which is the mothership for TUV suit, and got trained by one of the fathers of six zero one, the first edition, which came out in the early seventies, which I never saw the first edition. I got trained on the second edition. We're in the third edition right now, and I'm working on the fourth edition currently. And I'm in the leadership team of the fourth edition, plus I'm running one of the working groups in another working group. And I helped on the third edition amendment too.

其实我想参与第三版前期的修订，但他们说：不行，你经验还不够。很遗憾。

I wanted to help on one of the previous versions of third edition, but they said, no, you don't have enough experience. Sorry. Yeah.

所以我很好奇，我有一个两部分的问题。你知道，让我们先谈谈正在制定的第四版，但请大致介绍一下这些不同版本的重大更新。同时，能否为听众们解释一下——我个人比较熟悉，因为在我之前另一家公司任职时，我们近距离见证了ISO 10993的更新，特别是第十七、十八部分甚至第一部分，对于正在收听的各位来说，那是生物相容性标准。但我很好奇，请为听众们讲解一下标准更新的流程是怎样的。然后从你的角度来看，每个版本之间的更新幅度有多大？

So so I I I'm curious to know I had a two part question. You know, let's save edition four that's being worked on, but kind of walk me through how big updates are with these different editions. And also, can you just give the listeners, I'm familiar with it because when I was at a previous role at another company, we got a front row seat to updates to ISO 10,093, specifically part seventeen and eighteen and even part one, and which is for everyone listening in, that's the biocompatibility standard. But I'm curious, walk the listeners through what a process is like updating a standard. And then from your perspective, how big were these updates from each edition?

然后我们或许可以在这里暂停一下，接着讨论即将到来的第四版或第四期内容。

And and then let's maybe pause there, and then we could talk about episode or or edition four coming up here.

好的。第三版我记得花了十年时间制定，几乎半途而废，因为IEC差点就要宣布中止项目并重启——由于耗时过长，他们当时表示这严重超出了规定期限。现在大多数标准项目的允许周期是三到四年，这是IEC和ISO现行的规则。

Okay. So third edition, I think it was, took ten years to do and almost crashed and burned because the IEC yeah. IEC was so close to saying, we're gonna close down the project and restart it because it was taking so long that they were, like, saying this is taking way too long and we're, like, breaking every rule and regulation of how long the project is allowed to go. Most standards projects are allowed to go three to four years now. Those are the rules for IEC and ISO.

我记得过去可能允许五到六年，而第三版最初发布的时间...大概是80年代吧？我需要查证，记不清了。

I think they used to allow them to go to five or six years maybe back then, and third edition, I'm not even sure when it originally came out. That was like in the 80s, I think. I'd have to look back. I don't remember.

但是

But

3.2版发布于2020年，所以可能是2000年代的事，应该是2000年代。我可能把第二版的时间混淆了...总之流程非常漫长。第四版于2024年启动，计划在2030年2月发布，所以是六年周期。

3.2 came out in 2020, so I think it was, maybe it was the 2000s, probably was the 2000s. I think I'm going back to second edition in my So they're a very long process. Fourth edition started in 2024. It's scheduled to go out in 02/1930. So six years.

明白了。所以时间仍然相当充裕。

Gotcha. So still plenty still a lot of time.

是的，是的。虽然花费很多时间，但由于开发周期和需要处理的事务量，实际并不算太长。

Yeah. Yeah. A lot of time, but not so long because of development cycles and how much there is to Yeah. Deal with

这种合作是否吸纳了行业力量？我猜还会邀请专家分享建议？我的意思是，这是那种他们会拍拍你肩膀说‘我们希望你能参与进来’的情况吗，还是如何运作的？

And is this collaboration they pull in industry, I'm guessing, and have experts share advice as well? I mean, is this one of those things where they kind of tap you on the shoulder and say, We want you to be involved in this, or how does that work?

对于负责运营工作小组的人来说，你既需要被选中也要自愿参与，因为有时志愿者不足。对于想以专家身份加入工作小组的人，仍需证明你在特定领域的专业性。但这次有监管机构参与，且相比IEC 06/2001时期，这个特定项目涉及的监管机构更多——仅第四版60601就有18名FDA成员参与，规模惊人。我的工作组里有3名FDA人员，这在60多人的团队中占比很高（我的工作组超过60人，规模庞大）。在启动会议上，40人不到的会场里就有8、9名监管人员，令人印象深刻。

So for the people that are running the working groups, you have to be sort of tapped as well as volunteer because sometimes they don't have enough volunteers. For those that wanna be on the working groups as experts, still have to show that you're an expert within the specific area. But there's regulators involved, and there's more regulators involved in this specific project than there used to be for IEC, I would say, for 06/2001 because there's 18 FDA members involved in six zero one for fourth edition, which is huge. There's three FDA people in my working group, which is a lot out of 60 some I have over 60 people in my working group, which is a huge working group. There's I think there were eight or nine regulators in the room out of 40 just shy of 40 people in our kickoff meeting, which was amazing.

说实话这让我很震惊，因为在以往版本中，可能只有一两名监管人员参与60601。这次有美国FDA、日本PMDA、澳大利亚TJ，虽然新西兰未出席，但沙特SFDA已持续参与五到七年了。还有一家公告机构也在场。

It's actually it sort of blew my mind, actually, because in previous editions, there would have been maybe one or two regulators working on six zero one. There were there was FDA PMDA, which is Japan, TJ Australia. I don't think New Zealand was there, but there was s SFDA, Saudis. They've been involved for the last five to seven years now, I think. And there was a a notified body as well.

我记得BSI（英国标准协会）就在我的工作组里。其他工作组可能也有不同监管机构参与。但FDA确实对此投入了巨大资源。

BSI, I think, was in the room, in my working group. There's other working groups that there probably are other regulators as well. Okay. But FDA has done a significant investment in this.

好的。那么我们先回答这个问题：IEC 60601是什么？首先解释这个标准。

Okay. Alright. So so let's do this. Answer the question, what is IEC 60,601? Let's answer that question first.

这个标准是什么？是否被所有监管机构一致遵循？请给我们做个全面介绍。

What is this? What is the standard? Is generally followed unanimously throughout all the regulatory agencies? Kind of give us the rundown of it.

所以这是针对医用电气设备和系统的，但人们的误解在于，大家一看'医用电气设备'就以为只是电气安全测试。其实远不止如此，因为它涉及多种不同的风险——机械风险、辐射风险、标识问题，甚至包括生物相容性、灭菌、清洁消毒等许多你单看标题根本想不到的风险。这个标准名称确实容易让人产生误解，因为它涵盖了风险管理、基本性能等方方面面。有趣的是，FDA对这些内容的解读往往与标准存在差异。据我所知，全球几乎所有监管机构都在采用这个标准。

So it's for medical electrical equipment and systems, but the fallacy is that everyone thinks, okay, because it says medical electrical equipment, oh, it's just electrical safety tests. But it's a lot more than that because it deals with a lot of different hazards, mechanical hazards, radiation hazards, labeling. It even covers biocompatibility, sterilization, cleaning, disinfection, you know, a lot of different hazards that you wouldn't think about. Just based on the title, it's sort of misconstrued because you look at all the hazards that apply to that and it deals with risk management, essential performance, which the FDA doesn't always look at it the same way as what the standard says, which is always interesting. Almost every regulator around the world that I know about uses it.

这是个在全球范围内获得广泛认可的标准。虽然存在一些国家差异，但除了当地的电压类型、少量测试和语言问题等常见因素外，目前国家差异已经非常非常少了。这些就是导致国家差异最典型的原因。

It's a pretty internationally recognized standard across the world. There are some national deviations, but very, very few at this point other than local, like, voltage type things and some minor testing and language issues, typically. Those are the most typical reasons for national deviations.

明白了。也就是说和其他标准类似，不同监管机构会发布声明表示认可该标准的大部分或部分内容？你刚才说的国家差异就是指这个情况吧？

Okay. Yeah. So so very similar to other standards where different regulatory agencies will kind of put out a release that says, Hey, we recognize most of this standard or parts of the standard. I'm guessing that's kind of what you're talking about here that other regulatory agencies do?

是的，不过我说的国家差异更多是通过CB体系实现的——这是针对检测机构的测试报告体系。加入CB体系的每个国家都可以为本国签发测试报告，并制定国家差异或偏差。

Yeah, more of what I was talking about for national deviations is through what's called the CB scheme, which is the test reports for the test agencies. So each country that's within the CB scheme can issue test reports for the country and the country can issue national differences or deviations.

好的，清楚了。

Okay, gotcha. Okay.

这种情况更多见于IEC标准而非ISO标准，不过ISO标准也可以纳入CB体系，只是没那么常见。

And that's typically more an IEC thing than an ISO thing, but ISO can be part of CB scheme as well, but it's not as often.

好的。那么对于医疗器械制造商来说，如果产品含有电气部件，这个标准实际上意味着什么？是不是就像提供了测试大纲？比如相当于给出了60601标准的101入门课？

Okay, all right. And then, you know, I guess, so you talked about what's in it. What does this mean practically for medical device manufacturers? If there's an electrical component, this is where I go, where it outlines all the testing. You know, I give us the 60,601 class 101, if you will.

是的，这个标准中是否有类似的部分，我来举个例子，因为这是我熟悉的领域。以ISO 10993为例，你可以查阅第一部分，它大致概述了如何利用该标准的其他部分来证明生物相容性。60601标准也是这样设置的吗？我是否可以通过阅读第一部分来了解整个流程的要点？还是说我直接举手表示，让我去找服务提供商说‘嘿，带我过一遍这个流程’？

Yeah, is there a part of this standard similar to, I'll give an example because this is the world I know. For ISO 10,993, you you go to part one and it kinda outlines how you need to think about showing biocompatibility using the rest of the parts of that standard. Is that how six zero six zero one is set up? Do I go to part one and I can read through that and kinda get a good feel for what this process entails? Do I just raise my hand and say, let me go to a service provider and say, hey, walk me through this?

我想知道那具体是什么样子的？

I guess kinda what does that look like?

这是个很好的问题，但也不简单。我记得10993里有个类似路线图的东西，会指引你在后续系列中该查阅哪些部分。不过我自己也常被搞糊涂，毕竟我不是生物相容性方面的专家。

That's a great question and not a straightforward question, I guess. I know there's sort of a map in 10/1993, right, that then maps out where you go within the rest of the series. And then I get very confused on that because I'm not a bio comp type guy.

然后你就

And then you

去找专家咨询。就像你会为60601标准找专家一样——很多人就这个问题来找我。

go to the expert. I go to an expert for that just like you would go to an expert for six zero one, which there's a lot of people that come to me for that.

是啊。

Yeah.

这是个系列标准，而且非常庞大，因为现在仅第二部分就有大约95或97个标准，此外还有第一部分和通用标准。60601-1是通用标准，然后是 collateral标准（补充标准），这些collateral标准都带-1后缀。

So it's a series and it's a huge series because there's now I think we're on our ninety fifth or ninety seventh standard in the series roughly in the part twos, and there's part ones, and then there's the general standard. So six zero six zero one dash one is the general standard. Then there's the collaterals. The collaterals are dash ones. So the collaterals yeah.

60601-1-2标准针对的是EMC，即电磁兼容性。现在它涉及的是干扰问题，过去则是兼容性。这适用于所有医用电气设备。因此，通用标准适用于任何电力驱动的设备。

Six zero six zero one dash 1 dash two is for the EMC, electromagnetic. Now it's disturbance. It used to be compatibility. That applies to every medical electrical device. So the general standard applies to anything that's powered by electricity.

可能是电池供电，也可能是核能供电，或是通过砖式电源供电，又或是直接插墙式硬线供电。总之需要某种能量来源。我不关心具体是什么能源。是的，也可能是其他类型的电源。

Could be battery powered, could be nuclear powered, it could be powered by a brick power supply, or it could be powered by plugging a hardwire to the wall. Some type of power energy source. I don't care what that energy source is. It yeah. It could be some other power source too.

所以只要是通过电力驱动的，就适用60601标准。然后你需要通读标准，面对所有安全要求，判断哪些条款适用。这有点像设计规范，但写得比较混乱。目前这部分设计得并不完善。第四版修订的部分原因就是为了清理这些问题。

So if it's electrically powered of some way, then it would apply to the six zero one standard. Then you go through the standard and you have all these hazard requirements, and you have to decide does it apply or not. So it's sort of a design spec, but it's written messy. It's not very well designed at this point. That is one of the part reasons for fourth edition is to clean up some of that.

这是众多目标之一。我们为第四版制定了详细的设计规范。还有统领整个60601系列的架构规范，这些也指导了项目的设计规范。至于60601-1的配套标准，有60601-1-2，60601-1-6是关于可用性的，它桥接了62366和60666-1这些可用性标准，属于生命周期标准。

That's one of the goals, one of the many goals. We got a lot of we have a design spec for the fourth edition. We also have an architecture spec that's overarching for the whole six zero one series that drove the design spec for the project as well. Then the one dash six zero one dash one collaterals, there's the one dash two, the one dash six is for usability, which bridges to sixty two thousand three and sixty six dash one, which is usability. It's a life cycle standard.

60601系列不是生命周期标准，而是型式试验标准，属于一次性测试类型。生命周期标准范围更广，因为它涵盖整个产品周期，而型式试验是在生产前进行的。所以在型式试验标准里存在某些限制。

The six zero one series is not a life cycle series. It's a type test standard. So it's a one and done type. So life cycle is much broader because you're dealing with the whole life cycle where type test is before production. So you have a limit within the type test standard.

我们设定的某些限制与可用性标准62366不同，后者是需要持续更新的生命周期标准，就像风险管理——这也是整个60601系列涉及的内容。自第三版起，我们就始终引用14971标准贯穿60601的3.0、3.1、3.2版本（其中.1表示第三版第一次修订）。我知道这些术语对某些人来说像天书，所以需要稍作解释。

So there's some limits that we sort of stop at versus the usability standard six two three six six is a continual life cycle that you continually update sort of like risk management, which we deal with in the whole six zero one series. We reference fourteen thousand nine seventy one throughout 06/2001 since third edition. So three point zero, three point one, 3.2, which means, dot one means third edition amendment one. I'm talking Greek to some people, so I wanna explain it a little bit.

完全理解。

100%.

试着理解希腊语。是的，我知道我有时说话像希腊语。我们每个人都有自己的表达方式。

Try to de Greek. Yep. I know I talk Greek sometimes. We all do in our own way.

没错。

That's right.

所以附属条款延续到第11和12条。11条是家庭使用环境，12条是急救医疗服务环境，针对不同环境，这些并不适用于所有产品。它们只适用于特定类型的产品。因此，有些附属条款适用于所有情况，有些则不然。而第二部分则是针对特定技术类型的专门标准，比如2-2条是针对高频手术设备的。

So the collaterals go on to dash eleven and twelve. 11 is home use environment and 12 is the emergency medical services environment for different environments, which those don't apply to every product. Those apply to very specific type of products that are in those environments. So some collaterals apply to everything and some don't. And then the part twos are particular standards for specific type of technology like dash two dash two is for high frequency surgical equipment.

以消融设备为例。或者我担任召集人已有——说来难以置信——二十年的80601-2-58标准，关于晶体摘除和玻璃体切除设备的。这是你绝对不想经历的手术，基本上用于白内障手术。

So ablation equipment would be a great example. Or there's the one that I'm a convener of and I have been for, it blows my mind, twenty years now. I thought it was less, is 8060One-two-fifty8, lens removal and vitrectomy equipment. Something you don't wanna ever get done. It's for cataract surgery, basically.

明白了。

Okay.

很久以前我被四家公司雇佣，为了让他们的产品获得日本批准。他们需要制定一个标准。这就是我学会编写标准的经过。有趣吧，背后总有故事。确实如此，没错。

I got hired by four companies way back when so they could get their products into Japan for approval. They needed a standard written. And that's how I learned how to write standards. Interesting. There's always a story behind There's always a story, yeah, that's right.

没错，非常酷。

That's right, very cool.

这就是它的基本结构。

That's the sort of structure of it.

现在

Now

在第四版中，我们将取消所有附属条款，将其合并到通用标准中。

for fourth edition, we're gonna get rid of all the collaterals and collapse them into the general standard.

我正想问你们在02/1930项目上的工作进展。具体有哪些重大变化？你刚才提到其中之一。这些变化将如何切实影响企业将产品推向市场？

I was just gonna ask what you're working on for 02/1930. Yeah. What are the big changes? You just said one of them. And and and how's this going to tangibly affect companies taking products to market?

这个变化会将通用标准扩展成更庞大的文件。EMC要求仍然是所有企业必须满足的，因此在要求本身方面不会有实质性改变，只是条款位置调整了。可用性要求也依然是绝大多数制造商需要达到的。

Well, that one is gonna expand the general standard into a much bigger document. So the EMC requirements, everyone still has to meet. So that's not gonna be a tangible change in the sense that the requirement's still there. It's just where it's sitting. The usability requirements are still something pretty much every manufacturer has to meet.

这部分变动不大。警报要求可能会让某些制造商感到头疼——有些企业多年来一直回避这个标准，声称'我们只有通知功能，没有警报系统'。但实际上多数情况下他们确实具备，只是借口说'我们没有危险...'（我在回忆当时的措辞）。本质上他们是在逃避本应适用的警报标准。

That's not gonna change much. The alarms requirement, this is where I think some manufacturers are gonna have some, what I would call, some pain because there's some manufacturers that have been avoiding the standard for years because they say, oh, we only have notifications. We don't have any alarms. But they actually, most of the times, do, and they just say, oh, we don't have any hazardous I'm trying to remember the wording I used to I said. Basically, they're avoiding dealing with alarm standard when it really applies.

嗯。我们正在标准中明确措辞：若存在危险通知，则警报要求必须适用。我们会在标准开篇就清晰阐明这一点。

Mhmm. And we're writing the wording in the standard to make it clear that if you have a hazard for notification, then alarm requirements are gonna apply. And we're gonna make it very clear at the very front of the standard.

好的，没问题。就是

Yeah, okay. That's

一些非常基础的内容。是的，还有很多其他方面。

Some very basic stuff. Yeah. There's a lot more.

是的，我确定。那么考虑到所有这些，对于需要进行这类测试的公司，您最好的建议是什么？对吧？比如，特别是在生物相容性方面，我的建议肯定是：聘请一位持续跟进这些领域最新动态的专家。因为有时候人们容易陷入的误区是，当你查看标准时——比如需要评估细胞毒性、致敏性、刺激性、全身毒性、遗传毒性这些项目——ISO 10993中这些要求长期未变，但具体的评估方法已经改变，而仅通过阅读标准往往无法清晰了解这些变化。

Yeah, I'm sure. So I guess, with all of this, what's your best piece of advice for companies that are going to have to kind of go through this testing? Right? Like, I guess I'm sure it's something similar to, like, advice, especially when it comes to the biocompatibility is, hey, engage an expert who's staying up to date on these things because I think sometimes where people can get tripped up is when you're looking at a standard, you know, the fact that you need to evaluate cytotoxicity, sensitization, irritation, you know, systemic toxicity, genotoxicity, those things haven't changed in a long time within ISO 10,993. How you address those has changed, and it's not always clear just reading the standard on how that may have changed.

因此聘请熟悉最新动态的专家通常很有帮助。另外我的建议是：不要走捷径。这其实很简单——严格按照规定操作，就能满足任何监管机构的提交要求。关于60601标准，您也是类似建议吗？

And so engaging an expert who's staying up to date on those things is is often helpful. And, you know, my other recommendation is just like, don't don't cut the corners. This should be really straightforward. Like, just just follow what you're supposed to do, and you'll check this box for your submission to whatever regulatory agency you're submitting to. Is that kind of what you advise here with 60601?

类似。我首先要强调务必跟进最新动态。比如8月15日我与MLVX合作的网络研讨会，全球约有110人参与，包括测试实验室人员，可能还有一两位监管人员。有些制造商确实抱怨某些软件要求和电磁兼容要求的细致程度过高，这些新规正在逐步实施。

Similar, I would say first, definitely keep up on what's going on. So one thing, there's been, so I did a webinar on the August 15, with MLVX, and there were about 110 people around the world, including, test labs. And I think maybe a regulator or two. I'm not sure about that. And there were some manufacturers definitely griped about the extensiveness and the, details of some of the, like, software requirements and the EMC requirements that are pretty extensive that are coming into play.

我当时对他们说——后来也在LinkedIn上发文——要积极参与对修订内容的意见反馈，因为标准仍在完善中。你可以加入本国技术委员会提出意见，也可以通过行业协会发声。比如美国AdvaMed就发表了强烈意见，他们给IEC写了封分量很重的信，指出某些要求过度了，需要回调。通过合理发声，有些要求可能会被适当放宽。所以企业需要保持关注并参与委员会工作。

I said to them basically, and it was also in some of the LinkedIn post afterwards, just get involved in either commenting on the changes because they're still coming down the line that you have a chance to join your national committees and comment because the more voices there are, and you can also join your trade association's comment because I know AdvaMed in The US is making a lot of noise. They've written a pretty significant letter to the IEC saying some of these are overblown. You gotta back off. So, you know, with voice and reasonable comments, some changes will come into play to sometimes tone down some of the requirements. So they need to be aware what's going on, join the committees.

这是他们能做的第一点。第二点如你所说，显然要保持信息畅通。第三点是获取专家建议，可以是内部或外部专家。不一定非要由我来培训，还有很多其他专业人士。

That's one thing they can do. The other thing is to, like you said, be aware of what's going on, obviously. The other thing is get some expert advice, internal or external. I don't have to be the only one training them. There's lots of other people.

大公司和小公司里都有其他人在参与。小公司在标准制定工作中处于劣势，因为成本高昂。参加会议，尤其在美国——我不清楚其他国家是否都有相同的国家委员会会员费用支出，有些有，有些没有——再加上差旅费用、离开办公室的时间，所有这些加起来。我每月要花四十到六十小时在这上面，同时还要努力维持我的咨询公司运营。

There are other people within big companies and also small companies. Small companies are at a disadvantage when it comes to standards work because it's expensive. Going to the meetings, especially in The US, I don't know, other countries don't always have the same expenses to be part of national committee fees. Some do, some don't, but also the travel costs, the time away from being at the office, all those add up. I'm spending forty to sixty hours a month on this, on top of trying to keep my consulting firm going.

这是一项承诺。但通过这种方式，我能帮助客户保持领先。所以这对我来说是一种平衡。这就是我的承诺。

It's a commitment. But I'm able to help my clients stay ahead of things this way. So there's the balance for me. So that's my commitment.

是的。

Yeah.

但这些都是关键点，同时还要开始考虑这将如何影响我的设计和质量管理体系，因为我展示的一张幻灯片基本上会贯穿你整个设计流程中的主要设计文件。设计输入、设计输出以及验证与确认——几乎每一份重要文件都会受到影响。重大影响。我不说是细微层面，但在显著层面上，我做了个图表显示每个主要设计模块都会受到波及。

But those are the key things I think and also starting to look at how is this gonna impact my design and my qms because one of the slides I presented is is basically gonna impact major design documents throughout your whole design process. Sign input, design output, and V and V. Every almost every single major document's gonna get hit. Major. I won't say minor level, but on the significant level, I did a diagram that showed every block, major design block is hit.

对，对。所以你开头提到8月15日做过一个网络研讨会，是和哪个团体合作的？

Yeah. Yeah. So so you you mentioned the beginning you did a webinar August 15. What was the group you did it with?

MLVX。好的，链接我已经发给你了。

MLVX. Okay. I gave you the link.

好的。嗯，是Med Tech Leading Voice吗？我记得是肖恩·史密斯主持的，对吧？

Yeah. Okay. Yeah. Is it med tech leading voice? I think that's Sean Smith, is that right?

没错。好的，明白了，非常好。那么我们会在节目备注里附上那个网络研讨会的链接。我猜如果大家想深入了解这方面的更多信息，那里是个不错的选择，对吧？

Exactly. Okay, all right, very good. So we'll include a link to that webinar in the show notes. I'm guessing that's a pretty good spot for people to go to if they want to dig in a little bit more information on this, right?

是的，嗯。

Yes, well.

好的，让我试着理解一下——这个问题可能是我最后一个关于此的疑问了。就60601测试标准而言，如果我有一款医疗设备准备明年向FDA申请许可，这些更新内容其实对我完全没有影响吗？还是说只有当我修改医疗设备设计时才会产生影响？具体机制是怎样的？

Yeah. Okay, so because this is a let me understand I guess help me understand this a little bit more. This will be my last question around this is, as it relates to the 60700 testing, testing. If I have a medical device that I'm applying for clearance in the FDA in the next year, right, these updates don't affect me really at all then, or will they just affect me as I make design updates to the medical device? How does that work?

比如说，如果我更换了医疗设备中的某种材料或材料供应商，可能只需要向FDA提交一份备案信，并不需要重新提交510(k)申请。那么在这个标准里，是否有条款规定这种情况也需要重新评估60601合规性？是否需要因为这类备案而重新进行某些测试？标准里是否也涵盖了这类情况？

Like, is this something where, like if I change a material or a material supplier within my medical device, you know, that might be just a letter to file with the FDA. It's not really a new five ten submission. Is there a piece of this standard where also I would look at that to say, hey, oh, this does affect 60700. I'm gonna have to go back and redo some testing as a part of this letter to file or submission. Is that kind of in the standard as well?

是这样的，不过你参考的不会是第四版。第三版才是被认可的共识标准，这点很明确。电磁兼容标准（EMC）和很多-2系列标准也是。但并非所有-2标准都是公认共识标准，这个我需要查证，可能不是全部，因为有些尚未正式发布。

So, yeah, I mean, but it wouldn't be fourth edition. You'd be looking at edition It three point is a recognized consensus standard, definitely. And so is the EMC standard and a lot of the dash twos. I don't know that every dash two is a recognized consensus standard. I'd have to dig into that, but probably not everyone because some of them have not been published.

所以确实不是全部。另外FDA有个叫ASK IT的项目，这个程序允许他们直接采纳测试实验室数据，只需提交总结报告。这是近几年才从试行阶段转为正式实施的新项目，好处是现在不需要提交完整测试报告了。测试实验室将总结报告给到你们制造商，由你们决定是否提交给FDA。

So yeah, not everyone, But also there's, FDA has what's called the ASK IT program, which is a program where they basically take the test lab data and accept it, and they get a summary report, which is a fairly new program where they've fully they've gone from, like, a draft program. I don't know what they called the sort of temporary program to now fully accepting the program in the last couple years. K. Which is nice because now you don't have to submit the full test report. You get a summary report from the test lab, but it goes to you, the manufacturer, and you decide as the manufacturer if you want to submit that summary report to the FDA.

这是个可选项。不过据我了解，大多数制造商还是选择不提交总结报告，依然提交完整测试报告。

So that's an option. Most manufacturers have decided not to submit those and still submit the full test report is what I've heard.

好的，太棒了。那么，Leo，对于那些想了解更多信息的听众来说，有哪些最佳途径呢？我是说，可以在LinkedIn上关注你。

K. Awesome. Alright, Leo. So what are the best places for those listening in that wanna learn a little bit more? I mean, follow you on LinkedIn.

你有个人网站吗？显然，我们会举办你提到的那个网络研讨会。人们可以通过哪些好渠道来关注你、联系你，获取关于标准和更新的更多信息？

Do you have a website? Obviously, we're gonna have that webinar you spoke of. What are some really good places for people to kinda follow you, connect with you, get more information on the standard and the updates?

我的网站是EisnerSafety.com，也就是eisner,safety。我的博客也在网站上，网站上还有我的联系方式页面。

So my website, EisnerSafety dot com, so eisner,safety. My blog, which is on my website. I have a contact page on my website.

太好了。

Wonderful.

LinkedIn，我会给你链接，因为有点长。网络研讨会，我有研讨会的链接，已经给你了。我还做过很多播客，也给了你几个。在我的博客上，如果你搜索播客或其他关键词，会看到我和Greenlight Guru合作的一系列播客，多年来我还和他们一起举办过多次网络研讨会。我和他们合作可以追溯到很早以前。

LinkedIn, which I'll give you the link for that because it's a little long. The webinar, I have the webinar link, which I gave you, and I've done lots of podcasts, which I gave you a couple. On my blog, if you search for podcasts and some other ways of searching, you'll see a bunch of podcasts I've done with Greenlight Guru, and I've done webinars with them for years. I've been with them for way back when.

太棒了，太棒了。是的。

Awesome. Awesome. Yeah.

是的。

Yeah.

非常好。人们。是的。他们确实如此。这太棒了。

Very good. People. Yeah. They sure are. This that that's great.

好的。那么我们会把这些链接放在节目说明里，所以根据你收听的平台不同，听众们可以上下滑动一英寸就能看到。Leo，稍等一分钟。我们线下再聊，非常感谢你这么做。

Okay. So so we will include those links in the show notes, so depending on what you're listening to, platform, listeners up or down an inch, it'll be right there. Leo, hang on for one minute. We'll chat offline, but thanks so much for doing this.

是的。当然。谢谢。感激不尽。

Yeah. Definitely. Thank you. Appreciate

联系我们，请发送邮件至infoprojectmedtech.com。想了解更多关于Project MedTech的信息，请访问我们的网站www.projectmedtech.com。感谢收听，祝您有美好的一天。

from us, you can contact us at infoprojectmedtech dot com. And for more information on Project MedTech, visit our website at www.projectmedtech.com. Thanks for listening and have a great day.