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		<title>What&#8217;s NASA &#038; Star Trek have to do with IEC 60601?</title>
		<link>https://eisnersafety.com/2025/11/29/whats-nasa-star-trek-have-to-do-with-iec-60601/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=whats-nasa-star-trek-have-to-do-with-iec-60601</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Sat, 29 Nov 2025 05:19:05 +0000</pubDate>
				<category><![CDATA[60601 Series]]></category>
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					<description><![CDATA[From NASA to IEC 60601 - A Lifelong Trek for Safer Devices.

When I was in high school, I had no idea a simple work study opportunity would redirect my entire future. That is exactly what happened when I was beamed over to NASA for the first time. That early exposure to real world engineering lit a spark that has stayed with me ever since. A curiosity for science, safety, and how technology can genuinely serve people.

All these decades later, that same curiosity still energizes my work with IEC 60601, patient safety, and supporting the MedTech industry. So when I joined Faisal Kamal on The ⭕️ Podcast, it felt like a perfect chance to bring all these threads together. Star Trek. NASA. Standards. Innovation. Human factors. EMS &#038; Home use environments.. And above all, patient safety.]]></description>
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    <p>
      When I was in high school, I had no idea a simple work study opportunity would redirect my entire future. That is exactly what happened when I was beamed over to NASA for the first time. That early exposure to real world engineering lit a spark that has stayed with me ever since. A curiosity for science, safety, and how technology can genuinely serve people.
    </p>

    <p>
      All these decades later, that same curiosity still energizes my work with IEC 60601, patient safety, and supporting the MedTech industry. So when I joined Faisal Kamal on The <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/2b55.png" alt="⭕" class="wp-smiley" style="height: 1em; max-height: 1em;" /> Podcast, it felt like a perfect chance to bring all these threads together.
      Star Trek. NASA. Standards. Innovation. Human factors. EMS &amp; Home use environments.. And above all, patient safety.
    </p>

    <p>
      Judging by the conversation that unfolded across LinkedIn afterward, I was not the only one who felt the episode combined heart, humor, and hard won lessons in a very different way.
    </p>

    <h3>Standards Are Not Rulebooks. They Are Star Maps.</h3>

    <p>
      One of the core themes Faisal and I explored on the podcast was the idea that IEC 60601 is not just a set of rules. It is a star map.
    </p>

    <p>
      A star map built from decades of engineering mistakes, test data, regulatory learning, and field experience.
    </p>

    <p>
      Many people see standards as obstacles. In reality, standards like the IEC 60601 series are a knowledge base created to unlock innovation safely, not shut it down.
    </p>

    <p>
      Several people who reacted to the episode picked up on that idea. They commented on how the format allowed serious topics like risk, essential performance, and compliance to feel more approachable. That mix of education and entertainment was exactly what we were hoping for.
    </p>

    <h3>Why Star Trek Got So Much Right</h3>

    <p>
      A fun part of the episode, and something listeners responded to strongly, was connecting Star Trek’s fictional tools to real world design challenges.
    </p>

    <p>
      Take the tricorder.
      It is a great analogy for electronic medical devices used in the home and in EMS environments. These are unpredictable spaces filled with:
    </p>

    <ul>
      <li>noise</li>
      <li>chaotic motion</li>
      <li>temperature shifts</li>
      <li>RF interference</li>
      <li>unexpected stress</li>
    </ul>

    <p>
      The 4th edition of IEC 60601 intentionally integrates these concepts. It pushes engineers and manufacturers to design for the environments where devices actually get used, not just for clean lab conditions.
    </p>

    <p>
      The underlying idea is simple and powerful. Reliability under stress is at the heart of essential performance and patient safety.
    </p>

    <h3>The Human Side Of Standards Work</h3>

    <p>
      Another meaningful thread that came out in the comments was the human side of the story.
    </p>

    <p>
      People commented that the journey from NASA to MedTech felt inspiring and very real. Hearing that from respected peers in the MedTech community meant a lot to me personally.
    </p>

    <p>
      IEC 60601 discussions rarely highlight the human side of standards work. The early influences. The mentors. The choices that move someone from pure engineering into safety and compliance. Those pieces matter.
    </p>

    <p>
      As Faisal noted, learning about the path from NASA to medical device safety helped make the technical content more relatable and more human.
    </p>

    <h3>Building The Next Generation Of Standards Developers</h3>

    <p>
      A theme that resonated with several colleagues, including Beat Keller and others who shared or commented, was the hope that this episode reaches the “Next Generation” of engineers and standards enthusiasts.
    </p>

    <p>
      Right now, more experts are aging out of standards development than new people are joining. The future of safe medical device design depends on bringing younger professionals into the process.
    </p>

    <p>
      If even a handful of listeners feel curious enough to explore standards work after hearing this episode, that is a tremendous win not only for me personally but for the whole MedTech industry as a whole. We desperately need “new blood” to come into standards development.
    </p>

    <h3>A Community Effort</h3>

    <p>
      Many colleagues across LinkedIn reposted, amplified, and commented on the podcast. I am grateful for every one of them.
    </p>

    <p>
      From Trekkie references
      to technical reflections
      to notes from people who simply enjoyed the story
    </p>

    <p>
      the engagement showed how enthusiastic and thoughtful the MedTech safety community really is.
    </p>

    <h3>Where To Listen</h3>

    <p>
      If you have not listened yet, I welcome you to take the journey.
    </p>

    <p>
      “The Star Map to the Future with Leo Eisner The IEC 60601 Guy” on The <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/2b55.png" alt="⭕" class="wp-smiley" style="height: 1em; max-height: 1em;" /> Podcast.
    </p>

    <p>
      It mixes sci fi, standards, storytelling, and safety into a format that is both fun and unexpectedly educational to make it edu-tainment.
    </p>

    <p>
      You can listen to the full episode through The <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/2b55.png" alt="⭕" class="wp-smiley" style="height: 1em; max-height: 1em;" /> Podcast and through the episode links shared on my LinkedIn post and on Faisal’s page.
    </p>

    <h3>Closing Thoughts</h3>

    <p>
      Thank you to everyone who listened, commented, shared, or supported the conversation.
    </p>

    <p>
      Here is to curiosity, creativity, and keeping patients safe
      in every environment
      on every device
      across every generation
      whatever race you are
      where ever you are in the galaxy
    </p>

    <p>
      Live Long and Prosper my Friends one and all<br>
      <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f596.png" alt="🖖" class="wp-smiley" style="height: 1em; max-height: 1em;" /><img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f680.png" alt="🚀" class="wp-smiley" style="height: 1em; max-height: 1em;" />
    </p>

    <p>
      Leonard “Leo” Eisner<br>
      The IEC 60601 Guy
    </p>

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        If this journey from NASA to IEC 60601 resonated with you and you are working on a device that needs to be safe in every environment it touches, my team and I would be honored to help.
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<p></p>
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			</item>
		<item>
		<title>From Engineer To “The IEC 60601 Guy” &#8211; Project MedTech Podcast</title>
		<link>https://eisnersafety.com/2025/10/19/from-engineer-to-the-iec-60601-guy-project-medtech-podcast/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=from-engineer-to-the-iec-60601-guy-project-medtech-podcast</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Sun, 19 Oct 2025 00:04:30 +0000</pubDate>
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		<guid isPermaLink="false">https://eisnersafety.com/?p=8354</guid>

					<description><![CDATA[From engineer to “The IEC 60601 Guy” — my story and practical tips
I joined Duane Mancini on the Project Medtech Podcast to share how I became known for IEC 60601, why the series is a roadmap you can follow, and what 4th Edition changes mean for design, QMS, and documentation.

A quick personal note
Nobody starts at the top as “The IEC 60601 Guy.” My path ran through early days at NASA, many years in test labs, and deep work in standards committees. What stuck with me is simple — stay curious, do the work, and show the work. That’s how we turn a dense standard into a practical plan.]]></description>
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<article class="esc-wrap">
  <!-- HERO -->
  <section class="esc-hero">
    <div>
      <div class="esc-eyebrow">Podcast Feature</div>
      <h1 class="esc-title">From engineer to “The IEC 60601 Guy” — my story and practical tips</h1>
      <p class="esc-sub">
        I joined <strong>Duane Mancini</strong> on the <strong>Project Medtech Podcast</strong> to share how I became known for IEC 60601,
        why the series is a roadmap you can follow, and what 4th Edition changes mean for design, QMS, and documentation.
      </p>
      <p class="esc-meta">Episode 235</p>
    </div>

    <div>
      <img decoding="async" class="esc-img" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2025/10/Episode-235-Leo-Eisner-scaled.png" alt="Project Medtech Podcast Episode 235 – Leo Eisner">
    </div>

    <div class="esc-apple-embed">
      <iframe allow="autoplay *; encrypted-media *; fullscreen *" frameborder="0" height="175"
        style="width:100%;max-width:100%;overflow:hidden;border-radius:12px;"
        sandbox="allow-forms allow-popups allow-same-origin allow-scripts allow-top-navigation-by-user-activation"
        src="https://embed.podcasts.apple.com/us/podcast/episode-235-leo-eisner-founder-and-principal/id1513851432?i=1000730356742">
      </iframe>

      <div class="esc-cta">
        <a class="esc-btn esc-btn--primary" href="https://pod.wave.co/podcast/project-medtech/episode-235-leo-eisner-founder-and-principal-compliance-regulatory-consultant-of-eisner-safety-consu" target="_blank">Listen on Web</a>
        <a class="esc-btn esc-btn--soft" href="https://open.spotify.com/episode/7FanaVyIKfv4PaBkuWgZ5X" target="_blank">Open Spotify</a>
      </div>
    </div>
  </section>

  <!-- PERSONAL INTRO -->
  <section class="esc-section">
    <h2 class="esc-h2">A quick personal note</h2>
    <p>
      Nobody starts at the top as “The IEC 60601 Guy.” My path ran through early days at NASA, many years in test labs,
      and deep work in standards committees. What stuck with me is simple — <strong>stay curious</strong>,
      <strong>do the work</strong>, and <strong>show the work</strong>. That’s how we turn a dense standard into a practical plan.
    </p>
  </section>

  <!-- KEY TAKEAWAYS -->
  <section class="esc-section">
    <h2 class="esc-h2">Key takeaways from the episode</h2>
    <p>
      On the Project Medtech Podcast with Duane Mancini, M. Sc., I shared my <strong>genesis story</strong> of how I became known as The “IEC 60601 Guy”.
      Duane asked me to give listeners a <strong>101 course</strong> on the IEC 60601 series, and I explained how I strive to
      “de-Greek” or demystify the standard series, and gave a preview of the <strong>big shifts coming in 4th Edition</strong>.
    </p>

    <div class="esc-checklist">
      <p class="esc-check">The “big picture” structure of the <strong>general standard</strong>, <strong>collateral standards</strong>, and <strong>particular standards</strong></p>
      <p class="esc-check">How <strong>lifecycle standards</strong> (risk management, usability, software) compare to <strong>type test standards</strong> in the 60601 family</p>
      <p class="esc-check"><strong>Tangible changes</strong> to watch in the upcoming <strong>4th Edition</strong>: clearer alarm requirements and impacts on design, QMS, &amp; documentation</p>
      <p class="esc-check">Why <strong>leaning on experts</strong> (internal or external) is key to getting this right for the impacts of 4th Edition</p>
      <p class="esc-check">My goal is to <strong>“de-Greek” the process</strong> and show that IEC 60601 can be a <strong>roadmap</strong> <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f5fa.png" alt="🗺" class="wp-smiley" style="height: 1em; max-height: 1em;" />, not a riddle</p>
    </div>

    <p>
      Whether you’re new to standards or a seasoned MedTech veteran, this episode shows how to approach IEC 60601 as a <strong>roadmap you can follow</strong>,
      instead of a riddle you can never quite solve.
    </p>
  </section>

  <!-- QUOTES -->
  <section class="esc-section">
    <h2 class="esc-h2">What peers said</h2>
    <div class="esc-quote">
      <p>“If you want to know more about IEC 60601, Leo is the resource to go to … I recommend this episode to everybody working with medical electrical equipment.”</p>
      <cite>— Beat Keller</cite>
    </div>
    <div class="esc-quote">
      <p>“Great to see how you became such an expert … I hope your story inspires young professionals to invest in becoming experts themselves.”</p>
      <cite>— Ronald Boumans</cite>
    </div>
    <div class="esc-quote">
      <p>“It’s amazing that you covered the difference between process and test standards — there’s still a lot of confusion out there.”</p>
      <cite>— Tibor Zechmeister</cite>
    </div>
  </section>

  <!-- CONTINUE DISCUSSION -->
  <section class="esc-section">
    <p>
      <a href="https://www.linkedin.com/posts/leoeisnersafetyconsultants_medtech-medicaldevices-iec60601-activity-7381360523105415168-uuJq?utm_source=share&#038;utm_medium=member_desktop&#038;rcm=ACoAAABI0MQBuOSm1PL6Rtb3VTU5ORFgMiOgnQ0" target="_blank">
        Continue the discussion on this topic on LinkedIn
      </a>
    </p>
  </section>

  <!-- HOW WE CAN HELP -->
  <section class="esc-section">
    <h2 class="esc-h2">How We Can Help</h2>
    <p>
      If your team needs help with the IEC 60601 Series, or mapping the 4th Edition into your design controls, QMS, labeling, or testing strategy,
      my team at <strong>Eisner Safety Consultants</strong> and I are ready to support you.
    </p>
    <p style="text-align:center;">
      <a class="esc-btn esc-btn--primary" href="https://eisnersafety.com/schedule-call/" target="_blank">
        Schedule a call with me, Leo, the IEC 601 Guy
      </a>
    </p>
  </section>
</article>
]]></content:encoded>
					
		
		
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		<item>
		<title>Major changes to IEC 60601-1 are closer than you think</title>
		<link>https://eisnersafety.com/2025/08/15/major-changes-to-iec-60601-1-are-closer-than-you-think/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=major-changes-to-iec-60601-1-are-closer-than-you-think</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Fri, 15 Aug 2025 18:53:33 +0000</pubDate>
				<category><![CDATA[10993]]></category>
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		<guid isPermaLink="false">https://eisnersafety.com/?p=7854</guid>

					<description><![CDATA[Once the 4th Edition is published, redesigns and QMS updates will be far more costly.

Direct insights from someone in the development of IEC 60601-1, 4th Edition
Get an insider’s view of the upcoming changes, their real-world impact, and how to prepare, from someone directly involved in developing the standard.]]></description>
										<content:encoded><![CDATA[
<figure class="wp-block-image size-large"><img fetchpriority="high" decoding="async" width="1024" height="576" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2025/08/MLVx-Impact-Cover-Page-1024x576.jpg" alt="" class="wp-image-7855" srcset="https://eisnersafety.com/wp-content/uploads/2025/08/MLVx-Impact-Cover-Page-1024x576.jpg 1024w, https://eisnersafety.com/wp-content/uploads/2025/08/MLVx-Impact-Cover-Page-300x169.jpg 300w, https://eisnersafety.com/wp-content/uploads/2025/08/MLVx-Impact-Cover-Page-768x432.jpg 768w, https://eisnersafety.com/wp-content/uploads/2025/08/MLVx-Impact-Cover-Page-1536x864.jpg 1536w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>



<p>Once the 4th Edition is published, redesigns and QMS updates will be far more costly.</p>



<p><strong>Direct insights from someone in the development of IEC 60601-1, 4th Edition</strong></p>



<p>Get an insider’s view of the upcoming changes, their real-world impact, and how to prepare, from someone directly involved in developing the standard.</p>



<hr class="wp-block-separator has-alpha-channel-opacity"/>



<p class="has-medium-font-size"><strong>Event Recap – MLVx Friday In-Focus</strong></p>



<p>On Friday, August 15, the <strong>MLVx Friday In-Focus</strong> with <a href="https://www.linkedin.com/in/sean-smith-mlvx/">Sean Smith</a> brought together <a href="https://www.linkedin.com/in/leoeisnersafetyconsultants/">Leonard (Leo) Eisner</a>, <em>The IEC 60601 Guy</em>, and <strong>110+ professionals</strong> from around the globe,  including the UK, Romania, US, France, Switzerland, Germany, Finland, and Pakistan, representing <strong>medtech manufacturers, regulators, test houses, and standards developers</strong>.</p>



<p>We focused on <strong>the impact of IEC 60601-1, 4th Edition</strong>, the global standard that defines safety and essential performance for medical electrical equipment, and what’s coming that many companies are still not prepared for.</p>



<p>The highlight was an <strong>impromptu expert panel</strong> with leaders in <strong>risk management, software, cybersecurity, regulatory submissions, and combination devices</strong>. Together, we tackled questions from every angle, sharing real-world insights on design, testing, and compliance challenges. The discussion showed exactly what’s possible when top experts collaborate to help the industry prepare for disruptive change.</p>



<p><em><strong>(Full presentation available for download at the bottom of this post.)</strong></em></p>



<hr class="wp-block-separator has-alpha-channel-opacity"/>



<p class="has-medium-font-size"><strong>Unlock Your IEC 60601-1 Insider Advantage</strong></p>



<ul class="wp-block-list">
<li><strong>Mitigate Risks:</strong> Spot disruptive changes early, prevent costly redesigns, and align documentation ahead of competitors</li>



<li><strong>Accelerated Compliance:</strong> Seamlessly integrate evolving requirements into your development pipeline</li>



<li><strong>Leadership Insight:</strong> <em>The IEC 60601 Guy</em> and our expert team track areas of interest for your organization based on draft documents</li>



<li><strong>Behind Closed Doors:</strong> Access knowledge while it’s still being developed</li>



<li><strong>Ready to Leap Ahead?</strong> Let’s turn this insider pipeline into your <strong>4th Edition fast-track</strong></li>
</ul>



<p><img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f4de.png" alt="📞" class="wp-smiley" style="height: 1em; max-height: 1em;" /> <strong>+1-503-709-8328</strong> <br><img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f310.png" alt="🌐" class="wp-smiley" style="height: 1em; max-height: 1em;" /> <a href="https://www.EisnerSafety.com"><strong>EisnerSafety.com</strong></a> <br><img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f517.png" alt="🔗" class="wp-smiley" style="height: 1em; max-height: 1em;" /> <a href="https://eisnersafety.com/schedule-call/"><strong>Schedule a Free 30-Minute Web Meeting</strong></a></p>



<hr class="wp-block-separator has-alpha-channel-opacity"/>



<p>If you missed the live session, this recap and presentation will help you understand what’s coming — and more importantly, how to prepare.</p>



<div data-wp-interactive="core/file" class="wp-block-file"><object data-wp-bind--hidden="!state.hasPdfPreview" hidden class="wp-block-file__embed" data="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2025/08/MLVx-Impact-of-IEC-60601-1-4th-Ed-FINAL-Vers-2025-08-15-compressed-for-website.pdf" type="application/pdf" style="width:100%;height:600px" aria-label="Embed of MLVx Impact of IEC 60601-1 4th Ed FINAL Vers 2025-08-15 compressed for website."></object><a id="wp-block-file--media-08fc802f-8178-4f7c-a299-3b4b20341790" href="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2025/08/MLVx-Impact-of-IEC-60601-1-4th-Ed-FINAL-Vers-2025-08-15-compressed-for-website.pdf">MLVx Impact of IEC 60601-1 4th Ed FINAL Vers 2025-08-15 compressed for website</a><a href="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2025/08/MLVx-Impact-of-IEC-60601-1-4th-Ed-FINAL-Vers-2025-08-15-compressed-for-website.pdf" class="wp-block-file__button wp-element-button" download aria-describedby="wp-block-file--media-08fc802f-8178-4f7c-a299-3b4b20341790">Download</a></div>



<p></p>
]]></content:encoded>
					
		
		
			</item>
		<item>
		<title>🎩 Get your reviewer’s hat on &#8211; IEC 60601-1, 4th Edition Draft Fragments Have Dropped‼️ 🚀</title>
		<link>https://eisnersafety.com/2025/06/28/%f0%9f%8e%a9-get-your-reviewers-hat-on-iec-60601-1-4th-edition-draft-fragments-have-dropped%e2%80%bc%ef%b8%8f-%f0%9f%9a%80/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=%25f0%259f%258e%25a9-get-your-reviewers-hat-on-iec-60601-1-4th-edition-draft-fragments-have-dropped%25e2%2580%25bc%25ef%25b8%258f-%25f0%259f%259a%2580</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Sat, 28 Jun 2025 01:09:39 +0000</pubDate>
				<category><![CDATA[10993]]></category>
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		<category><![CDATA[Interpretation Sheet 1]]></category>
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		<category><![CDATA[June 2025]]></category>
		<category><![CDATA[Labeling]]></category>
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		<category><![CDATA[Medical Device]]></category>
		<category><![CDATA[MedTech]]></category>
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		<category><![CDATA[Physiologic Closed-Loop Control]]></category>
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		<category><![CDATA[Regulatory Affairs]]></category>
		<category><![CDATA[Reprocessing]]></category>
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		<category><![CDATA[User Interfaces]]></category>
		<guid isPermaLink="false">https://eisnersafety.com/?p=7826</guid>

					<description><![CDATA[Over the last two weeks – and with a Friday night (6/20/25 Geneva time - late) finale still to come – we’ve seen CD1s and CD2 (WG 47 ONLY) fly out for Fragments 5, 6, 7, 8, 10, 11, and 12 from WG 41 through WG 48, but for WG 45.

This is not just standards spring cleaning - these are foundational changes to the IEC 60601-1 General Standard, folding the Collateral standards into the core. If you have medical electrical equipment, medical electrical systems or software SaMD or SiMD you need to be aware of these changes. If you’re a manufacturer, test lab, trade association, Notified Body, Regulator or other interested party who owns a risk file… you need to review this.

]]></description>
										<content:encoded><![CDATA[
<figure class="wp-block-image size-full"><img decoding="async" width="2000" height="1177" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2025/06/Dr-w-stethoscope-med-icons-HUD-futuristic_L.jpg" alt="" class="wp-image-7844" srcset="https://eisnersafety.com/wp-content/uploads/2025/06/Dr-w-stethoscope-med-icons-HUD-futuristic_L.jpg 2000w, https://eisnersafety.com/wp-content/uploads/2025/06/Dr-w-stethoscope-med-icons-HUD-futuristic_L-300x177.jpg 300w, https://eisnersafety.com/wp-content/uploads/2025/06/Dr-w-stethoscope-med-icons-HUD-futuristic_L-1024x603.jpg 1024w, https://eisnersafety.com/wp-content/uploads/2025/06/Dr-w-stethoscope-med-icons-HUD-futuristic_L-768x452.jpg 768w, https://eisnersafety.com/wp-content/uploads/2025/06/Dr-w-stethoscope-med-icons-HUD-futuristic_L-1536x904.jpg 1536w" sizes="(max-width: 2000px) 100vw, 2000px" /></figure>



<p><br>Posted on LinkedIn June 19, 2025. Updated with extra blog content June 25, 2025.</p>



<p>Over the last two weeks – and with a Friday night (6/20/25 Geneva time &#8211; late) finale still to come – we’ve seen <strong>CD1s and CD2 (WG 47 ONLY)</strong> fly out for Fragments <strong>5, 6, 7, 8, 10, 11, and 12 </strong>from <strong>WG 41 through WG 48, but for WG 45</strong>. </p>



<p>This is not just standards spring cleaning &#8211; these are <strong>foundational changes</strong> to the IEC 60601-1 General Standard, <strong>folding the Collateral standards into the core</strong>. If you have medical electrical equipment, medical electrical systems or software SaMD or SiMD <strong>you need to be aware of these changes</strong>. If you’re a manufacturer, test lab, trade association, Notified Body, Regulator or other interested party who owns a risk file… you need to review this.</p>



<p>These <strong>fragments cover hazards related to</strong>: • Electrical, mechanical, thermal, and fire • Software &amp; PEMS (SaMD, SiMD, firmware, OS…) • EM Disturbance, wireless coexistence, ionizing radiation, and electromagnetic exposure (EMF)</p>



<p><img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f550.png" alt="🕐" class="wp-smiley" style="height: 1em; max-height: 1em;" /> The International comment deadlines start closing August 29th, with more due by September 12th. National deadlines close much sooner <strong>(does your summer holiday schedule conflict?<img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f379.png" alt="🍹" class="wp-smiley" style="height: 1em; max-height: 1em;" /><img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f3dd.png" alt="🏝" class="wp-smiley" style="height: 1em; max-height: 1em;" />)</strong></p>



<p><img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f4ce.png" alt="📎" class="wp-smiley" style="height: 1em; max-height: 1em;" /> Don’t wait for the FDIS – get involved now or get caught off guard later.<br><br><img decoding="async" width="750" height="1125" class="wp-image-7828" style="width: 750px;" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2025/06/CD1-CD-2-WG-41-48-RELASE-OF-CD1-CD-2-WG-47-ONLY-scaled.png" alt="" srcset="https://eisnersafety.com/wp-content/uploads/2025/06/CD1-CD-2-WG-41-48-RELASE-OF-CD1-CD-2-WG-47-ONLY-scaled.png 1706w, https://eisnersafety.com/wp-content/uploads/2025/06/CD1-CD-2-WG-41-48-RELASE-OF-CD1-CD-2-WG-47-ONLY-200x300.png 200w, https://eisnersafety.com/wp-content/uploads/2025/06/CD1-CD-2-WG-41-48-RELASE-OF-CD1-CD-2-WG-47-ONLY-683x1024.png 683w, https://eisnersafety.com/wp-content/uploads/2025/06/CD1-CD-2-WG-41-48-RELASE-OF-CD1-CD-2-WG-47-ONLY-768x1152.png 768w, https://eisnersafety.com/wp-content/uploads/2025/06/CD1-CD-2-WG-41-48-RELASE-OF-CD1-CD-2-WG-47-ONLY-1024x1536.png 1024w, https://eisnersafety.com/wp-content/uploads/2025/06/CD1-CD-2-WG-41-48-RELASE-OF-CD1-CD-2-WG-47-ONLY-1365x2048.png 1365w" sizes="(max-width: 750px) 100vw, 750px" /><br><img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f449.png" alt="👉" class="wp-smiley" style="height: 1em; max-height: 1em;" /> Read the full breakdown of all Working Groups, due dates, and what you should do now:</p>



<p>Here’s the who’s who of the Working Groups behind the fragments with CD1 to issue 20 July:</p>



<p>• <strong>WG 41</strong> – PEMS (e.g., SaMD (Software as a medical device), SiMD (Software in a medical device), firmware, software, apps, OS, drivers) related hazards <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f517.png" alt="🔗" class="wp-smiley" style="height: 1em; max-height: 1em;" /> <a href="https://www.iec.ch/dyn/www/f?p=103:14:700791811979381::::FSP_ORG_ID,FSP_LANG_ID:49844,25">WG 41 link</a></p>



<p>• <strong>WG 42</strong> – Electrical hazards <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f517.png" alt="🔗" class="wp-smiley" style="height: 1em; max-height: 1em;" /> <a href="https://www.iec.ch/dyn/www/f?p=103:14:700791811979381::::FSP_ORG_ID,FSP_LANG_ID:49845,25">WG 42 link</a></p>



<p>• <strong>WG 43</strong> – Mechanical hazards <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f517.png" alt="🔗" class="wp-smiley" style="height: 1em; max-height: 1em;" /> <a href="https://www.iec.ch/dyn/www/f?p=103:14:700791811979381::::FSP_ORG_ID,FSP_LANG_ID:49846,25">WG 43 link</a></p>



<p>• <strong>WG 44</strong> – Thermal and fire hazards <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f517.png" alt="🔗" class="wp-smiley" style="height: 1em; max-height: 1em;" /> <a href="https://www.iec.ch/dyn/www/f?p=103:14:700791811979381::::FSP_ORG_ID,FSP_LANG_ID:49847,25">WG 44 link</a></p>



<p><strong>Other Fragments CD1s &amp; CD2 have recently published &#8211; clock ticking <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f570.png" alt="🕰" class="wp-smiley" style="height: 1em; max-height: 1em;" /> to get your comments in:</strong></p>



<p>• <strong>Fragment 11 – WG 47</strong>: Electromagnetic exposure hazards (not optical or ionizing but including SAR) <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f517.png" alt="🔗" class="wp-smiley" style="height: 1em; max-height: 1em;" /> <a href="https://www.iec.ch/dyn/www/f?p=103:14:700791811979381::::FSP_ORG_ID,FSP_LANG_ID:49850,25">WG 47 link</a> <strong>CD2</strong>, closes <strong>29 August</strong></p>



<p>• <strong>Fragment 10 – WG 46</strong>: Ionizing radiation hazards <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f517.png" alt="🔗" class="wp-smiley" style="height: 1em; max-height: 1em;" /> <a href="https://www.iec.ch/dyn/www/f?p=103:14:700791811979381::::FSP_ORG_ID,FSP_LANG_ID:49849,25">WG 46 link</a> <strong>CD1</strong>, closes <strong>5 September</strong></p>



<p>• <strong>Fragment 12 – WG 48</strong>: Electromagnetic disturbances (including wireless coexistence) <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f517.png" alt="🔗" class="wp-smiley" style="height: 1em; max-height: 1em;" /> <a href="https://www.iec.ch/dyn/www/f?p=103:14:700791811979381::::FSP_ORG_ID,FSP_LANG_ID:49851,25">WG 48 link</a> <strong>CD1</strong>, closes <strong>5 September</strong></p>



<h3 class="wp-block-heading">The early pack of CD1 Fragments released late last year</h3>



<p>Fragments <strong>1–4</strong> and <strong>11</strong> from <strong>WG 37–40 &amp; WG 47</strong> were released as CD1 back on <strong>December 6, 2024</strong>, with comments closing <strong>February 28, 2025</strong>. You can still access them if you’re a National Committee member for SC62A or a WG participant. If not, consider joining — this is a major transformation, and early awareness = better preparation. <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f517.png" alt="🔗" class="wp-smiley" style="height: 1em; max-height: 1em;" /> <a href="https://link.eisnersafety.com/A3qLjp">Access link</a></p>



<p>Here&#8217;s a handy summary table of the IEC 60601 Fragments, their WG #s, their titles, the issue &amp; close dates &amp; more.</p>



<figure class="wp-block-image size-full"><img loading="lazy" decoding="async" width="1659" height="863" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2025/06/IEC-60601-Fragments-CD-Status-resized.png" alt="" class="wp-image-7842" srcset="https://eisnersafety.com/wp-content/uploads/2025/06/IEC-60601-Fragments-CD-Status-resized.png 1659w, https://eisnersafety.com/wp-content/uploads/2025/06/IEC-60601-Fragments-CD-Status-resized-300x156.png 300w, https://eisnersafety.com/wp-content/uploads/2025/06/IEC-60601-Fragments-CD-Status-resized-1024x533.png 1024w, https://eisnersafety.com/wp-content/uploads/2025/06/IEC-60601-Fragments-CD-Status-resized-768x400.png 768w, https://eisnersafety.com/wp-content/uploads/2025/06/IEC-60601-Fragments-CD-Status-resized-1536x799.png 1536w" sizes="auto, (max-width: 1659px) 100vw, 1659px" /></figure>



<h3 class="wp-block-heading">Who Should Be Reviewing</h3>



<ul class="wp-block-list">
<li>Design and Systems engineers</li>



<li>Risk management experts/leaders</li>



<li>Electrical &amp; mechanical designers</li>



<li>Software designers (SaMD/SiMD, firmware, OS)</li>



<li>EMC/EMF compliance leads</li>



<li>Compliance engineers</li>



<li>Regulatory and quality teams</li>



<li>Usability &amp; human factors engineers</li>



<li>Test labs</li>



<li>Trade Associations</li>



<li>Regulators</li>



<li>Notified Bodies</li>



<li>Other Interested Parties</li>
</ul>



<h3 class="wp-block-heading"><img src="https://s.w.org/images/core/emoji/17.0.2/72x72/2705.png" alt="✅" class="wp-smiley" style="height: 1em; max-height: 1em;" /> What You Need to Do</h3>



<ol class="wp-block-list">
<li><strong>Review the Drafts &amp; the 4th ed. Design &amp; Architecture Specs Now</strong> • Assign key experts by hazard/WG • Map against your design controls: <a href="https://link.eisnersafety.com/F7uviB">Design Spec</a> • Understand the architecture spec: <a href="https://link.eisnersafety.com/1qJhLB">Architecture Spec</a></li>



<li><strong>Track IEV Part 880 Terms</strong> • Stay aligned with the evolving definitions: <a href="https://link.eisnersafety.com/ELbg73">Terms &amp; Definitions</a></li>



<li><strong>Analyze Impact to Products</strong> • Run gap assessments • Identify implications for design, testing, and documentation</li>



<li><strong>Submit Comments</strong> • Through your National Committees (ANSI, BSI, DIN, etc.) • Clear, technically sound feedback = meaningful influence</li>



<li><strong>Update Design &amp; Risk Inputs</strong> • Don’t wait for the final version to start aligning</li>



<li><strong>Integrate Into Product Roadmaps</strong> • Work with R&amp;D, QA/RA, and exec sponsors • Flag projects needing early adaptation</li>



<li><strong>Engage the Right Experts</strong> • Join WGs or partner with someone who’s inside (<img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f44b.png" alt="👋" class="wp-smiley" style="height: 1em; max-height: 1em;" />) • Stay active – your input now shapes what becomes final</li>



<li><strong>Invest in Training</strong> • Get smart now to avoid surprises later</li>
</ol>



<p><img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f4ce.png" alt="📎" class="wp-smiley" style="height: 1em; max-height: 1em;" /> Don’t wait for the FDIS – get involved now or get caught off guard later.</p>



<p>Need help with standards?</p>



<p>We provide support for your design and development process for regulatory submissions.? Eisner Safety Consultants can help by</p>



<ul class="wp-block-list">
<li>Assisting with strategic compliance planning for your medical electrical product lines,</li>



<li>Providing regulatory support when FDA or a regulator asks technical questions on your submission.</li>



<li>Identification of applicable standards, laws, regulations, guidances, and directives up front to support your design process effectively.</li>



<li>Design Documentation Reviews providing expert analysis supporting the design development process to avoid unnecessary design and development delays.</li>



<li>We provide EU, US, and other countries regulatory requirement reviews of standards, laws, directives, and guidance.</li>



<li>Providing support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs, and more.</li>



<li>Interfacing with test houses for medical safety, EMC and arrange other testing.</li>
</ul>



<p>Feel free to schedule a&nbsp;<a href="https://eisnersafety.com/schedule-call/" target="_blank" rel="noreferrer noopener">web meeting with Leo</a>&nbsp;or&nbsp;<a href="https://eisnersafety.com/contact_eisner_safety/" target="_blank" rel="noreferrer noopener">contact us</a>.</p>
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		<title>10x Humanizing MedTech: Breaking The Mould For Conferences</title>
		<link>https://eisnersafety.com/2025/02/11/10x-humanizing-medtech-breaking-the-mould-for-conferences/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=10x-humanizing-medtech-breaking-the-mould-for-conferences</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Tue, 11 Feb 2025 06:39:03 +0000</pubDate>
				<category><![CDATA[10x]]></category>
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		<guid isPermaLink="false">https://eisnersafety.com/?p=7760</guid>

					<description><![CDATA[Join us for the fifteenth 10x Medical Device Conference on May 7 to 8, 2025 – Hyatt Regency Newport Beach, CA What&#8217;s 10x 2025 about you ask? Join experts Carrie Britton, Matthias Fink, Sean Smith, Jan Gates, Angelina Lisandrelli, Jose]]></description>
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<figure class="wp-block-gallery has-nested-images columns-default is-cropped wp-block-gallery-1 is-layout-flex wp-block-gallery-is-layout-flex">
<figure class="wp-block-image size-large" id="https://link.eisnersafety.com/8Cah1h"><img loading="lazy" decoding="async" width="784" height="1024" data-id="7765" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2025/02/Leonard-LEO-Eisner-10X-pg2-784x1024.png" alt="" class="wp-image-7765" srcset="https://eisnersafety.com/wp-content/uploads/2025/02/Leonard-LEO-Eisner-10X-pg2-784x1024.png 784w, https://eisnersafety.com/wp-content/uploads/2025/02/Leonard-LEO-Eisner-10X-pg2-230x300.png 230w, https://eisnersafety.com/wp-content/uploads/2025/02/Leonard-LEO-Eisner-10X-pg2-768x1003.png 768w, https://eisnersafety.com/wp-content/uploads/2025/02/Leonard-LEO-Eisner-10X-pg2-1176x1536.png 1176w, https://eisnersafety.com/wp-content/uploads/2025/02/Leonard-LEO-Eisner-10X-pg2.png 1204w" sizes="auto, (max-width: 784px) 100vw, 784px" /></figure>



<figure class="wp-block-image size-large" id="https://link.eisnersafety.com/2s2H59"><img loading="lazy" decoding="async" width="789" height="1024" data-id="7764" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2025/02/Leonard-LEO-Eisner-10X-pg1-789x1024.png" alt="" class="wp-image-7764" srcset="https://eisnersafety.com/wp-content/uploads/2025/02/Leonard-LEO-Eisner-10X-pg1-789x1024.png 789w, https://eisnersafety.com/wp-content/uploads/2025/02/Leonard-LEO-Eisner-10X-pg1-231x300.png 231w, https://eisnersafety.com/wp-content/uploads/2025/02/Leonard-LEO-Eisner-10X-pg1-768x997.png 768w, https://eisnersafety.com/wp-content/uploads/2025/02/Leonard-LEO-Eisner-10X-pg1.png 899w" sizes="auto, (max-width: 789px) 100vw, 789px" /></figure>
</figure>



<p>Join us for the fifteenth <a href="https://link.eisnersafety.com/2s2H59" target="_blank" rel="noreferrer noopener">10x Medical Device Conference</a> on May 7 to 8, 2025 – Hyatt Regency Newport Beach, CA</p>



<p>What&#8217;s 10x 2025 about you ask?</p>



<ul class="wp-block-list">
<li>The focus is on building meaningful relationships and tackling real challenges</li>



<li>Move through key stages of the MedTech lifecycle. Each workshop station focuses on critical topics such as:
<ul class="wp-block-list">
<li><strong>Regulatory Pathways</strong></li>



<li><strong>Cybersecurity</strong></li>



<li><strong>Engineering</strong></li>



<li><strong>Product Development</strong></li>



<li><strong>Market Access</strong></li>



<li><strong>Reimbursement</strong></li>



<li><strong>Commercialization</strong></li>
</ul>
</li>
</ul>



<p>Join experts <a href="https://www.linkedin.com/in/carrie-b-9476736/" target="_blank" rel="noreferrer noopener">Carrie Britton</a>,  <a href="https://www.linkedin.com/in/matthias-fink-akrateam/" target="_blank" rel="noreferrer noopener">Matthias Fink</a>, <a href="https://www.linkedin.com/in/sean-smith007/" target="_blank" rel="noreferrer noopener">Sean Smith</a>, <a href="https://www.linkedin.com/in/jan-gates-926ba12/" target="_blank" rel="noreferrer noopener">Jan Gates</a>, <a href="https://www.linkedin.com/in/angelinalisandrelli/" target="_blank" rel="noreferrer noopener">Angelina Lisandrelli</a>, <a href="https://www.linkedin.com/in/jose-bohorquez/" target="_blank" rel="noreferrer noopener">Jose Bohorquez</a>, and others experts for a journey through the MedTech lifecycle &#8211; from ideation to marketed product. Each workshop represents a stage of this journey, offering opportunities to collaborate, ask questions, and exchange expertise.</p>



<p>Thank you, <a href="https://www.linkedin.com/in/ACoAAADbAsIBAuJRam1B4PERjUXYQ970xhWOLiA"></a><a href="https://www.linkedin.com/in/sean-smith007/" target="_blank" rel="noreferrer noopener">Sean</a> for including <a href="https://link.eisnersafety.com/8Cah1h" target="_blank" rel="noreferrer noopener">me</a> on this impressive list of experts for 10x this year!</p>



<p>Looking forward to seeing you in Newport Beach, CA. &#8211; <a href="https://link.eisnersafety.com/2s2H59" target="_blank" rel="noreferrer noopener">Seats are limited</a></p>



<p><a href="https://link.eisnersafety.com/2s2H59" target="_blank" rel="noreferrer noopener">Join us</a> for this very personalized experience and <a href="https://www.linkedin.com/in/joehageonline/" target="_blank" rel="noreferrer noopener">Joe Hage</a>&#8216;s Ice Cream Social</p>
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		<title>Time and Regulators Wait for No One &#8211; Free Presentation</title>
		<link>https://eisnersafety.com/2024/09/28/time-and-regulators-wait-for-no-one-free-presentation/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=time-and-regulators-wait-for-no-one-free-presentation</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Sat, 28 Sep 2024 13:03:00 +0000</pubDate>
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		<guid isPermaLink="false">https://eisnersafety.com/?p=7700</guid>

					<description><![CDATA[Free presentation in London 🇬🇧🎡🏰 — With Leo Eisner, The60601Guy, &#038; Ian Sealey

𝗪𝗵𝗮𝘁’𝘀 𝗼𝗻 𝘁𝗵𝗲 𝗺𝗲𝗻𝘂🍰?

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

• IEC60601-1 , 4th Ed.
• Applicable Standards
• Future Proofing Test Plans
]]></description>
										<content:encoded><![CDATA[
<figure class="wp-block-image size-full is-resized"><img loading="lazy" decoding="async" width="800" height="457" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/10/1727694057373.jpeg" alt="" class="wp-image-7698" style="width:1108px;height:auto" srcset="https://eisnersafety.com/wp-content/uploads/2024/10/1727694057373.jpeg 800w, https://eisnersafety.com/wp-content/uploads/2024/10/1727694057373-300x171.jpeg 300w, https://eisnersafety.com/wp-content/uploads/2024/10/1727694057373-768x439.jpeg 768w" sizes="auto, (max-width: 800px) 100vw, 800px" /></figure>



<p>Free presentation in London <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f1ec-1f1e7.png" alt="🇬🇧" class="wp-smiley" style="height: 1em; max-height: 1em;" /><img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f3a1.png" alt="🎡" class="wp-smiley" style="height: 1em; max-height: 1em;" /><img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f3f0.png" alt="🏰" class="wp-smiley" style="height: 1em; max-height: 1em;" /> — With Leo Eisner, <a href="https://www.linkedin.com/feed/hashtag/?keywords=the60601guy&amp;highlightedUpdateUrns=urn%3Ali%3Aactivity%3A7244827046630039553" target="_blank" rel="noreferrer noopener">The60601Guy</a>, &amp; <a href="https://www.linkedin.com/in/ACoAACliuxsBMXem1PxJYp2Q_AAT4fHtGLuF-T4"></a><a href="https://www.linkedin.com/in/ian-sealey-b8b646174/" target="_blank" rel="noreferrer noopener">Ian Sealey</a><br><br>𝗪𝗵𝗮𝘁’𝘀 𝗼𝗻 𝘁𝗵𝗲 𝗺𝗲𝗻𝘂<img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f370.png" alt="🍰" class="wp-smiley" style="height: 1em; max-height: 1em;" />?<br><br>• Some 𝗳𝘂𝘁𝘂𝗿𝗲 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 of <a href="https://www.linkedin.com/feed/hashtag/?keywords=iec60601&amp;highlightedUpdateUrns=urn%3Ali%3Aactivity%3A7244827046630039553" target="_blank" rel="noreferrer noopener">IEC60601</a>-1 , 4th being considered you 𝙢𝙖𝙮 𝙣𝙤𝙩 𝙚𝙭𝙥𝙚𝙘𝙩:<br>Gas Pathways,<br>Cleaning,<br><a href="https://www.linkedin.com/feed/hashtag/?keywords=disinfection&amp;highlightedUpdateUrns=urn%3Ali%3Aactivity%3A7244827046630039553" target="_blank" rel="noreferrer noopener">Disinfection</a>,<br><a href="https://www.linkedin.com/feed/hashtag/?keywords=ai&amp;highlightedUpdateUrns=urn%3Ali%3Aactivity%3A7244827046630039553" target="_blank" rel="noreferrer noopener">AI</a>/<a href="https://www.linkedin.com/feed/hashtag/?keywords=ml&amp;highlightedUpdateUrns=urn%3Ali%3Aactivity%3A7244827046630039553" target="_blank" rel="noreferrer noopener">ML</a>,<br>Voice Input/Output,<br>Adhesives for Applied Parts,<br><a href="https://www.linkedin.com/feed/hashtag/?keywords=ppe&amp;highlightedUpdateUrns=urn%3Ali%3Aactivity%3A7244827046630039553" target="_blank" rel="noreferrer noopener">PPE</a>,<br>and so much more&#8230;.<br><br>• <a href="https://www.linkedin.com/feed/hashtag/?keywords=iec60601&amp;highlightedUpdateUrns=urn%3Ali%3Aactivity%3A7244827046630039553" target="_blank" rel="noreferrer noopener">IEC60601</a>-1 , 4th Ed.<br>• Applicable Standards<br>• Future Proofing Test Plans</p>



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



<p><a href="https://www.linkedin.com/in/ACoAAABI0MQBuOSm1PL6Rtb3VTU5ORFgMiOgnQ0"></a><a href="https://www.linkedin.com/in/ian-sealey-b8b646174/" target="_blank" rel="noreferrer noopener">Ian Sealey</a>, <a href="https://www.linkedin.com/in/ACoAAAD6Yk8BTVr09DHlyksFDVd0ZTnLqx4PqJE"></a><a href="https://www.linkedin.com/in/michaelkipping/" target="_blank" rel="noreferrer noopener">Michael Kipping</a>, <a href="https://www.linkedin.com/in/ACoAAAJJdtQB445ICtOk9bwCCkd2D-unGpFbrt8"></a><a href="https://www.linkedin.com/in/jappink/" target="_blank" rel="noreferrer noopener">James Pink</a> and I, <a href="https://www.linkedin.com/in/leoeisnersafetyconsultants/" target="_blank" rel="noreferrer noopener">Leonard (Leo) Eisner</a>,  <a href="https://www.linkedin.com/feed/hashtag/?keywords=the60601guy&amp;highlightedUpdateUrns=urn%3Ali%3Aactivity%3A7244827046630039553" target="_blank" rel="noreferrer noopener">The60601Guy</a>, will be discussing the changes, indicative timescales, and how to plan for them.</p>



<p>𝗪𝗵𝗲𝗻, 𝘄𝗵𝗲𝗿𝗲, 𝗵𝗼𝘄:<br>7 𝘖𝘤𝘵𝘰𝘣𝘦𝘳 2024<br>𝘊𝘭𝘢𝘺𝘵𝘰𝘯 𝘏𝘰𝘵𝘦𝘭 𝘊𝘩𝘪𝘴𝘸𝘪𝘤𝘬<br>𝘈𝘳𝘳𝘪𝘷𝘢𝘭 𝘧𝘳𝘰𝘮 𝟱:𝟬𝟬𝙥𝙢<br>𝘚𝘵𝘢𝘳𝘵 𝟱:𝟯𝟬𝙥𝙢<br>𝘌𝘯𝘥 𝟴:𝟰𝟱𝙥𝙢<br>𝙉𝙚𝙩𝙬𝙤𝙧𝙠𝙞𝙣𝙜 𝙖𝙣𝙙 𝙙𝙧𝙞𝙣𝙠𝙨 <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f37a.png" alt="🍺" class="wp-smiley" style="height: 1em; max-height: 1em;" /> afterwards</p>



<p>TICK TOCK <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/23f0.png" alt="⏰" class="wp-smiley" style="height: 1em; max-height: 1em;" /> <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f9e8.png" alt="🧨" class="wp-smiley" style="height: 1em; max-height: 1em;" /> &#8211; Time is starting to run out for signing up for this event.  If you wait too long there won&#8217;t be room so sign up now before we fill up.  Don&#8217;t wait tooooooo long and miss this great opportunity to learn from experts.</p>



<p>Register by using our <a href="https://bit.ly/ContactUsESC" target="_blank" rel="noreferrer noopener">Contact form</a>, send Leo an <a href="https://eisnersafety.com/contact_eisner_safety/" data-type="page" data-id="58" target="_blank" rel="noreferrer noopener">email </a>(go to bottom of page) or send Leo a <a href="https://bit.ly/LeoEisnerLinkedInProfile" target="_blank" rel="noreferrer noopener">LinkedIn message via his profile</a>.</p>



<p>Join the conversation on the <a href="https://bit.ly/TickTockSignUpNow" target="_blank" rel="noreferrer noopener">LinkedIn Post</a> and leave a comment.</p>
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		<title>Standards: Explosion and Challenges Maintaining/Updating￼</title>
		<link>https://eisnersafety.com/2024/04/18/standards-explosion-and-challenges-maintaining-updating%ef%bf%bc/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=standards-explosion-and-challenges-maintaining-updating%25ef%25bf%25bc</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Thu, 18 Apr 2024 03:09:22 +0000</pubDate>
				<category><![CDATA[13485]]></category>
		<category><![CDATA[14971]]></category>
		<category><![CDATA[15223-1]]></category>
		<category><![CDATA[20417]]></category>
		<category><![CDATA[60601 Series]]></category>
		<category><![CDATA[60601-1]]></category>
		<category><![CDATA[60601-1, 4th edition]]></category>
		<category><![CDATA[62304]]></category>
		<category><![CDATA[62366]]></category>
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		<category><![CDATA[Active Implants]]></category>
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		<category><![CDATA[Apr 2024]]></category>
		<category><![CDATA[Auditing]]></category>
		<category><![CDATA[Combination Device]]></category>
		<category><![CDATA[Combination Product]]></category>
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		<category><![CDATA[EU]]></category>
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		<category><![CDATA[Guidance Documents]]></category>
		<category><![CDATA[Harmonized Standards]]></category>
		<category><![CDATA[IEC]]></category>
		<category><![CDATA[IEC 60601-1]]></category>
		<category><![CDATA[ISO 13485]]></category>
		<category><![CDATA[ISO 15223-1]]></category>
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		<category><![CDATA[IVD]]></category>
		<category><![CDATA[Machine Learning]]></category>
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		<category><![CDATA[Medical Device]]></category>
		<category><![CDATA[Medical Device Regulation]]></category>
		<category><![CDATA[Notified Bodies]]></category>
		<category><![CDATA[Quality Assurance]]></category>
		<category><![CDATA[Recognized Consensus Standards]]></category>
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		<category><![CDATA[US]]></category>
		<guid isPermaLink="false">https://eisnersafety.com/?p=7518</guid>

					<description><![CDATA[Standards: Explosion and Challenges Maintaining/Updating

 My conversation with Subhi Saadeh of Combinate Podcast was very intriguing and he does a fun podcast.  Check out the Combinate podcast #132 as I, Leo Eisner, talk about Standards.]]></description>
										<content:encoded><![CDATA[
<figure class="wp-block-image size-large"><a href="https://bit.ly/LetsCombinatePodcastonStandardswithLeoEisner" target="_blank" rel="noopener"><img loading="lazy" decoding="async" width="1015" height="1024" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-1015x1024.png" alt="" class="wp-image-7520" srcset="https://eisnersafety.com/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-1015x1024.png 1015w, https://eisnersafety.com/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-297x300.png 297w, https://eisnersafety.com/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-150x150.png 150w, https://eisnersafety.com/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-768x775.png 768w, https://eisnersafety.com/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-45x45.png 45w, https://eisnersafety.com/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-600x606.png 600w, https://eisnersafety.com/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-100x100.png 100w, https://eisnersafety.com/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM.png 1300w" sizes="auto, (max-width: 1015px) 100vw, 1015px" /></a></figure>



<p>&nbsp;My conversation with <a href="https://www.linkedin.com/in/ACoAAASYqiIBwAoA_1K9vXX-snW26Y7H7REb9kk"></a><a href="https://www.linkedin.com/in/subhi-saadeh-1169aa21/" target="_blank" rel="noreferrer noopener">Subhi Saadeh</a> of <a href="https://www.linkedin.com/company/combinate-podcast/" target="_blank" rel="noreferrer noopener">Combinate Podcast</a> was very intriguing and he does a fun podcast.  Check out the <a rel="noreferrer noopener" href="https://bit.ly/LetsCombinatePodcastonStandardswithLeoEisner" data-type="URL" data-id="https://bit.ly/LetsCombinatePodcastonStandardswithLeoEisner" target="_blank">podcast</a> as I talk about Standards.</p>



<p>We covered a lot of ground in a short time (it flew by for me &#8211; I&#8217;m sure it will for you too) and if you compare him to an architect he would build something similar to the Louvre  Museum with its very unique but beautiful peaks and valleys with surprises around every corner.  The Lourve is recent in my mind as I was at an <a rel="noreferrer noopener" href="https://bit.ly/ParisISOTC210WG2WG3" data-type="URL" data-id="https://bit.ly/ParisISOTC210WG2WG3" target="_blank">ISO TC 210  standards meeting in Paris Dec &#8217;23</a> and visited the Louvre.   One of my many travels around the world in support of standards development over the last 20 years.</p>



<figure class="wp-block-image size-large"><img loading="lazy" decoding="async" width="768" height="1024" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/IMG_1092-768x1024.jpg" alt="" class="wp-image-7522" srcset="https://eisnersafety.com/wp-content/uploads/2024/04/IMG_1092-768x1024.jpg 768w, https://eisnersafety.com/wp-content/uploads/2024/04/IMG_1092-225x300.jpg 225w, https://eisnersafety.com/wp-content/uploads/2024/04/IMG_1092-1152x1536.jpg 1152w, https://eisnersafety.com/wp-content/uploads/2024/04/IMG_1092-1536x2048.jpg 1536w, https://eisnersafety.com/wp-content/uploads/2024/04/IMG_1092-600x800.jpg 600w, https://eisnersafety.com/wp-content/uploads/2024/04/IMG_1092-scaled.jpg 1920w" sizes="auto, (max-width: 768px) 100vw, 768px" /></figure>



<p>He really does his research.  He found my old reconnaissance standards database I was planning to publish but never did.  That was a total surprise.  </p>



<p>We dive right into  standards in many ways that you may not have thought of before in <a rel="noreferrer noopener" href="https://bit.ly/LetsCombinatePodcastonStandardswithLeoEisner" data-type="URL" data-id="https://bit.ly/LetsCombinatePodcastonStandardswithLeoEisner" target="_blank">Podcast</a> :<br>☞ The explosion of standards vs no standards (or chaos of no standards)<br>☞ The impact of standards on medical device development<br>☞ Standards and Regulatory Challenges<br>☞ My Notified Body Auditing Experience, Authorization Process, Product Reviewer<br>☞ The Challenges of Maintaining and Updating Standards</p>



<p>Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic compliance planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, &amp; other country regulatory requirements &amp; standards, laws, directives, and more.&nbsp;<a rel="noreferrer noopener" href="https://eisnersafety.com/about_us/associates/" target="_blank">Leo Eisner</a>&nbsp;is an expert on standards development and <a href="https://www.linkedin.com/in/leoeisnersafetyconsultants" target="_blank" rel="noreferrer noopener">sits on many standards committees</a>.&nbsp;He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs. </p>



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



<p>Feel free to&nbsp;<a rel="noreferrer noopener" href="http://www.eisnersafety.com/Schedule-Call/" target="_blank">schedule a call with Leo</a>&nbsp;or contact Leo at&nbsp;L&#101;&#111;&#64;&#69;&#105;&#115;n&#101;r&#83;&#97;&#102;&#101;&#116;y.c&#111;m&nbsp;or through our&nbsp;<a rel="noreferrer noopener" href="https://eisnersafety.com/contact_eisner_safety/" target="_blank">contact form</a>.</p>
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