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	<title>Podcast &#8211; Eisner Safety Consultants</title>
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		<title>IEC 60601, 4th Edition: What’s Changing and How to Prepare</title>
		<link>https://eisnersafety.com/2026/02/28/iec-60601-4th-edition-whats-changing-and-how-to-prepare/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=iec-60601-4th-edition-whats-changing-and-how-to-prepare</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Sat, 28 Feb 2026 21:33:00 +0000</pubDate>
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					<description><![CDATA[IEC 60601-1, 4th Edition
Strategic Shifts and How to Prepare

Companion post to my Easy Medical Device podcast episode on IEC 60601-1, 4th Ed., focused on what is shifting across the Working Groups and what RA/QA, Design, Test, and Management teams should do now.

Most organizations will feel the impact long before any formal transition date. The practical shift is that evidence expectations are tightening, scope is becoming clearer, and the standard’s direction is being shaped now through Working Group outputs. Teams that treat this as a design input and planning topic today will avoid late-cycle surprises in test strategy, labeling, and documentation tomorrow.]]></description>
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  <!-- TITLE + INTRO -->
  <div class="intro">
    <div class="page-title">IEC 60601-1, 4th Edition</div>
    <div class="page-subtitle">Strategic Shifts and How to Prepare</div>

    <p>
      Companion post to my Easy Medical Device podcast episode on IEC 60601-1, 4th Ed.,
      focused on what is shifting across the Working Groups and what RA/QA, Design, Test,
      and Management teams should do now.
    </p>

    <p>
      Most organizations will feel the impact long before any formal transition date.
      The practical shift is that evidence expectations are tightening, scope is becoming clearer,
      and the standard’s direction is being shaped now through Working Group outputs.
      Teams that treat this as a design input and planning topic today will avoid late-cycle surprises
      in test strategy, labeling, and documentation tomorrow.
    </p>
  </div>

  <!-- HERO RESOURCE PANEL + 4-PART KIT -->
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             alt="IEC 60601-1, 4th Edition Resource Kit One-Pager">
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      <div class="hero-copy">
        <h2>Translate 4th Edition Direction into Organizational Action</h2>
        <p>
          Quick to read and easy to share across RA/QA, Design, Documentation, Supply Chain, Test, and Management.
          Use it to brief teams and kick off impact planning for IEC 60601-1, 4th Edition.
        </p>
      </div>
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    <div style="height:16px;"></div>

    <div class="kit-heading">Your 4-Part Resource Kit</div>

    <div class="grid">
      <a class="btn" href="https://podcast.easymedicaldevice.com/377-2/" target="_blank" rel="noopener">Listen to Podcast Episode</a>
      <a class="btn" href="https://www.youtube.com/watch?v=pjgMcROzAeg" target="_blank" rel="noopener">Watch YouTube Interview</a>
      <a class="btn" href="https://mailchi.mp/easymedicaldevice/emd-mag-issue-2" target="_blank" rel="noopener">EMD Magazine #2 Feature</a>
      <a class="btn priority" href="https://eisnersafety.com/2025/09/30/iec-60601-1-4th-edition-survival-guide-why-it-matters-for-medtech/" target="_blank" rel="noopener">4th ed. Survival Guide</a>
    </div>
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       href="https://eisnersafety.com/wp-content/uploads/2026/03/IEC60601_4thEd_Podcast_Resource_Kit_One_Pager_v20.pdf"
       target="_blank" rel="noopener">Download One-Pager PDF</a>

    <div style="height:22px;"></div>

    <p style="font-size:18px; line-height:1.7; margin:0;">
      Use this one-page briefing handout to kick off internal alignment across RA/QA,
      Design, Test, Documentation, Supply Chain, and Management.
    </p>
  </div>

  <!-- NEWSLETTER OVERVIEW -->
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    <a class="btn half center"
       href="https://www.linkedin.com/pulse/preparing-iec-60601-fourth-edition-how-stay-ahead-compliance-9tfhe/"
       target="_blank" rel="noopener">Read High-Level Overview</a>

    <div style="height:18px;"></div>

    <p style="font-size:18px; line-height:1.7; margin:0;">
      This newsletter provides a high-level overview of 4th Edition preparation themes,
      including transition timing, regulatory positioning, and early planning actions.
      For deeper technical shifts that drive design inputs and evidence expectations,
      use the podcast and the one-pager as the primary briefing baseline.
    </p>
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  <div class="section">
    <h2>Why this matters for MedTech</h2>
    <p class="muted" style="line-height:1.6; margin-top:0;">
      The architecture is structured around 12 hazard-based Working Groups, with a much expanded and clearer scope.
      There are stronger expectations for intended use, user environments, software and PEMS, wireless coexistence,
      and emerging EMF exposure concepts. These changes will flow into design inputs, QMS documentation,
      labeling and IFUs, verification and validation evidence, and test strategy.
    </p>

    <h2>Across the Working Groups, changes are focused on</h2>
    <ul>
      <li><strong>Scope and Essential Performance</strong></li>
      <li><strong>User environments and intended use</strong></li>
      <li><strong>Software and PEMS</strong></li>
      <li><strong>International wireless coexistence expectations</strong></li>
      <li><strong>EMF exposure concepts</strong></li>
      <li><strong>Hazard-based structure</strong></li>
    </ul>

    <h2>How to use this kit</h2>
    <ol style="margin: 10px 0 0 20px; line-height:1.55;">
      <li>Brief leadership using the podcast as the shared baseline.</li>
      <li>Revisit your intended use, user environments, and understand the changing scope of the standard now.</li>
      <li>Assign owners to track the Working Groups most relevant to your product and markets.</li>
      <li>
        Track areas likely to affect:
        <ul>
          <li>QMS documentation</li>
          <li>Labeling and IFUs</li>
          <li>Test strategy and test planning</li>
          <li>Design impacts</li>
          <li>Impact register – track what impact your company expects and what decisions you are making now</li>
        </ul>
      </li>
    </ol>

    <h2>Related resources from my earlier Survival Guide</h2>
    <p class="muted" style="line-height:1.6; margin-top:0;">
      If you want the broader 4th Edition transition kit from my Survival Guide, it includes the MLVx one-pager,
      my MLVx webinar replay, a summary article, and the slide deck.
    </p>
    <ul>
      <li>
        <a href="https://eisnersafety.com/2025/09/30/iec-60601-1-4th-edition-survival-guide-why-it-matters-for-medtech/"
           target="_blank" rel="noopener">4th ed. Survival Guide Kit</a>
      </li>
      <li>
        <a href="https://www.youtube.com/watch?v=mMO91n4UajA" target="_blank" rel="noopener">4th ed. Impact Webinar</a>
      </li>
      <li>
        <a href="https://www.linkedin.com/pulse/iec-60601-4th-edition-medtech-what-raqa-leaders-need-prepare-smith-idjye/"
           target="_blank" rel="noopener">Summary Article on the 4th ed. Impact Webinar</a>
      </li>
    </ul>
  </div>

  <!-- CTA -->
  <div class="callout">
    <h2 style="margin:0 0 8px 0;">Want deeper analysis beyond LinkedIn?</h2>
    <p class="muted" style="margin:0; line-height:1.6;">
      My newsletter is where I publish longer-form breakdowns and structured updates that are not always fully posted on LinkedIn.
    </p>

    <div class="cta-row">
      <a class="btn"
         href="https://eisnersafety.us11.list-manage.com/subscribe?u=d89a34a59f280a14e12228ea0&#038;id=a83d084e5d"
         target="_blank" rel="noopener">Subscribe to the ESC Newsletter</a>
      <a class="btn"
         href="https://eisnersafety.com/schedule-call/"
         target="_blank" rel="noopener">Schedule a Call</a>
    </div>

    <p style="margin-top:18px; font-size:18px; line-height:1.7;">
      If your team needs help mapping 4th Edition direction into design controls, QMS,
      labeling, or test strategy, my team at Eisner Safety Consultants can support you.
    </p>
  </div>

</div>
</div>



<pre class="wp-block-code"><code></code></pre>
]]></content:encoded>
					
		
		
			</item>
		<item>
		<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>
		<category><![CDATA[60601-1]]></category>
		<category><![CDATA[60601-1-11]]></category>
		<category><![CDATA[60601-1-12]]></category>
		<category><![CDATA[60601-1-2]]></category>
		<category><![CDATA[60601-1-6]]></category>
		<category><![CDATA[60601-1-8]]></category>
		<category><![CDATA[60601-1, 4th edition]]></category>
		<category><![CDATA[62304]]></category>
		<category><![CDATA[62366]]></category>
		<category><![CDATA[AI]]></category>
		<category><![CDATA[Architecture Specification]]></category>
		<category><![CDATA[Cybersecurity]]></category>
		<category><![CDATA[Design Specification]]></category>
		<category><![CDATA[Device]]></category>
		<category><![CDATA[EMC]]></category>
		<category><![CDATA[Essential Performance]]></category>
		<category><![CDATA[Hazards]]></category>
		<category><![CDATA[IEC]]></category>
		<category><![CDATA[IEC 60601-1]]></category>
		<category><![CDATA[ISO 14708]]></category>
		<category><![CDATA[Labeling]]></category>
		<category><![CDATA[Medical Device]]></category>
		<category><![CDATA[Nov 2025]]></category>
		<category><![CDATA[Patient Safety]]></category>
		<category><![CDATA[Podcast]]></category>
		<category><![CDATA[Recognized Consensus Standards]]></category>
		<category><![CDATA[Regulation]]></category>
		<category><![CDATA[Regulatory Affairs]]></category>
		<category><![CDATA[Risk Management]]></category>
		<category><![CDATA[Software]]></category>
		<category><![CDATA[Standards]]></category>
		<category><![CDATA[Standards Development]]></category>
		<category><![CDATA[State of the Art]]></category>
		<category><![CDATA[Usability]]></category>
		<category><![CDATA[Usability Engineering Process]]></category>
		<category><![CDATA[User Interfaces]]></category>
		<guid isPermaLink="false">https://eisnersafety.com/?p=8368</guid>

					<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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        Ready to turn your own “star map” into a safer device?
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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>
]]></content:encoded>
					
		
		
			</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>
				<category><![CDATA[60601 Series]]></category>
		<category><![CDATA[60601-1]]></category>
		<category><![CDATA[60601-1-10]]></category>
		<category><![CDATA[60601-1-11]]></category>
		<category><![CDATA[60601-1-12]]></category>
		<category><![CDATA[60601-1-2]]></category>
		<category><![CDATA[60601-1-2, Ed. 4.1]]></category>
		<category><![CDATA[60601-1-6]]></category>
		<category><![CDATA[60601-1-8]]></category>
		<category><![CDATA[60601-1-9]]></category>
		<category><![CDATA[60601-1, 4th edition]]></category>
		<category><![CDATA[62304]]></category>
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		<category><![CDATA[IEC 60601-1]]></category>
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		<category><![CDATA[ISO 10993]]></category>
		<category><![CDATA[ISO 15223-1]]></category>
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		<category><![CDATA[MDD]]></category>
		<category><![CDATA[MDR]]></category>
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		<category><![CDATA[Medical Device Regulation]]></category>
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		<category><![CDATA[Oct 2025]]></category>
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		<category><![CDATA[Recognized Consensus Standards]]></category>
		<category><![CDATA[Regulation]]></category>
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		<category><![CDATA[Single Fault Condition]]></category>
		<category><![CDATA[Software]]></category>
		<category><![CDATA[Standards]]></category>
		<category><![CDATA[Standards Development]]></category>
		<category><![CDATA[State of the Art]]></category>
		<category><![CDATA[US]]></category>
		<category><![CDATA[Usability]]></category>
		<category><![CDATA[Usability Engineering Process]]></category>
		<category><![CDATA[User Interfaces]]></category>
		<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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        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.
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      <p class="esc-meta">Episode 235</p>
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      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.
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      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
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    </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>
					
		
		
			</item>
		<item>
		<title>IEC 60601 Updates: What MedTech Need to Know for 2025 and Beyond Podcast</title>
		<link>https://eisnersafety.com/2024/12/12/iec-60601-updates-what-medtech-need-to-know-for-2025-and-beyond-podcast/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=iec-60601-updates-what-medtech-need-to-know-for-2025-and-beyond-podcast</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Thu, 12 Dec 2024 21:46:24 +0000</pubDate>
				<category><![CDATA[10993]]></category>
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		<guid isPermaLink="false">https://eisnersafety.com/?p=7713</guid>

					<description><![CDATA[In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Leo Eisner, founder of Eisner Safety Consultants and a leading voice in IEC 60601 standards development. We unpack the upcoming revisions to IEC 60601, 4th ed.,]]></description>
										<content:encoded><![CDATA[
<figure class="wp-block-image size-large is-resized"><a href="https://bit.ly/IEC60601-14thEdGGPodcast" target="_blank" rel=" noreferrer noopener"><img fetchpriority="high" decoding="async" width="1024" height="1024" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/12/Global-Medical-Device-Podcast-Image-1024x1024.jpg" alt="" class="wp-image-7725" style="width:1218px;height:auto" srcset="https://eisnersafety.com/wp-content/uploads/2024/12/Global-Medical-Device-Podcast-Image-1024x1024.jpg 1024w, https://eisnersafety.com/wp-content/uploads/2024/12/Global-Medical-Device-Podcast-Image-300x300.jpg 300w, https://eisnersafety.com/wp-content/uploads/2024/12/Global-Medical-Device-Podcast-Image-150x150.jpg 150w, https://eisnersafety.com/wp-content/uploads/2024/12/Global-Medical-Device-Podcast-Image-768x768.jpg 768w" sizes="(max-width: 1024px) 100vw, 1024px" /></a></figure>



<p>In this <a href="https://bit.ly/IEC60601-14thEdGGPodcast" target="_blank" rel="noreferrer noopener">episode of the Global Medical Device Podcast</a>, Etienne Nichols sits down with Leo Eisner, founder of Eisner Safety Consultants and a leading voice in IEC 60601 standards development.</p>



<p>We unpack the upcoming revisions to IEC 60601, 4th ed., focusing on the rationale behind these changes, their impact on medical device design, and how MedTech professionals can prepare for the future.</p>



<p>Leo provides insights into the intricate process of updating global standards, shares practical advice for compliance, and discusses the role of risk management in ensuring safer, more effective medical devices.</p>



<p class="has-medium-font-size"><strong>Key Points:</strong></p>



<ol start="1" class="wp-block-list">
<li><strong>New Modular Approach</strong>:
<ul class="wp-block-list">
<li>The updated standard adopts a modular approach (12 working groups focused on specific hazard areas).</li>



<li>Simplifies updates by consolidating Collateral Standards into the General Standard.</li>



<li>Aligns better with global regulations.</li>
</ul>
</li>



<li><strong>IEC 60601-1 4th Edition</strong>:
<ul class="wp-block-list">
<li>Focuses on addressing various hazards including:
<ul class="wp-block-list">
<li>physical environment,</li>



<li>electrical,</li>



<li>thermal and fire,</li>



<li>mechanical,</li>



<li>user interface (usability, alarms, information supplied by the manufacturer &amp; user interface aspects),</li>



<li>materials,</li>



<li>optical radiation, and</li>



<li>electromagnetic exposure hazards.</li>
</ul>
</li>
</ul>
</li>



<li><strong>New Requirements</strong>:
<ul class="wp-block-list">
<li>Introduces new international requirements for wireless coexistence and other cutting-edge technologies (e.g., gas pathways, user interface aspects).</li>
</ul>
</li>



<li><strong>Consolidation of Standards</strong>:
<ul class="wp-block-list">
<li>Collateral standards are being consolidated to improve consistency and reduce the update cycle time for the 60601 series.</li>
</ul>
</li>



<li><strong>Timeline and Publication Dates</strong>:
<ul class="wp-block-list">
<li>Expected timeline for the fourth edition is 2029-2030.</li>



<li>Companies need to plan now, though the actual timeline may slip depending on various factors.</li>
</ul>
</li>



<li><strong>Benefits of Proactive Planning</strong>:
<ul class="wp-block-list">
<li>Proactive planning and test preparation are essential for regulatory success.</li>



<li>Staying informed and embracing continuous learning in MedTech are key factors for success.</li>
</ul>
</li>



<li><strong>Practical Advice for Compliance</strong>:
<ul class="wp-block-list">
<li>Begin designing for new standards early, even before they are finalized. MedTech design cycles are long.</li>



<li>Engage with industry groups and standards organizations.</li>



<li>Use test planning to streamline development and meet regulatory expectations efficiently.</li>
</ul>
</li>



<li><strong>Engaging in the Standards Development Process</strong>:
<ul class="wp-block-list">
<li>Manufacturers are encouraged to engage in the standards development process and submit comments.</li>



<li>This proactive approach can help shape the standards and ensure they are practical and achievable.</li>
</ul>
</li>
</ol>



<p>These updates aim to enhance safety and performance while keeping pace with technological advancements. Manufacturers need to stay informed and prepare for the impact these changes will have on their product lines and quality systems.</p>



<p class="has-large-font-size"><strong>Resources:</strong></p>



<p><a href="https://bit.ly/Download4thEd60601DsgnSpecFinal" target="_blank" rel="noreferrer noopener">Design specification Outline for the fourth edition of IEC 60601-1</a></p>



<p><a href="https://bit.ly/ArchitectureSpec" target="_blank" rel="noreferrer noopener">Architectural Specification For Safety Standards of Medical Electrical Equipment, Medical Electrical Systems, and Software Used in Healthcare</a></p>



<p>Only 5 of the 12 Fragments went out for CD on 6 Dec 2024, which were Working Groups (WGs) WG37, 38, 39, 40 &amp; 47 (Fragments 1, 2, 3, 4, &amp; 11 respectively).  The status of each of these Fragments is noted below:</p>



<ul class="wp-block-list">
<li>Fragment 1 (WG37) <a href="https://www.iec.ch/dyn/www/f?p=103:38:6707899433702::::FSP_ORG_ID,FSP_APEX_PAGE,FSP_PROJECT_ID:1359,23,124354" target="_blank" rel="noreferrer noopener">Status</a></li>



<li>Fragment 2 (WG38) <a href="https://www.iec.ch/dyn/www/f?p=103:38:6707899433702::::FSP_ORG_ID,FSP_APEX_PAGE,FSP_PROJECT_ID:1359,23,124355" target="_blank" rel="noreferrer noopener">Status</a></li>



<li>Fragment 3 (WG39) <a href="https://www.iec.ch/dyn/www/f?p=103:38:6707899433702::::FSP_ORG_ID,FSP_APEX_PAGE,FSP_PROJECT_ID:1359,23,124356" target="_blank" rel="noreferrer noopener">Status</a></li>



<li>Fragment 4 (WG40) <a href="https://www.iec.ch/dyn/www/f?p=103:38:6707899433702::::FSP_ORG_ID,FSP_APEX_PAGE,FSP_PROJECT_ID:1359,23,124357" target="_blank" rel="noreferrer noopener">Status</a></li>



<li>Fragment 11 (WG47) <a href="https://www.iec.ch/dyn/www/f?p=103:38:6707899433702::::FSP_ORG_ID,FSP_APEX_PAGE,FSP_PROJECT_ID:1359,23,124363" target="_blank" rel="noreferrer noopener">Status</a></li>
</ul>



<p>The other 7 fragments will go out for CD approximately May &#8217;25 (estimated schedule is my best intelligence).  Fragments 5 &#8211; 10 &amp; 12.  You can look at the <a href="https://www.iec.ch/dyn/www/f?p=103:23:6707899433702::::FSP_ORG_ID,FSP_LANG_ID:1359,25" target="_blank" rel="noreferrer noopener">SC 62A Work Programme</a> and find the Fragment number in the descriptions for each project on the first 12 projects of the Work Programme to find the status of each Fragment.</p>



<p>If you are a National Committee (NC) member and want to comment on the Fragment depending on your NC rules you may be placing your comments directly into the Online Standards Development (OSD) Platform for the Fragment.  Other NCs are collecting the comments and then the NC Secretariat (or similar role) will be responsible for placing all the comments into OSD. Please check with your NC for your specific rules. <a href="https://www.iec.ch/online-standards-development" target="_blank" rel="noreferrer noopener">Details about the OSD platform, How to use OSD, OSD resources (various training and other resources)</a></p>



<p>New terms and definitions which IEC 60601-1, 4th Ed. will be based on but other Technical Committees will adopt across the Healthcare sector to increase consistency &#8211; “International Electrotechnical Vocabulary (IEV) – Part 880: Electrical equipment, electrical systems and software used in healthcare” &#8211; <a href="https://www.iec.ch/ords/f?p=103:38:6707899433702::::FSP_ORG_ID,FSP_APEX_PAGE,FSP_PROJECT_ID:1231,23,104509" target="_blank" rel="noreferrer noopener">IEC Website that has the schedule, list of draft documents</a>.  The CDV was released on 13 Dec 2024.  If you are a National Committee Member of TC 1, TC 62, SC 62A, SC 62B, SC 62C, SC 62D, TC 65, TC 66, TC 76, TC 87, or SyC AAL you should be able to get access to this document and be able to comment on this document.  This document is also being distributed for comment to ISO TC 210 and some additional ISO TCs .</p>



<p class="has-medium-font-size"><strong>Engage with the <a href="https://bit.ly/IEC60601-14thEdGGPodcast" target="_blank" rel="noreferrer noopener">Podcast</a> on the LinkedIn Post we’d like to hear from you <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1faf5.png" alt="🫵" class="wp-smiley" style="height: 1em; max-height: 1em;" /></strong></p>



<p>If you found this interesting or helpful, consider reposting <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f504.png" alt="🔄" class="wp-smiley" style="height: 1em; max-height: 1em;" /> on <a href="http://linkedin.com/in/leoeisnersafetyconsultants" target="_blank" rel="noreferrer noopener">LinkedIn</a>; follow me, Leonard (Leo) Eisner, the60601Guy and click the <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f514.png" alt="🔔" class="wp-smiley" style="height: 1em; max-height: 1em;" /> so you don’t miss future content.</p>



<p><strong>Need Help?</strong></p>



<p>Need help with 60601 series standards including EMC? Eisner Safety Consultants can assist with strategic compliance planning for your medical electrical product lines, provide support when FDA or a regulator asks questions for a submission, and more. We deal with EU, US, and other country regulatory requirements, standards, laws, directives, and more. Our team also provides support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs, and more. We work with many test labs for medical safety and EMC and can arrange other testing as well. Feel free to schedule a <a href="https://eisnersafety.com/schedule-call/">web meeting with Leo</a> or <a href="https://eisnersafety.com/contact_eisner_safety/">contact us</a>.</p>
]]></content:encoded>
					
		
		
			</item>
		<item>
		<title>The most valuable asset we each bring to the table is⁉️ Our unique experiences and innovation</title>
		<link>https://eisnersafety.com/2024/09/30/the-most-valuable-asset-we-each-bring-to-the-table-is%e2%81%89%ef%b8%8f-our-unique-experiences-and-innovation/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=the-most-valuable-asset-we-each-bring-to-the-table-is%25e2%2581%2589%25ef%25b8%258f-our-unique-experiences-and-innovation</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Mon, 30 Sep 2024 06:46:00 +0000</pubDate>
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		<guid isPermaLink="false">https://eisnersafety.com/?p=7706</guid>

					<description><![CDATA[Leo Eisner, The60601Guy will be visiting London 🇬🇧🎡🏰 in October.  You have the chance to sit down with me, The60601Guy, have a cup a coffee or a beer and talk IEC60601, design for compliance, and standards that apply to your device. I have time slots open on 7, 8, and 11 of Oct. Or join me for a dinner on the 8 or 11 Oct. 

Meet me in London - I want to hear from you the week of 7 Oct. These two hour slots are limited before they are gone, 𝗯𝗼𝗼𝗸 𝗻𝗼𝘄 𝗼𝗻 𝗺𝘆 𝘀𝗽𝗲𝗰𝗶𝗮𝗹 𝗰𝗮𝗹𝗲𝗻𝗱𝗮𝗿 for 𝗺𝘆 𝗟𝗼𝗻𝗱𝗼𝗻 𝘃𝗶𝘀𝗶𝘁. I’d love to chat!]]></description>
										<content:encoded><![CDATA[
<figure class="wp-block-image size-large is-resized"><img decoding="async" width="1024" height="733" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/10/Are-You-A-MedTech-Co-1024x733.png" alt="" class="wp-image-7708" style="width:1071px;height:auto" srcset="https://eisnersafety.com/wp-content/uploads/2024/10/Are-You-A-MedTech-Co-1024x733.png 1024w, https://eisnersafety.com/wp-content/uploads/2024/10/Are-You-A-MedTech-Co-300x215.png 300w, https://eisnersafety.com/wp-content/uploads/2024/10/Are-You-A-MedTech-Co-768x550.png 768w, https://eisnersafety.com/wp-content/uploads/2024/10/Are-You-A-MedTech-Co.png 1514w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>



<p>Leo Eisner, <a href="https://www.linkedin.com/feed/hashtag/?keywords=the60601guy&amp;highlightedUpdateUrns=urn%3Ali%3Aactivity%3A7241437643480203265" target="_blank" rel="noreferrer noopener">The60601Guy</a> will be visiting 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;" /> in October.  You have the chance to sit down with me, <a href="https://www.linkedin.com/feed/hashtag/?keywords=the60601guy" target="_blank" rel="noreferrer noopener">The60601Guy</a>, have a cup a coffee or a beer and talk <a href="https://www.linkedin.com/feed/hashtag/?keywords=iec60601" target="_blank" rel="noreferrer noopener">IEC60601</a>, design for compliance, and <a href="http://cme.sh/DM7ct7" target="_blank" rel="noreferrer noopener">standards that apply to your device</a>. I have time slots open on 7, 8, and 11 of Oct. Or join me for a dinner on the 8 or 11 Oct. <br><br>Meet me in London &#8211; I want to hear from you the week of 7 Oct. These <strong>two hour slots</strong> are limited before they are gone, 𝗯𝗼𝗼𝗸 𝗻𝗼𝘄 𝗼𝗻 𝗺𝘆 <strong>𝘀𝗽𝗲𝗰𝗶𝗮𝗹 </strong>𝗰𝗮𝗹𝗲𝗻𝗱𝗮𝗿 for <a href="https://tidycal.com/the60601guy/meet-leo-in-london" target="_blank" rel="noreferrer noopener">𝗺𝘆 𝗟𝗼𝗻𝗱𝗼𝗻 𝘃𝗶𝘀𝗶𝘁</a>. I’d love to chat!<br><br>Let’s connect, and explore how we can support your company with our international team of compliance &amp; regulatory experts from <a href="https://eisnersafety.com/about_us/associates/" target="_blank" rel="noreferrer noopener">Eisner Safety Consultants</a>. I’m eager to learn what you’re working on and how you’re driving change and innovation in the industry, and how we can support you to get you to market faster.<br><br>Let’s meet up! 𝗕𝗼𝗼𝗸 𝘁𝗶𝗺𝗲 𝗼𝗻 𝗺𝘆 𝘀𝗽𝗲𝗰𝗶𝗮𝗹 𝗰𝗮𝗹𝗲𝗻𝗱𝗮𝗿 for <a href="https://tidycal.com/the60601guy/meet-leo-in-london" target="_blank" rel="noreferrer noopener">𝗺𝘆 𝗟𝗼𝗻𝗱𝗼𝗻 𝘃𝗶𝘀𝗶𝘁</a>.<br><br></p>
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		<title>What Standards Apply to My Device? Podcast #383</title>
		<link>https://eisnersafety.com/2024/09/25/what-standards-apply-to-my-device-podcast-383/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=what-standards-apply-to-my-device-podcast-383</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Wed, 25 Sep 2024 01:00:00 +0000</pubDate>
				<category><![CDATA[15223-1]]></category>
		<category><![CDATA[20417]]></category>
		<category><![CDATA[60601 Series]]></category>
		<category><![CDATA[60601-1]]></category>
		<category><![CDATA[60601-1 A2]]></category>
		<category><![CDATA[60601-1 Amendment 2]]></category>
		<category><![CDATA[60601-1-2, 4th ed.]]></category>
		<category><![CDATA[60601-1-2, Ed. 4.1]]></category>
		<category><![CDATA[60601-1, 4th edition]]></category>
		<category><![CDATA[62304]]></category>
		<category><![CDATA[62366]]></category>
		<category><![CDATA[62366-1]]></category>
		<category><![CDATA[Architecture Specification]]></category>
		<category><![CDATA[Combination Device]]></category>
		<category><![CDATA[Combination Product]]></category>
		<category><![CDATA[Design Specification]]></category>
		<category><![CDATA[Device]]></category>
		<category><![CDATA[Draft Guidance]]></category>
		<category><![CDATA[EMC]]></category>
		<category><![CDATA[Essential Performance]]></category>
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		<category><![CDATA[EU Commission]]></category>
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		<category><![CDATA[Final Guidance]]></category>
		<category><![CDATA[Greenlight Guru]]></category>
		<category><![CDATA[Guidance]]></category>
		<category><![CDATA[Guidance Documents]]></category>
		<category><![CDATA[Hamonised Standards]]></category>
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		<category><![CDATA[IEC 60601-1]]></category>
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		<category><![CDATA[ISO 15223-1]]></category>
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		<category><![CDATA[Labeling]]></category>
		<category><![CDATA[Law]]></category>
		<category><![CDATA[Marking]]></category>
		<category><![CDATA[Medical Device]]></category>
		<category><![CDATA[Medical Device Regulation]]></category>
		<category><![CDATA[MHRA]]></category>
		<category><![CDATA[Podcast]]></category>
		<category><![CDATA[Recognized Consensus Standards]]></category>
		<category><![CDATA[Regulation]]></category>
		<category><![CDATA[Regulatory Affairs]]></category>
		<category><![CDATA[Sept 2024]]></category>
		<category><![CDATA[Standards]]></category>
		<category><![CDATA[Standards Development]]></category>
		<category><![CDATA[State of the Art]]></category>
		<category><![CDATA[US]]></category>
		<guid isPermaLink="false">https://eisnersafety.com/?p=7686</guid>

					<description><![CDATA[𝗪𝗵𝗮𝘁 𝗦𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 𝗔𝗽𝗽𝗹𝘆 𝘁𝗼 𝗠𝘆 𝗗𝗲𝘃𝗶𝗰𝗲? Podcast with one of the best MedTech podcasters Etienne Nichols - Greenlight Guru's very own

𝗞𝗲𝘆 𝗧𝗼𝗽𝗶𝗰𝘀:‼️
• Why standards like IEC60601 are crucial for medical device development
• Steps for identifying proper standards for your product
• How to integrate standards into your design process
• Mistakes &#038; consequences of ignoring standards
• Tools for staying updated on changing standards &#038; regulations
• How startups can navigate standards with limited resources


]]></description>
										<content:encoded><![CDATA[
<figure class="wp-block-image size-large is-resized"><img decoding="async" width="939" height="1024" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/09/Screenshot-2024-09-26-at-10.20.09 AM-939x1024.png" alt="" class="wp-image-7685" style="aspect-ratio:0.9171686746987951;width:957px;height:auto" srcset="https://eisnersafety.com/wp-content/uploads/2024/09/Screenshot-2024-09-26-at-10.20.09 AM-939x1024.png 939w, https://eisnersafety.com/wp-content/uploads/2024/09/Screenshot-2024-09-26-at-10.20.09 AM-275x300.png 275w, https://eisnersafety.com/wp-content/uploads/2024/09/Screenshot-2024-09-26-at-10.20.09 AM-768x838.png 768w, https://eisnersafety.com/wp-content/uploads/2024/09/Screenshot-2024-09-26-at-10.20.09 AM.png 1104w" sizes="(max-width: 939px) 100vw, 939px" /></figure>



<p><img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f4e3.png" alt="📣" class="wp-smiley" style="height: 1em; max-height: 1em;" /><img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f4e3.png" alt="📣" class="wp-smiley" style="height: 1em; max-height: 1em;" /> 𝗪𝗵𝗮𝘁 𝗦𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 𝗔𝗽𝗽𝗹𝘆 𝘁𝗼 𝗠𝘆 𝗗𝗲𝘃𝗶𝗰𝗲? <a href="https://bit.ly/StdsApplytoMyDvcPodcast" target="_blank" rel="noreferrer noopener">Podcast</a> with one of the best MedTech podcasters <a href="https://www.linkedin.com/in/ACoAABLOl1MBgpdtq2ui3hxQ-g4qhSMMczn7foE"></a><a href="https://www.linkedin.com/in/etiennenichols/" target="_blank" rel="noreferrer noopener">Etienne Nichols</a> &#8211; <a href="https://www.linkedin.com/company/greenlight-guru/" target="_blank" rel="noreferrer noopener">Greenlight Guru</a>&#8216;s very own<img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f60e.png" alt="😎" class="wp-smiley" style="height: 1em; max-height: 1em;" /><img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f389.png" alt="🎉" class="wp-smiley" style="height: 1em; max-height: 1em;" /><br><br>𝗞𝗲𝘆 𝗧𝗼𝗽𝗶𝗰𝘀:<img src="https://s.w.org/images/core/emoji/17.0.2/72x72/203c.png" alt="‼" class="wp-smiley" style="height: 1em; max-height: 1em;" /><br>• Why standards like <a href="https://www.linkedin.com/feed/hashtag/?keywords=iec60601&amp;highlightedUpdateUrns=urn%3Ali%3Aactivity%3A7245128762487406592" target="_blank" rel="noreferrer noopener">IEC60601</a> are crucial for medical device development<br>• Steps for identifying proper standards for your product<br>• How to integrate standards into your design process<br>• Mistakes &amp; consequences of ignoring standards<br>• Tools for staying updated on changing standards &amp; regulations<br>• How startups can navigate standards with limited resources<br><br>If you have any thoughts and comments on the <a href="https://bit.ly/StdsApplytoMyDvcPodcast" target="_blank" rel="noreferrer noopener">podcast</a> I&#8217;d would like to hear from you <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1faf5.png" alt="🫵" class="wp-smiley" style="height: 1em; max-height: 1em;" /> Comment on the <a href="https://bit.ly/StdsApplyDvcsPodcastLI" target="_blank" rel="noreferrer noopener">LinkedIn post about the Podcast</a><br><br>If you found this interesting or helpful, consider Reposting <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f504.png" alt="🔄" class="wp-smiley" style="height: 1em; max-height: 1em;" /> on LinkedIn; follow me, <a href="https://bit.ly/LeoEisnerLinkedInProfile" target="_blank" rel="noreferrer noopener">Leonard (Leo) Eisner</a>, <a href="https://www.linkedin.com/feed/hashtag/?keywords=the60601guy&amp;highlightedUpdateUrns=urn%3Ali%3Aactivity%3A7245128762487406592" target="_blank" rel="noreferrer noopener">the60601Guy</a> and click the <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1f514.png" alt="🔔" class="wp-smiley" style="height: 1em; max-height: 1em;" /> so you don&#8217;t miss future content.</p>



<p>Need help with 60601 series standards including EMC; strategic compliance planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, &amp; other country regulatory requirements &amp; standards, laws, directives, and more. Eisner Safety Consultants <a href="https://eisnersafety.com/about_us/associates/" target="_blank" rel="noreferrer noopener">team of experts</a> also provides support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs and more. His team includes experts on additional standards committees and we all talk to the regulators regularly. We’re here 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 web meeting with Leo</a>&nbsp;or contact Leo at&nbsp;Leo&#64;&#69;isnerS&#97;&#102;&#101;&#116;y.&#99;&#111;m&nbsp;or through our&nbsp;<a rel="noreferrer noopener" href="https://eisnersafety.com/contact_eisner_safety/" target="_blank">contact form</a>.</p>



<p></p>
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		<title>How to ID Applicable Standards &#8211; Combinate Podcast</title>
		<link>https://eisnersafety.com/2024/08/07/how-to-id-applicable-standards-combinate-podcast/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=how-to-id-applicable-standards-combinate-podcast</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Wed, 07 Aug 2024 21:08:23 +0000</pubDate>
				<category><![CDATA[10993]]></category>
		<category><![CDATA[13485]]></category>
		<category><![CDATA[14708]]></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[61010]]></category>
		<category><![CDATA[62304]]></category>
		<category><![CDATA[62366]]></category>
		<category><![CDATA[62366-1]]></category>
		<category><![CDATA[Active Implants]]></category>
		<category><![CDATA[Architecture Specification]]></category>
		<category><![CDATA[Aug 2024]]></category>
		<category><![CDATA[Combination Device]]></category>
		<category><![CDATA[Combination Product]]></category>
		<category><![CDATA[Design Specification]]></category>
		<category><![CDATA[Device]]></category>
		<category><![CDATA[Draft Guidance]]></category>
		<category><![CDATA[EMC]]></category>
		<category><![CDATA[Essential Performance]]></category>
		<category><![CDATA[EU]]></category>
		<category><![CDATA[EU Commission]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Final Guidance]]></category>
		<category><![CDATA[Guidance]]></category>
		<category><![CDATA[Guidance Documents]]></category>
		<category><![CDATA[Hamonised Standards]]></category>
		<category><![CDATA[Harmonized Standards]]></category>
		<category><![CDATA[IEC]]></category>
		<category><![CDATA[IEC 60601-1]]></category>
		<category><![CDATA[IEC 61010]]></category>
		<category><![CDATA[IMDRF]]></category>
		<category><![CDATA[Information provided by the manufacturer]]></category>
		<category><![CDATA[Interpretation Sheet 1]]></category>
		<category><![CDATA[ISH1]]></category>
		<category><![CDATA[ISO 10993]]></category>
		<category><![CDATA[ISO 13485]]></category>
		<category><![CDATA[ISO 14708]]></category>
		<category><![CDATA[ISO 15223-1]]></category>
		<category><![CDATA[ISO 20417]]></category>
		<category><![CDATA[IVD]]></category>
		<category><![CDATA[Labeling]]></category>
		<category><![CDATA[Law]]></category>
		<category><![CDATA[Marking]]></category>
		<category><![CDATA[MDD]]></category>
		<category><![CDATA[MDR]]></category>
		<category><![CDATA[Medical Device]]></category>
		<category><![CDATA[Medical Device Regulation]]></category>
		<category><![CDATA[MHRA]]></category>
		<category><![CDATA[Notified Bodies]]></category>
		<category><![CDATA[PEMS]]></category>
		<category><![CDATA[Podcast]]></category>
		<category><![CDATA[Quality Assurance]]></category>
		<category><![CDATA[Recognized Consensus Standards]]></category>
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		<category><![CDATA[Regulatory Affairs]]></category>
		<category><![CDATA[Risk Management]]></category>
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		<category><![CDATA[Software]]></category>
		<category><![CDATA[Standards]]></category>
		<category><![CDATA[Standards Development]]></category>
		<category><![CDATA[State of the Art]]></category>
		<category><![CDATA[US]]></category>
		<category><![CDATA[Usability]]></category>
		<category><![CDATA[Usability Engineering Process]]></category>
		<category><![CDATA[User Interfaces]]></category>
		<guid isPermaLink="false">https://eisnersafety.com/?p=7632</guid>

					<description><![CDATA[Join me, Leonard (Leo) Eisner, the "IEC 60601 Guy",

in a conversation with Subhi Saadeh of Combinate Podcast

as we look at how to assess applicable standards for medical and combination devices and a few highlights on IEC 60601-1, 4th ed. in Combinate Podcast 148 ]]></description>
										<content:encoded><![CDATA[
<p>&nbsp;</p>



<figure class="wp-block-image size-full is-resized"><img loading="lazy" decoding="async" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/08/148-Leo-Eisner.jpeg" alt="" class="wp-image-7634" width="1218" height="1218" srcset="https://eisnersafety.com/wp-content/uploads/2024/08/148-Leo-Eisner.jpeg 540w, https://eisnersafety.com/wp-content/uploads/2024/08/148-Leo-Eisner-300x300.jpeg 300w, https://eisnersafety.com/wp-content/uploads/2024/08/148-Leo-Eisner-150x150.jpeg 150w, https://eisnersafety.com/wp-content/uploads/2024/08/148-Leo-Eisner-270x270.jpeg 270w, https://eisnersafety.com/wp-content/uploads/2024/08/148-Leo-Eisner-230x230.jpeg 230w, https://eisnersafety.com/wp-content/uploads/2024/08/148-Leo-Eisner-45x45.jpeg 45w, https://eisnersafety.com/wp-content/uploads/2024/08/148-Leo-Eisner-100x100.jpeg 100w" sizes="auto, (max-width: 1218px) 100vw, 1218px" /></figure>



<p>Join me, <a href="https://www.linkedin.com/in/ACoAAABI0MQBuOSm1PL6Rtb3VTU5ORFgMiOgnQ0"></a><a href="https://www.linkedin.com/in/leoeisnersafetyconsultants/" target="_blank" rel="noreferrer noopener">Leonard (Leo) Eisner</a>, the &#8220;IEC 60601 Guy&#8221;,<br><br>in a 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><br><br>as we look at how to assess applicable standards for medical and combination devices and a few highlights on IEC 60601-1, 4th ed. in <a href="https://www.linkedin.com/company/combinate-podcast/" target="_blank" rel="noreferrer noopener">Combinate Podcast</a> 148 <a rel="noreferrer noopener" href="https://bit.ly/LIPostCombinatePodcast148LeoEisner" target="_blank">https://bit.ly/LIPostCombinatePodcast148LeoEisner</a></p>



<p>He really does his research and is a great interviewer.  I always find it fun and intriguing to have a conversation with <a href="https://www.linkedin.com/in/subhi-saadeh-1169aa21/" target="_blank" rel="noreferrer noopener">Subhi</a> as I too learn from our conversations.</p>



<p>We discuss:<br>☞ complexities in assessing applicable standards<br>☞ understanding the impact of product environment, intended use, &amp; applicable markets<br>☞ challenges and strategies for documenting standards assessments<br>☞ leveraging existing standards to avoid unnecessary development<br>☞ tips for small and large companies<br>☞ significance of early research<br>☞ essential stakeholders involved in standards assessment<br>☞ and more&#8230;.</p>



<p>Join us <img src="https://s.w.org/images/core/emoji/17.0.2/72x72/1faf5.png" alt="🫵" class="wp-smiley" style="height: 1em; max-height: 1em;" /> in the conversation on <a rel="noreferrer noopener" href="https://bit.ly/LIPostCombinatePodcast148LeoEisner" target="_blank">LinkedIn</a> and <a rel="noreferrer noopener" href="https://bit.ly/LIPostCombinatePodcast148LeoEisner" target="_blank">leave your comments</a> so we can <a rel="noreferrer noopener" href="https://bit.ly/LIPostCombinatePodcast148LeoEisner" target="_blank">continue this discussion</a>. </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;E&#105;snerS&#97;&#102;e&#116;y&#46;co&#109;&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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		<title>FDA Announces Consensus Standards Guidances, Podcast &#038; Webinar</title>
		<link>https://eisnersafety.com/2018/09/22/fda-announces-consensus-standards-guidances-podcast-webinar/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=fda-announces-consensus-standards-guidances-podcast-webinar</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Sat, 22 Sep 2018 22:03:32 +0000</pubDate>
				<category><![CDATA[60601 Series]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Greenlight Guru]]></category>
		<category><![CDATA[Guidance Documents]]></category>
		<category><![CDATA[Podcast]]></category>
		<category><![CDATA[Recognized Consensus Standards]]></category>
		<category><![CDATA[Sept 2018]]></category>
		<category><![CDATA[Standards Development]]></category>
		<category><![CDATA[60601]]></category>
		<category><![CDATA[consensus standards]]></category>
		<category><![CDATA[Standards]]></category>
		<guid isPermaLink="false">https://www.eisnersafety.com/eisnersafetycom/?p=6123</guid>

					<description><![CDATA[On September 13, 2018 the FDA posted 2 Guidance Documents Recognition and Withdrawal of Voluntary Consensus Standards: Draft Guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices : Final Guidance Podcast on Standards &#38; FDA&#8217;s Release]]></description>
										<content:encoded><![CDATA[<picture><source srcset="https://d2ijz6o5xay1xq.cloudfront.net/account_5518/f86ec3acee438817c18952037e7bf6f0_800.jpg 1x" media="(max-width: 768px)"><source srcset="https://d2ijz6o5xay1xq.cloudfront.net/account_5518/f86ec3acee438817c18952037e7bf6f0_800.jpg 1x" media="(min-width: 769px)"><img loading="lazy" decoding="async" class="alignnone" src="https://d2ijz6o5xay1xq.cloudfront.net/account_5518/f86ec3acee438817c18952037e7bf6f0_800.jpg" alt="Surgical Suite" width="707" height="472"></picture><strong>On September 13, 2018 the FDA posted 2 Guidance Documents</strong></p>
<ul>
<li><a href="https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM620229.pdf" target="_blank" rel="noopener noreferrer">Recognition and Withdrawal of Voluntary Consensus Standards: Draft Guidance</a></li>
<li><a href="https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077295.pdf" target="_blank" rel="noopener noreferrer">Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices : Final Guidance</a></li>
</ul>
<p><strong>Podcast on Standards &amp; FDA&#8217;s Release of these Guidance Documents</strong></p>
<p>FDA&#8217;s Captain Scott Colburn and Leo Eisner of <a href="https://eisnersafety.com/eisnersafetycom/" target="_blank" rel="noopener noreferrer">Eisner Safety Consultants</a> did a <a href="https://www.greenlight.guru/blog/cdrh-experimental-learning-program" target="_blank" rel="noopener noreferrer">podcast</a> with Jon Speer of Greenlight Guru on Standards Development of the IEC 60601 Series and these recently released Guidance documents. Listen to this conversation&#8230;</p>
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<p><strong><br />
Some of items of note with the <a href="https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077295.pdf" target="_blank" rel="noopener noreferrer">Final FDA Guidance</a> include: </strong></p>
<ul>
<li>FDA can now Recognize a standard and place on the Recognized Consensus Standards db prior to a formal Federal Register updates</li>
<li>Declaration of Conformity (DOC) to follow requirements of ISO 17050-1 or as specified in the Final Guidance in section IV. A. (1)</li>
<li>DOC process different for Consensus Standards that are horizontal, process-oriented, or that include choices relating to test methods, test selection, or have guidelines that apply to a broad range of device types and safety issues then FDA recommends submitters follow ISO 17050-2 &#8211; Supplier&#8217;s DOC &#8211; Supporting Documentation per section IV. A. (2) of the Final Guidance</li>
</ul>
<p>IEC 60601-1, edition 3.2 (draft) and it&#8217;s collateral standards (IEC 60601-1-XX) are being updated and Leo discusses why this is happening, the timing and some of the impacts on manufacturers and design houses in this <a href="https://www.greenlight.guru/blog/cdrh-experimental-learning-program" target="_blank" rel="noopener noreferrer">podcast</a>.</p>
<p><strong>FDA Guidance Documents &#8211; Additional Information</strong></p>
<p>The draft guidance will be open for public comments and suggestions for 60 days at <a href="https://www.regulations.gov/?utm_campaign=FDA%20Issues%20Two%20Guidances%20on%20Voluntary%20Consensus%20Standards&amp;utm_medium=email&amp;utm_source=Eloqua&amp;elqTrackId=60466D2B9B286D3A28F04D5373C7809C&amp;elq=97851b6f072e45699c81d9c84d25b303&amp;elqaid=5044&amp;elqat=1&amp;elqCampaignId=4025" target="_blank" rel="noopener noreferrer">https://www.regulations.gov</a> under Docket Number: FDA-2018-D-2936.</p>
<p>The <a href="https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077295.pdf" target="_blank" rel="noopener noreferrer">Appropriate Use of Voluntary Consensus Standards final guidance</a> describes the appropriate use and documentation of consensus standards for premarket submissions and how FDA staff intends to rely on consensus standards during the review process. Appropriate use of voluntary consensus standards can reduce requests from FDA staff for additional information to address issue(s) the standard was intended to address.&nbsp; This guidance provides further clarity and explanation about the regulatory framework, policies, and practices regarding the appropriate utilization of consensus standards for premarket submissions.:&#8221;</p>
<p><strong>Webinar about the Appropriate Use Final Guidance:</strong></p>
<p>FDA will be hosting a Webinar on Thursday, October 25th, 2018. The webinar will be for manufacturers &amp; others interested in learning more about the Appropriate Use final guidance. No registration is required.</p>
<ul>
<li>Time: 1:00 – 2:00pm EST (To ensure you are connected, dial-in prior to the start of the webinar)</li>
<li>To hear the presentation and ask questions:<br />
Dial: 800-475-0481, International Callers Dial: 1-517-308-9467; Conference Number: 8090070; Passcode: 2387655</li>
<li>To view the slide presentation during the webinar: <a href="https://www.mymeetings.com/nc/join.php?i=PWXW8090070&amp;p=2387655&amp;t=c" target="_blank" rel="noopener noreferrer">https://www.mymeetings.com/nc/join.php?i=PWXW8090070&amp;p=2387655&amp;t=c</a></li>
<li>Following the webinar, a transcript, audio recording, and slides will be available at: <a href="http://www.fda.gov/CDRHWebinar?utm_campaign=FDA%20Issues%20Two%20Guidances%20on%20Voluntary%20Consensus%20Standards&amp;utm_medium=email&amp;utm_source=Eloqua&amp;elqTrackId=5A361E2894599ECB143078D238DB62DF&amp;elq=97851b6f072e45699c81d9c84d25b303&amp;elqaid=5044&amp;elqat=1&amp;elqCampaignId=4025" target="_blank" rel="noopener noreferrer">http://www.fda.gov/CDRHWebinar</a>. The slide presentation will also be available at this site on the morning of the webinar.</li>
</ul>
<p>Need help sorting out the proper medical device standards that apply to your device submission for the US, Canada, EU or elsewhere? Contact Leo &#8220;the IEC 60601 Guy&#8221; Eisner to help you thru this process at <a href="mailto:Leo at EisnerSafety dot com" data-wplink-edit="true">Leo at EisnerSafety</a> dot com or <a href="https://www.eisnersafety.com/eisnersafetycom/Schedule-Call/" rel="noopener noreferrer">schedule a call</a> with Leo.<!-- End strchf script --></p>
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