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	<title>Single Fault Condition &#8211; Eisner Safety Consultants</title>
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		<title>The most valuable asset we each bring to the table isโ‰๏ธ 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 ๐Ÿ‡ฌ๐Ÿ‡ง๐ŸŽก๐Ÿฐ 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, ๐—ฏ๐—ผ๐—ผ๐—ธ ๐—ป๐—ผ๐˜„ ๐—ผ๐—ป ๐—บ๐˜† ๐˜€๐—ฝ๐—ฒ๐—ฐ๐—ถ๐—ฎ๐—น ๐—ฐ๐—ฎ๐—น๐—ฒ๐—ป๐—ฑ๐—ฎ๐—ฟ for ๐—บ๐˜† ๐—Ÿ๐—ผ๐—ป๐—ฑ๐—ผ๐—ป ๐˜ƒ๐—ถ๐˜€๐—ถ๐˜. Iโ€™d love to chat!]]></description>
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<figure class="wp-block-image size-large is-resized"><img fetchpriority="high" 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/eisnersafetycom/wp-content/uploads/2024/10/Are-You-A-MedTech-Co-1024x733.png 1024w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/10/Are-You-A-MedTech-Co-300x215.png 300w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/10/Are-You-A-MedTech-Co-768x550.png 768w, https://eisnersafety.com/eisnersafetycom/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/15.0.3/72x72/1f1ec-1f1e7.png" alt="๐Ÿ‡ฌ๐Ÿ‡ง" class="wp-smiley" style="height: 1em; max-height: 1em;" /><img src="https://s.w.org/images/core/emoji/15.0.3/72x72/1f3a1.png" alt="๐ŸŽก" class="wp-smiley" style="height: 1em; max-height: 1em;" /><img src="https://s.w.org/images/core/emoji/15.0.3/72x72/1f3f0.png" alt="๐Ÿฐ" 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, ๐—ฏ๐—ผ๐—ผ๐—ธ ๐—ป๐—ผ๐˜„ ๐—ผ๐—ป ๐—บ๐˜† <strong>๐˜€๐—ฝ๐—ฒ๐—ฐ๐—ถ๐—ฎ๐—น </strong>๐—ฐ๐—ฎ๐—น๐—ฒ๐—ป๐—ฑ๐—ฎ๐—ฟ for <a href="https://tidycal.com/the60601guy/meet-leo-in-london" target="_blank" rel="noreferrer noopener">๐—บ๐˜† ๐—Ÿ๐—ผ๐—ป๐—ฑ๐—ผ๐—ป ๐˜ƒ๐—ถ๐˜€๐—ถ๐˜</a>. Iโ€™d love to chat!<br><br>Letโ€™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>. Iโ€™m eager to learn what youโ€™re working on and how youโ€™re driving change and innovation in the industry, and how we can support you to get you to market faster.<br><br>Letโ€™s meet up! ๐—•๐—ผ๐—ผ๐—ธ ๐˜๐—ถ๐—บ๐—ฒ ๐—ผ๐—ป ๐—บ๐˜† ๐˜€๐—ฝ๐—ฒ๐—ฐ๐—ถ๐—ฎ๐—น ๐—ฐ๐—ฎ๐—น๐—ฒ๐—ป๐—ฑ๐—ฎ๐—ฟ for <a href="https://tidycal.com/the60601guy/meet-leo-in-london" target="_blank" rel="noreferrer noopener">๐—บ๐˜† ๐—Ÿ๐—ผ๐—ป๐—ฑ๐—ผ๐—ป ๐˜ƒ๐—ถ๐˜€๐—ถ๐˜</a>.<br><br></p>
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			</item>
		<item>
		<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 ๐Ÿ‡ฌ๐Ÿ‡ง๐ŸŽก๐Ÿฐ โ€” With Leo Eisner, The60601Guy, &#038; Ian Sealey

๐—ช๐—ต๐—ฎ๐˜โ€™๐˜€ ๐—ผ๐—ป ๐˜๐—ต๐—ฒ ๐—บ๐—ฒ๐—ป๐˜‚๐Ÿฐ?

โ€ข Some ๐—ณ๐˜‚๐˜๐˜‚๐—ฟ๐—ฒ ๐—ฟ๐—ฒ๐—พ๐˜‚๐—ถ๐—ฟ๐—ฒ๐—บ๐—ฒ๐—ป๐˜๐˜€ of IEC60601-1 , 4th being considered you ๐™ข๐™–๐™ฎ ๐™ฃ๐™ค๐™ฉ ๐™š๐™ญ๐™ฅ๐™š๐™˜๐™ฉ:
Gas Pathways,
Cleaning,
Disinfection,
AI/ML,
Voice Input/Output,
Adhesives for Applied Parts,
PPE,
and so much more....

โ€ข IEC60601-1 , 4th Ed.
โ€ข Applicable Standards
โ€ข Future Proofing Test Plans
]]></description>
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<figure class="wp-block-image size-full is-resized"><img 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/eisnersafetycom/wp-content/uploads/2024/10/1727694057373.jpeg 800w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/10/1727694057373-300x171.jpeg 300w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/10/1727694057373-768x439.jpeg 768w" sizes="(max-width: 800px) 100vw, 800px" /></figure>



<p>Free presentation in London <img src="https://s.w.org/images/core/emoji/15.0.3/72x72/1f1ec-1f1e7.png" alt="๐Ÿ‡ฌ๐Ÿ‡ง" class="wp-smiley" style="height: 1em; max-height: 1em;" /><img src="https://s.w.org/images/core/emoji/15.0.3/72x72/1f3a1.png" alt="๐ŸŽก" class="wp-smiley" style="height: 1em; max-height: 1em;" /><img src="https://s.w.org/images/core/emoji/15.0.3/72x72/1f3f0.png" alt="๐Ÿฐ" class="wp-smiley" style="height: 1em; max-height: 1em;" /> โ€” 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>๐—ช๐—ต๐—ฎ๐˜โ€™๐˜€ ๐—ผ๐—ป ๐˜๐—ต๐—ฒ ๐—บ๐—ฒ๐—ป๐˜‚<img src="https://s.w.org/images/core/emoji/15.0.3/72x72/1f370.png" alt="๐Ÿฐ" class="wp-smiley" style="height: 1em; max-height: 1em;" />?<br><br>โ€ข Some ๐—ณ๐˜‚๐˜๐˜‚๐—ฟ๐—ฒ ๐—ฟ๐—ฒ๐—พ๐˜‚๐—ถ๐—ฟ๐—ฒ๐—บ๐—ฒ๐—ป๐˜๐˜€ 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 ๐™ข๐™–๐™ฎ ๐™ฃ๐™ค๐™ฉ ๐™š๐™ญ๐™ฅ๐™š๐™˜๐™ฉ:<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>โ€ข <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>โ€ข Applicable Standards<br>โ€ข 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>๐—ช๐—ต๐—ฒ๐—ป, ๐˜„๐—ต๐—ฒ๐—ฟ๐—ฒ, ๐—ต๐—ผ๐˜„:<br>7 ๐˜–๐˜ค๐˜ต๐˜ฐ๐˜ฃ๐˜ฆ๐˜ณ 2024<br>๐˜Š๐˜ญ๐˜ข๐˜บ๐˜ต๐˜ฐ๐˜ฏ ๐˜๐˜ฐ๐˜ต๐˜ฆ๐˜ญ ๐˜Š๐˜ฉ๐˜ช๐˜ด๐˜ธ๐˜ช๐˜ค๐˜ฌ<br>๐˜ˆ๐˜ณ๐˜ณ๐˜ช๐˜ท๐˜ข๐˜ญ ๐˜ง๐˜ณ๐˜ฐ๐˜ฎ ๐Ÿฑ:๐Ÿฌ๐Ÿฌ๐™ฅ๐™ข<br>๐˜š๐˜ต๐˜ข๐˜ณ๐˜ต ๐Ÿฑ:๐Ÿฏ๐Ÿฌ๐™ฅ๐™ข<br>๐˜Œ๐˜ฏ๐˜ฅ ๐Ÿด:๐Ÿฐ๐Ÿฑ๐™ฅ๐™ข<br>๐™‰๐™š๐™ฉ๐™ฌ๐™ค๐™ง๐™ ๐™ž๐™ฃ๐™œ ๐™–๐™ฃ๐™™ ๐™™๐™ง๐™ž๐™ฃ๐™ ๐™จ <img src="https://s.w.org/images/core/emoji/15.0.3/72x72/1f37a.png" alt="๐Ÿบ" class="wp-smiley" style="height: 1em; max-height: 1em;" /> afterwards</p>



<p>TICK TOCK <img src="https://s.w.org/images/core/emoji/15.0.3/72x72/23f0.png" alt="โฐ" class="wp-smiley" style="height: 1em; max-height: 1em;" /> <img src="https://s.w.org/images/core/emoji/15.0.3/72x72/1f9e8.png" alt="๐Ÿงจ" 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>Join Leo Eisner In The Next Let&#8217;s Talk Risk Episode</title>
		<link>https://eisnersafety.com/2024/08/30/join-leo-eisner-in-the-next-lets-talk-risk-episode/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=join-leo-eisner-in-the-next-lets-talk-risk-episode</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Fri, 30 Aug 2024 21:34:03 +0000</pubDate>
				<category><![CDATA[14971]]></category>
		<category><![CDATA[15223-1]]></category>
		<category><![CDATA[20417]]></category>
		<category><![CDATA[60601 Series]]></category>
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		<category><![CDATA[60601-1, 4th edition]]></category>
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		<category><![CDATA[62366-1]]></category>
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		<category><![CDATA[IEC 60601-1]]></category>
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		<guid isPermaLink="false">https://eisnersafety.com/?p=7674</guid>

					<description><![CDATA[<!-- wp:paragraph -->
<p>I'm excited to be joining this <a rel="noreferrer noopener" href="https://bit.ly/LTRLeoEisnerIEC60601GuyEpisode" target="_blank">event</a> with <a href="https://www.linkedin.com/in/ACoAAABlWEUByBE2kGOdruyItiFaQQPHlM03BNY"></a><a href="https://www.linkedin.com/in/naveenagarwal/">Naveen Agarwal, Ph.D.</a> on the <a rel="noreferrer noopener" href="https://bit.ly/LTRLeoEisnerIEC60601GuyEpisode" target="_blank">next Let's Talk Risk episode</a> on Sept 6, 11:00 -11:30AM EDT our discussions I'm sure will be interesting talking about my work in the development of 4th ed of IEC 60601-1 and so much more.  </p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p>Naveen likes to talk about Guest Speaker's career's and how they got to where they are. So, it is possible this topic may come up.  You can see much of my career information by going to Leo Eisner's <a rel="noreferrer noopener" href="https://bit.ly/LeoEisnerLinkedInProfile" target="_blank">LinkedIn Profile</a>.</p>
<!-- /wp:paragraph -->]]></description>
										<content:encoded><![CDATA[
<figure class="wp-block-image size-large"><img decoding="async" width="1024" height="576" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/08/1725025449889-1024x576.png" alt="" class="wp-image-7675" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/08/1725025449889-1024x576.png 1024w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/08/1725025449889-300x169.png 300w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/08/1725025449889-768x432.png 768w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/08/1725025449889.png 1280w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>



<p>I&#8217;m excited to be joining this <a rel="noreferrer noopener" href="https://bit.ly/LTRLeoEisnerIEC60601GuyEpisode" target="_blank">event</a> with <a href="https://www.linkedin.com/in/ACoAAABlWEUByBE2kGOdruyItiFaQQPHlM03BNY"></a><a href="https://www.linkedin.com/in/naveenagarwal/" target="_blank" rel="noreferrer noopener">Naveen Agarwal, Ph.D.</a> on the <a rel="noreferrer noopener" href="https://bit.ly/LTRLeoEisnerIEC60601GuyEpisode" target="_blank">next Let&#8217;s Talk Risk episode</a> on Sept 6, 11:00 -11:30AM EDT our discussions I&#8217;m sure will be interesting talking about my work in the development of 4th ed of IEC 60601-1 and so much more.  </p>



<p>Naveen likes to talk about Guest Speaker&#8217;s career&#8217;s and how they got to where they are. So, it is possible this topic may come up.  You can see much of my career information by going to Leo Eisner&#8217;s <a rel="noreferrer noopener" href="https://bit.ly/LeoEisnerLinkedInProfile" target="_blank">LinkedIn Profile</a>.</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.&nbsp;Eisner Safety Consultants&nbsp;<a rel="noreferrer noopener" href="https://eisnersafety.com/about_us/associates/" target="_blank">team of experts</a> also provides support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs and more.&nbsp;He team includes experts on additional standards committees and we all talk to the regulators regularly. We&#8217;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 <a rel="noreferrer noopener" href="http://www.eisnersafety.com/Schedule-Call/" target="_blank">schedule a web meeting with Leo</a> or contact Leo at &#76;&#101;&#111;&#64;&#69;&#105;sn&#101;&#114;&#83;a&#102;et&#121;.&#99;o&#109; or through our <a rel="noreferrer noopener" href="https://eisnersafety.com/contact_eisner_safety/" target="_blank">contact form</a>.</p>
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		<title>Free Presentation in London Oct 7 On IEC 60601-1, 4th Ed. and Meet with Leo Eisner in London</title>
		<link>https://eisnersafety.com/2024/08/29/free-presentation-in-london-oct-7-on-iec-60601-1-4th-ed-and-more-with-leo-eisner-and-ian-sealey/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=free-presentation-in-london-oct-7-on-iec-60601-1-4th-ed-and-more-with-leo-eisner-and-ian-sealey</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Thu, 29 Aug 2024 16:47:52 +0000</pubDate>
				<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[60601-1-11]]></category>
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		<category><![CDATA[60601-1-6]]></category>
		<category><![CDATA[60601-1-8]]></category>
		<category><![CDATA[60601-1, 4th edition]]></category>
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		<category><![CDATA[IEC]]></category>
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		<category><![CDATA[60601-1 4th ed.]]></category>
		<category><![CDATA[ESCNews]]></category>
		<category><![CDATA[Medical]]></category>
		<category><![CDATA[Medical Device Industry]]></category>
		<category><![CDATA[Medical Devices]]></category>
		<guid isPermaLink="false">https://eisnersafety.com/?p=7641</guid>

					<description><![CDATA[Free Presentation in London Oct 7 On IEC 60601-1, 4th Ed. and More with Leo Eisner and Ian Sealey

<!-- wp:paragraph -->
<p><strong><span style="text-decoration: underline;">Whatโ€™s on the menu๐Ÿฐ?</span></strong></p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p>Where are we headed with 4th Ed.?<br>Structure changes; <br>Project timeline: and <br>Critical documents<br><br>L<a rel="noreferrer noopener" href="https://bit.ly/LeoEisnerLinkedInProfile" target="_blank">eo Eisner</a>, the โ€œIEC 60601 Guyโ€, of Eisner Safety Consultants will be your guide</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p>What to do in the meantime? <br>Select applicable and normative standards for testing; and<br>How to set up a solid future-proof test plan</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><a rel="noreferrer noopener" href="https://bit.ly/IanSealeyLIProfile" target="_blank">Ian Sealey</a> of Vertexian will explain it</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><a href="https://www.claytonhotels.com/chiswick/" target="_blank" rel="noreferrer noopener">Clayton Hotel Chiswick</a><br>Arrive 5:15 PM<br>Starts 5:30 PM sharp<br>Ends 8:45 PM</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p>Networking and meet for drinks afterwards</p>
<!-- /wp:paragraph -->]]></description>
										<content:encoded><![CDATA[
<figure class="wp-block-image size-full is-resized"><img loading="lazy" decoding="async" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/08/LondonMarketign-Logo-Post-26Aug2024.png" alt="" class="wp-image-7652" width="1219" height="1065" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/08/LondonMarketign-Logo-Post-26Aug2024.png 936w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/08/LondonMarketign-Logo-Post-26Aug2024-300x262.png 300w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/08/LondonMarketign-Logo-Post-26Aug2024-768x671.png 768w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/08/LondonMarketign-Logo-Post-26Aug2024-600x524.png 600w" sizes="auto, (max-width: 1219px) 100vw, 1219px" /></figure>



<h2 class="wp-block-heading"><strong><span style="text-decoration: underline;">Whatโ€™s on the menu<img src="https://s.w.org/images/core/emoji/15.0.3/72x72/1f370.png" alt="๐Ÿฐ" class="wp-smiley" style="height: 1em; max-height: 1em;" />?</span></strong></h2>



<p>Where are we headed with 4th Ed.?<br>Structure changes; <br>Project timeline: and <br>Critical documents<br><br><a href="https://bit.ly/LeoEisnerLinkedInProfile" target="_blank" rel="noreferrer noopener">Leo Eisner</a>, the โ€œIEC 60601 Guyโ€, of Eisner Safety Consultants will be your guide</p>



<p>What to do in the meantime? <br>Select applicable and normative standards for testing; and<br>How to set up a solid future-proof test plan</p>



<p><a rel="noreferrer noopener" href="https://bit.ly/IanSealeyLIProfile" target="_blank">Ian Sealey</a> of Vertexian will explain it</p>



<h2 class="wp-block-heading"><span style="text-decoration: underline;"><strong>When, Where, How:</strong></span></h2>



<p>7 October 2024</p>



<p><a rel="noreferrer noopener" href="https://www.claytonhotels.com/chiswick/" target="_blank">Clayton Hotel Chiswick</a><br>Arrive 5:00 PM<br>Starts 5:30 PM<br>Ends 8:45 PM</p>



<p>Networking and meet for drinks afterwards</p>



<p>Register by either using our <a rel="noreferrer noopener" href="https://bit.ly/ContactUsESC" target="_blank">Contact form</a> or send Leo a <a rel="noreferrer noopener" href="https://bit.ly/LeoEisnerLinkedInProfile" target="_blank">LinkedIn message via his profile</a>.  </p>



<blockquote class="wp-block-quote has-text-align-left is-style-large is-layout-flow wp-block-quote-is-layout-flow" style="font-style:normal;font-weight:700"><p><strong>If you would like to meet with Leo during the week of 7 Oct in London please contact him to schedule this rare opportunity.</strong></p></blockquote>



<h2 class="wp-block-heading"><strong><span style="text-decoration: underline;"><strong>Presenters Background:</strong></span></strong></h2>



<p><a href="https://bit.ly/LeoEisnerLinkedInProfile" target="_blank" rel="noreferrer noopener">Leo</a> is the <strong>founder and principal compliance and regulatory consultant</strong> of Eisner Safety Consultants (ESC), ESC provides the medical device industry (from SMEโ€™s to Fortune 500โ€™s) with product safety compliance &amp; regulatory support focused on:</p>



<ul class="wp-block-list"><li>design for compliance to IEC 60601 series of standards;</li><li>design reviews against applicable requirements;</li><li>identification of applicable standards, laws, regulations, directives and guidances;</li><li>labeling reviews;</li><li>support with test labs;</li><li>training</li></ul>



<p>Leoโ€™s <strong>leadership</strong> <strong>and commitment</strong> in the <strong>standards development process</strong> <strong>runs deep</strong> and <strong>over many years</strong> including his involvement in numerous IEC, ISO, and AAMI working groups, committees, and maintenance teams over the last 20 years.&nbsp; <br>His IEC 60601-1, 4<sup>th</sup> edition involvement:</p>



<ul class="wp-block-list"><li>Co-Convener of <a rel="noreferrer noopener" href="https://www.iec.ch/dyn/www/f?p=103:14:612205979307807::::FSP_ORG_ID,FSP_LANG_ID:49842,25" target="_blank">IEC/TC 62/SC 62A/WG39</a> &#8211; User interface aspects</li><li>Advisory group member of <a rel="noreferrer noopener" href="https://www.iec.ch/dyn/www/f?p=103:14:612205979307807::::FSP_ORG_ID,FSP_LANG_ID:50421,25" target="_blank">IEC/TC 62/SC 62A/AG 50</a> &#8211; IEC 60601-1 Ed. 4.0 editing &amp; leadership team</li><li>Committee member <a rel="noreferrer noopener" href="https://www.iec.ch/dyn/www/f?p=103:14:612205979307807::::FSP_ORG_ID,FSP_LANG_ID:49840,25" target="_blank">IEC/SC 62A/WG37</a> &#8211; General requirements</li></ul>



<p>To see a more detailed list go to <a href="http://linkedin.com/in/leoeisnersafetyconsultants" target="_blank" rel="noreferrer noopener">Leoโ€™s LinkedIn Profile</a>.</p>



<p><a rel="noreferrer noopener" href="https://bit.ly/IanSealeyLIProfile" target="_blank">Ian Sealey</a> is the <strong>founder of Vertexian and is a medical device regulatory and quality consultant</strong>, with over 25 yearsโ€™ experience. Vertexian provides the medtech industry with support in the following areas:</p>



<ul class="wp-block-list"><li>electromedical devices;</li><li>risk management;</li><li>pre-compliance testing;</li><li>training;</li><li>UKCA marking; and</li><li>manufacture of IEC test equipment</li></ul>



<p>He was Assistant Secretary to the Board of the Department of Health (DH), a Medical Device Specialist at the Medicines and Healthcare products Regulatory Agency (MHRA), and a principal Medical Engineer in the National Health Service (NHS). He is a director of a health-related charity and a visiting university lecturer.</p>



<pre class="wp-block-preformatted"></pre>



<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.&nbsp;Eisner Safety Consultants&nbsp;<a rel="noreferrer noopener" href="https://eisnersafety.com/about_us/associates/" target="_blank">team of experts</a> also provides support with Swiss MedDO, EU MDR, clinical evaluation assessment, NB remediation, STEDs and more.&nbsp;He team includes experts on additional standards committees and we all talk to the regulators regularly. We&#8217;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 call with Leo</a>&nbsp;or contact Leo at&nbsp;&#76;e&#111;&#64;&#69;&#105;&#115;nerSafety&#46;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>
]]></content:encoded>
					
		
		
			</item>
		<item>
		<title>Leo Eisner the &#8220;IEC 60601 Guy&#8221; co-presenter in BSI Webinar</title>
		<link>https://eisnersafety.com/2024/05/30/leo-eisner-the-iec-60601-guy-co-presenter-in-bsi-webinar/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=leo-eisner-the-iec-60601-guy-co-presenter-in-bsi-webinar</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Thu, 30 May 2024 18:54:07 +0000</pubDate>
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		<guid isPermaLink="false">https://eisnersafety.com/?p=7559</guid>

					<description><![CDATA[Webinar: Leveraging the CB Scheme: A Guide for North American Medical Device Manufacturers

When: Tuesday, June 25, 2024

Time: 11:00 a.m - 12:00 p.m. EDT

About the Event: Join BSI &#038; Leo Eisner for an insightful webinar that explores how North American medical device manufacturers can harness the power of the CB Scheme to enhance their global market access. Leo the "IEC 60601-1 Guy" will be presenting on the significant updates introduced in the latest edition of IEC 60601-1 Ed. 3.2, which will impact medical device manufacturers.]]></description>
										<content:encoded><![CDATA[
<figure class="wp-block-image size-full is-resized"><img loading="lazy" decoding="async" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/05/Modern-Operating-Room-72dpi.jpg" alt="" class="wp-image-7562" width="1214" height="812" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/05/Modern-Operating-Room-72dpi.jpg 500w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/05/Modern-Operating-Room-72dpi-300x200.jpg 300w" sizes="auto, (max-width: 1214px) 100vw, 1214px" /></figure>



<p>Webinar: Leveraging the CB Scheme: A Guide for North American Medical Device Manufacturers</p>



<p>When: <strong>Tuesday, June&nbsp;25, 2024&nbsp;&nbsp;</strong></p>



<p>Time: <strong>11:00 a.m.&nbsp;&#8211; 12:00 p.m.&nbsp;EDT&nbsp;</strong></p>



<p>About the Event: Join BSI &amp; Leo Eisner for an insightful webinar that explores how North American medical device manufacturers can harness the power of the CB Scheme to enhance their global market access. Leo the &#8220;IEC 60601-1 Guy&#8221; will present the significant updates introduced in the latest edition of IEC 60601-1 Ed. 3.2, which will impact medical device manufacturers.</p>



<p><a href="https://bit.ly/BSIWebinarIEC60601andCBScheme" target="_blank" rel="noreferrer noopener">Sign up for this webinar</a> </p>



<p>Need help with 60601 series standards (Medical Electrical Equipment) including EMC; training to 3rd or 4th edition; strategic 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 sits on many standards committees.&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 Electrical 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;&#76;&#101;o&#64;Ei&#115;ne&#114;&#83;afe&#116;&#121;.c&#111;&#109;&nbsp;or through our&nbsp;<a rel="noreferrer noopener" href="https://eisnersafety.com/contact_eisner_safety/" target="_blank">contact form</a>.</p>
]]></content:encoded>
					
		
		
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		<title>IEC 60601-1 4th Ed Initial Launch: Positive Impacts Healthcare Standardization</title>
		<link>https://eisnersafety.com/2024/05/06/iec-60601-1-4th-ed-initial-launch-positive-impacts-healthcare-standardization/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=iec-60601-1-4th-ed-initial-launch-positive-impacts-healthcare-standardization</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Mon, 06 May 2024 04:46:53 +0000</pubDate>
				<category><![CDATA[14971]]></category>
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		<guid isPermaLink="false">https://eisnersafety.com/?p=7532</guid>

					<description><![CDATA[Last week, 29 Apr โ€“ 3 May 2024, marked a significant milestone for the advancement in the world of patient safety and healthcare. The IEC TC 62/SC 62A convened its IEC 60601-1, 4th edition project kick-off meeting at AAMI in Arlington, Virginia. More than 200 experts from all corners of the globe attended in person, contributing to an inspiring and impactful week-long meeting.]]></description>
										<content:encoded><![CDATA[
<figure class="wp-block-image size-large is-resized"><img loading="lazy" decoding="async" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/Boy-bright-idea-1024x682.jpg" alt="" class="wp-image-7118" width="1216" height="810" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/Boy-bright-idea-1024x682.jpg 1024w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/Boy-bright-idea-600x400.jpg 600w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/Boy-bright-idea-300x200.jpg 300w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/Boy-bright-idea-768x512.jpg 768w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/Boy-bright-idea-1536x1024.jpg 1536w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/Boy-bright-idea.jpg 2000w" sizes="auto, (max-width: 1216px) 100vw, 1216px" /></figure>



<p>Last week, 29 Apr โ€“ 3 May 2024, marked a significant milestone for the advancement in the world of patient safety and healthcare. The IEC TC 62/<a rel="noreferrer noopener" href="https://www.iec.ch/dyn/www/f?p=103:7:524589065717236::::FSP_ORG_ID,FSP_LANG_ID:1359,25" target="_blank">SC 62A</a> convened its IEC 60601-1, 4th edition project kick-off meeting at AAMI in Arlington, Virginia. More than 200 experts from all corners of the globe attended in person, contributing to an inspiring and impactful week-long meeting.</p>



<p>The focus of this meeting was โ€œlevel settingโ€ all the parties on the development of requirements for the 4th edition of IEC 60601-1, which sets safety requirements for medical electrical equipment (also known as active medical devices). Twelve working groups (WGs) gathered to strategize their efforts, guided by the <a rel="noreferrer noopener" href="https://assets.iec.ch/public/sc62a/IEC_60601-1_Ed._4.0_Design_Specification_2023-11-03.pdf?2024050447" target="_blank">Design Specification for the 4th edition</a> and the <a rel="noreferrer noopener" href="https://assets.iec.ch/public/tc62/62_348e_Q%20(posted).pdf?2024050620" target="_blank">Architecture Specification</a>.&nbsp; The first day was set with training to help all parties get an understanding of project requirements and ask questions based on the Design Specification and the Architecture Specification. The next 3 days focused on the 12 WGs working on their strategies for the start of the project and the plans to move forward. The last day was a wrap-up and getting feedback on how to improve the process with lots of great discussion from the week.&nbsp;</p>



<p>An Advisory Group (<a href="https://www.iec.ch/dyn/www/f?p=103:14:508790831449656::::FSP_ORG_ID,FSP_LANG_ID:50421,25" target="_blank" rel="noreferrer noopener">AG 50</a>) is used to collaborate with all 12 WG co-convenors and secretaries, and IEC <a rel="noreferrer noopener" href="https://www.iec.ch/dyn/www/f?p=103:7:524589065717236::::FSP_ORG_ID,FSP_LANG_ID:1359,25" target="_blank">SC 62A</a>  officers ensuring the overall success of the project.</p>



<p>As a co-convenor for <a href="https://www.iec.ch/dyn/www/f?p=103:14:508790831449656::::FSP_ORG_ID,FSP_LANG_ID:49842,25" target="_blank" rel="noreferrer noopener">WG39</a>, which addresses User Interfaces (Including information provided by the manufacturer, Alarm Systems and Usability Engineering Process), I am honored to be part of this excursion in the development of this standard for the support of the healthcare industry for the next edition. Alongside my co-convener, Martin Stangenberg, we led discussions and consensus-building within our WG. Our WG is comprised of amazing experts.  We had over 30 experts in the room including regulators from 5 countries; test houses; usability, labeling, alarm systems, and robotics experts. We had over half of our experts from the whole WG in attendance at the meeting.  Our responsibilities include coordinating with other experts to develop basic safety and essential performance requirements related to User Interface Aspects Hazards for our part of the standard.  Each WG is working on a different set of hazards as described in the post &#8220;<a rel="noreferrer noopener" href="https://bit.ly/IEC60601-14thEdWhereDoWeStand" target="_blank">IEC 60601-1, 4th ed. &#8212; Where do we stand?</a>&#8220;.</p>



<figure class="wp-block-image size-full"><img loading="lazy" decoding="async" width="1024" height="768" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/05/16C12742-20AC-48EC-8457-658D70AD94DE_1_105_c.jpeg" alt="" class="wp-image-7533" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/05/16C12742-20AC-48EC-8457-658D70AD94DE_1_105_c.jpeg 1024w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/05/16C12742-20AC-48EC-8457-658D70AD94DE_1_105_c-300x225.jpeg 300w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/05/16C12742-20AC-48EC-8457-658D70AD94DE_1_105_c-768x576.jpeg 768w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/05/16C12742-20AC-48EC-8457-658D70AD94DE_1_105_c-600x450.jpeg 600w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /><figcaption>WG 39 Group Photo</figcaption></figure>



<p>As an expert on <a rel="noreferrer noopener" href="https://www.iec.ch/dyn/www/f?p=103:14:508790831449656::::FSP_ORG_ID,FSP_LANG_ID:49840,25" target="_blank">WG37</a>, I also spent part of the week with <a rel="noreferrer noopener" href="https://www.iec.ch/dyn/www/f?p=103:14:508790831449656::::FSP_ORG_ID,FSP_LANG_ID:49840,25" target="_blank">WG 37</a> developing requirements related to general issues concerning underlying concepts including basic safety &amp; essential performance, single fault safety, type testing.&nbsp; Correlation with processes relevant for IEC 60601-1 defined by other process standards (e.g., risk management) for IEC 60601-1, 4<sup>th</sup> ed.</p>



<p>It was great to meet all the new people and see them get involved for the first time in the standardization process as well as work with familiar faces I have worked with for many years.  It is a well-rounded group of individuals, supporting this next edition, with many different perspectives but with the mindset to provide the patient with a safe product. </p>



<figure class="wp-block-image size-full"><img loading="lazy" decoding="async" width="1024" height="768" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/05/B233E18C-5EC9-42B1-B5B8-A379CD2EC7C8_1_105_c-2.jpeg" alt="" class="wp-image-7538" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/05/B233E18C-5EC9-42B1-B5B8-A379CD2EC7C8_1_105_c-2.jpeg 1024w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/05/B233E18C-5EC9-42B1-B5B8-A379CD2EC7C8_1_105_c-2-300x225.jpeg 300w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/05/B233E18C-5EC9-42B1-B5B8-A379CD2EC7C8_1_105_c-2-768x576.jpeg 768w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/05/B233E18C-5EC9-42B1-B5B8-A379CD2EC7C8_1_105_c-2-600x450.jpeg 600w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /><figcaption>Closing Meeting</figcaption></figure>



<p>I extend my appreciation to all who have made this happen &#8212; the officers, the design specification and architecture specification teams (a long road to get here), my mentors, and all the national committee experts for coming together in this massive effort. Now the real work of the experts in the WGs beginsโ€ฆ.</p>



<p>Need help with 60601 series standards (Medical Electrical Equipment) including EMC; training to 3rd or 4th edition; strategic 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 sits on many standards committees.&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 Electrical 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;Ei&#115;&#110;e&#114;Sa&#102;e&#116;&#121;&#46;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>



<p> </p>
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		<title>IEC 60601-1, 4th Ed. &#8211; Time to Get Involved Is Now!</title>
		<link>https://eisnersafety.com/2023/12/28/iec-60601-1-4th-ed-time-to-get-involved-is-now/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=iec-60601-1-4th-ed-time-to-get-involved-is-now</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Thu, 28 Dec 2023 05:19:45 +0000</pubDate>
				<category><![CDATA[60601 Series]]></category>
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		<category><![CDATA[Dec 2023]]></category>
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		<guid isPermaLink="false">https://eisnersafety.com/?p=7426</guid>

					<description><![CDATA[We need young(er) and experienced professionals to join in the development of IEC 60601-1, 4th ed. for the future success of medical electrical equipment standards development. 

This is a follow-up to the original post of IEC 60601-1, 4th Edition Project - Where Do We Stand?  - UPDATED 30 November

This post talks about the Call for Experts and nomination of convenors and the short time periods.  Get moving if you are interested.]]></description>
										<content:encoded><![CDATA[
<blockquote class="wp-block-quote is-style-large is-layout-flow wp-block-quote-is-layout-flow"><p>We need young(er) and experienced professionals to join in the development of IEC 60601-1, 4th ed. for the future success of medical electrical equipment standards development. </p></blockquote>



<figure class="wp-block-image size-large is-resized"><img loading="lazy" decoding="async" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/Boy-bright-idea-1024x682.jpg" alt="" class="wp-image-7118" width="1220" height="813" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/Boy-bright-idea-1024x682.jpg 1024w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/Boy-bright-idea-600x400.jpg 600w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/Boy-bright-idea-300x200.jpg 300w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/Boy-bright-idea-768x512.jpg 768w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/Boy-bright-idea-1536x1024.jpg 1536w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/02/Boy-bright-idea.jpg 2000w" sizes="auto, (max-width: 1220px) 100vw, 1220px" /></figure>



<p>This is a follow-up to the original post of <a rel="noreferrer noopener" href="https://bit.ly/IEC60601-1FourthEdProjWhereDoWeStand" target="_blank">IEC 60601-1, 4th Edition Project &#8211; Where Do We Stand?  &#8211; UPDATED 30 November</a></p>



<p style="font-size:15px">As I said in a <a rel="noreferrer noopener" href="https://bit.ly/IEC60601-14thEdWhereDoWeStand" target="_blank">LinkedIn Post </a>conversation with Beat Keller &#8230;<em>we need bodies &#8230; younger bodies</em>&#8230; <mark style="background-color:rgba(0, 0, 0, 0)" class="has-inline-color has-vivid-red-color"><strong>but I would like to amend this that we also need experienced professionals</strong></mark> to get involved in the development of the 4th edition of IEC 60601-1 as our whole Technical Committee 62 (<a rel="noreferrer noopener" href="https://www.iec.ch/dyn/www/f?p=103:7:503922367964246::::FSP_ORG_ID,FSP_LANG_ID:1245,25" target="_blank">IEC TC62</a>), which is the &#8220;mothership&#8221; for all things IEC 60601-1 titled &#8220;Medical equipment, software, and systems&#8221;, is a &#8230;<em>graying society&nbsp;this group of standards writers I would say (my personal opinion).</em>  To see the conversation thread see the links below (order of conversation):</p>



<ul class="wp-block-list"><li><a href="https://bit.ly/LIcommnet1" target="_blank" rel="noreferrer noopener">LinkedIn Comment 1</a></li><li><a href="https://bit.ly/LIcomment2" target="_blank" rel="noreferrer noopener">LinkedIn Comment 2</a></li><li><a href="https://bit.ly/LICommnet3" target="_blank" rel="noreferrer noopener">LinkedIn Comment 3</a></li></ul>



<p>The Q doc 62A/1528/Q closed on 8 Dec 2023 with all the P-member National Committees (NC&#8217;s) voting positively.   A total of 35 NC&#8217;s voted and they were all positive votes, some provided feedback.  All 27 P-members &#8211; participating NC&#8217;s voted. There were 15 O-members observing NCs that didn&#8217;t vote.  </p>



<blockquote class="wp-block-quote is-style-large is-layout-flow wp-block-quote-is-layout-flow"><p>The<strong> <mark style="background-color:rgba(0, 0, 0, 0)" class="has-inline-color has-vivid-red-color">big news</mark></strong> is that for 10 of the 12 WG&#8217;s &#8230; multiple documents (were) released 22 Dec 2023 announcing a call for experts &amp; a vote on nomination of convenors.</p></blockquote>



<p class="has-black-color has-text-color">The<strong> <mark style="background-color:rgba(0, 0, 0, 0)" class="has-inline-color has-vivid-red-color">big news</mark></strong> is that for 10 of the 12 Working Groups (WG&#8217;s) noted in the <a rel="noreferrer noopener" href="https://bit.ly/Download4thEd60601DsgnSpecFinal" target="_blank">Design Specification for the 4th ed. of IEC 60601-1</a> (free download) there were multiple documents released 22 Dec 2023 announcing a call for experts and a vote on the nomination of convenors.  Below is a table with all the details.  The end of the voting period for these documents is 2 Feb 2023.  You&#8217;ll want to submit your name thru your National Committee (NC) to become an expert on a WG <strong><em><mark style="background-color:rgba(0, 0, 0, 0)" class="has-inline-color has-vivid-red-color">almost immediately</mark></em></strong> as the voting period depending on your NC could end 1 week to several weeks prior to the close date of the vote.&nbsp;So, if you want to become an expert with one of the 10 WG&#8217;s get your name in through your NC.  See the previous <a rel="noreferrer noopener" href="https://bit.ly/IEC60601-1FourthEdProjWhereDoWeStand" target="_blank">post</a>, mentioned above, for more details. If you are a NC member <strong><mark style="background-color:rgba(0, 0, 0, 0)" class="has-inline-color has-vivid-red-color"><em>please support my nomination</em></mark></strong> for WG39 User interface aspects (including all labelling &amp; info to be provided) <em><strong><mark style="background-color:rgba(0, 0, 0, 0)" class="has-inline-color has-vivid-red-color">as a Co-Convenor</mark></strong></em>.  There should be one or two more call for experts and nomination of convenors documents coming out soon (probably early 2024), with a 6 week voting period.  This is also noted in the below table.</p>



<figure class="wp-block-table"><table class="has-black-color has-pale-cyan-blue-background-color has-text-color has-background"><thead><tr><th>4th Ed. WG</th><th>WG Title</th><th>WG Task/Description</th><th>Proposed Nomination of Co-Convenors</th><th>Call for Convenors &amp; Experts Document</th></tr></thead><tbody><tr><td><a href="https://bit.ly/WG_37" target="_blank" rel="noreferrer noopener">WG 37</a></td><td>General requirements</td><td>Develop requirements related to general issues with respect to underlying concepts (e.g., basic safety/essential performance, single fault safety, type testing), correlation with processes relevant for the IEC 60601-1 defined by other process standards (e.g., risk management) for the 4th edition of IEC 60601-1.</td><td>Mr. Richard Scott (UK) &amp;<br>Mr. Jos Van Vroonhoven (NL)</td><td>62A/1544/Q</td></tr><tr><td><a href="https://bit.ly/WG_38" target="_blank" rel="noreferrer noopener">WG 38</a></td><td>Physical environment hazards</td><td>Develop requirements to address safety issues due to specific environmental conditions, including power supply for the 4<sup>th</sup>&nbsp;edition of IEC 60601-1.</td><td>Mr. Michel Brossoit (CA) &amp;<br>Mr. Brodie Pedersen (US)</td><td>62A/1545/Q</td></tr><tr><td><a href="https://bit.ly/WG_39" target="_blank" rel="noreferrer noopener">WG 39</a></td><td>User interface aspects (including all labelling and information to be provided)</td><td>Develop requirements to address safety issues related to user interfaces including marking, indications, accompanying information, alarm systems and usability for the 4th edition of IEC 60601-1.</td><td>Mr. Leo Eisner (US) &amp;<br>Mr. Martin Stangenberg (DE)</td><td>62A/1549/Q</td></tr><tr><td><a href="https://bit.ly/WG_40" target="_blank" rel="noreferrer noopener">WG 40</a></td><td>Materials hazards</td><td>Develop requirements to address safety issues related to interferences of materials of MEE/MES with users, patients, used substances, including cleaning, disinfection, sterilization for the 4th edition of IEC 60601-1.</td><td>No co-convenors nominated.</td><td>62A/1541/AC</td></tr><tr><td><a href="https://bit.ly/WG_41" target="_blank" rel="noreferrer noopener">WG 41</a></td><td>PEMS (e.g., SaMD (Software as a medical device), SiMD (Software in a medical device), firmware, software, apps, OS, drivers) related hazards</td><td>Develop requirements to address hazards related to software driven functionality of MEE/MES for the 4th edition of IEC 60601-1.</td><td>Mr. Jullian Goldman (US) &amp;<br>Ms. Patty Krantz-Zuppan (US)</td><td>62A/1550/Q</td></tr><tr><td><a href="https://bit.ly/WG_42" target="_blank" rel="noreferrer noopener">WG 42</a></td><td>Electrical hazards</td><td>Develop requirements to address safety issues related to electricity for the 4th edition of IEC 60601-1.</td><td>Mr. Alex Grob (US) &amp;<br>Mr. Martin Schneeberg (DE)</td><td>62A/1547/Q</td></tr><tr><td><a href="https://bit.ly/WG_43" target="_blank" rel="noreferrer noopener">WG 43</a></td><td>Mechanical hazards</td><td>Develop requirements to address safety issues related to mechanics, including acoustic and pneumatic energy and vibration energy for the 4th edition of IEC 60601-1.</td><td>No Call for experts or nomination of co-convenors sent yet.&nbsp; Expect by sometime early Jan 2024.</td><td>Not issued yet</td></tr><tr><td><a href="https://bit.ly/WG_44" target="_blank" rel="noreferrer noopener">WG 44</a></td><td>Thermal and fire hazards</td><td>Develop requirements to address safety issues related to thermal effects caused by MEE/MES and to fire in MEE or MES for the 4th edition of IEC 60601-1.</td><td>Mr. Andreas Nilsson (NO) &amp;<br>Mr. Ayub Yancheshmeh (CA)</td><td>62A/1548/Q</td></tr><tr><td><a href="https://bit.ly/WG_45" target="_blank" rel="noreferrer noopener">WG 45</a></td><td>Optical radiation (visible, UV and IR) hazards</td><td>Develop requirements to address safety issues related to (visible radiation, UV and or IR) for the 4th edition of IEC 60601-1.</td><td>Mr. Winn Henderson (US) &amp;<br>Ms. Yaqing Liu (US)</td><td>62A/1546/Q</td></tr><tr><td><a href="https://bit.ly/WG_46" target="_blank" rel="noreferrer noopener">WG 46</a></td><td>Ionizing radiation hazards</td><td>Develop requirements to address safety issues related to ionizing radiation for the 4th edition of IEC 60601-1.</td><td>No Call for experts or nomination of co-convenors sent yet.&nbsp; Expect by sometime early Jan 2024.</td><td>Not issued yet</td></tr><tr><td><a href="https://bit.ly/WG_47" target="_blank" rel="noreferrer noopener">WG 47</a></td><td>Electromagnetic exposure hazards (not optical or ionizing but including SAR)</td><td>Develop requirements to address safety issues related to radiation (not optical or ionizing radiation hazards but including SAR) for the 4th&nbsp;edition of IEC 60601-1.</td><td>No co-convenors nominated.</td><td>62A/1541/AC</td></tr><tr><td><a href="https://bit.ly/WG_48" target="_blank" rel="noreferrer noopener">WG 48</a></td><td>Electromagnetic disturbances hazards (including coexistence) hazards</td><td>Develop requirements to address safety issues related to electromagnetic emissions or electromagnetic immunity, (including wireless coexistence) for the 4th edition of IEC 60601-1.</td><td>Mr. Harald Buchwald (DE) &amp;<br>Mr. Curt Sponberg (US)</td><td>62A/1551/Q</td></tr></tbody></table></figure>



<p>Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic 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 sits on many standards committees.&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 Electrical 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;o&#64;E&#105;sne&#114;&#83;afet&#121;.&#99;&#111;&#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>Interpretation Sheet on Essential Performance &#038; Single Fault Condition for IEC 60601-1:2005+A1:2012</title>
		<link>https://eisnersafety.com/2021/03/15/interpretation-sheet-on-essential-performance-single-fault-condition-for-iec-60601-12005a12012/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=interpretation-sheet-on-essential-performance-single-fault-condition-for-iec-60601-12005a12012</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Mon, 15 Mar 2021 04:02:28 +0000</pubDate>
				<category><![CDATA[60601 Series]]></category>
		<category><![CDATA[60601-1]]></category>
		<category><![CDATA[60601-1 A2]]></category>
		<category><![CDATA[60601-1-2]]></category>
		<category><![CDATA[60601-1-2, 4th ed.]]></category>
		<category><![CDATA[Essential Performance]]></category>
		<category><![CDATA[IEC]]></category>
		<category><![CDATA[Mar 2021]]></category>
		<category><![CDATA[Single Fault Condition]]></category>
		<category><![CDATA[Standards Development]]></category>
		<category><![CDATA[60601]]></category>
		<category><![CDATA[60601 series]]></category>
		<category><![CDATA[60601-1 3rd ed.]]></category>
		<category><![CDATA[60601-1 3rd ed. Amendment 1]]></category>
		<category><![CDATA[60601-2-XX (Particular Stds)]]></category>
		<category><![CDATA[Collateral Standards]]></category>
		<category><![CDATA[Essential Performnance]]></category>
		<category><![CDATA[IEC60601-1 3rd ed.]]></category>
		<category><![CDATA[Interpretation Sheet]]></category>
		<category><![CDATA[Particular Standards]]></category>
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					<description><![CDATA[Essential Performance (EP) initially came into the IEC 60601 series of standards when the 3rd edition of IEC 60601-1:2005 was published.  The definition was quite confusing and many manufacturers, regulators and test houses had a hard time with it and how to apply it properly.  In 3rd edition (2005) + amendment 1 (2012) some clarification came into play which made it easier to understand but there is still a fair amount of confusion.  ]]></description>
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<figure class="wp-block-image size-large"><img loading="lazy" decoding="async" width="1000" height="667" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2021/03/Hand-holding-an-insuline-pump.jpg" alt="" class="wp-image-6875" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2021/03/Hand-holding-an-insuline-pump.jpg 1000w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2021/03/Hand-holding-an-insuline-pump-600x400.jpg 600w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2021/03/Hand-holding-an-insuline-pump-300x200.jpg 300w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2021/03/Hand-holding-an-insuline-pump-768x512.jpg 768w" sizes="auto, (max-width: 1000px) 100vw, 1000px" /></figure>



<p class="has-medium-font-size">Essential Performance (EP) initially came into the IEC 60601 series of standards when the 3rd edition of IEC 60601-1:2005 was published.  The definition was quite confusing and many manufacturers, regulators and test houses had a hard time with it and how to apply it properly.  In 3rd edition (2005) + amendment 1 (2012) some clarification came into play which made it easier to understand but there is still a fair amount of confusion.  </p>



<p class="has-medium-font-size">About 2 years ago a test lab did some research and brought up the issue that a significant number of test reports (a high percentage of them) of critical devices didn&#8217;t define essential performance appropriately to the Sub Committee SC62A on &#8220;Common aspects of electrical equipment used in medical practice&#8221;.  From this research, an ad-hoc group was formed to come up with a solution.  </p>



<p class="has-medium-font-size">The initial solution was to come up with this Interpretation Sheet (ISH) to explain Essential Performance (clause 4.3 which is not as clear as the ISH but for those that know the standard have been doing it this way for years) and Single Fault Condition (SFC) (clause 4.7) that is related to Essential Performance.   Access a copy thru the IEC website if you know where to find it or the easier route is to download it <strong><a rel="noreferrer noopener" aria-label="here (opens in a new tab)" href="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2021/03/ISH-1-IEC-60601-1-ed-3.1-EP-SFC.pdf" target="_blank">here</a></strong>.  Note, this document doesn&#8217;t cover all the issues about Essential Performance as it is a complex situation but it does help explain some of the issues involved.  The ISH per IEC requirements is limited to 2 pages of written text of explanation allowed by IEC requirements and so has a constraint on how detailed it can get.  It is good for explaining the concept for the General standard IEC 60601-1, edition 3.1 which covers also ed. 3.2 (no change there).  The General standard concept is based on limits but for some Particular standards (IEC 60601-2-XX or IEC/ISO80601-2-XX), limits don&#8217;t work for all products applicable (not all display-based product that the clinical function is based on the display function for example).  But the ISH doesn&#8217;t really get into the details of how EP deals with Particular standards much (covered a little in the ISH) so that really needs to be looked at further still.</p>



<p class="has-medium-font-size">So, what is the next step?  This ad-hoc group with the help of some additional people in the standards development community (I hope to be in this group) will start in the next couple of months (probably after the IEC TC 62 General meeting of April 12 &#8211; 23, 2021) to work on a guidance document to provide further guidance on EP as I still find that many regulators around the world, test labs, and manufacturers all have varying understanding of what EP &amp; SFC are.  </p>



<p class="has-medium-font-size">This varying understanding has a huge impact on projects as if say the test lab asks the manufacturer what their EP is, the manufacturer may say I don&#8217;t have any, the test lab will check the test report form (TRF) as none.  When gets to say FDA the first thing FDA would ask is why is there no EP on the device?  If found out there is EP the client would have to retest under the applicable IEC 60601-1, Particular (60601-2-XX/80601-2-XX) and Collateral Standards (60601-1-XX) + the EM Disturbances standard IEC 60601-1-2 which would add cost and time delays to a project. </p>



<p class="has-medium-font-size">Need help with Essential Performance.  Feel free to schedule a call with Leo www.EisnerSafety.com/Schedule-Call/ or contact Leo at&nbsp;&#76;eo&#64;&#69;&#105;sner&#83;&#97;&#102;&#101;&#116;&#121;.&#99;&#111;m.</p>
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