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	<title>Jul 2020 &#8211; Eisner Safety Consultants</title>
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	<link>https://eisnersafety.com</link>
	<description>Regulatory &#38; Safety Experts for Global Medical Device Approvals</description>
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	<title>Jul 2020 &#8211; Eisner Safety Consultants</title>
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		<title>New IEC 60601 Collateral Standards Published Early</title>
		<link>https://eisnersafety.com/2020/07/23/new-iec-60601-collateral-standards-published-early/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=new-iec-60601-collateral-standards-published-early</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Thu, 23 Jul 2020 22:38:02 +0000</pubDate>
				<category><![CDATA[60601 Amendments]]></category>
		<category><![CDATA[60601-1]]></category>
		<category><![CDATA[60601-1 A2]]></category>
		<category><![CDATA[60601-1 Amendment 2]]></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[60601-1-6]]></category>
		<category><![CDATA[60601-1-8]]></category>
		<category><![CDATA[60601-1-9]]></category>
		<category><![CDATA[Jul 2020]]></category>
		<category><![CDATA[iec 60601]]></category>
		<category><![CDATA[IEC 60601-1-10]]></category>
		<category><![CDATA[IEC 60601-1-11]]></category>
		<category><![CDATA[IEC 60601-1-12]]></category>
		<category><![CDATA[IEC 60601-1-6]]></category>
		<category><![CDATA[IEC 60601-1-8]]></category>
		<category><![CDATA[IEC 60601-1-9]]></category>
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					<description><![CDATA[Big News!!! IEC published ahead of schedule 6 of the 8 standards from the IEC 60601 Amendments Project. These standards are in Consolidated format meaning the latest edition plus amendments are all consolidated together. IEC notes this as a CSV.]]></description>
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<figure class="wp-block-image alignwide size-large"><img fetchpriority="high" decoding="async" width="575" height="500" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2020/07/iec_logo_500px.jpg" alt="" class="wp-image-6788" srcset="https://eisnersafety.com/wp-content/uploads/2020/07/iec_logo_500px.jpg 575w, https://eisnersafety.com/wp-content/uploads/2020/07/iec_logo_500px-300x261.jpg 300w" sizes="(max-width: 575px) 100vw, 575px" /></figure>



<p style="font-size:64px"><strong>Big News!!!</strong> </p>



<p class="has-medium-font-size"><br>IEC published ahead of schedule 6 of the 8 standards from the <a href="https://eisnersafety.com/2020/07/21/iec-60601-amendments-updates-are-coming-are-you-ready/">IEC 60601 Amendments Project</a>.  These standards are in Consolidated format meaning the latest edition plus amendments are all consolidated together. IEC notes this as a CSV. On 22 July 5 standards that published were: IEC 60601-1-6 Ed. 3.2, IEC 60601-1-9 Ed. 1.2, IEC 60601-1-10 Ed. 1.2, IEC 60601-1-11 Ed. 2.1, IEC 60601-1-12 Ed. 1.1. On 23 July 2020 IEC 60601-1-8 Ed. 2.2 was also published <a href="https://bit.ly/2Bui5mK" target="_blank" rel="noreferrer noopener" aria-label="https://bit.ly/2Bui5mK (opens in a new tab)">https://bit.ly/2Bui5mK</a>  <br>The other IEC 60601 Amendments (2 standards) still to be published include &#8212; IEC 60601-1 (ed. 3.2), IEC 60601-1-2 (Ed. 4.1) and maybe published as early as the end of this month (rumor has it but looking more likely) but it could be til Sept time range too.<br><br><a href="https://eisnersafety.com/2020/07/21/iec-60601-amendments-updates-are-coming-are-you-ready/">Join us for a webinar</a> on July 29, 9AM PT (Noon ET) for a live Zoom conversation on the IEC 60601 Amendments Updates (the 8 standards being published now &amp; soon) with Leo Eisner the “IEC 60601 Guy” of Eisner Safety Consultants and Rob Packard of Medical Device Academy.</p>



<div class="wp-block-image"><figure class="aligncenter size-large is-resized"><img decoding="async" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2020/07/IEC-Amendment-Stds-Published-22-23-July-2020--410x1024.jpg" alt="" class="wp-image-6786" width="599" height="1496" srcset="https://eisnersafety.com/wp-content/uploads/2020/07/IEC-Amendment-Stds-Published-22-23-July-2020--410x1024.jpg 410w, https://eisnersafety.com/wp-content/uploads/2020/07/IEC-Amendment-Stds-Published-22-23-July-2020--120x300.jpg 120w" sizes="(max-width: 599px) 100vw, 599px" /></figure></div>
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		<item>
		<title>IEC 60601 Amendments Updates Are Coming &#8211; Are You Ready?</title>
		<link>https://eisnersafety.com/2020/07/21/iec-60601-amendments-updates-are-coming-are-you-ready/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=iec-60601-amendments-updates-are-coming-are-you-ready</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Tue, 21 Jul 2020 06:21:35 +0000</pubDate>
				<category><![CDATA[60601 Amendments]]></category>
		<category><![CDATA[60601-1]]></category>
		<category><![CDATA[60601-1 A2]]></category>
		<category><![CDATA[60601-1 Amendment 2]]></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[60601-1-6]]></category>
		<category><![CDATA[60601-1-8]]></category>
		<category><![CDATA[60601-1-9]]></category>
		<category><![CDATA[Free Webinar]]></category>
		<category><![CDATA[Jul 2020]]></category>
		<category><![CDATA[60601 series]]></category>
		<category><![CDATA[Document Reviews]]></category>
		<category><![CDATA[EMC]]></category>
		<category><![CDATA[Gap Assessment]]></category>
		<category><![CDATA[IEC 60601-1]]></category>
		<category><![CDATA[IEC 60601-1-10]]></category>
		<category><![CDATA[IEC 60601-1-11]]></category>
		<category><![CDATA[IEC 60601-1-12]]></category>
		<category><![CDATA[IEC 60601-1-2]]></category>
		<category><![CDATA[IEC 60601-1-6]]></category>
		<category><![CDATA[IEC 60601-1-8]]></category>
		<category><![CDATA[IEC 60601-1-9]]></category>
		<category><![CDATA[MDR]]></category>
		<category><![CDATA[MDR 2017/745]]></category>
		<category><![CDATA[Risk Management File]]></category>
		<category><![CDATA[Training]]></category>
		<category><![CDATA[Usability]]></category>
		<category><![CDATA[Usability Engineering]]></category>
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					<description><![CDATA[Join us on Wednesday, July 29, 9 AM Pacific (Noon Eastern), for a live Zoom conversation with Leo Eisner the "IEC 60601 Guy" of Eisner Safety Consultants and Rob Packard of Medical Device Academy.    Learn about some of the major changes from the IEC 60601 Amendments coming during this Zoom conversation.  See the infographic to get an understanding of which standards are being updated, when the updates are estimated, how long the proposed transition period is, what are some of the concerns to consider, and what ways can we help you prepare and train your staff up for these changes.]]></description>
										<content:encoded><![CDATA[
<p style="font-size:22px"><strong>Join us on Wednesday, July 29, 9 AM Pacific (Noon Eastern), for a live Zoom conversation with Leo Eisner the &#8220;IEC 60601 Guy&#8221; of Eisner Safety Consultants and Rob Packard of Medical Device Academy</strong>. </p>



<p style="font-size:22px"><strong>To sign up for this Zoom conversation <a href="https://medicaldeviceacademy.com/iec-60601-standards-status-update/" target="_blank" rel="noreferrer noopener" aria-label=" (opens in a new tab)">click </a><a href="https://medicaldeviceacademy.com/iec-60601-standards-status-update/" target="_blank" rel="noreferrer noopener" aria-label="here (opens in a new tab)">here</a>.</strong> This Zoom Conversation is being hosted by Rob Packard of Medical Device Academy.</p>



<p class="has-medium-font-size">Learn about some of the major changes from the IEC 60601 Amendments coming during this Zoom conversation.  Read the below infographic to get an understanding of which standards are being updated, when the updates are estimated, how long the proposed transition period is, what are some of the concerns to consider, and what ways can we help you prepare and train your staff up for these changes.</p>



<figure class="wp-block-image alignwide size-large is-style-default"><img decoding="async" width="410" height="1024" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2020/07/IEC-60601-Amendments-Infographic-1-410x1024.jpg" alt="" class="wp-image-6779" srcset="https://eisnersafety.com/wp-content/uploads/2020/07/IEC-60601-Amendments-Infographic-1-410x1024.jpg 410w, https://eisnersafety.com/wp-content/uploads/2020/07/IEC-60601-Amendments-Infographic-1-600x1500.jpg 600w, https://eisnersafety.com/wp-content/uploads/2020/07/IEC-60601-Amendments-Infographic-1-120x300.jpg 120w, https://eisnersafety.com/wp-content/uploads/2020/07/IEC-60601-Amendments-Infographic-1-768x1920.jpg 768w, https://eisnersafety.com/wp-content/uploads/2020/07/IEC-60601-Amendments-Infographic-1.jpg 800w" sizes="(max-width: 410px) 100vw, 410px" /></figure>
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