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	<title>standards library &#8211; Eisner Safety Consultants</title>
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	<description>Regulatory &#38; Safety Experts for Global Medical Device Approvals</description>
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		<title>Great Resource &#8211; Current/Draft IEC 60601/80601 Series of Stds &#038; Test Rprts Now Available</title>
		<link>https://eisnersafety.com/2013/07/17/great-resource-currentdraft-iec-6060180601-series-of-stds-test-rprts-now-available/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=great-resource-currentdraft-iec-6060180601-series-of-stds-test-rprts-now-available</link>
		
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		<pubDate>Wed, 17 Jul 2013 06:09:24 +0000</pubDate>
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		<category><![CDATA[510(k)]]></category>
		<category><![CDATA[60601 series]]></category>
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		<category><![CDATA[60601-2-XX (Particular Stds)]]></category>
		<category><![CDATA[80601-2-X]]></category>
		<category><![CDATA[A1]]></category>
		<category><![CDATA[Amendment 1]]></category>
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		<category><![CDATA[documents library]]></category>
		<category><![CDATA[draft standards]]></category>
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		<category><![CDATA[iec 60601]]></category>
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		<category><![CDATA[IEC60601-1 3rd ed.]]></category>
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		<category><![CDATA[test report]]></category>
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					<description><![CDATA[We recently updated our website to make it easier for you to check the current IEC 60601 standards and the test report forms (TRFs) and you can check the status of draft standards and where in the process they are.   We]]></description>
										<content:encoded><![CDATA[<p><span style="font-size: small; font-family: arial, helvetica, sans-serif;">We recently updated our website to make it easier for you to check the <a href="http://www.iec.ch/dyn/www/f?p=103:105:0::::FSP_SEARCH_ORG_ID,FSP_SEARCH_AND,FSP_SEARCH_QUOTE,FSP_SEARCH_OR,FSP_SEARCH_NONE,FSP_SEARCH_DOCREF,FSP_SEARCH_STAGECODE,FSP_SEARCH_HEAD,FSP_SEARCH_PUBPROJREF,FSP_SEARCH_DATERANGE,FSP_SEARCH_DATEFROM,FSP_SEARCH_DATETO,FSP_REQUEST:,,,,,,,,60601,0,,,4" target="_blank" rel="noopener noreferrer">current IEC 60601 standards and the test report forms (TRFs)</a> and you can check the status of <a href="http://www.iec.ch/dyn/www/f?p=103:105:0::::FSP_SEARCH_ORG_ID,FSP_SEARCH_AND,FSP_SEARCH_QUOTE,FSP_SEARCH_OR,FSP_SEARCH_NONE,FSP_SEARCH_DOCREF,FSP_SEARCH_STAGECODE,FSP_SEARCH_HEAD,FSP_SEARCH_PUBPROJREF,FSP_SEARCH_DATERANGE,FSP_SEARCH_DATEFROM,FSP_SEARCH_DATETO,FSP_REQUEST:,,,,,,,,60601,0,,,6" target="_blank" rel="noopener noreferrer">draft standards</a> and where in the process they are.  </span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: small;"><span id="more-3417"></span>We also set-up pages to do the same for checking on the status of the IEC 80601 series of </span><a style="font-family: arial, helvetica, sans-serif; font-size: small;" href="http://www.iec.ch/dyn/www/f?p=103:105:0::::FSP_SEARCH_ORG_ID,FSP_SEARCH_AND,FSP_SEARCH_QUOTE,FSP_SEARCH_OR,FSP_SEARCH_NONE,FSP_SEARCH_DOCREF,FSP_SEARCH_STAGECODE,FSP_SEARCH_HEAD,FSP_SEARCH_PUBPROJREF,FSP_SEARCH_DATERANGE,FSP_SEARCH_DATEFROM,FSP_SEARCH_DATETO,FSP_REQUEST:,,,,,,,,80601,0,,,4" target="_blank" rel="noopener noreferrer">current</a><span style="font-family: arial, helvetica, sans-serif; font-size: small;"> &amp; </span><a style="font-family: arial, helvetica, sans-serif; font-size: small;" href="http://www.iec.ch/dyn/www/f?p=103:105:0::::FSP_SEARCH_ORG_ID,FSP_SEARCH_AND,FSP_SEARCH_QUOTE,FSP_SEARCH_OR,FSP_SEARCH_NONE,FSP_SEARCH_DOCREF,FSP_SEARCH_STAGECODE,FSP_SEARCH_HEAD,FSP_SEARCH_PUBPROJREF,FSP_SEARCH_DATERANGE,FSP_SEARCH_DATEFROM,FSP_SEARCH_DATETO,FSP_REQUEST:,,,,,,,,80601,0,,,6" target="_blank" rel="noopener noreferrer">draft</a><span style="font-family: arial, helvetica, sans-serif; font-size: small;"> standards, which are standards that are jointly developed between IEC &amp; ISO, and TRFs of the current 806012 series standards.  These later standards are called either IEC 80601-X-Y standards or ISO 80601-X-Y standards.  The lead organization gets their organization initials in the standards identifier.</span></p>
<p><span style="font-size: small; font-family: arial, helvetica, sans-serif;">This is a great resource to be able to stay up to date on the standards that are being developed, the updates to current standards and to ensure your standards library is up to date as required under ISO 13485 and also under most medical device regulatory national schemes.  If your organization needs help keeping track of current &amp;/or developing standards our organization can help you develop a system or we can do this work for your organization&#8217;s standards and external documents library.  Please feel free to contact us about this at <a href="mailto:&#76;&#101;o&#64;&#69;i&#115;n&#101;&#114;Safety.c&#111;&#109;" target="_blank" rel="noopener noreferrer">&#76;&#101;o&#64;E&#105;&#115;&#110;erS&#97;&#102;&#101;t&#121;&#46;co&#109;</a> or 503-244-6151.</span></p>
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