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	<title>60601-2-XX &#8211; Eisner Safety Consultants</title>
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		<title>FDA Draft Guidance &#8211; Info to Support a Claim of EMC for Medical Devices</title>
		<link>https://eisnersafety.com/2015/11/03/fda-draft-guidance-on-info-to-support-a-claim-of-emc-for-medical-devices/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=fda-draft-guidance-on-info-to-support-a-claim-of-emc-for-medical-devices</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Tue, 03 Nov 2015 01:06:42 +0000</pubDate>
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		<guid isPermaLink="false">http://www.eisnersafety.com/eisnersafetycom/?p=4484</guid>

					<description><![CDATA[On 2 Nov 2015 FDA issued a draft Guidance document titled: &#8220;Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices&#8221;.  The Guidance was developed to describe the types of information that the FDA expects to be]]></description>
										<content:encoded><![CDATA[<p><a href="http://www.eisnersafety.com/wp-content/uploads/2015/11/FDA-Draft-Guidance-on-EMC-Info-support-claims.jpg"><img fetchpriority="high" decoding="async" class="alignleft size-medium wp-image-4488" src="http://www.eisnersafety.com/wp-content/uploads/2015/11/FDA-Draft-Guidance-on-EMC-Info-support-claims-232x300.jpg" alt="FDA Draft Guidance on EMC Info support claims" width="232" height="300" /></a>On 2 Nov 2015 FDA issued a <strong><a href="http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM470201.pdf?source=govdelivery&amp;utm_medium=email&amp;utm_source=govdelivery" target="_blank" rel="noopener noreferrer">draft Guidance document titled: &#8220;Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices&#8221;</a></strong>.  The Guidance was developed to describe the types of information that the FDA expects to be provided in a premarket submission to support a claim of Electromagnetic compatibility (EMC) for electrically-powered medical devices.  The FDA specifically defines, for this Guidance document, that EMC is &#8220;the ability of a device to function (a) properly in its intended electromagnetic environment, including immunity to electromagnetic disturbance (interference<sup><a id="ref1" href="#fn1">1</a></sup>), and (b) without introducing excessive electromagnetic disturbances (emissions) that might interfere with other devices.&#8221;</p>
<p>A reminder that FDA Guidances and Recognized Consensus Standards are voluntary.  But I remind my clients&#8217; that if you don&#8217;t use these voluntary documents for premarket submissions you make your life and the reviewer&#8217;s life a lot harder, typically.  So, I recommend, in most cases, to use these voluntary documents to speed up the process, in the long run.  In the short run, you may need to do more testing but if you don&#8217;t you risk the chance of your product not being accepted by the FDA.</p>
<p>The Guidance goes on to say that &#8220;the review of EMC information in a submission is based on the risk associated with EMC malfunction or degradation of the device under review, as well as the use of appropriate FDA-recognized standards or appropriate consensus standards.&#8221;  The Guidance indicates that manufacturers typically reference in premarket submissions Recognized consesnsus national (US) and international standards such as IEC 60601-1-2<sup><a id="ref2" href="#fn2">2</a></sup>) (3rd or 4th edition) Medical Electrical Equipment EMC standard, device specific Particular Standards such as IEC 60601-2-XX, and lastly they reference other consensus standards for electrically-powered deevices that include information on EMC such as ISO 14708<sup><a id="ref3" href="#fn3">3</a></sup> for active implantable medical devices.</p>
<p>The Guidance continues with a listing of details that FDA is expecting manufacturer&#8217;s provide in their premarket submissions, so the medical device EMC information is clear and consistent information for the submission, and are consistent with the specifications included in the standards, as referenced above, that are applied to the premarket submission.  The Guidance points to the FDA Recognized Consensus Standards database located at <strong><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm" target="_blank" rel="noopener noreferrer">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm</a></strong>.</p>
<p>The rest of the <strong><a href="http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM470201.pdf?source=govdelivery&amp;utm_medium=email&amp;utm_source=govdelivery" target="_blank" rel="noopener noreferrer">Guidance</a>,</strong> Section II &#8220;EMC Information&#8221;, details the list of items the FDA is expecting of the manufacturer&#8217;s for premarket submissions.  And of course the FDA leaves an opening for a broad statement at the end of the section that says: &#8220;Additional information not outlined above may be requested by FDA depending on intended use and intended use environment for specific active medical devices (e.g. implantable portions of active devices) to demonstrate the device’s claims regarding electromagnetic compatibility (EMC).&#8221;</p>
<p>If you need help with this FDA Draft Guidance or with IEC 60601-1-2 edition 3 or edition 4 or you are interested in our new <strong><a href="http://www.eisnersafety.com/products/">Eisner Safety Consultants Standards Reconnaissance Database</a></strong> please email Leo Eisner directly at <strong><a href="mailto:Le&#111;&#64;E&#105;sn&#101;rSa&#102;&#101;&#116;y.c&#111;&#109;">&#76;&#101;&#111;&#64;&#69;isn&#101;&#114;Safet&#121;.&#99;o&#109;</a></strong>, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (<strong><a title="Link to Eisner Safety Consultants Website" href="http://bit.ly/EisnerSafetyConsultants">bit.ly/EisnerSafetyConsultants</a></strong>).</p>
<hr />
<p><sup>Footnotes cited from FDA Draft Guidance Document issued on 2 Nov 2015 titled: &#8220;Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices&#8221;</sup></p>
<p><sup>1. According to International definitions, “disturbance” is the cause and “interference” is the effect. In the US, “interference” is often used interchangeably for both cause and effect though more often for the cause. <a style="vertical-align: super;" title="Jump back to footnote 1 in the text." href="#ref1"><img src="https://s.w.org/images/core/emoji/15.0.3/72x72/21a9.png" alt="↩" class="wp-smiley" style="height: 1em; max-height: 1em;" /></a></sup><br />
<sup>2. IEC 60601-1-2: 2007 [3<sup>rd</sup> Ed.]:Medical Electrical Equipment &#8211; Part 1-2: General Requirements for Safety &#8211; Collateral Standard: Electromagnetic Compatibility &#8211; Requirements and Tests, IEC 60601-1-2:2014 [4<sup>th</sup> Ed.], Medical Electrical Equipment, Part 1 2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests, AAMI/ANSI/IEC 60601-1-2: 2007 [3<sup>rd</sup> Ed.]:Medical Electrical Equipment &#8211; Part 1-2: General Requirements for Safety &#8211; Collateral Standard: Electromagnetic Compatibility &#8211; Requirements and Tests, and AAMI/ANSI/IEC 60601-1-2: 2014 [4<sup>th</sup> Ed.]:Medical Electrical Equipment &#8211; Part 1-2: General Requirements for Safety &#8211; Collateral Standard: Electromagnetic Disturbances &#8211; Requirements and Tests </sup><a style="vertical-align: super;" title="Jump back to footnote 2 in the text." href="#ref2"><img src="https://s.w.org/images/core/emoji/15.0.3/72x72/21a9.png" alt="↩" class="wp-smiley" style="height: 1em; max-height: 1em;" /></a><br />
<sup>3. ISO 14708-3 Implants for surgery &#8212; Active implantable medical devices &#8212; Part 3: Implantable neurostimulators <a style="vertical-align: super;" title="Jump back to footnote 3 in the text." href="#ref3"><img src="https://s.w.org/images/core/emoji/15.0.3/72x72/21a9.png" alt="↩" class="wp-smiley" style="height: 1em; max-height: 1em;" /></a></sup></p>
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		<title>Health Canada&#8217;s Guidance &#8211; Transition fr 2nd to 3rd ed. of IEC 60601-1 &#038; related 60601 Series of Stds</title>
		<link>https://eisnersafety.com/2012/03/23/health-canadas-guidance-transition-fr-2nd-to-3rd-ed-of-iec-60601-1-related-60601-series-of-stds/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=health-canadas-guidance-transition-fr-2nd-to-3rd-ed-of-iec-60601-1-related-60601-series-of-stds</link>
		
		<dc:creator><![CDATA[leoeisner]]></dc:creator>
		<pubDate>Fri, 23 Mar 2012 01:25:12 +0000</pubDate>
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		<guid isPermaLink="false">http://www.eisnersafety.com/eisnersafetycom/?p=2420</guid>

					<description><![CDATA[Today (22 MARCH 2012) Health Canada (HC) has issued to manufacturer&#8217;s of record (those mfr&#8217;s with a HC License to sell &#38; market product in Canada) a NOTICE titled &#8220;ADDITIONAL GUIDANCE ON TRANSITION FROM THE SECOND TO THE THIRD EDITIONS]]></description>
										<content:encoded><![CDATA[<p><span style="font-size: small; font-family: arial, helvetica, sans-serif;">Today (22 MARCH 2012) Health Canada (HC) has issued to manufacturer&#8217;s of record (those mfr&#8217;s with a HC License to sell &amp; market product in Canada) a <a title="Health Canada Notice - IEC 60601-1 2nd to 3rd edition Transition" href="http://www.eisnersafety.com/wp-content/uploads/2012/03/IEC-60601-Transition-EN-Final-22MAR12.doc" target="_blank" rel="noopener noreferrer">NOTICE titled &#8220;ADDITIONAL GUIDANCE ON TRANSITION FROM THE SECOND TO THE THIRD EDITIONS OF THE IEC 60601 FAMILY OF STANDARDS ON HEALTH CANADA’S LIST OF RECOGNIZED STANDARDS.&#8221;</a>  HC has said that this guidance document will be posted on the HC website by around 1 APRIL 2012.  This document is much simpler and more straightforward than the <a style="font-family: arial, helvetica, sans-serif;" title="NB-MED EN60601-1 3rd ed. Implementation FAQ" href="http://www.eisnersafety.com/wp-content/uploads/2012/02/Rlsed-copy-6Feb12-EN_60601-1_Implementation_NB-Med-comments_11-V1.1.pdf">Version 1.1 NB-MED EN 60601-1 3rd ed Implementation FAQ document</a>.  (See more details on the NB-MED document by going to our <a style="font-family: arial, helvetica, sans-serif;" title="Blog Post on NB-MED EN60601-1 3rd ed. Implementation FAQ" href="http://www.eisnersafety.com/nb-med-issues-v1_1-faq-on-implementation-of-en60601-1_2006-with-respect-to-mdd/">6 FEB 2012 posting</a> on the subject.) </span></p>
<p><span style="font-size: small; font-family: arial, helvetica, sans-serif;">Currently, HC recognizes both 2nd &amp; 3rd edition of IEC 60601-1.  Based on what has been published, before this notice, after June 1, 2012 HC would only accept IEC 60601-1, 3rd ed. with the related Collateral standards (i.e. IEC 60601-1-XX that are aligned with IEC 60601-1, 3rd ed.) and related Particular standards (i.e. IEC 60601-2-XX that are aligned with IEC 60601-1, 3rd ed.).  This doesn&#8217;t work well as there are some Particular standards that aren&#8217;t aligned with 3rd ed., as of yet, or that have only recently (in the last year or so) been published by IEC and so many manufacturers haven&#8217;t had the time and/or resources to understand the requirements, do any redesign work, update to their labeling, update their Risk Management File to meet IEC 60601-1, 3rd. ed with any related Collateral &amp; Particular standards, prepare the product for testing (including gathering all appropriate information [component info, etc.] to support the testing), test the product that will hopefully show that the manufacturer complies with all the requirements of the IEC 60601-1, 3rd ed. and the applicable Colateral and Particular standards.  That is unless the manufacturer has a lot of resources and are on top of the standards as they are being developed thru IEC and are starting on all this work prior to the applicable standards being published.</span></p>
<p><span style="font-size: small; font-family: arial, helvetica, sans-serif;">So, <a title="Health Canada Notice - IEC 60601-1 2nd to 3rd edition Transition" href="http://www.eisnersafety.com/wp-content/uploads/2012/03/IEC-60601-Transition-EN-Final-22MAR12.doc" target="_blank" rel="noopener noreferrer">this HC guidance document</a> sets out the following for the transition rules to be applied as of June 1, 2012:<br />
</span></p>
<p><span style="font-size: small; font-family: arial, helvetica, sans-serif;"><span id="more-2420"></span></span></p>
<ol>
<li><span style="font-size: small; font-family: arial, helvetica, sans-serif;">If there is no Particular standard that is directly applicable to the device, it should conform to IEC 60601-1:2005 and its applicable Collateral standards.</span></li>
<li><span style="font-size: small; font-family: arial, helvetica, sans-serif;">If there is a Particular standard(s) that is directly applicable to the device and the version that aligns with IEC 60601-1:2005 was published by IEC <em><strong>before</strong></em> June 1, 2009, then the device should conform to IEC 60601-1:2005 and its applicable Collateral standards in addition to the(se) Particular standard(s).</span><br />
<span style="font-size: small; font-family: arial, helvetica, sans-serif;"> NOTE: If there are multiple Particular standards that apply to the device you will want to take the latest Particular standard publication date and if that is still before June 1, 2009 use this item 2.  If it is after June 1, 2009n then use item 3.</span></li>
<li><span style="font-size: small; font-family: arial, helvetica, sans-serif;">If there is a Particular standard(s) that is directly applicable to the device and the version that aligns with IEC 60601-1: 2005 was published by IEC <em><strong>after</strong></em> June 1, 2009, a three year transition period from the date of publication by IEC will apply.  During this transition, HC will accept conformity to both editions and related Collateral standards (and both will be listed on HC’s List of Recognized Standards).  </span><br />
<span style="font-size: small; font-family: arial, helvetica, sans-serif;"> Refer to NOTE in item 2. </span></li>
</ol>
<p><span style="font-size: small; font-family: arial, helvetica, sans-serif;">These transition rules will not be applied retroactively, meaning that if you have a HC Medical Device License for your product and you used IEC 60601-1, 2nd ed. unless there is a significant change to your product that impacts the characteristics of IEC 60601 series of standards you won&#8217;t have to retest to IEC 60601, 3rd ed and submit for an Amended License Application.  HC doesn&#8217;t require meeting the &#8216;state of the art&#8217; in the same sense as is stated in the Essential Requirements of Annex I in the EU Medical Device Directive (MDD) or similarly in the Active Implantable Medical Device Directive (AIMDD) so the manufacturer only needs to submit to HC when they have a new medical device that requires a HC license or the manufacturer has to amend their HC medical device license because they have significant change(s) to the product(s) that impact characteristics addressed by the 60601 series of standards.</span></p>
<p><span style="font-size: small; font-family: arial, helvetica, sans-serif;">You still can submit for a HC Medical Device License to 2nd edition of IEC 60601-1 before June 1, 2012 but you will need to make sure it is shipped prior to June 1, 2012.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif;">Standards are voluntary per the CMDR so if you have test data to IEC 60601-1, 2nd ed. and the applicable Particular &amp; Collateral Standards you still could submit this test data to HC after the Transition Rules (items 1 &#8211; 3 above) prescribe IEC 60601-1:2005 &amp; applicable standards.  The mfr would have to provide a summary of the differences in the testing compared to IEC 60601-1:2005 and provide a rationale to demonstrate that these differences do not affect the validity of the testing in demonstrating of the device’s safety and effectiveness.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif;">The <a title="Health Canada Notice - IEC 60601-1 2nd to 3rd edition Transition" href="http://www.eisnersafety.com/wp-content/uploads/2012/03/IEC-60601-Transition-EN-Final-22MAR12.doc" target="_blank" rel="noopener noreferrer">guidance document</a> does state that HC reserves the right to require additional testing deemed necessary to demonstrate safety and effectiveness of any device. </span></p>
<p><span style="font-family: arial, helvetica, sans-serif;">A very important note is stated near the end of the document which says:</span></p>
<p style="padding-left: 30px;"><span style="font-family: arial, helvetica, sans-serif;">&#8221; A Medical Device Licence issued by Health Canada provides authorization to import or sell a medical device in Canada and is evidence that the device meets the requirements of the <em>Medical Devices Regulations</em>.  Manufacturers are reminded that Provincial or Territorial electrical safety requirements are separate and distinct from the requirements of the <em>Regulations</em>.  For further information regarding these requirements, contact the applicable regulatory authorities.  A listing of some such authorities is available at: <a href="http://www.csa.ca/cm/ca/en/community/electrical/regulators">http://www.csa.ca/cm/ca/en/community/electrical/regulators</a>.&#8221;</span></p>
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