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<?xml version="1.0" encoding="UTF-8"?><rss version="2.0" xmlns:content="http://purl.org/rss/1.0/modules/content/" xmlns:wfw="http://wellformedweb.org/CommentAPI/" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:atom="http://www.w3.org/2005/Atom" xmlns:sy="http://purl.org/rss/1.0/modules/syndication/" xmlns:slash="http://purl.org/rss/1.0/modules/slash/" > <channel> <title>Eisner Safety Consultants</title> <atom:link href="https://eisnersafety.com/feed/" rel="self" type="application/rss+xml" /> <link>https://eisnersafety.com</link> <description>Just another WordPress site</description> <lastBuildDate>Mon, 06 May 2024 04:58:49 +0000</lastBuildDate> <language>en-US</language> <sy:updatePeriod> hourly </sy:updatePeriod> <sy:updateFrequency> 1 </sy:updateFrequency> <generator>https://wordpress.org/?v=5.9.9</generator> <item> <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&utm_medium=rss&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> <category><![CDATA[15223-1]]></category> <category><![CDATA[20417]]></category> <category><![CDATA[60601 Series]]></category> <category><![CDATA[60601-1]]></category> <category><![CDATA[60601-1-10]]></category> <category><![CDATA[60601-1-11]]></category> <category><![CDATA[60601-1-12]]></category> <category><![CDATA[60601-1-6]]></category> <category><![CDATA[60601-1-8]]></category> <category><![CDATA[60601-1, 4th edition]]></category> <category><![CDATA[62304]]></category> <category><![CDATA[62366]]></category> <category><![CDATA[62366-1]]></category> <category><![CDATA[AAMI]]></category> <category><![CDATA[Alarm Systems]]></category> <category><![CDATA[Architecture Specification]]></category> <category><![CDATA[Coexistence]]></category> <category><![CDATA[Cybersecurity]]></category> <category><![CDATA[Design Specification]]></category> <category><![CDATA[Device]]></category> <category><![CDATA[Draft Guidance]]></category> <category><![CDATA[EMC]]></category> <category><![CDATA[Essential Performance]]></category> <category><![CDATA[EU]]></category> <category><![CDATA[FDA]]></category> <category><![CDATA[Guidance Documents]]></category> <category><![CDATA[Hazards]]></category> <category><![CDATA[IEC]]></category> <category><![CDATA[IEC 60601-1]]></category> <category><![CDATA[IMDRF]]></category> <category><![CDATA[Information provided by the manufacturer]]></category> <category><![CDATA[Interpretation Sheet 1]]></category> <category><![CDATA[Ionizing radiation]]></category> <category><![CDATA[ISH1]]></category> <category><![CDATA[ISO]]></category> <category><![CDATA[ISO 15223-1]]></category> <category><![CDATA[ISO 20417]]></category> <category><![CDATA[Labeling]]></category> <category><![CDATA[Machine Learning]]></category> <category><![CDATA[Marking]]></category> <category><![CDATA[May 2024]]></category> <category><![CDATA[MDD]]></category> <category><![CDATA[MDR]]></category> <category><![CDATA[Mechanical]]></category> <category><![CDATA[Medical Device]]></category> <category><![CDATA[Medical Device Regulation]]></category> <category><![CDATA[MHRA]]></category> <category><![CDATA[Notified Bodies]]></category> <category><![CDATA[PEMS]]></category> <category><![CDATA[Physiologic Closed-Loop Control]]></category> <category><![CDATA[Regulation]]></category> <category><![CDATA[Regulatory Affairs]]></category> <category><![CDATA[Risk Management]]></category> <category><![CDATA[SaMD]]></category> <category><![CDATA[SiMD]]></category> <category><![CDATA[Single Fault Condition]]></category> <category><![CDATA[Software]]></category> <category><![CDATA[Standards]]></category> <category><![CDATA[Standards Development]]></category> <category><![CDATA[State of the Art]]></category> <category><![CDATA[UDI]]></category> <category><![CDATA[Usability]]></category> <category><![CDATA[Usability Engineering Process]]></category> <category><![CDATA[User Interfaces]]></category> <guid isPermaLink="false">https://eisnersafety.com/?p=7532</guid> <description><![CDATA[Last week, 29 Apr – 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 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="(max-width: 1216px) 100vw, 1216px" /></figure> <p>Last week, 29 Apr – 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 “level setting” 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>. 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. </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 “<a rel="noreferrer noopener" href="https://bit.ly/IEC60601-14thEdWhereDoWeStand" target="_blank">IEC 60601-1, 4th ed. — Where do we stand?</a>“.</p> <figure class="wp-block-image size-full"><img loading="lazy" 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="(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 & essential performance, single fault safety, type testing. 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" 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="(max-width: 1024px) 100vw, 1024px" /><figcaption>Closing Meeting</figcaption></figure> <p>I extend my appreciation to all who have made this happen — 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 begins….</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, & other country regulatory requirements & standards, laws, directives, and more. <a rel="noreferrer noopener" href="https://eisnersafety.com/about_us/associates/" target="_blank">Leo Eisner</a> is an expert on standards development and sits on many standards committees. 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 & 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 call with Leo</a> or contact Leo at Leo@EisnerSafety.com or through our <a rel="noreferrer noopener" href="https://eisnersafety.com/contact_eisner_safety/" target="_blank">contact form</a>.</p> <p> </p>]]></content:encoded> </item> <item> <title>Standards: Explosion and Challenges Maintaining/Updating</title> <link>https://eisnersafety.com/2024/04/18/standards-explosion-and-challenges-maintaining-updating%ef%bf%bc/?utm_source=rss&utm_medium=rss&utm_campaign=standards-explosion-and-challenges-maintaining-updating%25ef%25bf%25bc</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Thu, 18 Apr 2024 03:09:22 +0000</pubDate> <category><![CDATA[13485]]></category> <category><![CDATA[14971]]></category> <category><![CDATA[15223-1]]></category> <category><![CDATA[20417]]></category> <category><![CDATA[60601 Series]]></category> <category><![CDATA[60601-1]]></category> <category><![CDATA[60601-1, 4th edition]]></category> <category><![CDATA[62304]]></category> <category><![CDATA[62366]]></category> <category><![CDATA[62366-1]]></category> <category><![CDATA[Active Implants]]></category> <category><![CDATA[AI]]></category> <category><![CDATA[Apr 2024]]></category> <category><![CDATA[Auditing]]></category> <category><![CDATA[Combination Device]]></category> <category><![CDATA[Combination Product]]></category> <category><![CDATA[Cybersecurity]]></category> <category><![CDATA[Device]]></category> <category><![CDATA[Essential Performance]]></category> <category><![CDATA[EU]]></category> <category><![CDATA[FDA]]></category> <category><![CDATA[Guidance Documents]]></category> <category><![CDATA[Harmonized Standards]]></category> <category><![CDATA[IEC]]></category> <category><![CDATA[IEC 60601-1]]></category> <category><![CDATA[ISO 13485]]></category> <category><![CDATA[ISO 15223-1]]></category> <category><![CDATA[ISO 20417]]></category> <category><![CDATA[IVD]]></category> <category><![CDATA[Machine Learning]]></category> <category><![CDATA[MDD]]></category> <category><![CDATA[MDR]]></category> <category><![CDATA[Medical Device]]></category> <category><![CDATA[Medical Device Regulation]]></category> <category><![CDATA[Notified Bodies]]></category> <category><![CDATA[Quality Assurance]]></category> <category><![CDATA[Recognized Consensus Standards]]></category> <category><![CDATA[Regulation]]></category> <category><![CDATA[Regulatory Affairs]]></category> <category><![CDATA[Risk Management]]></category> <category><![CDATA[SaMD]]></category> <category><![CDATA[Software]]></category> <category><![CDATA[Standards]]></category> <category><![CDATA[Standards Development]]></category> <category><![CDATA[US]]></category> <guid isPermaLink="false">https://eisnersafety.com/?p=7518</guid> <description><![CDATA[Standards: Explosion and Challenges Maintaining/Updating My conversation with Subhi Saadeh of Combinate Podcast was very intriguing and he does a fun podcast. Check out the Combinate podcast #132 as I, Leo Eisner, talk about Standards.]]></description> <content:encoded><![CDATA[<figure class="wp-block-image size-large"><a href="https://bit.ly/LetsCombinatePodcastonStandardswithLeoEisner" target="_blank" rel="noopener"><img loading="lazy" width="1015" height="1024" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-1015x1024.png" alt="" class="wp-image-7520" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-1015x1024.png 1015w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-297x300.png 297w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-150x150.png 150w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-768x775.png 768w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-45x45.png 45w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-600x606.png 600w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM-100x100.png 100w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/Screenshot-2024-04-17-at-4.48.37 PM.png 1300w" sizes="(max-width: 1015px) 100vw, 1015px" /></a></figure> <p> My conversation with <a href="https://www.linkedin.com/in/ACoAAASYqiIBwAoA_1K9vXX-snW26Y7H7REb9kk"></a><a href="https://www.linkedin.com/in/subhi-saadeh-1169aa21/" target="_blank" rel="noreferrer noopener">Subhi Saadeh</a> of <a href="https://www.linkedin.com/company/combinate-podcast/" target="_blank" rel="noreferrer noopener">Combinate Podcast</a> was very intriguing and he does a fun podcast. Check out the <a rel="noreferrer noopener" href="https://bit.ly/LetsCombinatePodcastonStandardswithLeoEisner" data-type="URL" data-id="https://bit.ly/LetsCombinatePodcastonStandardswithLeoEisner" target="_blank">podcast</a> as I talk about Standards.</p> <p>We covered a lot of ground in a short time (it flew by for me – I’m sure it will for you too) and if you compare him to an architect he would build something similar to the Louvre Museum with its very unique but beautiful peaks and valleys with surprises around every corner. The Lourve is recent in my mind as I was at an <a rel="noreferrer noopener" href="https://bit.ly/ParisISOTC210WG2WG3" data-type="URL" data-id="https://bit.ly/ParisISOTC210WG2WG3" target="_blank">ISO TC 210 standards meeting in Paris Dec ’23</a> and visited the Louvre. One of my many travels around the world in support of standards development over the last 20 years.</p> <figure class="wp-block-image size-large"><img loading="lazy" width="768" height="1024" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/IMG_1092-768x1024.jpg" alt="" class="wp-image-7522" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/IMG_1092-768x1024.jpg 768w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/IMG_1092-225x300.jpg 225w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/IMG_1092-1152x1536.jpg 1152w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/IMG_1092-1536x2048.jpg 1536w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/IMG_1092-600x800.jpg 600w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/04/IMG_1092-scaled.jpg 1920w" sizes="(max-width: 768px) 100vw, 768px" /></figure> <p>He really does his research. He found my old reconnaissance standards database I was planning to publish but never did. That was a total surprise. </p> <p>We dive right into standards in many ways that you may not have thought of before in <a rel="noreferrer noopener" href="https://bit.ly/LetsCombinatePodcastonStandardswithLeoEisner" data-type="URL" data-id="https://bit.ly/LetsCombinatePodcastonStandardswithLeoEisner" target="_blank">Podcast</a> :<br>☞ The explosion of standards vs no standards (or chaos of no standards)<br>☞ The impact of standards on medical device development<br>☞ Standards and Regulatory Challenges<br>☞ My Notified Body Auditing Experience, Authorization Process, Product Reviewer<br>☞ The Challenges of Maintaining and Updating Standards</p> <p>Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic compliance planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. <a rel="noreferrer noopener" href="https://eisnersafety.com/about_us/associates/" target="_blank">Leo Eisner</a> is an expert on standards development and <a href="https://www.linkedin.com/in/leoeisnersafetyconsultants" target="_blank" rel="noreferrer noopener">sits on many standards committees</a>. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs. </p> <p>We work with many test labs for Medical Safety & 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 call with Leo</a> or contact Leo at Leo@EisnerSafety.com or through our <a rel="noreferrer noopener" href="https://eisnersafety.com/contact_eisner_safety/" target="_blank">contact form</a>.</p>]]></content:encoded> </item> <item> <title>Stop Waiting to Join New WGs for IEC 60601-1, 4th ed.</title> <link>https://eisnersafety.com/2024/01/14/stop-waiting-join-new-wgs-iec-60601-1-4th-ed/?utm_source=rss&utm_medium=rss&utm_campaign=stop-waiting-join-new-wgs-iec-60601-1-4th-ed</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Sun, 14 Jan 2024 21:29:36 +0000</pubDate> <category><![CDATA[60601 Series]]></category> <category><![CDATA[60601-1]]></category> <category><![CDATA[60601-1, 4th edition]]></category> <category><![CDATA[AAMI]]></category> <category><![CDATA[IEC]]></category> <category><![CDATA[IEC 60601-1]]></category> <category><![CDATA[Ionizing radiation]]></category> <category><![CDATA[Jan 2024]]></category> <category><![CDATA[Mechanical]]></category> <category><![CDATA[Medical Device]]></category> <category><![CDATA[Standards]]></category> <category><![CDATA[Standards Development]]></category> <guid isPermaLink="false">https://eisnersafety.com/?p=7493</guid> <description><![CDATA[This is a follow-up to IEC 60601-1, 4th Ed. – Time to Get Involved Is Now! and IEC 60601-1, 4th Edition Project – Where Do We Stand? – UPDATED 30 Nov 2023. 3 Weeks after the initial Nomination of experts]]></description> <content:encoded><![CDATA[<div class="wp-block-image"><figure class="aligncenter size-large"><img loading="lazy" width="853" height="1024" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/01/Stop-Waiting-XLrg-853x1024.jpg" alt="" class="wp-image-7495" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/01/Stop-Waiting-XLrg-853x1024.jpg 853w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/01/Stop-Waiting-XLrg-scaled-600x720.jpg 600w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/01/Stop-Waiting-XLrg-250x300.jpg 250w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/01/Stop-Waiting-XLrg-768x922.jpg 768w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/01/Stop-Waiting-XLrg-1280x1536.jpg 1280w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2024/01/Stop-Waiting-XLrg-1707x2048.jpg 1707w" sizes="(max-width: 853px) 100vw, 853px" /><figcaption>Stop waiting time – take action and join a Working Group for IEC 60601-1, 4th ed. project</figcaption></figure></div> <p>This is a follow-up to <a rel="noreferrer noopener" href="https://bit.ly/IEC60601-1_4thEdTimeToGetInvolvedIsNow" target="_blank">IEC 60601-1, 4th Ed. – Time to Get Involved Is Now!</a> and <a rel="noreferrer noopener" href="https://bit.ly/IEC60601-1FourthEdProjWhereDoWeStand" target="_blank">IEC 60601-1, 4th Edition Project – Where Do We Stand? – UPDATED 30 Nov 2023</a>. 3 Weeks after the initial Nomination of experts and Co-conveners went out on 22 Dec 2023, the last 2 Working Group (WG) Q documents were released on 12 Jan 2024 for WG43 Mechanical Hazards and WG46 Ionizing Hazards. For WG43 & WG46 the Q document nomination period ends on 23 Feb 2024.</p> <p>Having new people (young and old alike) interested in joining all the new WGs (12 in total) who have the technical experience and expertise for the WG subject matter (not all subjects within a WG but some and each National Committee (NC) decides on its selection process and criteria). </p> <p>Some NCs may accept experts after the applicable Q documents close (no guarantee which countries) but if you wait too long you won’t be able to join the kickoff meeting for the IEC 60601-1, 4<sup>th</sup> ed. project. The meeting will be held at AAMI in the US (Virginia) the week of 29 April – 3 May 2024. This is a closed meeting – you have to be nominated as an NC expert for a specific WG. </p> <blockquote class="wp-block-quote is-style-large has-medium-font-size" style="font-style:normal;font-weight:600"><p><strong>So, stop waiting to become an expert on 1 of the 12 WGs for IEC 60601-1, 4th ed. Now is the time to take action & contact your National Committee to get nominated as an expert</strong>.</p></blockquote> <p>I have updated the table in the <a rel="noreferrer noopener" href="https://bit.ly/IEC60601-1_4thEdTimeToGetInvolvedIsNow" target="_blank">IEC 60601-1, 4th Ed. – Time to Get Involved Is Now!</a> post to include the two new WG Q documents (WG43 & WG46) just released so all in one place – below. The two previous posts discuss nominations of experts and considerations of being an expert. Please review before putting your name in for nomination.</p> <figure class="wp-block-table is-style-stripes"><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 & 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) &<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> edition of IEC 60601-1.</td><td>Mr. Michel Brossoit (CA) &<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) &<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) &<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) &<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>Ms. Pamela Gwynn (US) & <br>Mr. Roland Hans (DE) </td><td>62A/1552/Q</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) &<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) &<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>Mr. Jan Jans (NL) &<br>Mr. Damien Kopyto (DE)</td><td>62A/1554/Q</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 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) &<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 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, & other country regulatory requirements & standards, laws, directives, and more. <a rel="noreferrer noopener" href="https://eisnersafety.com/about_us/associates/" target="_blank">Leo Eisner</a> is an expert on standards development and <a href="https://www.linkedin.com/in/leoeisnersafetyconsultants" target="_blank" rel="noreferrer noopener">sits on many standards committees</a>. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs. </p> <p>We work with many test labs for Medical Safety & 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 call with Leo</a> or contact Leo at Leo@EisnerSafety.com or through our <a rel="noreferrer noopener" href="https://eisnersafety.com/contact_eisner_safety/" target="_blank">contact form</a>.</p>]]></content:encoded> </item> <item> <title>IEC 60601-1, 4th Ed. – 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&utm_medium=rss&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> <category><![CDATA[60601-1]]></category> <category><![CDATA[AAMI]]></category> <category><![CDATA[Architecture Specification]]></category> <category><![CDATA[Coexistence]]></category> <category><![CDATA[Cybersecurity]]></category> <category><![CDATA[Dec 2023]]></category> <category><![CDATA[Design Specification]]></category> <category><![CDATA[Device]]></category> <category><![CDATA[EMC]]></category> <category><![CDATA[Hazards]]></category> <category><![CDATA[IEC]]></category> <category><![CDATA[IEC 60601-1]]></category> <category><![CDATA[Labeling]]></category> <category><![CDATA[Medical Device]]></category> <category><![CDATA[PEMS]]></category> <category><![CDATA[SaMD]]></category> <category><![CDATA[SiMD]]></category> <category><![CDATA[Single Fault Condition]]></category> <category><![CDATA[Software]]></category> <category><![CDATA[Standards]]></category> <category><![CDATA[Standards Development]]></category> <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"><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" 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="(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 – Where Do We Stand? – 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 …<em>we need bodies … younger bodies</em>… <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 “mothership” for all things IEC 60601-1 titled “Medical equipment, software, and systems”, is a …<em>graying society 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><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’s) voting positively. A total of 35 NC’s voted and they were all positive votes, some provided feedback. All 27 P-members – participating NC’s voted. There were 15 O-members observing NCs that didn’t vote. </p> <blockquote class="wp-block-quote is-style-large"><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’s … multiple documents (were) released 22 Dec 2023 announcing a call for experts & 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’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’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. So, if you want to become an expert with one of the 10 WG’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 & 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 & 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) &<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> edition of IEC 60601-1.</td><td>Mr. Michel Brossoit (CA) &<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) &<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) &<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) &<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. 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) &<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) &<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. 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 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) &<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, & other country regulatory requirements & standards, laws, directives, and more. <a rel="noreferrer noopener" href="https://eisnersafety.com/about_us/associates/" target="_blank">Leo Eisner</a> is an expert on standards development and sits on many standards committees. 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 & 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 call with Leo</a> or contact Leo at Leo@EisnerSafety.com or through our <a rel="noreferrer noopener" href="https://eisnersafety.com/contact_eisner_safety/" target="_blank">contact form</a>.</p>]]></content:encoded> </item> <item> <title>IEC 60601-1, 4th Edition Project – Where Do We Stand? – UPDATED 30 Nov 2023</title> <link>https://eisnersafety.com/2023/11/30/iec-60601-1-4th-edition-project-where-do-we-stand/?utm_source=rss&utm_medium=rss&utm_campaign=iec-60601-1-4th-edition-project-where-do-we-stand</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Thu, 30 Nov 2023 08:22:00 +0000</pubDate> <category><![CDATA[60601 Series]]></category> <category><![CDATA[60601-1]]></category> <category><![CDATA[AAMI]]></category> <category><![CDATA[Architecture Specification]]></category> <category><![CDATA[Coexistence]]></category> <category><![CDATA[Design Specification]]></category> <category><![CDATA[Device]]></category> <category><![CDATA[EMC]]></category> <category><![CDATA[Hazards]]></category> <category><![CDATA[IEC]]></category> <category><![CDATA[IEC 60601-1]]></category> <category><![CDATA[Labeling]]></category> <category><![CDATA[Medical Device]]></category> <category><![CDATA[Nov 2023]]></category> <category><![CDATA[PEMS]]></category> <category><![CDATA[SaMD]]></category> <category><![CDATA[Standards]]></category> <category><![CDATA[Standards Development]]></category> <guid isPermaLink="false">https://eisnersafety.com/?p=7378</guid> <description><![CDATA[During the IEC TC62 / SC62A meetings in Seoul, South Korea, 18 – 22 Sept 2023 there was general consensus between the National Committees (NCs) to move forward with the IEC 60601-1 4th edition project. Yeah, finally after so many years!!!!]]></description> <content:encoded><![CDATA[<figure class="wp-block-image size-large is-resized"><img loading="lazy" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/11/Compliance-Lightbulb-w-Standards-etc-1024x673.jpg" alt="" class="wp-image-7398" width="1217" height="800" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/11/Compliance-Lightbulb-w-Standards-etc-1024x673.jpg 1024w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/11/Compliance-Lightbulb-w-Standards-etc-600x394.jpg 600w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/11/Compliance-Lightbulb-w-Standards-etc-300x197.jpg 300w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/11/Compliance-Lightbulb-w-Standards-etc-768x505.jpg 768w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/11/Compliance-Lightbulb-w-Standards-etc-1536x1009.jpg 1536w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/11/Compliance-Lightbulb-w-Standards-etc.jpg 2000w" sizes="(max-width: 1217px) 100vw, 1217px" /></figure> <h3>Some History</h3> <p>The “Architectural Specification for Safety Standards of Medical Electrical Equipment, Medical Electrical Systems, and Software Used in Healthcare”, version 3.0 was issued 5 May 2020. One of the main reasons for the document it was intended to be used by those who prepared the design specification of the 4<sup>th</sup> edition of IEC 60601-1. You can access this <a rel="noreferrer noopener" href="https://bit.ly/ArchitectureSpec" target="_blank">document</a>.</p> <p>A resolution at the 2015 Kobe meeting of IEC SC62A that once the Architecture Specification (document noted above) is approved IEC SC 62A will start to prepare a Design Specification (Dsgn Spec) for the 4<sup>th</sup> edition of IEC 60601-1. </p> <p class="has-vivid-red-color has-text-color" style="font-size:26px"><strong><em>The finalized version of the Design Specification to the 4th ed. of IEC 60601-1 was just approved and was placed on the IEC SC62A website as of 30 November 2023. You can access it <a rel="noreferrer noopener" href="https://bit.ly/Download4thEd60601DsgnSpecFinal" target="_blank">here</a></em></strong> <em>and selecting the “Design Specification Outline for the fourth edition of IEC 60601-1” document<strong> .</strong> It is available for free at the link provided.</em></p> <p>This Dsgn Spec has been developed to provide guidance and mapping for drafting the 4th edition of IEC 60601-1. The aim of the Dsgn Spec is to provide a clear & concise basis for developing the next edition of IEC 60601-1. It is intended to provide information to develop a user-friendly, distinct, and easily readable edition of IEC 60601-1. It is a guidance document that will help the Working Groups (WGs – Clusters – see below) understand what are the main topics to cover. It will be up to the WGs to do the heavy lifting and write the actual requirements.</p> <h3>Going forward with the Fourth Edition of IEC 60601-1</h3> <p>During the IEC TC62 / SC62A meetings in Seoul, South Korea, 18 – 22 Sept 2023 there was general consensus between the National Committees (NCs) to move forward with the IEC 60601-1 4<sup>th</sup> edition project. Yeah, finally after so many years!!!! A questionnaire (Q document 62A/1528/Q) dated 2023-10-27 was sent out to the NCs to get formal approval for the project to start and for establishing the new Working Groups (WGs) for 12 new WGs.</p> <p>The 12 new WGs are:</p> <ul><li>General requirements</li><li>Physical environment hazards</li><li>User interface aspects (including all labelling and information to be provided)</li><li>Materials hazards</li><li>PEMS (e.g., SaMD (Software as a medical device), SiMD (Software in a medical device), firmware, software, apps, OS, drivers) related hazards</li><li>Electrical hazards</li><li>Mechanical hazards</li><li>Thermal and fire hazards</li><li>Optical radiation (visible, UV and IR) hazards</li><li>Ionizing radiation hazards</li><li>Electromagnetic exposure hazards (not optical or ionizing but including SAR)</li><li>Electromagnetic disturbances hazards (including coexistence) hazards</li></ul> <p>There is a 6-week voting period that will end 8 Dec 2023 for the Q doc. Once the voting period is completed it is anticipated that there will be an affirmative result for this Q doc from the NCs (based on the Seoul meeting’s positive response from the NCs).</p> <p>The next step is a 2<sup>nd</sup> Q doc will be sent out for a call for experts and conveners about 1 week after 62A/1528/Q closes. The call for conveners and experts will be for the new WGs. Note that the current experts for the existing WGs, Joint WGs, and Maintenance Teams (MTs) will not be registered for the new WGs. So, all interested experts must be nominated by the NCs’ Secretaries when the call for experts is circulated after the establishment of these new WGs is approved. This 2nd Q doc will likely identify most, if not all the conveners and secretaries for each cluster (WG) for the 12 new WGs established in the 1<sup>st</sup> Q doc for IEC 60601-1, 4<sup>th</sup> ed.</p> <p>If you or your company, the notified body, the regulator you work for want to be involved in the development of the 4<sup>th</sup> ed. of IEC 60601-1 you need to make sure the organization you work for needs to make sure you are either already a member of your NC IEC SC62A (but first to the appropriate NC mirror committee so you can then be nominated to the IEC SC62A and applicable WG’s – this all takes time and with some big companies this can be a very long process & political) or if not you better start the process ASAP so you don’t miss the window to get added as a member of the WGs.</p> <p>The kickoff meeting to start the work on IEC 60601-1, 4<sup>th</sup> ed. will be held at AAMI in the US (Virginia) the week of 29 April – 3 May 2024. This is a closed meeting – you have to be nominated as an NC expert, as mentioned above, through the 2<sup>nd</sup> Q doc. To be a member of a WG as an expert you will need to commit to 2 face to face meetings that run approximately 1 week each year (but one of the meetings I plan on it being 2 weeks a year and if you are interested I can talk to you more about those details – <a rel="noreferrer noopener" href="http://www.eisnersafety.com/Schedule-Call/" target="_blank">contact me</a>) and approximately 3+ hours/month of virtual meetings plus additional time to support the work of the WG. This information will likely be stated in the 2<sup>nd</sup> Q doc. Currently, from what I am hearing, it sounds like experts will be limited to a maximum of 2 WGs, but this hasn’t been confirmed for sure.</p> <blockquote class="wp-block-quote is-style-default" style="font-size:32px"><p>“this is a great opportunity to get some newer individuals involved in developing the IEC 60601-1 standard”</p></blockquote> <p>You will want to make sure you have the budget set up for travel for face to face meetings, time to focus on this work, and have the support of your organization before you commit to this work. IEC TC62 and SC62A are looking for additional people from the existing group of experts as many have either retired or are getting close to retirement or are in mid to late careers with few early in their careers. So, this is a great opportunity to get some newer individuals involved in developing the IEC 60601-1 standard who are familiar with the standard and have been in the medical device industry for some time. It would be ideal if they know 60601-1, have some design experience, have worked for a test lab, worked for a notified body or a regulator, understand the IEC 6060-1 compliance process, or similar. If you are interested in the process and have any questions about joining an NC please let me know.</p> <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, & other country regulatory requirements & standards, laws, directives, and more. <a rel="noreferrer noopener" href="https://eisnersafety.com/about_us/associates/" target="_blank">Leo Eisner</a> is an expert on standards development and sits on many standards committees. 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 & 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 call with Leo</a> or contact Leo at Leo@EisnerSafety.com or through our <a rel="noreferrer noopener" href="https://eisnersafety.com/contact_eisner_safety/" target="_blank">contact form</a>.</p>]]></content:encoded> </item> <item> <title>FDA Officially Withdraws from GHWP</title> <link>https://eisnersafety.com/2023/11/27/fda-officially-withdraws-from-ghwp/?utm_source=rss&utm_medium=rss&utm_campaign=fda-officially-withdraws-from-ghwp</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Mon, 27 Nov 2023 18:38:58 +0000</pubDate> <category><![CDATA[FDA]]></category> <category><![CDATA[GHWP]]></category> <category><![CDATA[IMDRF]]></category> <category><![CDATA[Nov 2023]]></category> <guid isPermaLink="false">https://eisnersafety.com/?p=7407</guid> <description><![CDATA[27 November 2023 The FDA announced today that it is withdrawing “as a member of the Global Harmonization Working Party (GHWP), which the agency joined in December 2021. The FDA will continue its outreach to global partners and its efforts]]></description> <content:encoded><![CDATA[<div class="wp-block-image"><figure class="aligncenter size-full"><img loading="lazy" width="800" height="172" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/11/FDA-Logo-e1701110218570.png" alt="" class="wp-image-7412" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/11/FDA-Logo-e1701110218570.png 800w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/11/FDA-Logo-e1701110218570-600x129.png 600w" sizes="(max-width: 800px) 100vw, 800px" /></figure></div> <p>27 November 2023</p> <p>The FDA announced today that it is withdrawing “as a member of the Global Harmonization Working Party (GHWP), which the agency joined in December 2021. The FDA will continue its outreach to global partners and its efforts to ensure alignment of medical device international harmonization by primarily working with the International Medical Device Regulators Forum (IMDRF). In 2024, the FDA, as chair of IMDRF, will continue to work collaboratively to reach consensus on common goals, foster global regulatory convergence, and leverage resources to make safe and effective medical devices available globally.”</p> <p>The letter sent to the GHWP can be downloaded or viewed below. It is pretty critical of the GHWP processes including leadership not being diverse or representative of a global perspective in the major committees; the imbalance of regulator and industry participation in working groups impacting work not representing the regulator’s perspective; and more…. </p> <div class="wp-block-file"><object class="wp-block-file__embed" data="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/11/GHWP-withdrawal-letter-nov-2023.pdf" type="application/pdf" style="width:100%;height:1126px" aria-label="Embed of FDA GHWP withdrawal letter nov 27 2023."></object><a id="wp-block-file--media-5a05f720-78b1-4c07-bb04-46f6f56dabc4" href="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/11/GHWP-withdrawal-letter-nov-2023.pdf">FDA GHWP withdrawal letter nov 27 2023</a><a href="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/11/GHWP-withdrawal-letter-nov-2023.pdf" class="wp-block-file__button" download aria-describedby="wp-block-file--media-5a05f720-78b1-4c07-bb04-46f6f56dabc4">Download</a></div> <p>Need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic planning for your medical electrical product lines. <a rel="noreferrer noopener" href="https://eisnersafety.com/about_us/associates/" target="_blank">Leo Eisner</a> is an expert on standards development and sits on many standards committees. 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 & 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 call with Leo</a> or contact Leo at Leo@EisnerSafety.com or through our <a rel="noreferrer noopener" href="https://eisnersafety.com/contact_eisner_safety/" target="_blank">contact form</a>.</p>]]></content:encoded> </item> <item> <title>Draft EUDAMED Roadmap of Modules</title> <link>https://eisnersafety.com/2023/10/21/draft-eudamed-roadmap-of-modules/?utm_source=rss&utm_medium=rss&utm_campaign=draft-eudamed-roadmap-of-modules</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Sat, 21 Oct 2023 21:10:44 +0000</pubDate> <category><![CDATA[13485]]></category> <category><![CDATA[14971]]></category> <category><![CDATA[15223-1]]></category> <category><![CDATA[60601 Amendments]]></category> <category><![CDATA[60601 Series]]></category> <category><![CDATA[60601-1]]></category> <category><![CDATA[60601-1 A2]]></category> <category><![CDATA[60601-1 Amendment 2]]></category> <category><![CDATA[60601-1-10]]></category> <category><![CDATA[60601-1-11]]></category> <category><![CDATA[60601-1-12]]></category> <category><![CDATA[60601-1-2]]></category> <category><![CDATA[60601-1-2, 4th ed.]]></category> <category><![CDATA[60601-1-6]]></category> <category><![CDATA[60601-1-8]]></category> <category><![CDATA[60601-1-9]]></category> <category><![CDATA[62304]]></category> <category><![CDATA[62366]]></category> <category><![CDATA[62366-1]]></category> <category><![CDATA[Active Implants]]></category> <category><![CDATA[Auditing]]></category> <category><![CDATA[Combination Product]]></category> <category><![CDATA[Cybersecurity]]></category> <category><![CDATA[Device]]></category> <category><![CDATA[EMC]]></category> <category><![CDATA[Essential Performance]]></category> <category><![CDATA[EU]]></category> <category><![CDATA[EU Commission]]></category> <category><![CDATA[EUDAMED]]></category> <category><![CDATA[ISO 15223-1]]></category> <category><![CDATA[IVDR]]></category> <category><![CDATA[Labeling]]></category> <category><![CDATA[Marking]]></category> <category><![CDATA[MDCG]]></category> <category><![CDATA[MDR]]></category> <category><![CDATA[Medical Device]]></category> <category><![CDATA[Medical Device Regulation]]></category> <category><![CDATA[Notified Bodies]]></category> <category><![CDATA[Oct 2023]]></category> <category><![CDATA[Regulation]]></category> <category><![CDATA[State of the Art]]></category> <category><![CDATA[UDI]]></category> <guid isPermaLink="false">https://eisnersafety.com/?p=7365</guid> <description><![CDATA[Draft EUDAMED roadmap (of modules*) was published on 20 Oct 2023 with updated timelines for each module and mandatory use dates for the MDR & IVDR.]]></description> <content:encoded><![CDATA[<figure class="wp-block-image size-large"><img loading="lazy" width="1024" height="576" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/10/md_eudamed_roadmap_en-1024x576.png" alt="" class="wp-image-7373" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/10/md_eudamed_roadmap_en-1024x576.png 1024w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/10/md_eudamed_roadmap_en-600x337.png 600w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/10/md_eudamed_roadmap_en-300x169.png 300w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/10/md_eudamed_roadmap_en-768x432.png 768w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/10/md_eudamed_roadmap_en-1536x864.png 1536w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/10/md_eudamed_roadmap_en-2048x1152.png 2048w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure> <p>Draft EUDAMED roadmap (of modules*) was published on 20 Oct 2023 with updated timelines for each module and mandatory use dates for the MDR & IVDR.</p> <p>Q4’ 2027: Article 123 (3) (d) MDR/113 (3) (f) IVDR</p> <ul><li>Actor (Economic Operators register in EUDAMED; Supervising Entities has access to EUDAMED that is not public),</li><li>Certificates (Active, suspended, reinstated, withdrawn, refused, other restrictions on certificates),</li><li>MSU (Evaluation of devices on the market by Competent Authorities),</li><li>Vigilance (& Post Market Surveillance), and</li><li>CI/PS (Before a device is placed on the market – Clinical Investigation and Performance Study)</li></ul> <p>Q2’ 2029: Article 123 (3) (e) MDR/113 (3) (a) IVDR</p> <ul><li>Devices (Based on UDIs registered in EUDAMED) and</li><li>Certificates (see above)</li></ul> <p>* For a brief explanation of EUDAMED modules refer to the below</p> <figure class="wp-block-image size-large"><img loading="lazy" width="1024" height="531" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/10/EUDAMED-Modules-1024x531.png" alt="" class="wp-image-7371" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/10/EUDAMED-Modules-1024x531.png 1024w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/10/EUDAMED-Modules-600x311.png 600w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/10/EUDAMED-Modules-300x156.png 300w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/10/EUDAMED-Modules-768x398.png 768w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/10/EUDAMED-Modules.png 1070w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure> <p>Need help with Medical Electrical Equipment standards (60601/80601 series) including Safety/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, & other country regulatory requirements & standards, laws, directives, and more. <a rel="noreferrer noopener" href="https://eisnersafety.com/about_us/associates/" target="_blank">Leo Eisner</a> is an expert on standards development and sits on many standards committees. 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. Feel free to <a rel="noreferrer noopener" href="http://www.eisnersafety.com/Schedule-Call/" target="_blank">schedule a call with Leo</a> or contact Leo at Leo@EisnerSafety.com or through our <a rel="noreferrer noopener" href="https://eisnersafety.com/contact_eisner_safety/" target="_blank">contact form</a>.</p> <p>We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.</p>]]></content:encoded> </item> <item> <title>FDA’s ASCA Program Becomes Permanent</title> <link>https://eisnersafety.com/2023/09/22/fdas-asca-program-becomes-permanent/?utm_source=rss&utm_medium=rss&utm_campaign=fdas-asca-program-becomes-permanent</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Fri, 22 Sep 2023 21:16:52 +0000</pubDate> <category><![CDATA[60601 Series]]></category> <category><![CDATA[60601-1]]></category> <category><![CDATA[60601-1 A2]]></category> <category><![CDATA[60601-1 Amendment 2]]></category> <category><![CDATA[60601-1-10]]></category> <category><![CDATA[60601-1-11]]></category> <category><![CDATA[60601-1-12]]></category> <category><![CDATA[60601-1-2]]></category> <category><![CDATA[60601-1-2, Ed. 4.1]]></category> <category><![CDATA[60601-1-6]]></category> <category><![CDATA[60601-1-8]]></category> <category><![CDATA[62304]]></category> <category><![CDATA[62366-1]]></category> <category><![CDATA[AAMI]]></category> <category><![CDATA[ASCA]]></category> <category><![CDATA[FDA]]></category> <category><![CDATA[Final Guidance]]></category> <category><![CDATA[Guidance Documents]]></category> <category><![CDATA[IEC]]></category> <category><![CDATA[ISO]]></category> <category><![CDATA[Medical Device]]></category> <category><![CDATA[Recognized Consensus Standards]]></category> <category><![CDATA[Standards]]></category> <category><![CDATA[US]]></category> <category><![CDATA[60601-1 3rd ed.]]></category> <category><![CDATA[ESCNews]]></category> <category><![CDATA[Medical]]></category> <category><![CDATA[Medical Device Industry]]></category> <category><![CDATA[Medical Device Regulatory]]></category> <category><![CDATA[Medical Devices]]></category> <guid isPermaLink="false">https://eisnersafety.com/?p=7354</guid> <description><![CDATA[Great News!!!! Effective 19 September 2023 FDA’s Accreditation Scheme for Conformity Assessment (ASCA) Program converted from a pilot program after 3 years to a permanent program, the agency announced. The transition is authorized under the Medical Device User Fee Amendments]]></description> <content:encoded><![CDATA[<figure class="wp-block-image size-large is-style-rounded"><img loading="lazy" width="1024" height="446" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/09/Standards-banner-image-1024x446.jpg" alt="" class="wp-image-7356" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/09/Standards-banner-image-1024x446.jpg 1024w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/09/Standards-banner-image-600x261.jpg 600w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/09/Standards-banner-image-300x131.jpg 300w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/09/Standards-banner-image-768x334.jpg 768w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/09/Standards-banner-image-1536x669.jpg 1536w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/09/Standards-banner-image.jpg 2000w" sizes="(max-width: 1024px) 100vw, 1024px" /><figcaption>Standards process</figcaption></figure> <p>Great News!!!! Effective 19 September 2023 FDA’s Accreditation Scheme for Conformity Assessment (ASCA) Program converted from a pilot program after 3 years to a permanent program, <a rel="noreferrer noopener" href="https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/accreditation-scheme-conformity-assessment-asca" target="_blank">the agency announced</a>. The transition is authorized under the Medical Device User Fee Amendments of 2022 (MDUFA V). The ASCA program’s goals are to: </p> <ul><li>streamline the conformity assessment in medical device submissions, </li><li>enhance the FDA’s confidence in test methods and results,</li><li>decrease the need for additional information related to conformance with a standard,</li><li>promote consistency, predictability, and efficiency in medical device review,</li><li>serve as a least burdensome approach to conformity assessment</li></ul> <p>The ASCA program’s <a rel="noreferrer noopener" href="https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/accreditation-scheme-conformity-assessment-asca#resources" target="_blank">final guidance documents</a>, issued in 2020, set the current framework for the program: </p> <ul><li><a rel="noreferrer noopener" href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/accreditation-scheme-conformity-assessment-asca-pilot-program" target="_blank">Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program – Final Guidance</a> (Program Guidance)</li><li><a rel="noreferrer noopener" href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/basic-safety-and-essential-performance-medical-electrical-equipment-medical-electrical-systems-and" target="_blank">Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the ASCA Pilot Program – Final Guidance</a> (Standards Specific Guidance)</li><li><a rel="noreferrer noopener" href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/biocompatibility-testing-medical-devices-standards-specific-information-accreditation-scheme" target="_blank">Biocompatibility Testing of Medical Devices – Standards Specific Information for the ASCA Pilot Program – Final Guidance</a> (Standards Specific Guidance)</li></ul> <p>The FDA grants ASCA accreditation to test labs that meet the requirements of the program. The ASCA test labs are authorized to conduct testing and the output from the lab is a summary report that the manufacturer submits to the FDA (more to come). Once the FDA approves an ASCA test lab the FDA identifies the scope of recognized consensus standards that the lab is able to test too (they are able to expand that list over time & the FDA may suspend any and all of the scope of the lab, if appropriate), the name & address of the lab and the ASCA contact on the <a rel="noreferrer noopener" href="https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/asca-accredited-testing-laboratories" target="_blank">ASCA test lab list</a>. If the lab is suspended there seems to be a note in the current scope, there is no separate search feature on the db for active and suspended labs. I just sent in a request to the standards and conformity assessment (S-CAP) group that is in charge of this db to ask if they can make this more user friendly. </p> <p>FDA has added standards to the list of approved standards beyond what is noted in both Standards Specific Final Guidance documents and plans to continue to add recognized consensus standards to the list/db. You can search the <a rel="noreferrer noopener" href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm" target="_blank">list of recognized consensus standards db</a> but make sure you click the check box next to “Included in ASCA?” to view the list of standards that are included in the ASCA program. When you get to the link for a specific standard make sure you review the standard and see if any limitations on the standard if a partial or full recognition and also if there are any limits from the ASCA program perspective so you know what to expect. Then you need to make sure the test lab you are planning to use has the applicable standards in scope, that apply to the product that you want to test for your submission to the FDA. </p> <p>You’ve chosen a test lab and gotten a test quote including the ASCA costs. Now you need to get the testing done but please make sure before you submit to the FDA you don’t have any comments on the summary report from the ASCA lab that aren’t positive towards the approval. If there are any issues you want to resolve them before a final report is issued from the test lab to the manufacturer. The manufacturer provides the summary report as part of the premarket submission, not the test lab. You want a clean summary report going to the FDA, as the FDA relies on the ASCA’s test lab summary report instead of the full test report that has been submitted in the past.</p> <p>Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic planning for your medical electrical product lines; need support when FDA, the ASCA program or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. <a rel="noreferrer noopener" href="https://eisnersafety.com/about_us/associates/" target="_blank">Leo Eisner</a> is an expert on standards development and sits on many standards committees. 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. Feel free to <a rel="noreferrer noopener" href="http://www.eisnersafety.com/Schedule-Call/" target="_blank">schedule a call with Leo</a> or contact Leo at Leo@EisnerSafety.com or through our <a rel="noreferrer noopener" href="https://eisnersafety.com/contact_eisner_safety/" target="_blank">contact form</a>.</p> <p>We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.</p>]]></content:encoded> </item> <item> <title>FDA Recognizes IEC 60601-1 Edition 3.2</title> <link>https://eisnersafety.com/2023/04/10/fda-recognizes-iec-60601-1-edition-3-2/?utm_source=rss&utm_medium=rss&utm_campaign=fda-recognizes-iec-60601-1-edition-3-2</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Mon, 10 Apr 2023 18:14:20 +0000</pubDate> <category><![CDATA[60601 Amendments]]></category> <category><![CDATA[60601 Series]]></category> <category><![CDATA[60601-1]]></category> <category><![CDATA[60601-1 A2]]></category> <category><![CDATA[60601-1 Amendment 2]]></category> <category><![CDATA[AAMI]]></category> <category><![CDATA[ANSI]]></category> <category><![CDATA[Apr 2023]]></category> <category><![CDATA[FDA]]></category> <category><![CDATA[IEC]]></category> <category><![CDATA[Interpretation Sheet 1]]></category> <category><![CDATA[ISH1]]></category> <category><![CDATA[Medical Device]]></category> <category><![CDATA[Medical Device Regulation]]></category> <category><![CDATA[Recognized Consensus Standards]]></category> <category><![CDATA[Standards]]></category> <category><![CDATA[US]]></category> <category><![CDATA[ESCNews]]></category> <category><![CDATA[Medical Device Industry]]></category> <category><![CDATA[Medical Device Regulatory]]></category> <category><![CDATA[Medical Devices]]></category> <guid isPermaLink="false">https://eisnersafety.com/?p=7333</guid> <description><![CDATA[On April 3, 2023 FDA added IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment – Part 1: General requirements for basic safety and essential performance to their list of Recognized Consensus Standards as Recognition # 19-49 in Recognition List]]></description> <content:encoded><![CDATA[<figure class="wp-block-image size-large is-resized"><img loading="lazy" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/04/Screenshot-2023-04-07-at-11.29.41-AM-1024x550.png" alt="" class="wp-image-7336" width="1221" height="656" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/04/Screenshot-2023-04-07-at-11.29.41-AM-1024x550.png 1024w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/04/Screenshot-2023-04-07-at-11.29.41-AM-600x322.png 600w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/04/Screenshot-2023-04-07-at-11.29.41-AM-300x161.png 300w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/04/Screenshot-2023-04-07-at-11.29.41-AM-768x412.png 768w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/04/Screenshot-2023-04-07-at-11.29.41-AM-1536x824.png 1536w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2023/04/Screenshot-2023-04-07-at-11.29.41-AM-2048x1099.png 2048w" sizes="(max-width: 1221px) 100vw, 1221px" /></figure> <p>On April 3, 2023 FDA added <a rel="noreferrer noopener" href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?standard__identification_no=44029&utm_medium=email&utm_source=govdelivery" target="_blank">IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment – Part 1: General requirements for basic safety and essential performance</a> to their list of Recognized Consensus Standards as <a rel="noreferrer noopener" href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?standard__identification_no=44029&utm_medium=email&utm_source=govdelivery" target="_blank">Recognition # 19-49</a> in Recognition List # 060. A reminder that Recognized Consensus standards are considered voluntary by the FDA for premarket submissions but they are what the majority of manufacturers use to facilitate & streamline the premarket process. </p> <p></p> <h2><strong>Relevant FDA Guidance and/or Supportive Publications*</strong></h2> <p> US national differences: </p> <p> 1. (<a rel="noreferrer noopener" href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=43309" target="_blank">Recognition Number: 19-46</a>) <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=43309" target="_blank" rel="noreferrer noopener">ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]</a></p> <p> 2. Attachment Form No.: US_ND_IEC60601_1U ATTACHMENT TO TEST REPORT IEC 60601-1: US NATIONAL DIFFERENCES – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance<br>(<a href="https://documents.iecee.org/ords/f?p=702:558:::::P558_DOCUMENT_FILE_ID:2955038" target="_blank" rel="noreferrer noopener">https://documents.iecee.org/ords/f?p=702:558:::::P558_DOCUMENT_FILE_ID:2955038</a>)</p> <p>Note from Leo: This is a US National Difference Test Report Form issued by the CB Scheme for CB scheme reports. </p> <p></p> <h2>You have 3 options <br>1 expires after December 17, 2023<br>The first 2 are acceptable now & going forward.</h2> <p> 1) Use IEC 60601-1 Edition 3.2 (<a rel="noreferrer noopener" href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?standard__identification_no=44029&utm_medium=email&utm_source=govdelivery" target="_blank">Recognition # 19-49</a>) from now onward making sure to use References #1 <strong>AND</strong> #2. <br>Note: This first option is the best of the three. Test to the IEC standard as that way you can prepare your product for the US domestic and international markets at the same time. If you pass the testing you’ll meet most if not all requirements and then you can deal with the few US National Differences by applying the US National Differences which are also in item 2) of this list anyway. This is less restrictive for your product than if you test your product to the US version of the standard (ANSI AAMI – Item 2 of this list) and then try to go to the international market which most countries will require IEC testing anyway.</p> <p></p> <p> 2) Use ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] (<a rel="noreferrer noopener" href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=43309" target="_blank">Recognition Number: 19-46</a>) from now onward. <br>Note: This SIS is an older Recognized Consensus Standard but by inference, one would be wise to make sure that you also get the US National Difference Test Report mentioned above for the IEC 60601-1, ed. 3.2 which is based on the ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] (<a rel="noreferrer noopener" href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=43309" target="_blank">Recognition Number: 19-46</a>)</p> <p></p> <p> 3) During the transition period FDA will accept a declaration of conformity in support of premarket submissions to the older ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) (<a rel="noreferrer noopener" href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=43310" target="_blank">Recognition Number: 19-4</a>) but it will be superseded by recognition of ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) [Including Amendment 2 (2021)] (<a rel="noreferrer noopener" href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=43309" target="_blank">Recognition Number: 19-46</a>) after December 17, 2023. <br>Note: The SIS says that <a rel="noreferrer noopener" href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=43310" target="_blank">Recognition Number: 19-4</a> (ANSI/AAMI ES60601-1, edition 3.1) by <a rel="noreferrer noopener" href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=43309" target="_blank">Recognition Number: 19-46</a> (ANSI/AAMI ES60601-1, edition 3.2) but if you are smart I would switch to <a rel="noreferrer noopener" href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?standard__identification_no=44029&utm_medium=email&utm_source=govdelivery" target="_blank">Recognition Number 19-49</a> (IEC 60601-1, edition 3.2). FDA should accept this Recognized Consensus standard for your premarket submission as long as your submission includes the US national differences References #1 & #2.</p> <p></p> <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, & other country regulatory requirements & standards, laws, directives, and more. <a rel="noreferrer noopener" href="https://eisnersafety.com/about_us/associates/" target="_blank">Leo Eisner</a> is an expert on standards development and sits on many standards committees. 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. Feel free to <a rel="noreferrer noopener" href="http://www.eisnersafety.com/Schedule-Call/" target="_blank">schedule a call with Leo</a> or contact Leo at Leo@EisnerSafety.com or through our <a rel="noreferrer noopener" href="https://eisnersafety.com/contact_eisner_safety/" target="_blank">contact form</a>.</p> <p>We work with many test labs for Medical Electrical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.</p>]]></content:encoded> </item> <item> <title>June International Regulatory Updates</title> <link>https://eisnersafety.com/2022/06/30/june-international-regulatory-updates/?utm_source=rss&utm_medium=rss&utm_campaign=june-international-regulatory-updates</link> <dc:creator><![CDATA[leoeisner]]></dc:creator> <pubDate>Thu, 30 Jun 2022 18:22:00 +0000</pubDate> <category><![CDATA[60601 Series]]></category> <category><![CDATA[60601-1]]></category> <category><![CDATA[60601-1-2]]></category> <category><![CDATA[Cybersecurity]]></category> <category><![CDATA[EU]]></category> <category><![CDATA[FDA]]></category> <category><![CDATA[Health Canada]]></category> <category><![CDATA[IEC]]></category> <category><![CDATA[June 2022]]></category> <category><![CDATA[MDR]]></category> <category><![CDATA[Saudia Arabia]]></category> <category><![CDATA[Standards]]></category> <category><![CDATA[UDI]]></category> <category><![CDATA[US]]></category> <guid isPermaLink="false">https://eisnersafety.com/?p=7312</guid> <description><![CDATA[June International Regulatory Updates for Canada, Saudi Arabia, EU, & US]]></description> <content:encoded><![CDATA[<figure class="wp-block-image size-full"><img loading="lazy" width="500" height="350" src="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/01/Worldflatimage500x350-72dpi.jpg" alt="" class="wp-image-7054" srcset="https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/01/Worldflatimage500x350-72dpi.jpg 500w, https://eisnersafety.com/eisnersafetycom/wp-content/uploads/2022/01/Worldflatimage500x350-72dpi-300x210.jpg 300w" sizes="(max-width: 500px) 100vw, 500px" /></figure> <p><strong>CANADA</strong></p> <p>Health Canada has a <a rel="noreferrer noopener" href="https://www.canada.ca/en/health-canada/programs/consultation-proposed-changes-medical-devices-directorate-list-recognized-standards-medical-devices.html" target="_blank"><strong>Consultation: Proposed Changes to the Medical Devices Directorate’s List of Recognized Standards for Medical Devices</strong></a>. I’m surprised they are not updating any of the IEC 60601 based General and Collateral standards to the most recent updates of the summer of 2020 updates. Even the EMC standard IEC 60601-1-2 is still based on the 4.0 edition which is from 2014 and IEC 60601-1 the list references the 3.0 and 3.1 editions 2005 and 2012 respectively.</p> <p><strong>SAUDI ARABIA</strong></p> <p><a rel="noreferrer noopener" href="https://www.sfda.gov.sa/sites/default/files/2022-06/saudi-DI.pdf" target="_blank">Postponement announcement of <strong>the requirements timeline of medical devices unique device identification (Saudi -DI)</strong></a></p> <p><strong><a href="https://www.sfda.gov.sa/sites/default/files/2022-06/RequirementsUDI_0.pdf" target="_blank" rel="noreferrer noopener">MDS-REQ 7 – Requirements for Unique Device Identification (UDI) for Medical Devices Version 4</a></strong></p> <p><strong>EU</strong><br><a rel="noreferrer noopener" href="https://www.camd-europe.eu/health/questions-and-answers-on-certificates-of-free-sale-and-article-60-of-regulation-eu-2017-745-on-medical-devices-mdr/" target="_blank"><strong>Questions And Answers On Certificates Of Free Sale And Article 60 Of Regulation (EU) 2017/745 On Medical Devices (MDR)</strong></a> – This document was developed by competent authorities, with the aim of providing guidance in the area of Certificates of Free Sale.<br>It considers how certificates of free sale should be processed/ generated for ‘old’, ‘legacy’ and MDR compliant devices. It highlights where certificates of free sale can be issued in the context of Article 60 (1) of the Regulation and where the use of national provisions may be required.<br>The <a rel="noreferrer noopener" href="http://140622_CoFS_QnA_CAMDEndorsed" target="_blank">document</a> was endorsed by the CAMD during the 50th plenary meeting held in Paris in June 2022.</p> <p><a rel="noreferrer noopener" href="https://ec.europa.eu/health/latest-updates/mdcg-2022-11-mdcg-position-paper-notice-manufacturers-ensure-timely-compliance-mdr-requirements-2022-06-13_en" target="_blank"><strong>MDCG 2022-11 – MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements</strong></a> – Places <strong><em>FULL responsibility</em></strong> on manufacturers to complete the transition in time FULL STOP. Don’t expect any extension of the transition period beyond what has been established at this point.</p> <p><strong>US</strong></p> <p><strong><a rel="noreferrer noopener" href="https://www.fda.gov/media/94758/download" target="_blank">Electromagnetic Compatibility (EMC) of Medical Devices: Final Guidance for Industry and Food and Drug Administration Staff</a></strong> – Issued June 6, 2022, replaces draft of November 17, 2020. <strong><em>NOTE</em></strong> <em><strong>transition period:</strong></em> This document will supersede “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices,” issued July 11, 2016, 1 year after the publication of this guidance for in vitro diagnostics and 60 days after the publication of this guidance for other device types (e.g. medical devices including home use devices and active implantables) within the scope of this guidance.</p> <p><strong><a rel="noreferrer noopener" href="https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-cybersecurity-medical-devices-quality-system-considerations-and-content-premarket#materials" target="_blank">Webinar Recording (June 14, 2022) on Draft Guidance on Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions</a></strong> – The webinar focused on the following key subjects:</p> <ul><li>Differences between 2018 and 2022 drafts</li><li>General Principles of the guidance</li><li>Design and documentation recommendations</li><li>Transparency and labeling recommendations</li><li>Answered questions</li></ul> <p></p> <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, & other country regulatory requirements & standards, laws, directives, and more. <a rel="noreferrer noopener" href="https://eisnersafety.com/about_us/associates/" target="_blank">Leo Eisner</a> is an expert on standards development and sits on many standards committees. 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. Feel free to <a rel="noreferrer noopener" href="http://www.eisnersafety.com/Schedule-Call/" target="_blank">schedule a call with Leo</a> or contact Leo at Leo@EisnerSafety.com or through our <a rel="noreferrer noopener" href="https://eisnersafety.com/contact_eisner_safety/" target="_blank">contact form</a>.</p>]]></content:encoded> </item> </channel></rss> If you would like to create a banner that links to this page (i.e. this validation result), do the following:
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