{"id":7426,"date":"2023-12-28T05:19:45","date_gmt":"2023-12-28T05:19:45","guid":{"rendered":"https:\/\/eisnersafety.com\/?p=7426"},"modified":"2023-12-30T19:54:16","modified_gmt":"2023-12-30T19:54:16","slug":"iec-60601-1-4th-ed-time-to-get-involved-is-now","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2023\/12\/28\/iec-60601-1-4th-ed-time-to-get-involved-is-now\/","title":{"rendered":"IEC 60601-1, 4th Ed. &#8211; Time to Get Involved Is Now!"},"content":{"rendered":"\n<blockquote class=\"wp-block-quote is-style-large is-layout-flow wp-block-quote-is-layout-flow\"><p>We need young(er) and experienced professionals to join in the development of IEC 60601-1, 4th ed. for the future success of medical electrical equipment standards development. <\/p><\/blockquote>\n\n\n\n<figure class=\"wp-block-image size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2022\/02\/Boy-bright-idea-1024x682.jpg\" alt=\"\" class=\"wp-image-7118\" width=\"1220\" height=\"813\" srcset=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2022\/02\/Boy-bright-idea-1024x682.jpg 1024w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2022\/02\/Boy-bright-idea-600x400.jpg 600w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2022\/02\/Boy-bright-idea-300x200.jpg 300w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2022\/02\/Boy-bright-idea-768x512.jpg 768w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2022\/02\/Boy-bright-idea-1536x1024.jpg 1536w, https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2022\/02\/Boy-bright-idea.jpg 2000w\" sizes=\"auto, (max-width: 1220px) 100vw, 1220px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">This is a follow-up to the original post of <a rel=\"noreferrer noopener\" href=\"https:\/\/bit.ly\/IEC60601-1FourthEdProjWhereDoWeStand\" target=\"_blank\">IEC 60601-1, 4th Edition Project &#8211; Where Do We Stand?  &#8211; UPDATED 30 November<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\" style=\"font-size:15px\">As I said in a <a rel=\"noreferrer noopener\" href=\"https:\/\/bit.ly\/IEC60601-14thEdWhereDoWeStand\" target=\"_blank\">LinkedIn Post <\/a>conversation with Beat Keller &#8230;<em>we need bodies &#8230; younger bodies<\/em>&#8230; <mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-vivid-red-color\"><strong>but I would like to amend this that we also need experienced professionals<\/strong><\/mark> to get involved in the development of the 4th edition of IEC 60601-1 as our whole Technical Committee 62 (<a rel=\"noreferrer noopener\" href=\"https:\/\/www.iec.ch\/dyn\/www\/f?p=103:7:503922367964246::::FSP_ORG_ID,FSP_LANG_ID:1245,25\" target=\"_blank\">IEC TC62<\/a>), which is the &#8220;mothership&#8221; for all things IEC 60601-1 titled &#8220;Medical equipment, software, and systems&#8221;, is a &#8230;<em>graying society&nbsp;this group of standards writers I would say (my personal opinion).<\/em>  To see the conversation thread see the links below (order of conversation):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><a href=\"https:\/\/bit.ly\/LIcommnet1\" target=\"_blank\" rel=\"noreferrer noopener\">LinkedIn Comment 1<\/a><\/li><li><a href=\"https:\/\/bit.ly\/LIcomment2\" target=\"_blank\" rel=\"noreferrer noopener\">LinkedIn Comment 2<\/a><\/li><li><a href=\"https:\/\/bit.ly\/LICommnet3\" target=\"_blank\" rel=\"noreferrer noopener\">LinkedIn Comment 3<\/a><\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The Q doc 62A\/1528\/Q closed on 8 Dec 2023 with all the P-member National Committees (NC&#8217;s) voting positively.   A total of 35 NC&#8217;s voted and they were all positive votes, some provided feedback.  All 27 P-members &#8211; participating NC&#8217;s voted. There were 15 O-members observing NCs that didn&#8217;t vote.  <\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-style-large is-layout-flow wp-block-quote-is-layout-flow\"><p>The<strong> <mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-vivid-red-color\">big news<\/mark><\/strong> is that for 10 of the 12 WG&#8217;s &#8230; multiple documents (were) released 22 Dec 2023 announcing a call for experts &amp; a vote on nomination of convenors.<\/p><\/blockquote>\n\n\n\n<p class=\"has-black-color has-text-color wp-block-paragraph\">The<strong> <mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-vivid-red-color\">big news<\/mark><\/strong> is that for 10 of the 12 Working Groups (WG&#8217;s) noted in the <a rel=\"noreferrer noopener\" href=\"https:\/\/bit.ly\/Download4thEd60601DsgnSpecFinal\" target=\"_blank\">Design Specification for the 4th ed. of IEC 60601-1<\/a> (free download) there were multiple documents released 22 Dec 2023 announcing a call for experts and a vote on the nomination of convenors.  Below is a table with all the details.  The end of the voting period for these documents is 2 Feb 2023.  You&#8217;ll want to submit your name thru your National Committee (NC) to become an expert on a WG <strong><em><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-vivid-red-color\">almost immediately<\/mark><\/em><\/strong> as the voting period depending on your NC could end 1 week to several weeks prior to the close date of the vote.&nbsp;So, if you want to become an expert with one of the 10 WG&#8217;s get your name in through your NC.  See the previous <a rel=\"noreferrer noopener\" href=\"https:\/\/bit.ly\/IEC60601-1FourthEdProjWhereDoWeStand\" target=\"_blank\">post<\/a>, mentioned above, for more details. If you are a NC member <strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-vivid-red-color\"><em>please support my nomination<\/em><\/mark><\/strong> for WG39 User interface aspects (including all labelling &amp; info to be provided) <em><strong><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-vivid-red-color\">as a Co-Convenor<\/mark><\/strong><\/em>.  There should be one or two more call for experts and nomination of convenors documents coming out soon (probably early 2024), with a 6 week voting period.  This is also noted in the below table.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-black-color has-pale-cyan-blue-background-color has-text-color has-background\"><thead><tr><th>4th Ed. WG<\/th><th>WG Title<\/th><th>WG Task\/Description<\/th><th>Proposed Nomination of Co-Convenors<\/th><th>Call for Convenors &amp; Experts Document<\/th><\/tr><\/thead><tbody><tr><td><a href=\"https:\/\/bit.ly\/WG_37\" target=\"_blank\" rel=\"noreferrer noopener\">WG 37<\/a><\/td><td>General requirements<\/td><td>Develop requirements related to general issues with respect to underlying concepts (e.g., basic safety\/essential performance, single fault safety, type testing), correlation with processes relevant for the IEC 60601-1 defined by other process standards (e.g., risk management) for the 4th edition of IEC 60601-1.<\/td><td>Mr. Richard Scott (UK) &amp;<br>Mr. Jos Van Vroonhoven (NL)<\/td><td>62A\/1544\/Q<\/td><\/tr><tr><td><a href=\"https:\/\/bit.ly\/WG_38\" target=\"_blank\" rel=\"noreferrer noopener\">WG 38<\/a><\/td><td>Physical environment hazards<\/td><td>Develop requirements to address safety issues due to specific environmental conditions, including power supply for the 4<sup>th<\/sup>&nbsp;edition of IEC 60601-1.<\/td><td>Mr. Michel Brossoit (CA) &amp;<br>Mr. Brodie Pedersen (US)<\/td><td>62A\/1545\/Q<\/td><\/tr><tr><td><a href=\"https:\/\/bit.ly\/WG_39\" target=\"_blank\" rel=\"noreferrer noopener\">WG 39<\/a><\/td><td>User interface aspects (including all labelling and information to be provided)<\/td><td>Develop requirements to address safety issues related to user interfaces including marking, indications, accompanying information, alarm systems and usability for the 4th edition of IEC 60601-1.<\/td><td>Mr. Leo Eisner (US) &amp;<br>Mr. Martin Stangenberg (DE)<\/td><td>62A\/1549\/Q<\/td><\/tr><tr><td><a href=\"https:\/\/bit.ly\/WG_40\" target=\"_blank\" rel=\"noreferrer noopener\">WG 40<\/a><\/td><td>Materials hazards<\/td><td>Develop requirements to address safety issues related to interferences of materials of MEE\/MES with users, patients, used substances, including cleaning, disinfection, sterilization for the 4th edition of IEC 60601-1.<\/td><td>No co-convenors nominated.<\/td><td>62A\/1541\/AC<\/td><\/tr><tr><td><a href=\"https:\/\/bit.ly\/WG_41\" target=\"_blank\" rel=\"noreferrer noopener\">WG 41<\/a><\/td><td>PEMS (e.g., SaMD (Software as a medical device), SiMD (Software in a medical device), firmware, software, apps, OS, drivers) related hazards<\/td><td>Develop requirements to address hazards related to software driven functionality of MEE\/MES for the 4th edition of IEC 60601-1.<\/td><td>Mr. Jullian Goldman (US) &amp;<br>Ms. Patty Krantz-Zuppan (US)<\/td><td>62A\/1550\/Q<\/td><\/tr><tr><td><a href=\"https:\/\/bit.ly\/WG_42\" target=\"_blank\" rel=\"noreferrer noopener\">WG 42<\/a><\/td><td>Electrical hazards<\/td><td>Develop requirements to address safety issues related to electricity for the 4th edition of IEC 60601-1.<\/td><td>Mr. Alex Grob (US) &amp;<br>Mr. Martin Schneeberg (DE)<\/td><td>62A\/1547\/Q<\/td><\/tr><tr><td><a href=\"https:\/\/bit.ly\/WG_43\" target=\"_blank\" rel=\"noreferrer noopener\">WG 43<\/a><\/td><td>Mechanical hazards<\/td><td>Develop requirements to address safety issues related to mechanics, including acoustic and pneumatic energy and vibration energy for the 4th edition of IEC 60601-1.<\/td><td>No Call for experts or nomination of co-convenors sent yet.&nbsp; Expect by sometime early Jan 2024.<\/td><td>Not issued yet<\/td><\/tr><tr><td><a href=\"https:\/\/bit.ly\/WG_44\" target=\"_blank\" rel=\"noreferrer noopener\">WG 44<\/a><\/td><td>Thermal and fire hazards<\/td><td>Develop requirements to address safety issues related to thermal effects caused by MEE\/MES and to fire in MEE or MES for the 4th edition of IEC 60601-1.<\/td><td>Mr. Andreas Nilsson (NO) &amp;<br>Mr. Ayub Yancheshmeh (CA)<\/td><td>62A\/1548\/Q<\/td><\/tr><tr><td><a href=\"https:\/\/bit.ly\/WG_45\" target=\"_blank\" rel=\"noreferrer noopener\">WG 45<\/a><\/td><td>Optical radiation (visible, UV and IR) hazards<\/td><td>Develop requirements to address safety issues related to (visible radiation, UV and or IR) for the 4th edition of IEC 60601-1.<\/td><td>Mr. Winn Henderson (US) &amp;<br>Ms. Yaqing Liu (US)<\/td><td>62A\/1546\/Q<\/td><\/tr><tr><td><a href=\"https:\/\/bit.ly\/WG_46\" target=\"_blank\" rel=\"noreferrer noopener\">WG 46<\/a><\/td><td>Ionizing radiation hazards<\/td><td>Develop requirements to address safety issues related to ionizing radiation for the 4th edition of IEC 60601-1.<\/td><td>No Call for experts or nomination of co-convenors sent yet.&nbsp; Expect by sometime early Jan 2024.<\/td><td>Not issued yet<\/td><\/tr><tr><td><a href=\"https:\/\/bit.ly\/WG_47\" target=\"_blank\" rel=\"noreferrer noopener\">WG 47<\/a><\/td><td>Electromagnetic exposure hazards (not optical or ionizing but including SAR)<\/td><td>Develop requirements to address safety issues related to radiation (not optical or ionizing radiation hazards but including SAR) for the 4th&nbsp;edition of IEC 60601-1.<\/td><td>No co-convenors nominated.<\/td><td>62A\/1541\/AC<\/td><\/tr><tr><td><a href=\"https:\/\/bit.ly\/WG_48\" target=\"_blank\" rel=\"noreferrer noopener\">WG 48<\/a><\/td><td>Electromagnetic disturbances hazards (including coexistence) hazards<\/td><td>Develop requirements to address safety issues related to electromagnetic emissions or electromagnetic immunity, (including wireless coexistence) for the 4th edition of IEC 60601-1.<\/td><td>Mr. Harald Buchwald (DE) &amp;<br>Mr. Curt Sponberg (US)<\/td><td>62A\/1551\/Q<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, &amp; other country regulatory requirements &amp; standards, laws, directives, and more.&nbsp;<a rel=\"noreferrer noopener\" href=\"https:\/\/eisnersafety.com\/about_us\/associates\/\" target=\"_blank\">Leo Eisner<\/a>&nbsp;is an expert on standards development and sits on many standards committees.&nbsp;He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">We work with many test labs for Medical Electrical Safety &amp; EMC and can arrange other testing, as well.  Please let us know if we can help when you contact us.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Feel free to&nbsp;<a rel=\"noreferrer noopener\" href=\"http:\/\/www.eisnersafety.com\/Schedule-Call\/\" target=\"_blank\">schedule a call with Leo<\/a>&nbsp;or contact Leo at&nbsp;Leo@EisnerSafety.com&nbsp;or through our&nbsp;<a rel=\"noreferrer noopener\" href=\"https:\/\/eisnersafety.com\/contact_eisner_safety\/\" target=\"_blank\">contact form<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<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>\n<p>This is a follow-up to the original post of IEC 60601-1, 4th Edition Project &#8211; Where Do We Stand?  &#8211; UPDATED 30 November<\/p>\n<p>This post talks about the Call for Experts and nomination of convenors and the short time periods.  Get moving if you are interested.<\/p>\n","protected":false},"author":4,"featured_media":7118,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1386,1325,1481,1502,1496,1493,1509,1503,1445,1466,1499,1394,1501,1427,1461,1497,1498,1508,1411,1444,1435,1391],"tags":[],"class_list":["post-7426","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-60601-series","category-60601-1","category-aami","category-architecture-specification","category-coexistence","category-cybersecurity","category-dec-2023","category-design-specification","category-device","category-emc","category-hazards","category-iec","category-iec-60601-1","category-labeling","category-medical-device","category-pems","category-samd","category-simd","category-single-fault-condition","category-software","category-standards","category-standards-development"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7426","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=7426"}],"version-history":[{"count":58,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7426\/revisions"}],"predecessor-version":[{"id":7488,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7426\/revisions\/7488"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media\/7118"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=7426"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=7426"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=7426"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}