{"id":4712,"date":"2016-03-18T05:58:48","date_gmt":"2016-03-18T05:58:48","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=4712"},"modified":"2022-06-12T18:25:43","modified_gmt":"2022-06-12T18:25:43","slug":"esc-new-annual-standard-reports-available-by-early-april-16","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2016\/03\/18\/esc-new-annual-standard-reports-available-by-early-april-16\/","title":{"rendered":"ESC New Annual Standard Reports Available by Early April &#8217;16"},"content":{"rendered":"<p><iframe loading=\"lazy\" src=\"https:\/\/www.youtube.com\/embed\/Kzzo-hrcL5U?rel=0\" width=\"480\" height=\"311\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\"><\/iframe><\/p>\n<p><span style=\"color: #ff6600;\"><strong><em>(Note this service is not offered anymore please <a href=\"https:\/\/www.eisnersafety.com\/eisnersafetycom\/contact_eisner_safety\/\">contact us<\/a> with your questions.)<\/em><\/strong><\/span><\/p>\n<p>Do you make Medical Electrical Equipment &amp; Systems (MEE&amp;S) or Home Use MEE&amp;S? Are you up to date on all the applicable Current &amp; Draft Medical Electrical Equipment Standards, Technical Reports, etc?<\/p>\n<p>Do you have the resources to do this efficiently and with minimal cost &amp; time?<\/p>\n<ol>\n<li>Are you able to have one or more employees\u00a0from your company sit in all the standards developing meetings to write the standards?<\/li>\n<li>Can you afford the high fees of being on the National Committees?<\/li>\n<\/ol>\n<p>If not, consider an Industry Leader&#8217;s specialized <a href=\"http:\/\/www.eisnersafety.com\/products\/\">Annual Reports on Medical Electrical Equipment &amp; Systems (MEE&amp;S) Standards or on Home Use MEE&amp;S Standards<\/a>.\u00a0<span style=\"line-height: 1.5;\">Leo Eisner has over 20 years experience in the medical electrical equipment product safety industry with standards development as one of his primary focuses for over 12 years and he is on many of the standards committees that develop the standards in these reports both on the MEE&amp;S and Home Use MEE&amp;S markets.<\/span><\/p>\n<p>What are the implications if you don\u2019t stay up to date on these critical documents?<\/p>\n<ol>\n<li>You may need to redesign your product before submitting to a regulatory agency for review and approval,<\/li>\n<li>Your Notified Body Auditor or your Quality System Certifier may issue a Non-Conformance for not being up to date on the applicable standards and technical reports that apply to your products.<\/li>\n<li>Your regulatory strategy for your products lines may be out of date which could delay your products getting to market on time.<\/li>\n<li>And more\u2026.<\/li>\n<\/ol>\n<p>If you&#8217;re a medical device company that makes any type of electrical equipment you will want one or both of these reports as there are a lot new standards, Technical Reports and related documents recently released and also being developed that you should be on top of.\u00a0Many Medical Device Companies don\u2019t have the resources (time &amp; money) to afford to have someone sit in the standards meetings, commit to the time to support the committee work to write the standards, and pay the high fees needed to be a national committee member of ANSI, AAMI and other standards developing organizations. That\u2019s why many in the medical device industry rely on Leo Eisner of Eisner Safety Consultants to provide them with detailed reports on what is happening with all these changes.<\/p>\n<p><a href=\"http:\/\/www.eisnersafety.com\/products\/\">If you want to stay up with the currently and in process medical electrical equipment and system (MEE&amp;S) standards and home use MEE&amp;S standards and\u00a0technical reports<\/a> before they are published or while in development to help with their regulatory strategy it is always helpful to know what is coming up in the near to long term. Also, it is good to know what has been published too as new titles don&#8217;t always get into standard update services clients get from standards sales houses because those are not being monitored yet.<\/p>\n<p><a href=\"http:\/\/www.eisnersafety.com\/products\/\">These reports<\/a> are based on the Annual Standards Committee Meetings plus all Leo\u2019s standard committee involvement. \u00a0Leo\u00a0was at the\u00a0Kobe meeting in Japan Nov 2015 and <a href=\"http:\/\/www.eisnersafety.com\/products\/\">this report<\/a> covers what are the future plans for many of those Standards &amp; Technical Reports including:<\/p>\n<p style=\"padding-left: 30px;\">1) IEC 60601 series of standards on Electrical Medical Equipment and Systems (status update on changes in process),<\/p>\n<p style=\"padding-left: 30px;\">2) Draft IEC\/TR 60601-4-2\u00a0 Electromagnetic immunity\u00a0Guidance &amp; interpretations,<\/p>\n<p style=\"padding-left: 30px;\">3) IEC\/TR 60601-4-3 interpretations of IEC 60601-1, Ed. 3.0 &amp; 3.1 (I am on this Working Group),<\/p>\n<p style=\"padding-left: 30px;\">4) Draft IEC 62366-2\u00a0Guidance on the application of usability,<\/p>\n<p style=\"padding-left: 30px;\">5) IEC\/ISO \/TR 80001-X-Y series on\u00a0Application of risk management for IT-networks incorporating medical devices,<\/p>\n<p style=\"padding-left: 30px;\">6) Draft IEC 82304-1, ed. 1.0\u00a0Health software \u2013 Part 1: General requirements for product safety,<\/p>\n<p style=\"padding-left: 30px;\">7) IEC 62304, Ed. 2.0 &#8211;\u00a0Software\u00a0Lifecycle Process,<\/p>\n<p style=\"padding-left: 30px;\">8) Draft IEC\/TR 60601-4-1\u00a0Guidance and interpretation &#8211; Medical electrical equipment and medical electrical systems employing a\u00a0degree of autonomy,<\/p>\n<p style=\"padding-left: 30px;\">9) Draft IEC\/TR 60601-4-4 Guidance for writers of particular standards on creating alarm system related requirements\u00a0(Not even on the official IEC Work Program as of March 15, 2016\u00a0but being on these committees I get a birds eye view of what is going on and I have direct links with lots of the committees I am not directly on as well),<\/p>\n<p style=\"padding-left: 30px;\">10) US Version of IEC 60601-1-11 on home healthcare environment for Medical Electrical Equipment and Systems,<\/p>\n<p style=\"padding-left: 30px;\">11) Draft of US Version of IEC 60601-1-12 on Emergency medical services environment\u00a0for Medical Electrical Equipment and Systems,<\/p>\n<p style=\"padding-left: 30px;\">12)\u00a0Draft AAMI TIR75, <em>Factors to Consider When Multi-Vendor Devices Interact Via an Electronic Interface, <\/em>(Proposed new Technical Information Report),<\/p>\n<p style=\"padding-left: 30px;\">13)\u00a0IEC 62366-1, Edition 1.0\u00a0Medical devices &#8211; Part 1: Application of usability engineering to medical devices, and how FDA is dealing with this and the older version of the standard,<\/p>\n<p style=\"padding-left: 30px;\">14) etc&#8230;<\/p>\n<p>Other area of Interest in the report include:<\/p>\n<p style=\"padding-left: 30px;\">1) Some regulatory impacts of some of the standards in the report like what is FDA expecting on IEC 60601-1-2:2014 (4th ed vs 3rd ed)<\/p>\n<p style=\"padding-left: 30px;\">2)\u00a0Harmonization\u00a0roadblock issues for the EN 60601 series and how best approach it.<\/p>\n<p>This should give you a flavor of the <a href=\"http:\/\/www.eisnersafety.com\/products\/\">reports<\/a>. \u00a0I also provide listings of the TC62, SC62A &amp; 62D (some 62B &amp; 62C) Committees for Electrical Medical Devices for IEC &amp; EN standards &amp; technical reports that have been issued in the last year or so and drafts of EN standards close to publication (not Harmonized just EN).<\/p>\n<p>For the <a href=\"http:\/\/www.eisnersafety.com\/products\/\">Home Use Report<\/a> I have 13 pages of information on the Committees that focus on Home Use for the US and also for IEC (new Systems Committee for Active Assisted Living) plus lot of additional information.<\/p>\n<p><a href=\"http:\/\/www.eisnersafety.com\/products\/\">These reports <\/a>will be ready for release by the end of March or early April 2016. Cost $3,500* (US$) per report or for both of them just $6,500** (US$). \u00a0This is steal compared the time I socked into each one of these reports, the meetings I sat in on for 2 weeks in Nov in Japan (Kobe &amp; Tokyo) in Nov 2015, and also the money saved not having to be on the committees, the travel expenses for\u00a0getting\u00a0to the meetings, \u00a0the time in the meetings, and the expected contribution to the standards development for being in these committees. \u00a0That is a lot of man hours that you\u00a0get inexpensively from my hard work.<\/p>\n<p><a href=\"http:\/\/www.eisnersafety.com\/contact_eisner_safety\/\">Contact us<\/a> to <a href=\"http:\/\/www.eisnersafety.com\/products\/\">purchase a copy<\/a> of these reports now. Leo@EisnerSafety.com or call us at 503-244-6151.<\/p>\n<p>* Current &amp; past Eisner Safety Consultants Clients\u00a0are eligible for a bigger\u00a0discount if you purchase one of the reports. \u00a0To see the current discount go to the <a href=\"http:\/\/www.eisnersafety.com\/products\/\">specialized services webpage<\/a>\u00a0for more details and for payment terms.\u00a0 Please contact us to arrange for this special discount.<\/p>\n<p>**\u00a0Current &amp; past Eisner Safety Consultants Clients are eligible for a bigger\u00a0discount if you purchase both\u00a0of the reports. \u00a0To see the current discount go to the <a href=\"http:\/\/www.eisnersafety.com\/products\/\">specialized services webpage<\/a>\u00a0for more details and for payment terms.\u00a0 Please contact us to arrange for this special discount.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>(Note this service is not offered anymore please contact us with your questions.) Do you make Medical Electrical Equipment &amp; Systems (MEE&amp;S) or Home Use MEE&amp;S? Are you up to date on all the applicable Current &amp; Draft Medical Electrical<\/p>\n","protected":false},"author":4,"featured_media":5871,"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":[1],"tags":[402,1286,1287,1288,1289,88,1290,218,22,330,861,1118,1291,632,1292],"class_list":["post-4712","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","tag-402","tag-animated-clip","tag-animated-videos","tag-annual-standards-report","tag-explainer-video","tag-home-use","tag-home-use-medical-equipment","tag-iec-60601-1","tag-medical","tag-medical-device","tag-medical-electrical-equipment","tag-medical-equipment","tag-powtoon","tag-standards","tag-technical-reports"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/4712","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=4712"}],"version-history":[{"count":1,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/4712\/revisions"}],"predecessor-version":[{"id":7273,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/4712\/revisions\/7273"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=4712"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=4712"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=4712"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}