{"id":59,"date":"2009-05-09T00:57:43","date_gmt":"2009-05-09T00:57:43","guid":{"rendered":"http:\/\/www.eisnersafety.net\/?page_id=13"},"modified":"2022-02-20T02:12:52","modified_gmt":"2022-02-20T02:12:52","slug":"safety_articles","status":"publish","type":"page","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/safety_articles\/","title":{"rendered":"Archive Publications"},"content":{"rendered":"<ul class=\"esc_list\">\n<li class=\"esc_list\"><a href=\"http:\/\/www.eisnersafety.net\/wp-content\/uploads\/2009\/05\/Part-1-Everything-you-needed-to-know1.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Everything you needed to know about who&#8217;s doing what where with IEC 60601-1 &#8211; Part 1<\/a> &#8211; Published 11 June 2015 in Scrip Regulatory Affairs Article discusses how the standard (IEC 60601-1 3rd ed. or ed. 3.1) is being used by Regulatory &amp; Standards Organizations for the USA and Canada.<br \/>\n<!-- Go to www.addthis.com\/dashboard to customize your tools --><\/li>\n<li class=\"esc_list\" style=\"text-align: left;\"><img decoding=\"async\" class=\"alignleft framecolor\" src=\"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-content\/uploads\/2020\/02\/JMDR-May-2012-Cover-pg.jpg\" alt=\"JMDR May 2012 issue Cover Page\" width=\"180\" \/><a href=\"http:\/\/www.eisnersafety.net\/wp-content\/uploads\/2009\/05\/JMDRMay2012-Eisner-secure.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Update on National Implementations of IEC 60601-1:2005<\/a> &#8211; Published May 2012 in the Journal of Medical Device Regulation Article discussed the National Implementation of IEC 60601-1:2005 into the National Regulatory schemes for the EU, Canada, USA, and Brazil.<br \/>\n<!-- Go to www.addthis.com\/dashboard to customize your tools --><\/p>\n<div class=\"at-above-post-arch-page\"><\/div>\n<\/li>\n<li style=\"text-align: left;\"><\/li>\n<li style=\"text-align: left;\"><\/li>\n<li style=\"text-align: left;\"><\/li>\n<li class=\"esc_list\"><a href=\"http:\/\/www.mddionline.com\/article\/regulatory-strategies-third-edition-iec-60601-1\" target=\"_blank\" rel=\"noopener noreferrer\">Regulatory Strategies for the Third Edition of IEC 60601-1<\/a><span style=\"color: #666666;\"> &#8212; Published September 2009 in MD&amp;DI Article discusses when IEC 60601-1:2005 will be <\/span><span style=\"color: #666666;\"> mandatory, including the US, EU, and Canadian National versions of the standard.<\/span><!-- Go to www.addthis.com\/dashboard to customize your tools --><a href=\"http:\/\/www.mddionline.com\/article\/new-us-national-standard-medical-devices\" target=\"_blank\" rel=\"noopener noreferrer\"><img decoding=\"async\" class=\"alignleft framecolor\" src=\"http:\/\/www.eisnersafety.net\/images\/mddi0609_cover.jpg\" alt=\"\" width=\"180\" \/><\/a><\/li>\n<li style=\"text-align: left;\"><\/li>\n<li class=\"esc_list\"><a href=\"http:\/\/www.mddionline.com\/article\/new-us-national-standard-medical-devices\" target=\"_blank\" rel=\"noopener noreferrer\">A New U.S. National Standard for Medical Devices<\/a> &#8212; Published September 2006 in MD&amp;DI Article discusses the new US standard ANSI\/AAMI ES 60601-1:2005 including the history of US medical electrical device standards, a summary of the national deviations., and discussion of leakage current issues.<a href=\"http:\/\/www.addthis.com\/bookmark.php?v=250&amp;pub=eisnersafety\"><br \/>\n<\/a><!-- Go to www.addthis.com\/dashboard to customize your tools --><\/li>\n<li class=\"esc_list\" style=\"text-align: left;\"><a href=\"http:\/\/eisnersafety.net\/downloads\/IEC60601-1_JMDRMay2006.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"><br \/>\n<\/a><a href=\"http:\/\/eisnersafety.net\/downloads\/IEC60601-1_JMDRMay2006.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">IEC 60601-1 \u2013 The Third Edition<\/a> &#8212; Published May 2006 in Journal of Medical Device Regulation Article covers IEC 60601-1 and its&#8217; major changes including amended scope, modification of medical electrical equipment definition, inclusion of risk management, essential performance, and impact on manufacturers &amp; certification bodies.<!-- Go to www.addthis.com\/dashboard to customize your tools --><\/li>\n<li><\/li>\n<li class=\"esc_list\"><a href=\"http:\/\/www.ce-mag.com\/archive\/05\/01\/013.html\" target=\"_blank\" rel=\"noopener noreferrer\"><img decoding=\"async\" class=\"framecolor\" src=\"http:\/\/www.eisnersafety.net\/images\/ce0501cover.jpg\" alt=\"\" width=\"180\" \/><\/a><a href=\"http:\/\/www.ce-mag.com\/archive\/05\/01\/013.html\" target=\"_blank\" rel=\"noopener noreferrer\">Risk Management Implications of IEC 60601-1, 3rd Ed.<\/a> &#8212; Published January 2005 in CE Discusses that manufacturers should gear up to change their practice of risk management in engineering medical electrical equipment per the upcoming IEC 60601-1, third edition.<br \/>\n<!-- Go to www.addthis.com\/dashboard to customize your tools --><\/li>\n<li><\/li>\n<li class=\"esc_list\"><a href=\"http:\/\/www.ce-mag.com\/archive\/05\/01\/004.html\" target=\"_blank\" rel=\"noopener noreferrer\">A Regulatory Review of the EMC Standard for Medical Devices<\/a> &#8212; Published January 2005 in CE Discussion for manufacturers to get prepared for tougher requirements now that the second edition of IEC 60601-1-2 is supplanting the first.<br \/>\n<!-- Go to www.addthis.com\/dashboard to customize your tools --><\/li>\n<li><\/li>\n<li class=\"esc_list\" style=\"text-align: left;\"><a href=\"http:\/\/www.devicelink.com\/mem\/archive\/04\/10\/010.html\" target=\"_blank\" rel=\"noopener noreferrer\">Safety Requirements: Understanding IEC 60601-1<\/a><span style=\"color: #666666;\"> &#8212; Published Fall 2004 in MEM This article explains the IEC 60601-1 standard, the series, national standards, structure of base standard, &amp; basic concepts including classifications.<\/span><!-- Go to www.addthis.com\/dashboard to customize your tools --><\/li>\n<li><\/li>\n<li class=\"esc_list\"><a href=\"http:\/\/www.mddionline.com\/article\/leakage-current-standards-simplified\" target=\"_blank\" rel=\"noopener noreferrer\">Leakage Current Standards Simplified<\/a> &#8212; Published July 2004 in MD&amp;DI IEC 60601-1 and related standards provide detailed explanations of testing strategies for leakage current. Understanding those tests and applying them effectively is a critical aspect of making electromedical equipment.<br \/>\n<!-- Go to www.addthis.com\/dashboard to customize your tools --><\/p>\n<div class=\"at-above-post-arch-page\"><\/div>\n<\/li>\n<li class=\"esc_list\"><a href=\"http:\/\/www.mddionline.com\/article\/iec-60601-1-medical-device-marking-and-labeling\" target=\"_blank\" rel=\"noopener noreferrer\">IEC 60601-1: Medical Device Marking and Labeling<\/a> &#8212; Published May 2004 in MD&amp;DI This article discusses how IEC 60601-1 treats labeling as a critical component of medical devices and provides comprehensive requirements for marking and labeling.<br \/>\n<!-- Go to www.addthis.com\/dashboard to customize your tools --><\/li>\n<li><\/li>\n<li class=\"esc_list\"><a href=\"http:\/\/www.mddionline.com\/article\/national-deviations-iec-60601-1\" target=\"_blank\" rel=\"noopener noreferrer\">National Deviations to IEC 60601-1<\/a>Published February 2004 in MD&amp;DI This articles discusses the national deviations to the U.S., Canadian, and Australian requirements related to IEC 60601-1, 2nd ed.<br \/>\n<!-- Go to www.addthis.com\/dashboard to customize your tools --><\/p>\n<div class=\"at-above-post-arch-page\"><\/div>\n<\/li>\n<li class=\"esc_list\"><a href=\"http:\/\/www.mddionline.com\/article\/primer-iec-60601-1\" target=\"_blank\" rel=\"noopener noreferrer\">A Primer for IEC 60601-1<\/a> &#8212; Published September 2003 in MD&amp;DI This article discusses the process of &#8220;designing in&#8221; safety is a must to ensure that electrical medical products (IEC 60601-1) succeed in meeting both regulatory requirements and market prospects. Projects are often delayed due to underestimating the product safety requirements in the initial design phase.<br \/>\n<!-- Go to www.addthis.com\/dashboard to customize your tools --><\/p>\n<div class=\"at-above-post-arch-page\"><\/div>\n<\/li>\n<li class=\"esc_list\"><a href=\"http:\/\/www.ce-mag.com\/archive\/04\/Richards.html\" target=\"_blank\" rel=\"noopener noreferrer\">Finding and Using Electrical Safety Testing Resources<\/a> &#8212; Authored by James Richards and published in Compliance Engineering.<br \/>\n<!-- Go to www.addthis.com\/dashboard to customize your tools --><\/li>\n<\/ul>\n<h6>We are Pleased to Present a Series of Articles on IEC60601-1 the International Standard for Electro-Medical Equipment in Cooperation with <a href=\"http:\/\/www.quadtech.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">QuadTech<\/a><\/h6>\n<ul class=\"esc_list\">\n<li class=\"esc_listsub\">At last, in this <a href=\"http:\/\/www.eisnersafety.net\/wp-content\/uploads\/2009\/06\/8th-article-final.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">final installment<\/a>, specific parameters from Nationals standards are highlighted and their differences from IEC 60601-1 are detailed. A short discussion on medical device approval is provided also.<\/li>\n<li class=\"esc_listsub\">The seventh in the series explains <a href=\"http:\/\/www.eisnersafety.net\/wp-content\/uploads\/2009\/06\/seventh-article.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Leakage Currents &#8211; Part 2<\/a> Part 2 builds on the basic principles and details from the Part 1 article of IEC60601-1 measurement circuits for Earth, Touch\/Chassis and Patient leakage current tests.<\/li>\n<li class=\"esc_listsub\">The sixth in the series explains <a href=\"http:\/\/www.eisnersafety.net\/wp-content\/uploads\/2009\/06\/sixth-article.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Leakage Current<\/a> concepts for medical device requirements &#8211; This is part 1 of 2<\/li>\n<li class=\"esc_listsub\">The fifth in the series explains <a href=\"http:\/\/www.eisnersafety.net\/wp-content\/uploads\/2009\/06\/fifth-article.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">production line electrical safety tests (EST)<\/a><\/li>\n<li class=\"esc_listsub\">The fourth in the series explains the <a href=\"http:\/\/www.eisnersafety.net\/wp-content\/uploads\/2009\/06\/8th-article-final.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Classification<\/a> system used in IEC60601-1<\/li>\n<li class=\"esc_listsub\">The third in the series looks at litigation risks and market recognition as drivers for\u00a0why you should use IEC60601-1.\u00a0 The article is titled <a href=\"http:\/\/www.eisnersafety.net\/wp-content\/uploads\/2009\/06\/IEC60601-1-and-Your-Electrical-Medical-ProductUpdated4-21-03.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">IEC60601-1 and Your Electrical Medical Product<\/a><\/li>\n<li class=\"esc_listsub\">The second in the series explains the legal requirements for <a href=\"http:\/\/www.eisnersafety.net\/wp-content\/uploads\/2009\/06\/Why-Prod-Sfty-Testing-ESC-VerUpdated4-21-03.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Why Product Safety Testing for Your Electrical Medical Products?<\/a><\/li>\n<li class=\"esc_listsub\">The first part in this series provides an overview of the IEC60601 series of standards <a href=\"http:\/\/www.eisnersafety.net\/wp-content\/uploads\/2009\/06\/OverviewbyESC-issued08May01Updated4-21-03.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Overview of IEC60601-1<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Everything you needed to know about who&#8217;s doing what where with IEC 60601-1 &#8211; Part 1 &#8211; Published 11 June 2015 in Scrip Regulatory Affairs Article discusses how the standard (IEC 60601-1 3rd ed. or ed. 3.1) is being used<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-59","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/pages\/59","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=59"}],"version-history":[{"count":9,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/pages\/59\/revisions"}],"predecessor-version":[{"id":7117,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/pages\/59\/revisions\/7117"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=59"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}