{"id":6550,"date":"2021-02-22T11:21:39","date_gmt":"2021-02-22T10:21:39","guid":{"rendered":"https:\/\/www.riskmanager.net\/?page_id=6550"},"modified":"2023-06-29T17:05:14","modified_gmt":"2023-06-29T15:05:14","slug":"medical-electrical-equipment-iec-60601-1","status":"publish","type":"page","link":"https:\/\/www.riskmanager.net\/en\/medical-electrical-equipment-iec-60601-1\/","title":{"rendered":"Medical electrical equipment IEC 60601-1"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kky3qegl-e0b51bff546f7dd3d74cad91705b39e6\">\n.avia-section.av-kky3qegl-e0b51bff546f7dd3d74cad91705b39e6{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/shutterstock_527544358-1030x567.jpg);\nbackground-position:50% 50%;\nbackground-attachment:fixed;\n}\n.avia-section.av-kky3qegl-e0b51bff546f7dd3d74cad91705b39e6 .av-section-color-overlay{\nopacity:0.7;\nbackground-color:#000000;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-kky3qegl-e0b51bff546f7dd3d74cad91705b39e6 alternate_color avia-section-default avia-no-border-styling  avia-builder-el-0  el_before_av_section  avia-builder-el-first  avia-full-stretch avia-bg-style-fixed av-section-color-overlay-active container_wrap fullsize'  data-section-bg-repeat='stretch'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' ><main  role=\"main\" itemprop=\"mainContentOfPage\"  class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-6550'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-714kvd-815af3640acd65cc8f052990d64f59ad\">\n.flex_column.av-714kvd-815af3640acd65cc8f052990d64f59ad{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-714kvd-815af3640acd65cc8f052990d64f59ad av_one_full  avia-builder-el-1  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2m8uee-d694032575b54d87683765ee206b784b\">\n#top .av-special-heading.av-2m8uee-d694032575b54d87683765ee206b784b{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-2m8uee-d694032575b54d87683765ee206b784b .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-2m8uee-d694032575b54d87683765ee206b784b .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-2m8uee-d694032575b54d87683765ee206b784b av-special-heading-h1 blockquote modern-quote modern-centered  avia-builder-el-2  el_before_av_textblock  avia-builder-el-first '><h1 class='av-special-heading-tag '  itemprop=\"headline\"  >Process acceleration with the Risk Manager<\/h1><div class='av-subheading av-subheading_below'><p>Conformity report of the medical electrical<br \/>\ndevice according to IEC EN 60601-1<\/p>\n<\/div><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-kky30rwr-34b96e283acadb1c77294049c471a570 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p style=\"text-align: center\">Edition 3.1 of IEC 60601-1 for medical electrical equipment brings with it more than 400 pages of requirements and over 1500 applicability tests. With BAYOOSOFT Risk Manager you can efficiently design the process up to the conformity report &#8211; and accelerate it by up to 62%.<\/p>\n<\/div><\/section><br \/>\n<div  class='avia-button-wrap av-kky30gyh-7e1de61e7a248641513a1bee21076535-wrap avia-button-center  avia-builder-el-4  el_after_av_textblock  avia-builder-el-last '><a href='\/en\/medical-electrical-equipment-iec-60601-1\/#meeform'  class='avia-button av-kky30gyh-7e1de61e7a248641513a1bee21076535 av-link-btn avia-icon_select-no avia-size-large avia-position-center avia-color-theme-color'   aria-label=\"Make an appointment now or join one of our webinars for free\"><span class='avia_iconbox_title' >Make an appointment now or join one of our webinars for free<\/span><\/a><\/div><\/p><\/div>\n\n<\/div><\/div><\/main><!-- close content main element --><\/div><\/div><\/div><div id='av_section_2'  class='avia-section av-dlr3jd-97a20e81ae4cda447700b6c62c882ba6 main_color avia-section-default avia-no-border-styling  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a{\nwidth:20%;\n}\n<\/style>\n<div  class='avia-gallery av-kky6mdg6-360bbfa24cb87145621907e0717e74dc avia_animate_when_visible  avia-builder-el-7  avia-builder-el-no-sibling  avia_lazyload av-slideshow-ui av-loop-manual-endless av-control-hidden av-navigate-arrows av-navigate-dots hover-effect av-control-hidden avia-gallery-animate avia-gallery-1'  itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><meta itemprop=\"contentURL\" content=\"https:\/\/www.riskmanager.net\/en\/medical-electrical-equipment-iec-60601-1\/\"><a class='avia-gallery-big fakeLightbox lightbox avia-gallery-big-crop-thumb ' href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-1030x644.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1.png 1680w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\"  data-onclick='1' title='Conformity report for medical electrical equipment according to IEC EN 60601-1 3.1 OUTPUT\u00a0' ><span class='avia-gallery-big-inner'  itemprop=\"thumbnailUrl\" ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3754 avia-img-lazy-loading-not-3754\"  width=\"1030\" height=\"644\" src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-1030x644.png\" title='1-10' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1.png 1680w\" sizes=\"(max-width: 1030px) 100vw, 1030px\" \/><span class='avia-gallery-caption'>Conformity report for medical electrical equipment according to IEC EN 60601-1 3.1 OUTPUT\u00a0<\/span><\/span><\/a><div class='avia-gallery-thumb'><a href=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-1030x644.png\" data-srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-1030x644.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-300x188.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-768x480.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-1536x960.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-1500x938.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-705x441.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-450x281.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1.png 1680w\" data-sizes=\"(max-width: 1030px) 100vw, 1030px\" data-rel='gallery-1' data-prev-img='https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-1030x644.png' class='first_thumb lightbox ' data-onclick='1' title='Conformity report for medical electrical equipment according to IEC EN 60601-1 3.1 OUTPUT\u00a0'  itemprop=\"thumbnailUrl\"  ><img decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-3754 avia-img-lazy-loading-not-3754\"  data-avia-tooltip='Conformity report for medical electrical equipment according to IEC EN 60601-1 3.1 OUTPUT\u00a0' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-845x684.png\" width=\"845\" height=\"684\"  title='1-10' alt='' srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/07\/1-10-1-845x684.png 845w, 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'     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-fku8m-aac3a8fcc262e182cbfcab71cb5a2dd6\">\n#top .av-special-heading.av-fku8m-aac3a8fcc262e182cbfcab71cb5a2dd6{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-fku8m-aac3a8fcc262e182cbfcab71cb5a2dd6 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-fku8m-aac3a8fcc262e182cbfcab71cb5a2dd6 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-fku8m-aac3a8fcc262e182cbfcab71cb5a2dd6 av-special-heading-h2 blockquote modern-quote  avia-builder-el-9  el_before_av_iconlist  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Process acceleration of up to 62% &#8211; how does that work?<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<div  class='avia-icon-list-container av-kky7mman-cca04515a823091536d73e578a95d7ed  avia-builder-el-10  el_after_av_heading  avia-builder-el-last '><ul class='avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-big av-kky7mman-cca04515a823091536d73e578a95d7ed avia-iconlist-animate'>\n<li><div class='iconlist_icon av-20mlfa-d0d6b7c0ba940ea81822e4925cc06e32 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue86f' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Filtering out non-relevant exams\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Filtering out non-relevant exams<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><p>Through intelligent queries, the BAYOOSOFT Risk Manager filters out test questions that are not applicable to your medical device and answers them automatically. This provides you with interactive guidance through the standardisation process.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-4ujd1i-0102419d4bf46a11e1488df3259c92e8 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue895' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Integration of the risk management process according to ISO 14971\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Integration of the risk management process according to ISO 14971<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><p>The full integration of the risk management process makes it quick and easy to link your existing 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