{"id":203,"date":"2023-04-20T15:07:26","date_gmt":"2023-04-20T13:07:26","guid":{"rendered":"https:\/\/ceiso.fr\/en\/?page_id=203"},"modified":"2023-04-20T15:13:34","modified_gmt":"2023-04-20T13:13:34","slug":"normative-context","status":"publish","type":"page","link":"https:\/\/ceiso.fr\/en\/normative-context\/","title":{"rendered":"Normative context"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"203\" class=\"elementor elementor-203\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-fd4d7ce elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"fd4d7ce\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-300a3e2\" data-id=\"300a3e2\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-22d2b7d elementor-widget elementor-widget-heading\" data-id=\"22d2b7d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.12.2 - 23-04-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h2 class=\"elementor-heading-title elementor-size-default\">Referentials<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f29e7dc elementor-tabs-view-vertical tabs-custom elementor-widget elementor-widget-tabs\" data-id=\"f29e7dc\" data-element_type=\"widget\" data-widget_type=\"tabs.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.12.2 - 23-04-2023 *\/\n.elementor-widget-tabs.elementor-tabs-view-vertical .elementor-tabs-wrapper{width:25%;flex-shrink:0}.elementor-widget-tabs.elementor-tabs-view-vertical .elementor-tab-desktop-title.elementor-active{border-right-style:none}.elementor-widget-tabs.elementor-tabs-view-vertical .elementor-tab-desktop-title.elementor-active:after,.elementor-widget-tabs.elementor-tabs-view-vertical .elementor-tab-desktop-title.elementor-active:before{height:999em;width:0;right:0;border-right-style:solid}.elementor-widget-tabs.elementor-tabs-view-vertical .elementor-tab-desktop-title.elementor-active:before{top:0;transform:translateY(-100%)}.elementor-widget-tabs.elementor-tabs-view-vertical .elementor-tab-desktop-title.elementor-active:after{top:100%}.elementor-widget-tabs.elementor-tabs-view-horizontal .elementor-tab-desktop-title{display:table-cell}.elementor-widget-tabs.elementor-tabs-view-horizontal .elementor-tab-desktop-title.elementor-active{border-bottom-style:none}.elementor-widget-tabs.elementor-tabs-view-horizontal .elementor-tab-desktop-title.elementor-active:after,.elementor-widget-tabs.elementor-tabs-view-horizontal .elementor-tab-desktop-title.elementor-active:before{bottom:0;height:0;width:999em;border-bottom-style:solid}.elementor-widget-tabs.elementor-tabs-view-horizontal .elementor-tab-desktop-title.elementor-active:before{right:100%}.elementor-widget-tabs.elementor-tabs-view-horizontal .elementor-tab-desktop-title.elementor-active:after{left:100%}.elementor-widget-tabs .elementor-tab-content,.elementor-widget-tabs .elementor-tab-title,.elementor-widget-tabs .elementor-tab-title:after,.elementor-widget-tabs .elementor-tab-title:before,.elementor-widget-tabs .elementor-tabs-content-wrapper{border:1px #d5d8dc}.elementor-widget-tabs .elementor-tabs{text-align:left}.elementor-widget-tabs .elementor-tabs-wrapper{overflow:hidden}.elementor-widget-tabs .elementor-tab-title{cursor:pointer;outline:var(--focus-outline,none)}.elementor-widget-tabs .elementor-tab-desktop-title{position:relative;padding:20px 25px;font-weight:700;line-height:1;border:solid transparent}.elementor-widget-tabs .elementor-tab-desktop-title.elementor-active{border-color:#d5d8dc}.elementor-widget-tabs .elementor-tab-desktop-title.elementor-active:after,.elementor-widget-tabs .elementor-tab-desktop-title.elementor-active:before{display:block;content:\"\";position:absolute}.elementor-widget-tabs .elementor-tab-desktop-title:focus-visible{border:1px solid #000}.elementor-widget-tabs .elementor-tab-mobile-title{padding:10px;cursor:pointer}.elementor-widget-tabs .elementor-tab-content{padding:20px;display:none}@media (max-width:767px){.elementor-tabs .elementor-tab-content,.elementor-tabs .elementor-tab-title{border-style:solid solid none}.elementor-tabs .elementor-tabs-wrapper{display:none}.elementor-tabs .elementor-tabs-content-wrapper{border-bottom-style:solid}.elementor-tabs .elementor-tab-content{padding:10px}}@media (min-width:768px){.elementor-widget-tabs.elementor-tabs-view-vertical .elementor-tabs{display:flex}.elementor-widget-tabs.elementor-tabs-view-vertical .elementor-tabs-wrapper{flex-direction:column}.elementor-widget-tabs.elementor-tabs-view-vertical .elementor-tabs-content-wrapper{flex-grow:1;border-style:solid solid solid none}.elementor-widget-tabs.elementor-tabs-view-horizontal .elementor-tab-content{border-style:none solid solid}.elementor-widget-tabs.elementor-tabs-alignment-center .elementor-tabs-wrapper,.elementor-widget-tabs.elementor-tabs-alignment-end .elementor-tabs-wrapper,.elementor-widget-tabs.elementor-tabs-alignment-stretch .elementor-tabs-wrapper{display:flex}.elementor-widget-tabs.elementor-tabs-alignment-center .elementor-tabs-wrapper{justify-content:center}.elementor-widget-tabs.elementor-tabs-alignment-end .elementor-tabs-wrapper{justify-content:flex-end}.elementor-widget-tabs.elementor-tabs-alignment-stretch.elementor-tabs-view-horizontal .elementor-tab-title{width:100%}.elementor-widget-tabs.elementor-tabs-alignment-stretch.elementor-tabs-view-vertical .elementor-tab-title{height:100%}.elementor-tabs .elementor-tab-mobile-title{display:none}}<\/style>\t\t<div class=\"elementor-tabs\">\n\t\t\t<div class=\"elementor-tabs-wrapper\" role=\"tablist\" >\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-2541\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"true\" data-tab=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"elementor-tab-content-2541\" aria-expanded=\"false\">ISO 14155<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-2542\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"2\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-2542\" aria-expanded=\"false\">ISO 9001<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-2543\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"3\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-2543\" aria-expanded=\"false\">ISO 13485<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-2544\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"4\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-2544\" aria-expanded=\"false\">EN 62366-1<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-2545\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"5\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-2545\" aria-expanded=\"false\">EN 60601-1<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-2546\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"6\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-2546\" aria-expanded=\"false\">EN 62304<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-2547\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"7\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-2547\" aria-expanded=\"false\">EN ISO 14971<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-2548\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"8\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-2548\" aria-expanded=\"false\">EN ISO 15189<\/div>\n\t\t\t\t\t\t\t\t\t<div id=\"elementor-tab-title-2549\" class=\"elementor-tab-title elementor-tab-desktop-title\" aria-selected=\"false\" data-tab=\"9\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-2549\" aria-expanded=\"false\">NF S 96-900 - EN ISO 20387<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t<div class=\"elementor-tabs-content-wrapper\" role=\"tablist\" aria-orientation=\"vertical\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"true\" data-tab=\"1\" role=\"tab\" tabindex=\"0\" aria-controls=\"elementor-tab-content-2541\" aria-expanded=\"false\">ISO 14155<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2541\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-2541\" tabindex=\"0\" hidden=\"false\"><p><span style=\"color: #023e7d; font-weight: bold;\">Goal\/scope :<\/span><\/p><p>Good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out on human subjects to assess the safety or performance of Medical Devices or Active Implantable Medical Devices.<\/p><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"2\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-2542\" aria-expanded=\"false\">ISO 9001<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2542\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-2542\" tabindex=\"0\" hidden=\"hidden\"><p><span style=\"color: #023e7d; font-weight: bold;\">Goal\/scope :<\/span><\/p><p>Defines a series of requirements regarding the implementation of a quality management system in an organization, regardless of its size and sector of activity. It is part of the ISO 9000 series of standards.<\/p><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"3\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-2543\" aria-expanded=\"false\">ISO 13485<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2543\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-2543\" tabindex=\"0\" hidden=\"hidden\"><p><span style=\"color: #023e7d; font-weight: bold;\">Goal\/scope :<\/span><\/p><p>Specifies the quality management system (QMS) requirements for regulatory purposes for the medical device industry.<\/p><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"4\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-2544\" aria-expanded=\"false\">EN 62366-1<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2544\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-2544\" tabindex=\"0\" hidden=\"hidden\"><p><span style=\"color: #023e7d; font-weight: bold;\">Goal\/scope :<\/span><\/p><p>Application of usability engineering to medical devices.<\/p><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"5\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-2545\" aria-expanded=\"false\">EN 60601-1<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2545\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-2545\" tabindex=\"0\" hidden=\"hidden\"><p><span style=\"color: #023e7d; font-weight: bold;\">Objectif\/scope :<\/span><\/p><p>Basic safety and essential performance of medical electrical equipment.<\/p><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"6\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-2546\" aria-expanded=\"false\">EN 62304<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2546\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"6\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-2546\" tabindex=\"0\" hidden=\"hidden\"><p><span style=\"color: #023e7d; font-weight: bold;\">Goal\/scope :<\/span><\/p><p>Dedicated to Medical Device Software &#8211; Software life cycle processes.<\/p><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"7\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-2547\" aria-expanded=\"false\">EN ISO 14971<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2547\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"7\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-2547\" tabindex=\"0\" hidden=\"hidden\"><p><span style=\"color: #023e7d; font-weight: bold;\">Goal\/scope :<\/span><\/p><p>Application of risk management to medical devices.<\/p><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"8\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-2548\" aria-expanded=\"false\">EN ISO 15189<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2548\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"8\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-2548\" tabindex=\"0\" hidden=\"hidden\"><p><span style=\"color: #023e7d; font-weight: bold;\">Goal\/scope :<\/span><\/p><p>Requirements for quality and competence applicable to medical biology laboratories.<\/p><\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-tab-title elementor-tab-mobile-title\" aria-selected=\"false\" data-tab=\"9\" role=\"tab\" tabindex=\"-1\" aria-controls=\"elementor-tab-content-2549\" aria-expanded=\"false\">NF S 96-900 - EN ISO 20387<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2549\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"9\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-2549\" tabindex=\"0\" hidden=\"hidden\"><p><span style=\"color: #023e7d; font-weight: bold;\">Goal\/scope :<\/span><\/p><p>Requirements necessary to ensure the quality of biological resources (for research, conservation of genetic heritage, education or economic valorization) &#8211; Certification of Biological Resource Centers.<\/p><\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Referentials ISO 14155 ISO 9001 ISO 13485 EN 62366-1 EN 60601-1 EN 62304 EN ISO 14971 EN ISO 15189 NF S 96-900 &#8211; EN ISO 20387 ISO 14155 Goal\/scope : Good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out on human subjects to assess the safety or performance of [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/pages\/203"}],"collection":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/comments?post=203"}],"version-history":[{"count":10,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/pages\/203\/revisions"}],"predecessor-version":[{"id":213,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/pages\/203\/revisions\/213"}],"wp:attachment":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/media?parent=203"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}