{"id":14178,"date":"2024-06-06T16:47:26","date_gmt":"2024-06-06T14:47:26","guid":{"rendered":"https:\/\/phatocon.com\/2024\/06\/06\/biological-evaluation-plan\/"},"modified":"2024-12-02T18:06:48","modified_gmt":"2024-12-02T17:06:48","slug":"biological-evaluation-plan","status":"publish","type":"post","link":"https:\/\/phatocon.com\/en\/2024\/06\/06\/biological-evaluation-plan\/","title":{"rendered":"Biological evaluation plan"},"content":{"rendered":"<section class=\"l-section wpb_row height_auto\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_middle type_default stacking_default\"><div class=\"vc_col-sm-6 vc_hidden-md vc_hidden-sm vc_hidden-xs wpb_column vc_column_container has_bg_color\" id=\"gradientrechts\"><div class=\"vc_column-inner us_custom_005f1b5e\"><div class=\"vc_column-overlay\" style=\"background:linear-gradient(-90deg, rgba(255,255,255,1) 3%, rgba(255,255,255,0.89) 20%, rgba(255,255,255,0.59) 42%, rgba(255,255,255,0.07) 62%, rgba(255,255,255,0) 88%)\"><\/div><div class=\"wpb_wrapper\"><\/div><\/div><\/div><div class=\"vc_col-sm-12 vc_col-lg-6 wpb_column vc_column_container\"><div class=\"vc_column-inner us_custom_870fb40f\"><div class=\"wpb_wrapper\"><div class=\"g-cols wpb_row hide_on_default via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container gradientunten has_bg_color\"><div class=\"vc_column-inner us_custom_29547bd8\"><div class=\"vc_column-overlay\" style=\"background:linear-gradient(360deg, rgba(255,255,255,1) 3%, rgba(255,255,255,0.89) 20%, rgba(255,255,255,0.59) 42%, rgba(255,255,255,0.07) 62%, rgba(255,255,255,0) 88%)\"><\/div><div class=\"wpb_wrapper\"><\/div><\/div><\/div><\/div><div class=\"wpb_text_column us_custom_3090c82c\"><div class=\"wpb_wrapper\"><h4><span style=\"color: #18add9;\">2.<\/span> TOXICOLOGICAL RISK ASSESSMENT<\/h4>\n<\/div><\/div><div class=\"wpb_text_column us_custom_26060442\"><div class=\"wpb_wrapper\"><p>Calculation of safety margins based on toxicity and concentration of identified extractables<\/p>\n<\/div><\/div><div class=\"w-popup w-btn-wrapper align_none\"><button aria-label=\"Read more\" class=\"w-popup-trigger type_btn w-btn us-btn-style_59 icon_atright\"><span class=\"w-btn-label\">Read more<\/span><i class=\"fal fa-long-arrow-right\"><\/i><\/button><div class=\"w-popup-overlay\" style=\"background:rgba(0,0,0,0.25);\"><\/div><div class=\"w-popup-wrap layout_right_panel\" style=\"--title-color:var(--color-content-heading);--title-bg-color:var(--color-content-bg-alt);--content-color:;--content-bg-color:var(--color-content-bg);--popup-width:800px;--popup-padding:0px;\"><div class=\"w-popup-box animation_slideRight closerpos_inside without_title\"><div class=\"w-popup-box-h\"><div class=\"w-popup-box-content\"><section class=\"l-section wpb_row height_auto\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-separator size_medium\"><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column us_custom_07960d64\"><div class=\"wpb_wrapper\"><h3>TOXICOLOGICAL RISK ASSESSMENT (TRA)<\/h3>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>Calculation of safety margins based on toxicity and concentration of identified extractables<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_small with_line width_default thick_1 style_solid color_border align_center\"><div class=\"w-separator-h\"><\/div><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column us_custom_9c33410b gradient-text-dark\"><div class=\"wpb_wrapper\"><h5>WHAT IS THE TOXICOLOGICAL RISK ASSESSMENT FOR MEDICAL DEVICES?<\/h5>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>A toxicological risk assessment is a comprehensive safety assessment of a device, based on its composition, the materials used and taking into account the intended use. The detailed scientific report on the toxicological assessment contains all available and relevant information and data on a specific ingredient in relation to the medical device under investigation. This includes the dosage, the concentration and the specific exposure scenario.<\/p>\n<p>The toxicological risk assessment is a scientific evaluation and includes the following activities:<\/p>\n<\/div><\/div><div class=\"w-separator size_custom\" style=\"height:10px\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left no_text\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-link);--icon-bg-color:var(--color-content-bg-alt);\"><i class=\"fal fa-check\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\" style=\"font-size:17px;\">Characterization of substances that can be extracted and leached<\/h5><\/div><\/div><div class=\"w-separator size_custom\" style=\"height:10px\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left no_text\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-link);--icon-bg-color:var(--color-content-bg-alt);\"><i class=\"fal fa-check\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\" style=\"font-size:17px;\">Evaluation of exposure<\/h5><\/div><\/div><div class=\"w-separator size_custom\" style=\"height:10px\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left no_text\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-link);--icon-bg-color:var(--color-content-bg-alt);\"><i class=\"fal fa-check\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\" style=\"font-size:17px;\">Dose-response assessment<\/h5><\/div><\/div><div class=\"w-separator size_custom\" style=\"height:10px\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left no_text\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-link);--icon-bg-color:var(--color-content-bg-alt);\"><i class=\"fal fa-check\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\" style=\"font-size:17px;\">Identification of hazards and evaluation of data<\/h5><\/div><\/div><div class=\"w-separator size_custom\" style=\"height:10px\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left no_text\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-link);--icon-bg-color:var(--color-content-bg-alt);\"><i class=\"fal fa-check\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\" style=\"font-size:17px;\">Risk characterization<\/h5><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_small with_line width_default thick_1 style_solid color_border align_center\"><div class=\"w-separator-h\"><\/div><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column us_custom_9c33410b gradient-text-dark\"><div class=\"wpb_wrapper\"><h5>WHY IS TOXICOLOGICAL RISK ASSESSMENT SO IMPORTANT FOR THE SAFETY OF MEDICAL DEVICES?<\/h5>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>Properly evaluating and assessing the biological and toxicological risks, posed by extractables or chemical residues that may impact patient safety, is one of the more challenging aspects of the chemical characterization process.<br \/>\nTo control the risk associated with extractable substances, these substances are identified, the related risks are quantified and exposure to these substances is limited so that acceptable limits are not exceeded.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_small with_line width_default thick_1 style_solid color_border align_center\"><div class=\"w-separator-h\"><\/div><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column us_custom_9c33410b gradient-text-dark\"><div class=\"wpb_wrapper\"><h5>RISK MANAGEMENT?<\/h5>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>Risk assessment is an important and essential part of the chemical characterization and biocompatibility testing, since it defines the acceptable limits for extractable and leachable substances.<\/p>\n<p>The ISO 10993 standard series serves as a framework for assessing the biocompatibility of medical devices and the management of biological risks. The specific standards ISO 10993-17 and ISO\/TS 21726 regulate the evaluation criteria for the toxicological risk analysis of the components of medical devices and the determination of the acceptable limit values for extractable substances.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_medium\"><\/div><div class=\"w-separator size_medium\"><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n<\/div><div class=\"w-popup-closer\"><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section><section class=\"l-section wpb_row height_auto\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><\/div><\/div><\/div><\/div><\/div><\/section>\n","protected":false},"excerpt":{"rendered":"2. TOXICOLOGICAL RISK ASSESSMENT Calculation of safety margins based on toxicity and concentration of identified extractables Read moreTOXICOLOGICAL RISK ASSESSMENT (TRA) Calculation of safety margins based on toxicity and concentration of identified extractables WHAT IS THE TOXICOLOGICAL RISK ASSESSMENT FOR MEDICAL DEVICES? A toxicological risk assessment is a comprehensive safety assessment of a device, based...","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-14178","post","type-post","status-publish","format-standard","hentry","category-unkategorisiert"],"_links":{"self":[{"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/posts\/14178","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/comments?post=14178"}],"version-history":[{"count":2,"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/posts\/14178\/revisions"}],"predecessor-version":[{"id":14182,"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/posts\/14178\/revisions\/14182"}],"wp:attachment":[{"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/media?parent=14178"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/categories?post=14178"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/tags?post=14178"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}