{"id":14186,"date":"2024-06-06T16:49:41","date_gmt":"2024-06-06T14:49:41","guid":{"rendered":"https:\/\/phatocon.com\/2024\/06\/06\/biocompatibility-documentation\/"},"modified":"2024-12-02T18:09:32","modified_gmt":"2024-12-02T17:09:32","slug":"biocompatibility-documentation","status":"publish","type":"post","link":"https:\/\/phatocon.com\/en\/2024\/06\/06\/biocompatibility-documentation\/","title":{"rendered":"BIOCOMPATIBILITY DOCUMENTATION"},"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_b38a3ea3\"><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_63f60c5d\"><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;\">6.<\/span> BIOCOMPATIBILITY DOCUMENTATION<\/h4>\n<\/div><\/div><div class=\"wpb_text_column us_custom_26060442\"><div class=\"wpb_wrapper\"><p>If It Wasn&#8217;t Documented, It Didn&#8217;t Happen \u2026 ?<\/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>BIOCOMPATIBILITY DOCUMENTATION<\/h3>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>If It Wasn&#8217;t Documented, It Didn&#8217;t Happen \u2026 ?<\/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=\"w-image align_none\"><a ref=\"magnificPopup\" href=\"https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/Bildschirmfoto-2024-06-16-um-13.58.01.png\" aria-label=\"Bildschirmfoto 2024-06-16 um 13.58.01\" class=\"w-image-h\"><img decoding=\"async\" width=\"1024\" height=\"258\" src=\"https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/Bildschirmfoto-2024-06-16-um-13.58.01-1024x258.png\" class=\"attachment-large size-large\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/Bildschirmfoto-2024-06-16-um-13.58.01-1024x258.png 1024w, https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/Bildschirmfoto-2024-06-16-um-13.58.01-300x76.png 300w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/a><\/div><div class=\"wpb_text_column us_custom_f73f4019\"><div class=\"wpb_wrapper\"><p style=\"text-align: center;\">Click on the graphic to view it in full screen<\/p>\n<\/div><\/div><div class=\"w-separator size_small\"><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>The Biological Evaluation Plan (BEP) describes the strategy for investigating and ensuring the medical risk or biocompatibility of the medical device. The plan should describe and justify the biocompatibility assessment procedure in detail. All available information on the intended use of the device, the device configuration and design, the materials used in the device and in the manufacturing process, the production conditions and, if applicable, existing preclinical and clinical data should be taken into account.<\/p>\n<p>The biological evaluation plan will then identify the gaps in the biocompatibility assessment and, based on ISO 10993-1, provide an expert recommendation on how to close these gaps most efficiently.<\/p>\n<p>The development of a qualified biological assessment plan is expected by the authorizing institutions and authorities. In accordance with ISO 10993-1, it is also expected that all steps of the biocompatibility test in planning, execution, evaluation and documentation are carried out by experts.<\/p>\n<p>Finally, all data are compiled and evaluated by experts and summarized in the Biological Evaluation Report (BER). At the end, a qualified statement on biocompatibility and, if applicable, a biocompatibility certificate should be available as an important part of the authorization documents.<\/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>\n","protected":false},"excerpt":{"rendered":"6. BIOCOMPATIBILITY DOCUMENTATION If It Wasn&#8217;t Documented, It Didn&#8217;t Happen \u2026 ? Read moreBIOCOMPATIBILITY DOCUMENTATION If It Wasn&#8217;t Documented, It Didn&#8217;t Happen \u2026 ? Click on the graphic to view it in full screen The Biological Evaluation Plan (BEP) describes the strategy for investigating and ensuring the medical risk or biocompatibility of the medical device....","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-14186","post","type-post","status-publish","format-standard","hentry","category-unkategorisiert"],"_links":{"self":[{"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/posts\/14186","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=14186"}],"version-history":[{"count":3,"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/posts\/14186\/revisions"}],"predecessor-version":[{"id":14189,"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/posts\/14186\/revisions\/14189"}],"wp:attachment":[{"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/media?parent=14186"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/categories?post=14186"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/tags?post=14186"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}