{"id":14174,"date":"2024-06-06T16:48:22","date_gmt":"2024-06-06T14:48:22","guid":{"rendered":"https:\/\/phatocon.com\/2024\/06\/06\/biological-toxicological-endpoints\/"},"modified":"2024-12-02T18:07:15","modified_gmt":"2024-12-02T17:07:15","slug":"biological-toxicological-endpoints","status":"publish","type":"post","link":"https:\/\/phatocon.com\/en\/2024\/06\/06\/biological-toxicological-endpoints\/","title":{"rendered":"Biological\/toxicological endpoints"},"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_8e6a97a4\"><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_63e85b32\"><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;\">3.<\/span> BIOLOGICAL \/ TOXICOLOGICAL ENDPOINTS<\/h4>\n<\/div><\/div><div class=\"wpb_text_column us_custom_26060442\"><div class=\"wpb_wrapper\"><p>Identification of biological effects after exposure<\/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>BIOLOGICAL\/TOXICOLOGICAL ENDPOINTS<\/h3>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p><span style=\"font-weight: 400;\">Identification of biological effects after exposure<br \/>\n<\/span><\/p>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>Medical devices often come into direct contact with human body tissue or fluids. It is important to check that the material of the device does not cause harmful reactions such as inflammation, allergies or tissue damage.<\/p>\n<p>For the approval of medical devices and to ensure that the products are safe for human use, biological tests are carried out in addition to the physical\/chemical tests. These tests may be decisive not only to confirm the biocompatibility of the individual extractable substances identified, but also to investigate the effect of the extracts as complex mixtures under clinical conditions and thus minimize potential health risks.<\/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 ARE THE BIOLOGICAL ENDPOINTS FOR ASSESSING BIOCOMPATIBILITY?<\/h5>\n<\/div><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left\"><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;\">Cytotoxicity &#8211; ISO 10993-5<\/h5><div class=\"w-iconbox-text\"><p style=\"font-size: 16px; line-height: 26px;\">Cytotoxicity tests determine the general degree of toxicity of medical devices or their material, i.e. the potential for non-specific cell damage, by means of an elution test or agarose overlay test in cell cultures. A cytotoxicity test is a comparatively inexpensive and very sensitive method of determining the toxic effect of medical devices.<\/p>\n<\/div><\/div><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left\"><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;\">Genotoxicity &#8211; ISO 10993-3 and FDA<\/h5><div class=\"w-iconbox-text\"><p style=\"font-size: 16px; line-height: 26px;\">Genotoxicity tests are used to detect toxins that can interact with and possibly modify the genetic material of cells. This is to ensure that the substances do not cause genetic changes that can lead to cancer or other serious diseases.<\/p>\n<\/div><\/div><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left\"><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;\">Hemocompatibility &#8211; ISO 10993-4 and ASTM<\/h5><div class=\"w-iconbox-text\"><p style=\"font-size: 16px; line-height: 26px;\">Hemocompatibility tests use hematology and thrombosis tests to evaluate the effects of medical devices in contact with human blood and blood components. Devices that come into contact with blood (e.g. catheters or heart valves) must be tested to ensure that they do not cause blood clots or hemolysis.<\/p>\n<\/div><\/div><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left\"><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;\">Irritation &#8211; ISO 10993-23<\/h5><div class=\"w-iconbox-text\"><p style=\"font-size: 16px; line-height: 26px;\">Skin irritation tests assess medical devices for their potential skin damaging\/irritating effects. For this purpose, skin and eye reaction tests, intracutaneous reaction tests and in vitro tests for skin irritation are performed.<\/p>\n<\/div><\/div><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left\"><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;\">Sensitization &#8211; ISO 10993-10<\/h5><div class=\"w-iconbox-text\"><p style=\"font-size: 16px; line-height: 26px;\">Sensitization tests are performed to assess possible immune reactions using in vivo and in vitro test methods. The extent to which the products can trigger allergic reactions is investigated.<\/p>\n<\/div><\/div><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left\"><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;\">Systemic effects of potential toxicity and pyrogenicity &#8211; ISO 10993-11 and ASTM<\/h5><div class=\"w-iconbox-text\"><p style=\"font-size: 16px; line-height: 26px;\">These are tests for acute to chronic systemic toxicity from substances that may be harmful to the body. Pyrogenicity tests prove medical devices for fever-causing substances, so-called pyrogens, which affects patients coming into contact with the medical device.<\/p>\n<\/div><\/div><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left\"><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;\">Testing for implantation effects &#8211; ISO 10993-6<\/h5><div class=\"w-iconbox-text\"><p style=\"font-size: 16px; line-height: 26px;\">These tests assess histologically and pathologically how medical devices affect the surrounding living tissue. The aim is to ensure that there are no negative effects on the surrounding tissue, such as scarring or rejection reactions.<\/p>\n<\/div><\/div><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-separator size_small\"><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>There are numerous other testing methods and biological endpoints. All of these tests are part of a comprehensive risk management process and are often carried out in accordance with international standards such as ISO 10993. Ultimately, they serve to protect and ensure the safety of patients and confirm the reliability and effectiveness of medical devices.<\/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":"3. BIOLOGICAL \/ TOXICOLOGICAL ENDPOINTS Identification of biological effects after exposure Read moreBIOLOGICAL\/TOXICOLOGICAL ENDPOINTS Identification of biological effects after exposure Medical devices often come into direct contact with human body tissue or fluids. It is important to check that the material of the device does not cause harmful reactions such as inflammation, allergies or tissue...","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-14174","post","type-post","status-publish","format-standard","hentry","category-unkategorisiert"],"_links":{"self":[{"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/posts\/14174","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=14174"}],"version-history":[{"count":2,"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/posts\/14174\/revisions"}],"predecessor-version":[{"id":14183,"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/posts\/14174\/revisions\/14183"}],"wp:attachment":[{"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/media?parent=14174"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/categories?post=14174"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/tags?post=14174"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}