{"id":14129,"date":"2024-03-14T11:51:03","date_gmt":"2024-03-14T10:51:03","guid":{"rendered":"https:\/\/phatocon.com\/2024\/03\/14\/chemical-characterization\/"},"modified":"2024-12-02T18:05:01","modified_gmt":"2024-12-02T17:05:01","slug":"chemical-characterization","status":"publish","type":"post","link":"https:\/\/phatocon.com\/en\/2024\/03\/14\/chemical-characterization\/","title":{"rendered":"Chemical characterization"},"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_37b2812c\"><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_e086fdbb\"><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;\">1.<\/span> CHEMICAL CHARACTERIZATION<\/h4>\n<\/div><\/div><div class=\"wpb_text_column us_custom_26060442\"><div class=\"wpb_wrapper\"><p>Identification and quantification of extractables and leachables (E&amp;L)<\/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>Chemical characterization<\/h3>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>Identification and quantification of extractables and leachables (E&amp;L)<\/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>CHEMICAL CHARACTERIZATION FOR MORE SAFETY OF MEDICAL DEVICES<\/h5>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>According to the biocompatibility standard ISO 10993-1, information on the chemical composition must be obtained for all medical devices. As a result, chemical characterization is required for most medical devices, from low-risk products such as plasters or medical spatulas to high-risk products such as implants. Analyzing the chemical substances released from a device into the patient&#8217;s body enables the prediction and reduction of potential toxicities.<\/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>WHICH PHYSICAL\/CHEMICAL METHODS ARE SUITABLE FOR CHEMICAL CHARACTERIZATION?<\/h5>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>In the chemical characterization of medical devices according to ISO 10993-18, volatile, semi-volatile and non-volatile organic and inorganic substances are analyzed using various methods and techniques. Using suitable methods these substances are extracted or washed out of the products and provide an overview of potentially undesirable substances released during use. This chemical profile is used to assess the overall risk to the patient or user when using the product.<br \/>\nThe analytical methods used for this purpose are high-resolution and sensitive techniques. Depending on the hazard potential of the products, the following methods are usually used:<\/p>\n<\/div><\/div><div class=\"w-separator size_custom\" style=\"height:10px\"><\/div><\/div><\/div><\/div><\/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;\">Inductively coupled plasma mass spectrometry (ICP-MS)<\/h5><div class=\"w-iconbox-text\"><p style=\"font-size: 16px; line-height: 26px;\">Analytical method used to screen for metallic and inorganic elements in the chemical characterization of medical devices.<\/p>\n<\/div><\/div><\/div><div class=\"w-separator size_custom\" style=\"height:10px\"><\/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;\">Gas chromatography with vapor phase (head space) separation and coupled mass spectrometry (HS GC-MS)<\/h5><div class=\"w-iconbox-text\"><p style=\"font-size: 16px; line-height: 26px;\">Analytical method for the identification and quantification of volatile organic molecules (VOC).<\/p>\n<\/div><\/div><\/div><div class=\"w-separator size_custom\" style=\"height:10px\"><\/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;\">Gas chromatography with coupled mass spectrometry (GC-MS)<\/h5><div class=\"w-iconbox-text\"><p style=\"font-size: 16px; line-height: 26px;\">Analytical method for the separation and identification of semi-volatile organic molecules (SVOC) up to a molecular weight of approx. 600 Da.<\/p>\n<\/div><\/div><\/div><div class=\"w-separator size_custom\" style=\"height:10px\"><\/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;\">Liquid chromatography with coupled mass spectrometry (LC-MS)<\/h5><div class=\"w-iconbox-text\"><p style=\"font-size: 16px; line-height: 26px;\">Analytical method for the separation and identification of non-volatile organic molecules (NVOC) as part of the chemical characterization of medical devices.<\/p>\n<\/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":"1. CHEMICAL CHARACTERIZATION Identification and quantification of extractables and leachables (E&amp;L) Read moreChemical characterization Identification and quantification of extractables and leachables (E&amp;L) CHEMICAL CHARACTERIZATION FOR MORE SAFETY OF MEDICAL DEVICES According to the biocompatibility standard ISO 10993-1, information on the chemical composition must be obtained for all medical devices. As a result, chemical characterization is...","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-14129","post","type-post","status-publish","format-standard","hentry","category-unkategorisiert"],"_links":{"self":[{"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/posts\/14129","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=14129"}],"version-history":[{"count":4,"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/posts\/14129\/revisions"}],"predecessor-version":[{"id":14166,"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/posts\/14129\/revisions\/14166"}],"wp:attachment":[{"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/media?parent=14129"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/categories?post=14129"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/tags?post=14129"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}