{"id":442,"date":"2020-12-16T01:36:01","date_gmt":"2020-12-16T01:36:01","guid":{"rendered":"https:\/\/www.chemtoxbiolab.com\/tr\/contagion\/"},"modified":"2024-01-01T14:10:13","modified_gmt":"2024-01-01T11:10:13","slug":"urunlerimiz","status":"publish","type":"page","link":"https:\/\/www.chemtoxbiolab.com\/tr\/urunlerimiz\/","title":{"rendered":"\u00dcr\u00fcnlerimiz"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"442\" class=\"elementor elementor-442\">\n\t\t\t\t<div class=\"elementor-element elementor-element-faac7ed e-flex e-con-boxed wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-parent\" data-id=\"faac7ed\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-0189176 e-flex e-con-boxed wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-parent\" data-id=\"0189176\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3900213 e-flex e-con-boxed wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-parent\" data-id=\"3900213\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-e7d670f e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"e7d670f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-59e2b10 elementor-widget elementor-widget-image\" data-id=\"59e2b10\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"240\" height=\"240\" src=\"https:\/\/www.chemtoxbiolab.com\/tr\/wp-content\/uploads\/2023\/12\/Adsiz-tasarim-2.png\" class=\"attachment-full size-full wp-image-1913\" alt=\"\" srcset=\"https:\/\/www.chemtoxbiolab.com\/tr\/wp-content\/uploads\/2023\/12\/Adsiz-tasarim-2.png 240w, https:\/\/www.chemtoxbiolab.com\/tr\/wp-content\/uploads\/2023\/12\/Adsiz-tasarim-2-150x150.png 150w\" sizes=\"(max-width: 240px) 100vw, 240px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3d1a1d0 e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"3d1a1d0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-db7b4f7 elementor-widget elementor-widget-heading\" data-id=\"db7b4f7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h6 class=\"elementor-heading-title elementor-size-default\">CHEMTOXBIOLAB\n<\/h6>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-372685a elementor-widget elementor-widget-heading\" data-id=\"372685a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">TESTLER<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f60ca63 elementor-widget elementor-widget-text-editor\" data-id=\"f60ca63\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Chemtoxbiolab Y\u0131ld\u0131z Teknik \u00dcniversitesi akademisyenleri ve \u00f6zel sekt\u00f6rde uzun y\u0131llard\u0131r faaliyet g\u00f6steren tecr\u00fcbeli bir ekip taraf\u0131ndan kurulmu\u015ftur. Bu kadronun olu\u015fturdu\u011fu ekip ruhu ve sinerji neticesinde\u00a0<b>ISO 10993-18 Kimyasal Karakterizasyon<\/b>\u00a0alan\u0131nda T\u00fcrkiye\u2019nin ilk ve Avrupa\u2019n\u0131n say\u0131l\u0131 akredite laboratuvarlar\u0131ndan biri olmu\u015ftur. Chemtoxbiolab, T\u0131bbi cihazlar\u0131n hem kimyasal hem de fiziksel karakterizasyon testleri alan\u0131nda \u0130yi Laboratuvar Uygulamalar\u0131 (GLP) i\u00e7in \u00e7al\u0131\u015fmalar\u0131na ba\u015flam\u0131\u015f ve bu kapsamda 2024 y\u0131l\u0131 i\u00e7inde s\u00fcrecin tamamlanmas\u0131n\u0131 hedef olarak belirlemi\u015ftir<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e70da64 e-flex e-con-boxed wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"e70da64\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-fc30f3d e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"fc30f3d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f85a95c elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"f85a95c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"#animal\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-down\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M413.1 222.5l22.2 22.2c9.4 9.4 9.4 24.6 0 33.9L241 473c-9.4 9.4-24.6 9.4-33.9 0L12.7 278.6c-9.4-9.4-9.4-24.6 0-33.9l22.2-22.2c9.5-9.5 25-9.3 34.3.4L184 343.4V56c0-13.3 10.7-24 24-24h32c13.3 0 24 10.7 24 24v287.4l114.8-120.5c9.3-9.8 24.8-10 34.3-.4z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Kimyasal Karakterizasyon<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"#personal\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-down\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M413.1 222.5l22.2 22.2c9.4 9.4 9.4 24.6 0 33.9L241 473c-9.4 9.4-24.6 9.4-33.9 0L12.7 278.6c-9.4-9.4-9.4-24.6 0-33.9l22.2-22.2c9.5-9.5 25-9.3 34.3.4L184 343.4V56c0-13.3 10.7-24 24-24h32c13.3 0 24 10.7 24 24v287.4l114.8-120.5c9.3-9.8 24.8-10 34.3-.4z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Toksikolojik Risk De\u011ferlendirmesi <\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-fc797ed e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"fc797ed\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fef7048 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"fef7048\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"#air\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-down\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M413.1 222.5l22.2 22.2c9.4 9.4 9.4 24.6 0 33.9L241 473c-9.4 9.4-24.6 9.4-33.9 0L12.7 278.6c-9.4-9.4-9.4-24.6 0-33.9l22.2-22.2c9.5-9.5 25-9.3 34.3.4L184 343.4V56c0-13.3 10.7-24 24-24h32c13.3 0 24 10.7 24 24v287.4l114.8-120.5c9.3-9.8 24.8-10 34.3-.4z\"><\/path><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Fiziksel ve Kimyasal Performans Testleri<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\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\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-02f7b7a e-flex e-con-boxed wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-parent\" data-id=\"02f7b7a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-8a99a9c e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"8a99a9c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-bffcc46 e-flex e-con-boxed wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"bffcc46\" data-element_type=\"container\" data-e-type=\"container\" id=\"animal\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-b92dbd1 e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"b92dbd1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fc4e95f elementor-widget elementor-widget-heading\" data-id=\"fc4e95f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">01.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-bde525f e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"bde525f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9a880bb elementor-widget elementor-widget-heading\" data-id=\"9a880bb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Kimyasal Karakterizasyon <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f43a3da elementor-widget elementor-widget-text-editor\" data-id=\"f43a3da\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Kimyasal Karakterizasyon Testi, ISO 10993-18 standard\u0131 kapsam\u0131nda ger\u00e7ekle\u015ftirilen \u00f6zellikle T\u0131bbi Cihaz\u0131n tasarlanmas\u0131nda, en \u00f6nemli kriterlerinden biri olan malzeme se\u00e7imi i\u00e7in kullan\u0131lan \u00f6nemli ve gerekli bir testtir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0ec500c elementor-widget elementor-widget-text-editor\" data-id=\"0ec500c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Bu testin sonucuna g\u00f6re, \u00fcr\u00fcn\u00fcn biyolojik uyumlulu\u011funun belirlenmesinde risk temelli bir de\u011ferlendirme analizi yap\u0131labilmesi i\u00e7in sadece malzeme kompozisyonu de\u011fil \u00f6zellikle ekstrat edilebilir ve s\u0131zabilir maddelerin tayinlerinin yap\u0131lmas\u0131 gerekmektedir.<\/p>\n<p>Ayr\u0131ca t\u0131bbi cihaz\u0131n e\u015fde\u011ferli\u011fin belirlenmesinde de kullan\u0131labilen bu analiz y\u00f6ntemi, \u00f6nerilen bir materyalin ba\u015fka bir \u00fcr\u00fcne e\u015fde\u011ferli\u011fini belirlemek i\u00e7inde kullan\u0131lmaktad\u0131r. \u00d6zellikle nihai cihaz \/ prototip veya \u00f6nerilen bir klinik uygulama i\u00e7in bir t\u0131bbi cihaza uygunluk a\u00e7\u0131s\u0131ndan potansiyel yeni malzemelerin taranmas\u0131 i\u00e7in h\u0131zl\u0131 bir test y\u00f6ntemidir.<\/p>\n<p>Bu test y\u00f6nteminin uygulanmas\u0131nda en k\u00f6t\u00fc durum senaryosunu sim\u00fcle etmek i\u00e7in ISO 10993-18 standard\u0131nda farkl\u0131 ekstraksiyon ortamlar\u0131nda ( polar- semipolar -non polar)\u00e7al\u0131\u015fma protokolleri olu\u015fturulmal\u0131 ve testler belirlenen metotlara uygun olarak ger\u00e7ekle\u015ftirilmelidir.<\/p>\n<p>Yap\u0131lacak \u00e7al\u0131\u015fman\u0131n temel ba\u015flang\u0131\u00e7 noktas\u0131 analitik de\u011ferlendirme e\u015fi\u011finin hesaplanarak, do\u011fru AET seviyesinin belirlenip; kimyasal \u00f6zelliklerine g\u00f6re \u00fc\u00e7 ana gruba \u00fczerinden <br>\u2022 U\u00e7ucu Olmayan Organik Bile\u015fikler (NVOC)<br>\u2022 Yar\u0131 U\u00e7ucu Organik Bile\u015fikler (SVOC)<br>\u2022 U\u00e7ucu Organik Bile\u015fikler (VOC)<\/p>\n<p>Analitik y\u00f6ntemlerle standartta belirlenen cihazlar kullan\u0131larak veriler olu\u015fturulur. Bu veriler toksikolojik de\u011ferlendirme i\u00e7in girdi olu\u015fturur.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5318a75 elementor-widget elementor-widget-button\" data-id=\"5318a75\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/www.chemtoxbiolab.com\/tr\/bize-ulasin\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Detayl\u0131 Bilgi \u0130\u00e7in \u0130leti\u015fime Ge\u00e7ebilirsiniz<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c6d1213 e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"c6d1213\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-45298ba elementor-widget elementor-widget-image\" data-id=\"45298ba\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"576\" height=\"576\" src=\"https:\/\/www.chemtoxbiolab.com\/tr\/wp-content\/uploads\/2023\/12\/2.png\" class=\"attachment-full size-full wp-image-1917\" alt=\"\" srcset=\"https:\/\/www.chemtoxbiolab.com\/tr\/wp-content\/uploads\/2023\/12\/2.png 576w, https:\/\/www.chemtoxbiolab.com\/tr\/wp-content\/uploads\/2023\/12\/2-300x300.png 300w, https:\/\/www.chemtoxbiolab.com\/tr\/wp-content\/uploads\/2023\/12\/2-150x150.png 150w\" sizes=\"(max-width: 576px) 100vw, 576px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-fda0c5a e-flex e-con-boxed wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"fda0c5a\" data-element_type=\"container\" data-e-type=\"container\" id=\"personal\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-d1d4e26 e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"d1d4e26\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ca9a0dc elementor-widget elementor-widget-heading\" data-id=\"ca9a0dc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">02.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1844e00 e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"1844e00\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ce8ece3 elementor-widget elementor-widget-heading\" data-id=\"ce8ece3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Toksikolojik Risk De\u011ferlendirmesi <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d6d10e0 elementor-widget elementor-widget-text-editor\" data-id=\"d6d10e0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Toksikolojik Risk De\u011ferlendirmesi ISO 10993-17 Toxicological Risk Assessment of Medical Device Constituents <\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-48a8e4a elementor-widget elementor-widget-text-editor\" data-id=\"48a8e4a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Tokiskolojik risk de\u011ferlendirmesi temel olarak; ISO 10993-18 standard\u0131na g\u00f6re ger\u00e7ekle\u015ftirilmi\u015f olan ekstrakt edilebilir ve s\u0131zabilir madde miktarlar\u0131n\u0131n analizi sonucuna g\u00f6re, teste konu olan t\u0131bbi cihaz\u0131n \u00fcretiminde ilgi materyallerin toksikolojik a\u00e7\u0131dan herhangi bir risk te\u015fkil edip etmedi\u011fine dair yap\u0131lacak bir de\u011ferlendirmedir metodudur. \u00d6zellikle, bu risk de\u011ferlendirmesini yapan uzman\u0131n, Avrupa Toksikoloji Derne\u011fi taraf\u0131ndan sertifikaland\u0131r\u0131lm\u0131\u015f bir toksikolog olmas\u0131 yap\u0131lacak olan de\u011ferlendirmenin yetkin ve yeterli oldu\u011fu konusunda \u00fcreticilerin aramas\u0131 gereken en \u00f6nemli kriterdir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0264f93 elementor-widget elementor-widget-button\" data-id=\"0264f93\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/www.chemtoxbiolab.com\/tr\/bize-ulasin\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Detayl\u0131 Bilgi \u0130\u00e7in \u0130leti\u015fime Ge\u00e7ebilirsiniz<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-56ca2c3 e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"56ca2c3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5107220 elementor-widget elementor-widget-image\" data-id=\"5107220\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"576\" height=\"576\" src=\"https:\/\/www.chemtoxbiolab.com\/tr\/wp-content\/uploads\/2023\/12\/3.png\" class=\"attachment-full size-full wp-image-1918\" alt=\"\" srcset=\"https:\/\/www.chemtoxbiolab.com\/tr\/wp-content\/uploads\/2023\/12\/3.png 576w, https:\/\/www.chemtoxbiolab.com\/tr\/wp-content\/uploads\/2023\/12\/3-300x300.png 300w, https:\/\/www.chemtoxbiolab.com\/tr\/wp-content\/uploads\/2023\/12\/3-150x150.png 150w\" sizes=\"(max-width: 576px) 100vw, 576px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-33d9d06 e-flex e-con-boxed wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"33d9d06\" data-element_type=\"container\" data-e-type=\"container\" id=\"air\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-8998b9d e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"8998b9d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4dcaabe elementor-widget elementor-widget-heading\" data-id=\"4dcaabe\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">03.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c3f0000 e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"c3f0000\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fcf8b0e elementor-widget elementor-widget-heading\" data-id=\"fcf8b0e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Fiziksel ve Kimyasal Performans Testleri\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bedbc10 elementor-widget elementor-widget-text-editor\" data-id=\"bedbc10\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>KATATERLER<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-04b16c8 elementor-widget elementor-widget-text-editor\" data-id=\"04b16c8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>\u00c7al\u0131\u015fman\u0131n amac\u0131, t\u00fcm kateterlerin (aspirasyon kateteri, G\u00f6\u011f\u00fcs kateteri, Rektal kateter, IV Kan\u00fcl kateteri, Tiemann kateteri, Nelaton kateteri gibi) ISO 8836, ISO 10555-1, ISO 20696 ve ISO 20697 standartlar\u0131 kapsam\u0131nda testlerinin ger\u00e7ekle\u015ftirilmesidir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e054700 elementor-widget elementor-widget-text-editor\" data-id=\"e054700\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>\u015eIRINGALAR<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ac85eb4 elementor-widget elementor-widget-text-editor\" data-id=\"ac85eb4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>\u00c7al\u0131\u015fman\u0131n amac\u0131, ISO 7886-2 standard\u0131na g\u00f6re \u2018tek kullan\u0131ml\u0131k steril hipodermik \u015f\u0131r\u0131ngalar\u0131n\u2019 kimyasal ve fiziksel gereksinimlerinin do\u011frulu\u011funu test etmektir. Fiziksel gereksinimler aras\u0131nda, kademeli kapasite tolerans\u0131, dereceli \u00f6l\u00e7ek, \u015f\u0131r\u0131nga tasar\u0131m\u0131, piston\/piston montaj\u0131, nozul, performans ve paketleme testleri ISO 7886-2 standard\u0131na g\u00f6re yap\u0131lmaktad\u0131r.<\/p><p><br \/>\u0130htiya\u00e7 duyulan kimyasal testler aras\u0131nda asitlik veya alkalilik limitleri, ya\u011flay\u0131c\u0131 ve ekstrakte edilebilir metal limitleri testleri ger\u00e7ekle\u015ftirilmektedir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ff28bea elementor-widget elementor-widget-text-editor\" data-id=\"ff28bea\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>KONNEKT\u00d6R TESTLER\u0130<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b0651e7 elementor-widget elementor-widget-text-editor\" data-id=\"b0651e7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>\u00c7al\u0131\u015fman\u0131n amac\u0131, sa\u011fl\u0131k alan\u0131nda kullan\u0131lan k\u00fc\u00e7\u00fck \u00e7apl\u0131 konekt\u00f6rlerin fiziksel gereksinimlerinin do\u011frulu\u011funun ve yeterlili\u011finin ISO 80369-20 standard\u0131na g\u00f6re test etmektir.<\/p><p>Fiziksel gereksinimler aras\u0131nda, bas\u0131n\u00e7 d\u00fc\u015f\u00fc\u015f\u00fc ile s\u0131z\u0131nt\u0131, d\u00fc\u015fen damla pozitif bas\u0131n\u00e7l\u0131 s\u0131v\u0131 s\u0131z\u0131nt\u0131s\u0131, atmosfer alt\u0131 bas\u0131n\u00e7ta hava s\u0131z\u0131nt\u0131s\u0131, stres \u00e7atlamas\u0131, eksenel y\u00fckten ayr\u0131lmaya diren\u00e7, s\u00f6kme ile ba\u011flant\u0131 kesme vb. testler yer almaktad\u0131r.<\/p><p>\u0130htiya\u00e7 duyulan kimyasal testler aras\u0131nda asitlik veya alkalilik limitleri, ya\u011flay\u0131c\u0131 ve ekstrakte edilebilir metal limitleri testleri ger\u00e7ekle\u015ftirilmektedir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3e4f8f3 elementor-widget elementor-widget-text-editor\" data-id=\"3e4f8f3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>\u015eIRINGALAR \u0130\u00c7\u0130N \u0130\u011eNE TESTLER\u0130<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-eaea9c0 elementor-widget elementor-widget-text-editor\" data-id=\"eaea9c0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>\u00c7al\u0131\u015fman\u0131n amac\u0131, \u201ctek kullan\u0131ml\u0131k steril hipodermik i\u011fnelerin\u201d kimyasal ve fiziksel gereksinimlerinin ISO 7864: standard\u0131na g\u00f6re do\u011frulu\u011funu test etmektir.<\/p><p>Fiziksel gereksinimler aras\u0131nda boyut belirleme, renk kodlamas\u0131, i\u011fne g\u00f6be\u011fi, i\u011fne kapa\u011f\u0131, i\u011fne t\u00fcp\u00fc, i\u011fne ucu, g\u00f6bek ve i\u011fne t\u00fcp\u00fc aras\u0131ndaki ba\u011f, l\u00fcmen a\u00e7\u0131kl\u0131\u011f\u0131 ve par\u00e7alanma testleri yap\u0131lmaktad\u0131r.<\/p><p>Gerekli kimyasal testler aras\u0131nda asitlik veya alkalilik limitleri ve ekstrakte edilebilir metal testleri i\u00e7in limitler de\u011ferleri analiz edilmektedir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-64cc5ca elementor-widget elementor-widget-text-editor\" data-id=\"64cc5ca\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>\u0130NF\u0130ZYON SET<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f79a962 elementor-widget elementor-widget-text-editor\" data-id=\"f79a962\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>\u00c7al\u0131\u015fman\u0131n amac\u0131, bas\u0131n\u00e7l\u0131 inf\u00fczyon ekipman\u0131 ile tek kullan\u0131ml\u0131k ak\u0131\u015fkan hatlar\u0131n\u0131n kimyasal ve fiziksel gereksinimlerinin ISO 8536-9 ve ISO 8536-4 standartlar\u0131na g\u00f6re do\u011frulu\u011funu test etmektir.<\/p><p>Fiziksel gereksinimler aras\u0131nda \u015feffafl\u0131k, \u00e7ekme mukavemeti, s\u0131z\u0131nt\u0131, koruyucu kapaklar kontrol\u00fc. Ayr\u0131ca inf\u00fczyon setinde yer alan i\u011fnenin boyut kontrol\u00fc, i\u011fne ucu muayenesi, par\u00e7alanma testi ve penetrasyon testi ISO 8536-9\u2019a g\u00f6re yap\u0131lmaktad\u0131r.<\/p><p>Gerekli kimyasal testler aras\u0131nda, \u0130ndirgeyici (oksitlenebilir) madde, Metal iyonlar\u0131, Titrasyon asitli\u011fi veya alkalinitesi, Buharla\u015fmada kal\u0131nt\u0131, Ekstrakt \u00e7\u00f6zeltisinin UV absorpsiyonu testleri ger\u00e7ekle\u015ftirilmektedir.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-768c619 elementor-widget elementor-widget-button\" data-id=\"768c619\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/www.chemtoxbiolab.com\/tr\/bize-ulasin\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Detayl\u0131 Bilgi \u0130\u00e7in \u0130leti\u015fime Ge\u00e7ebilirsiniz<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-214150a e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"214150a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c155b12 elementor-widget elementor-widget-image\" data-id=\"c155b12\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"576\" height=\"576\" src=\"https:\/\/www.chemtoxbiolab.com\/tr\/wp-content\/uploads\/2023\/12\/4.png\" class=\"attachment-full size-full wp-image-1919\" alt=\"\" srcset=\"https:\/\/www.chemtoxbiolab.com\/tr\/wp-content\/uploads\/2023\/12\/4.png 576w, https:\/\/www.chemtoxbiolab.com\/tr\/wp-content\/uploads\/2023\/12\/4-300x300.png 300w, https:\/\/www.chemtoxbiolab.com\/tr\/wp-content\/uploads\/2023\/12\/4-150x150.png 150w\" sizes=\"(max-width: 576px) 100vw, 576px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\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\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>CHEMTOXBIOLAB TESTLER Chemtoxbiolab Y\u0131ld\u0131z Teknik \u00dcniversitesi akademisyenleri ve \u00f6zel sekt\u00f6rde uzun y\u0131llard\u0131r faaliyet g\u00f6steren tecr\u00fcbeli bir ekip taraf\u0131ndan kurulmu\u015ftur. Bu kadronun olu\u015fturdu\u011fu ekip ruhu ve sinerji neticesinde\u00a0ISO 10993-18 Kimyasal Karakterizasyon\u00a0alan\u0131nda T\u00fcrkiye\u2019nin ilk ve Avrupa\u2019n\u0131n say\u0131l\u0131 akredite laboratuvarlar\u0131ndan biri olmu\u015ftur. Chemtoxbiolab, T\u0131bbi cihazlar\u0131n hem kimyasal hem de fiziksel karakterizasyon testleri alan\u0131nda \u0130yi Laboratuvar Uygulamalar\u0131 (GLP) i\u00e7in \u00e7al\u0131\u015fmalar\u0131na ba\u015flam\u0131\u015f ve bu kapsamda 2024 y\u0131l\u0131 i\u00e7inde s\u00fcrecin tamamlanmas\u0131n\u0131 hedef olarak belirlemi\u015ftir Kimyasal Karakterizasyon Toksikolojik Risk De\u011ferlendirmesi Fiziksel ve Kimyasal Performans Testleri 01. Kimyasal Karakterizasyon Kimyasal Karakterizasyon Testi, ISO 10993-18 standard\u0131 kapsam\u0131nda ger\u00e7ekle\u015ftirilen \u00f6zellikle T\u0131bbi Cihaz\u0131n tasarlanmas\u0131nda, en \u00f6nemli kriterlerinden biri olan malzeme se\u00e7imi i\u00e7in kullan\u0131lan \u00f6nemli ve gerekli bir testtir. Bu testin sonucuna g\u00f6re, \u00fcr\u00fcn\u00fcn biyolojik uyumlulu\u011funun belirlenmesinde risk temelli bir de\u011ferlendirme analizi yap\u0131labilmesi i\u00e7in sadece malzeme kompozisyonu de\u011fil \u00f6zellikle ekstrat edilebilir ve s\u0131zabilir maddelerin tayinlerinin yap\u0131lmas\u0131 gerekmektedir. Ayr\u0131ca t\u0131bbi cihaz\u0131n e\u015fde\u011ferli\u011fin belirlenmesinde de kullan\u0131labilen bu analiz y\u00f6ntemi, \u00f6nerilen bir materyalin ba\u015fka bir \u00fcr\u00fcne e\u015fde\u011ferli\u011fini belirlemek i\u00e7inde kullan\u0131lmaktad\u0131r. \u00d6zellikle nihai cihaz \/ prototip veya \u00f6nerilen bir klinik uygulama i\u00e7in bir t\u0131bbi cihaza uygunluk a\u00e7\u0131s\u0131ndan potansiyel yeni malzemelerin taranmas\u0131 i\u00e7in h\u0131zl\u0131 bir test y\u00f6ntemidir. Bu test y\u00f6nteminin uygulanmas\u0131nda en k\u00f6t\u00fc durum senaryosunu sim\u00fcle etmek i\u00e7in ISO 10993-18 standard\u0131nda farkl\u0131 ekstraksiyon ortamlar\u0131nda ( polar- semipolar -non polar)\u00e7al\u0131\u015fma protokolleri olu\u015fturulmal\u0131 ve testler belirlenen metotlara uygun olarak ger\u00e7ekle\u015ftirilmelidir. Yap\u0131lacak \u00e7al\u0131\u015fman\u0131n temel ba\u015flang\u0131\u00e7 noktas\u0131 analitik de\u011ferlendirme e\u015fi\u011finin hesaplanarak, do\u011fru AET seviyesinin belirlenip; kimyasal \u00f6zelliklerine g\u00f6re \u00fc\u00e7 ana gruba \u00fczerinden \u2022 U\u00e7ucu Olmayan Organik Bile\u015fikler (NVOC)\u2022 Yar\u0131 U\u00e7ucu Organik Bile\u015fikler (SVOC)\u2022 U\u00e7ucu Organik Bile\u015fikler (VOC) Analitik y\u00f6ntemlerle standartta belirlenen cihazlar kullan\u0131larak veriler olu\u015fturulur. Bu veriler toksikolojik de\u011ferlendirme i\u00e7in girdi olu\u015fturur. Detayl\u0131 Bilgi \u0130\u00e7in \u0130leti\u015fime Ge\u00e7ebilirsiniz 02. Toksikolojik Risk De\u011ferlendirmesi Toksikolojik Risk De\u011ferlendirmesi ISO 10993-17 Toxicological Risk Assessment of Medical Device Constituents Tokiskolojik risk de\u011ferlendirmesi temel olarak; ISO 10993-18 standard\u0131na g\u00f6re ger\u00e7ekle\u015ftirilmi\u015f olan ekstrakt edilebilir ve s\u0131zabilir madde miktarlar\u0131n\u0131n analizi sonucuna g\u00f6re, teste konu olan t\u0131bbi cihaz\u0131n \u00fcretiminde ilgi materyallerin toksikolojik a\u00e7\u0131dan herhangi bir risk te\u015fkil edip etmedi\u011fine dair yap\u0131lacak bir de\u011ferlendirmedir metodudur. \u00d6zellikle, bu risk de\u011ferlendirmesini yapan uzman\u0131n, Avrupa Toksikoloji Derne\u011fi taraf\u0131ndan sertifikaland\u0131r\u0131lm\u0131\u015f bir toksikolog olmas\u0131 yap\u0131lacak olan de\u011ferlendirmenin yetkin ve yeterli oldu\u011fu konusunda \u00fcreticilerin aramas\u0131 gereken en \u00f6nemli kriterdir. Detayl\u0131 Bilgi \u0130\u00e7in \u0130leti\u015fime Ge\u00e7ebilirsiniz 03. Fiziksel ve Kimyasal Performans Testleri KATATERLER \u00c7al\u0131\u015fman\u0131n amac\u0131, t\u00fcm kateterlerin (aspirasyon kateteri, G\u00f6\u011f\u00fcs kateteri, Rektal kateter, IV Kan\u00fcl kateteri, Tiemann kateteri, Nelaton kateteri gibi) ISO 8836, ISO 10555-1, ISO 20696 ve ISO 20697 standartlar\u0131 kapsam\u0131nda testlerinin ger\u00e7ekle\u015ftirilmesidir. \u015eIRINGALAR \u00c7al\u0131\u015fman\u0131n amac\u0131, ISO 7886-2 standard\u0131na g\u00f6re \u2018tek kullan\u0131ml\u0131k steril hipodermik \u015f\u0131r\u0131ngalar\u0131n\u2019 kimyasal ve fiziksel gereksinimlerinin do\u011frulu\u011funu test etmektir. Fiziksel gereksinimler aras\u0131nda, kademeli kapasite tolerans\u0131, dereceli \u00f6l\u00e7ek, \u015f\u0131r\u0131nga tasar\u0131m\u0131, piston\/piston montaj\u0131, nozul, performans ve paketleme testleri ISO 7886-2 standard\u0131na g\u00f6re yap\u0131lmaktad\u0131r. \u0130htiya\u00e7 duyulan kimyasal testler aras\u0131nda asitlik veya alkalilik limitleri, ya\u011flay\u0131c\u0131 ve ekstrakte edilebilir metal limitleri testleri ger\u00e7ekle\u015ftirilmektedir. KONNEKT\u00d6R TESTLER\u0130 \u00c7al\u0131\u015fman\u0131n amac\u0131, sa\u011fl\u0131k alan\u0131nda kullan\u0131lan k\u00fc\u00e7\u00fck \u00e7apl\u0131 konekt\u00f6rlerin fiziksel gereksinimlerinin do\u011frulu\u011funun ve yeterlili\u011finin ISO 80369-20 standard\u0131na g\u00f6re test etmektir. Fiziksel gereksinimler aras\u0131nda, bas\u0131n\u00e7 d\u00fc\u015f\u00fc\u015f\u00fc ile s\u0131z\u0131nt\u0131, d\u00fc\u015fen damla pozitif bas\u0131n\u00e7l\u0131 s\u0131v\u0131 s\u0131z\u0131nt\u0131s\u0131, atmosfer alt\u0131 bas\u0131n\u00e7ta hava s\u0131z\u0131nt\u0131s\u0131, stres \u00e7atlamas\u0131, eksenel y\u00fckten ayr\u0131lmaya diren\u00e7, s\u00f6kme ile ba\u011flant\u0131 kesme vb. testler yer almaktad\u0131r. \u0130htiya\u00e7 duyulan kimyasal testler aras\u0131nda asitlik veya alkalilik limitleri, ya\u011flay\u0131c\u0131 ve ekstrakte edilebilir metal limitleri testleri ger\u00e7ekle\u015ftirilmektedir. \u015eIRINGALAR \u0130\u00c7\u0130N \u0130\u011eNE TESTLER\u0130 \u00c7al\u0131\u015fman\u0131n amac\u0131, \u201ctek kullan\u0131ml\u0131k steril hipodermik i\u011fnelerin\u201d kimyasal ve fiziksel gereksinimlerinin ISO 7864: standard\u0131na g\u00f6re do\u011frulu\u011funu test etmektir. Fiziksel gereksinimler aras\u0131nda boyut belirleme, renk kodlamas\u0131, i\u011fne g\u00f6be\u011fi, i\u011fne kapa\u011f\u0131, i\u011fne t\u00fcp\u00fc, i\u011fne ucu, g\u00f6bek ve i\u011fne t\u00fcp\u00fc aras\u0131ndaki ba\u011f, l\u00fcmen a\u00e7\u0131kl\u0131\u011f\u0131 ve par\u00e7alanma testleri yap\u0131lmaktad\u0131r. Gerekli kimyasal testler aras\u0131nda asitlik veya alkalilik limitleri ve ekstrakte edilebilir metal testleri i\u00e7in limitler de\u011ferleri analiz edilmektedir. \u0130NF\u0130ZYON SET \u00c7al\u0131\u015fman\u0131n amac\u0131, bas\u0131n\u00e7l\u0131 inf\u00fczyon ekipman\u0131 ile tek kullan\u0131ml\u0131k ak\u0131\u015fkan hatlar\u0131n\u0131n kimyasal ve fiziksel gereksinimlerinin ISO 8536-9 ve ISO 8536-4 standartlar\u0131na g\u00f6re do\u011frulu\u011funu test etmektir. Fiziksel gereksinimler aras\u0131nda \u015feffafl\u0131k, \u00e7ekme mukavemeti, s\u0131z\u0131nt\u0131, koruyucu kapaklar kontrol\u00fc. Ayr\u0131ca inf\u00fczyon setinde yer alan i\u011fnenin boyut kontrol\u00fc, i\u011fne ucu muayenesi, par\u00e7alanma testi ve penetrasyon testi ISO 8536-9\u2019a g\u00f6re yap\u0131lmaktad\u0131r. Gerekli kimyasal testler aras\u0131nda, \u0130ndirgeyici (oksitlenebilir) madde, Metal iyonlar\u0131, Titrasyon asitli\u011fi veya alkalinitesi, Buharla\u015fmada kal\u0131nt\u0131, Ekstrakt \u00e7\u00f6zeltisinin UV absorpsiyonu testleri ger\u00e7ekle\u015ftirilmektedir. Detayl\u0131 Bilgi \u0130\u00e7in \u0130leti\u015fime Ge\u00e7ebilirsiniz<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"enabled","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-442","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>\u00dcr\u00fcnlerimiz - Chemtox Biolab<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.chemtoxbiolab.com\/tr\/urunlerimiz\/\" \/>\n<meta property=\"og:locale\" content=\"tr_TR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u00dcr\u00fcnlerimiz - Chemtox Biolab\" \/>\n<meta property=\"og:description\" content=\"CHEMTOXBIOLAB TESTLER Chemtoxbiolab Y\u0131ld\u0131z Teknik \u00dcniversitesi akademisyenleri ve \u00f6zel sekt\u00f6rde uzun y\u0131llard\u0131r faaliyet g\u00f6steren tecr\u00fcbeli bir ekip taraf\u0131ndan kurulmu\u015ftur. Bu kadronun olu\u015fturdu\u011fu ekip ruhu ve sinerji neticesinde\u00a0ISO 10993-18 Kimyasal Karakterizasyon\u00a0alan\u0131nda T\u00fcrkiye\u2019nin ilk ve Avrupa\u2019n\u0131n say\u0131l\u0131 akredite laboratuvarlar\u0131ndan biri olmu\u015ftur. Chemtoxbiolab, T\u0131bbi cihazlar\u0131n hem kimyasal hem de fiziksel karakterizasyon testleri alan\u0131nda \u0130yi Laboratuvar Uygulamalar\u0131 (GLP) i\u00e7in \u00e7al\u0131\u015fmalar\u0131na ba\u015flam\u0131\u015f ve bu kapsamda 2024 y\u0131l\u0131 i\u00e7inde s\u00fcrecin tamamlanmas\u0131n\u0131 hedef olarak belirlemi\u015ftir Kimyasal Karakterizasyon Toksikolojik Risk De\u011ferlendirmesi Fiziksel ve Kimyasal Performans Testleri 01. Kimyasal Karakterizasyon Kimyasal Karakterizasyon Testi, ISO 10993-18 standard\u0131 kapsam\u0131nda ger\u00e7ekle\u015ftirilen \u00f6zellikle T\u0131bbi Cihaz\u0131n tasarlanmas\u0131nda, en \u00f6nemli kriterlerinden biri olan malzeme se\u00e7imi i\u00e7in kullan\u0131lan \u00f6nemli ve gerekli bir testtir. Bu testin sonucuna g\u00f6re, \u00fcr\u00fcn\u00fcn biyolojik uyumlulu\u011funun belirlenmesinde risk temelli bir de\u011ferlendirme analizi yap\u0131labilmesi i\u00e7in sadece malzeme kompozisyonu de\u011fil \u00f6zellikle ekstrat edilebilir ve s\u0131zabilir maddelerin tayinlerinin yap\u0131lmas\u0131 gerekmektedir. Ayr\u0131ca t\u0131bbi cihaz\u0131n e\u015fde\u011ferli\u011fin belirlenmesinde de kullan\u0131labilen bu analiz y\u00f6ntemi, \u00f6nerilen bir materyalin ba\u015fka bir \u00fcr\u00fcne e\u015fde\u011ferli\u011fini belirlemek i\u00e7inde kullan\u0131lmaktad\u0131r. \u00d6zellikle nihai cihaz \/ prototip veya \u00f6nerilen bir klinik uygulama i\u00e7in bir t\u0131bbi cihaza uygunluk a\u00e7\u0131s\u0131ndan potansiyel yeni malzemelerin taranmas\u0131 i\u00e7in h\u0131zl\u0131 bir test y\u00f6ntemidir. Bu test y\u00f6nteminin uygulanmas\u0131nda en k\u00f6t\u00fc durum senaryosunu sim\u00fcle etmek i\u00e7in ISO 10993-18 standard\u0131nda farkl\u0131 ekstraksiyon ortamlar\u0131nda ( polar- semipolar -non polar)\u00e7al\u0131\u015fma protokolleri olu\u015fturulmal\u0131 ve testler belirlenen metotlara uygun olarak ger\u00e7ekle\u015ftirilmelidir. Yap\u0131lacak \u00e7al\u0131\u015fman\u0131n temel ba\u015flang\u0131\u00e7 noktas\u0131 analitik de\u011ferlendirme e\u015fi\u011finin hesaplanarak, do\u011fru AET seviyesinin belirlenip; kimyasal \u00f6zelliklerine g\u00f6re \u00fc\u00e7 ana gruba \u00fczerinden \u2022 U\u00e7ucu Olmayan Organik Bile\u015fikler (NVOC)\u2022 Yar\u0131 U\u00e7ucu Organik Bile\u015fikler (SVOC)\u2022 U\u00e7ucu Organik Bile\u015fikler (VOC) Analitik y\u00f6ntemlerle standartta belirlenen cihazlar kullan\u0131larak veriler olu\u015fturulur. Bu veriler toksikolojik de\u011ferlendirme i\u00e7in girdi olu\u015fturur. Detayl\u0131 Bilgi \u0130\u00e7in \u0130leti\u015fime Ge\u00e7ebilirsiniz 02. Toksikolojik Risk De\u011ferlendirmesi Toksikolojik Risk De\u011ferlendirmesi ISO 10993-17 Toxicological Risk Assessment of Medical Device Constituents Tokiskolojik risk de\u011ferlendirmesi temel olarak; ISO 10993-18 standard\u0131na g\u00f6re ger\u00e7ekle\u015ftirilmi\u015f olan ekstrakt edilebilir ve s\u0131zabilir madde miktarlar\u0131n\u0131n analizi sonucuna g\u00f6re, teste konu olan t\u0131bbi cihaz\u0131n \u00fcretiminde ilgi materyallerin toksikolojik a\u00e7\u0131dan herhangi bir risk te\u015fkil edip etmedi\u011fine dair yap\u0131lacak bir de\u011ferlendirmedir metodudur. \u00d6zellikle, bu risk de\u011ferlendirmesini yapan uzman\u0131n, Avrupa Toksikoloji Derne\u011fi taraf\u0131ndan sertifikaland\u0131r\u0131lm\u0131\u015f bir toksikolog olmas\u0131 yap\u0131lacak olan de\u011ferlendirmenin yetkin ve yeterli oldu\u011fu konusunda \u00fcreticilerin aramas\u0131 gereken en \u00f6nemli kriterdir. Detayl\u0131 Bilgi \u0130\u00e7in \u0130leti\u015fime Ge\u00e7ebilirsiniz 03. Fiziksel ve Kimyasal Performans Testleri KATATERLER \u00c7al\u0131\u015fman\u0131n amac\u0131, t\u00fcm kateterlerin (aspirasyon kateteri, G\u00f6\u011f\u00fcs kateteri, Rektal kateter, IV Kan\u00fcl kateteri, Tiemann kateteri, Nelaton kateteri gibi) ISO 8836, ISO 10555-1, ISO 20696 ve ISO 20697 standartlar\u0131 kapsam\u0131nda testlerinin ger\u00e7ekle\u015ftirilmesidir. \u015eIRINGALAR \u00c7al\u0131\u015fman\u0131n amac\u0131, ISO 7886-2 standard\u0131na g\u00f6re \u2018tek kullan\u0131ml\u0131k steril hipodermik \u015f\u0131r\u0131ngalar\u0131n\u2019 kimyasal ve fiziksel gereksinimlerinin do\u011frulu\u011funu test etmektir. Fiziksel gereksinimler aras\u0131nda, kademeli kapasite tolerans\u0131, dereceli \u00f6l\u00e7ek, \u015f\u0131r\u0131nga tasar\u0131m\u0131, piston\/piston montaj\u0131, nozul, performans ve paketleme testleri ISO 7886-2 standard\u0131na g\u00f6re yap\u0131lmaktad\u0131r. \u0130htiya\u00e7 duyulan kimyasal testler aras\u0131nda asitlik veya alkalilik limitleri, ya\u011flay\u0131c\u0131 ve ekstrakte edilebilir metal limitleri testleri ger\u00e7ekle\u015ftirilmektedir. KONNEKT\u00d6R TESTLER\u0130 \u00c7al\u0131\u015fman\u0131n amac\u0131, sa\u011fl\u0131k alan\u0131nda kullan\u0131lan k\u00fc\u00e7\u00fck \u00e7apl\u0131 konekt\u00f6rlerin fiziksel gereksinimlerinin do\u011frulu\u011funun ve yeterlili\u011finin ISO 80369-20 standard\u0131na g\u00f6re test etmektir. Fiziksel gereksinimler aras\u0131nda, bas\u0131n\u00e7 d\u00fc\u015f\u00fc\u015f\u00fc ile s\u0131z\u0131nt\u0131, d\u00fc\u015fen damla pozitif bas\u0131n\u00e7l\u0131 s\u0131v\u0131 s\u0131z\u0131nt\u0131s\u0131, atmosfer alt\u0131 bas\u0131n\u00e7ta hava s\u0131z\u0131nt\u0131s\u0131, stres \u00e7atlamas\u0131, eksenel y\u00fckten ayr\u0131lmaya diren\u00e7, s\u00f6kme ile ba\u011flant\u0131 kesme vb. testler yer almaktad\u0131r. \u0130htiya\u00e7 duyulan kimyasal testler aras\u0131nda asitlik veya alkalilik limitleri, ya\u011flay\u0131c\u0131 ve ekstrakte edilebilir metal limitleri testleri ger\u00e7ekle\u015ftirilmektedir. \u015eIRINGALAR \u0130\u00c7\u0130N \u0130\u011eNE TESTLER\u0130 \u00c7al\u0131\u015fman\u0131n amac\u0131, \u201ctek kullan\u0131ml\u0131k steril hipodermik i\u011fnelerin\u201d kimyasal ve fiziksel gereksinimlerinin ISO 7864: standard\u0131na g\u00f6re do\u011frulu\u011funu test etmektir. Fiziksel gereksinimler aras\u0131nda boyut belirleme, renk kodlamas\u0131, i\u011fne g\u00f6be\u011fi, i\u011fne kapa\u011f\u0131, i\u011fne t\u00fcp\u00fc, i\u011fne ucu, g\u00f6bek ve i\u011fne t\u00fcp\u00fc aras\u0131ndaki ba\u011f, l\u00fcmen a\u00e7\u0131kl\u0131\u011f\u0131 ve par\u00e7alanma testleri yap\u0131lmaktad\u0131r. Gerekli kimyasal testler aras\u0131nda asitlik veya alkalilik limitleri ve ekstrakte edilebilir metal testleri i\u00e7in limitler de\u011ferleri analiz edilmektedir. \u0130NF\u0130ZYON SET \u00c7al\u0131\u015fman\u0131n amac\u0131, bas\u0131n\u00e7l\u0131 inf\u00fczyon ekipman\u0131 ile tek kullan\u0131ml\u0131k ak\u0131\u015fkan hatlar\u0131n\u0131n kimyasal ve fiziksel gereksinimlerinin ISO 8536-9 ve ISO 8536-4 standartlar\u0131na g\u00f6re do\u011frulu\u011funu test etmektir. Fiziksel gereksinimler aras\u0131nda \u015feffafl\u0131k, \u00e7ekme mukavemeti, s\u0131z\u0131nt\u0131, koruyucu kapaklar kontrol\u00fc. Ayr\u0131ca inf\u00fczyon setinde yer alan i\u011fnenin boyut kontrol\u00fc, i\u011fne ucu muayenesi, par\u00e7alanma testi ve penetrasyon testi ISO 8536-9\u2019a g\u00f6re yap\u0131lmaktad\u0131r. Gerekli kimyasal testler aras\u0131nda, \u0130ndirgeyici (oksitlenebilir) madde, Metal iyonlar\u0131, Titrasyon asitli\u011fi veya alkalinitesi, Buharla\u015fmada kal\u0131nt\u0131, Ekstrakt \u00e7\u00f6zeltisinin UV absorpsiyonu testleri ger\u00e7ekle\u015ftirilmektedir. 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Bu kadronun olu\u015fturdu\u011fu ekip ruhu ve sinerji neticesinde\u00a0ISO 10993-18 Kimyasal Karakterizasyon\u00a0alan\u0131nda T\u00fcrkiye\u2019nin ilk ve Avrupa\u2019n\u0131n say\u0131l\u0131 akredite laboratuvarlar\u0131ndan biri olmu\u015ftur. Chemtoxbiolab, T\u0131bbi cihazlar\u0131n hem kimyasal hem de fiziksel karakterizasyon testleri alan\u0131nda \u0130yi Laboratuvar Uygulamalar\u0131 (GLP) i\u00e7in \u00e7al\u0131\u015fmalar\u0131na ba\u015flam\u0131\u015f ve bu kapsamda 2024 y\u0131l\u0131 i\u00e7inde s\u00fcrecin tamamlanmas\u0131n\u0131 hedef olarak belirlemi\u015ftir Kimyasal Karakterizasyon Toksikolojik Risk De\u011ferlendirmesi Fiziksel ve Kimyasal Performans Testleri 01. Kimyasal Karakterizasyon Kimyasal Karakterizasyon Testi, ISO 10993-18 standard\u0131 kapsam\u0131nda ger\u00e7ekle\u015ftirilen \u00f6zellikle T\u0131bbi Cihaz\u0131n tasarlanmas\u0131nda, en \u00f6nemli kriterlerinden biri olan malzeme se\u00e7imi i\u00e7in kullan\u0131lan \u00f6nemli ve gerekli bir testtir. Bu testin sonucuna g\u00f6re, \u00fcr\u00fcn\u00fcn biyolojik uyumlulu\u011funun belirlenmesinde risk temelli bir de\u011ferlendirme analizi yap\u0131labilmesi i\u00e7in sadece malzeme kompozisyonu de\u011fil \u00f6zellikle ekstrat edilebilir ve s\u0131zabilir maddelerin tayinlerinin yap\u0131lmas\u0131 gerekmektedir. Ayr\u0131ca t\u0131bbi cihaz\u0131n e\u015fde\u011ferli\u011fin belirlenmesinde de kullan\u0131labilen bu analiz y\u00f6ntemi, \u00f6nerilen bir materyalin ba\u015fka bir \u00fcr\u00fcne e\u015fde\u011ferli\u011fini belirlemek i\u00e7inde kullan\u0131lmaktad\u0131r. \u00d6zellikle nihai cihaz \/ prototip veya \u00f6nerilen bir klinik uygulama i\u00e7in bir t\u0131bbi cihaza uygunluk a\u00e7\u0131s\u0131ndan potansiyel yeni malzemelerin taranmas\u0131 i\u00e7in h\u0131zl\u0131 bir test y\u00f6ntemidir. Bu test y\u00f6nteminin uygulanmas\u0131nda en k\u00f6t\u00fc durum senaryosunu sim\u00fcle etmek i\u00e7in ISO 10993-18 standard\u0131nda farkl\u0131 ekstraksiyon ortamlar\u0131nda ( polar- semipolar -non polar)\u00e7al\u0131\u015fma protokolleri olu\u015fturulmal\u0131 ve testler belirlenen metotlara uygun olarak ger\u00e7ekle\u015ftirilmelidir. Yap\u0131lacak \u00e7al\u0131\u015fman\u0131n temel ba\u015flang\u0131\u00e7 noktas\u0131 analitik de\u011ferlendirme e\u015fi\u011finin hesaplanarak, do\u011fru AET seviyesinin belirlenip; kimyasal \u00f6zelliklerine g\u00f6re \u00fc\u00e7 ana gruba \u00fczerinden \u2022 U\u00e7ucu Olmayan Organik Bile\u015fikler (NVOC)\u2022 Yar\u0131 U\u00e7ucu Organik Bile\u015fikler (SVOC)\u2022 U\u00e7ucu Organik Bile\u015fikler (VOC) Analitik y\u00f6ntemlerle standartta belirlenen cihazlar kullan\u0131larak veriler olu\u015fturulur. Bu veriler toksikolojik de\u011ferlendirme i\u00e7in girdi olu\u015fturur. Detayl\u0131 Bilgi \u0130\u00e7in \u0130leti\u015fime Ge\u00e7ebilirsiniz 02. Toksikolojik Risk De\u011ferlendirmesi Toksikolojik Risk De\u011ferlendirmesi ISO 10993-17 Toxicological Risk Assessment of Medical Device Constituents Tokiskolojik risk de\u011ferlendirmesi temel olarak; ISO 10993-18 standard\u0131na g\u00f6re ger\u00e7ekle\u015ftirilmi\u015f olan ekstrakt edilebilir ve s\u0131zabilir madde miktarlar\u0131n\u0131n analizi sonucuna g\u00f6re, teste konu olan t\u0131bbi cihaz\u0131n \u00fcretiminde ilgi materyallerin toksikolojik a\u00e7\u0131dan herhangi bir risk te\u015fkil edip etmedi\u011fine dair yap\u0131lacak bir de\u011ferlendirmedir metodudur. \u00d6zellikle, bu risk de\u011ferlendirmesini yapan uzman\u0131n, Avrupa Toksikoloji Derne\u011fi taraf\u0131ndan sertifikaland\u0131r\u0131lm\u0131\u015f bir toksikolog olmas\u0131 yap\u0131lacak olan de\u011ferlendirmenin yetkin ve yeterli oldu\u011fu konusunda \u00fcreticilerin aramas\u0131 gereken en \u00f6nemli kriterdir. Detayl\u0131 Bilgi \u0130\u00e7in \u0130leti\u015fime Ge\u00e7ebilirsiniz 03. Fiziksel ve Kimyasal Performans Testleri KATATERLER \u00c7al\u0131\u015fman\u0131n amac\u0131, t\u00fcm kateterlerin (aspirasyon kateteri, G\u00f6\u011f\u00fcs kateteri, Rektal kateter, IV Kan\u00fcl kateteri, Tiemann kateteri, Nelaton kateteri gibi) ISO 8836, ISO 10555-1, ISO 20696 ve ISO 20697 standartlar\u0131 kapsam\u0131nda testlerinin ger\u00e7ekle\u015ftirilmesidir. \u015eIRINGALAR \u00c7al\u0131\u015fman\u0131n amac\u0131, ISO 7886-2 standard\u0131na g\u00f6re \u2018tek kullan\u0131ml\u0131k steril hipodermik \u015f\u0131r\u0131ngalar\u0131n\u2019 kimyasal ve fiziksel gereksinimlerinin do\u011frulu\u011funu test etmektir. Fiziksel gereksinimler aras\u0131nda, kademeli kapasite tolerans\u0131, dereceli \u00f6l\u00e7ek, \u015f\u0131r\u0131nga tasar\u0131m\u0131, piston\/piston montaj\u0131, nozul, performans ve paketleme testleri ISO 7886-2 standard\u0131na g\u00f6re yap\u0131lmaktad\u0131r. \u0130htiya\u00e7 duyulan kimyasal testler aras\u0131nda asitlik veya alkalilik limitleri, ya\u011flay\u0131c\u0131 ve ekstrakte edilebilir metal limitleri testleri ger\u00e7ekle\u015ftirilmektedir. KONNEKT\u00d6R TESTLER\u0130 \u00c7al\u0131\u015fman\u0131n amac\u0131, sa\u011fl\u0131k alan\u0131nda kullan\u0131lan k\u00fc\u00e7\u00fck \u00e7apl\u0131 konekt\u00f6rlerin fiziksel gereksinimlerinin do\u011frulu\u011funun ve yeterlili\u011finin ISO 80369-20 standard\u0131na g\u00f6re test etmektir. Fiziksel gereksinimler aras\u0131nda, bas\u0131n\u00e7 d\u00fc\u015f\u00fc\u015f\u00fc ile s\u0131z\u0131nt\u0131, d\u00fc\u015fen damla pozitif bas\u0131n\u00e7l\u0131 s\u0131v\u0131 s\u0131z\u0131nt\u0131s\u0131, atmosfer alt\u0131 bas\u0131n\u00e7ta hava s\u0131z\u0131nt\u0131s\u0131, stres \u00e7atlamas\u0131, eksenel y\u00fckten ayr\u0131lmaya diren\u00e7, s\u00f6kme ile ba\u011flant\u0131 kesme vb. testler yer almaktad\u0131r. \u0130htiya\u00e7 duyulan kimyasal testler aras\u0131nda asitlik veya alkalilik limitleri, ya\u011flay\u0131c\u0131 ve ekstrakte edilebilir metal limitleri testleri ger\u00e7ekle\u015ftirilmektedir. \u015eIRINGALAR \u0130\u00c7\u0130N \u0130\u011eNE TESTLER\u0130 \u00c7al\u0131\u015fman\u0131n amac\u0131, \u201ctek kullan\u0131ml\u0131k steril hipodermik i\u011fnelerin\u201d kimyasal ve fiziksel gereksinimlerinin ISO 7864: standard\u0131na g\u00f6re do\u011frulu\u011funu test etmektir. Fiziksel gereksinimler aras\u0131nda boyut belirleme, renk kodlamas\u0131, i\u011fne g\u00f6be\u011fi, i\u011fne kapa\u011f\u0131, i\u011fne t\u00fcp\u00fc, i\u011fne ucu, g\u00f6bek ve i\u011fne t\u00fcp\u00fc aras\u0131ndaki ba\u011f, l\u00fcmen a\u00e7\u0131kl\u0131\u011f\u0131 ve par\u00e7alanma testleri yap\u0131lmaktad\u0131r. Gerekli kimyasal testler aras\u0131nda asitlik veya alkalilik limitleri ve ekstrakte edilebilir metal testleri i\u00e7in limitler de\u011ferleri analiz edilmektedir. \u0130NF\u0130ZYON SET \u00c7al\u0131\u015fman\u0131n amac\u0131, bas\u0131n\u00e7l\u0131 inf\u00fczyon ekipman\u0131 ile tek kullan\u0131ml\u0131k ak\u0131\u015fkan hatlar\u0131n\u0131n kimyasal ve fiziksel gereksinimlerinin ISO 8536-9 ve ISO 8536-4 standartlar\u0131na g\u00f6re do\u011frulu\u011funu test etmektir. Fiziksel gereksinimler aras\u0131nda \u015feffafl\u0131k, \u00e7ekme mukavemeti, s\u0131z\u0131nt\u0131, koruyucu kapaklar kontrol\u00fc. Ayr\u0131ca inf\u00fczyon setinde yer alan i\u011fnenin boyut kontrol\u00fc, i\u011fne ucu muayenesi, par\u00e7alanma testi ve penetrasyon testi ISO 8536-9\u2019a g\u00f6re yap\u0131lmaktad\u0131r. Gerekli kimyasal testler aras\u0131nda, \u0130ndirgeyici (oksitlenebilir) madde, Metal iyonlar\u0131, Titrasyon asitli\u011fi veya alkalinitesi, Buharla\u015fmada kal\u0131nt\u0131, Ekstrakt \u00e7\u00f6zeltisinin UV absorpsiyonu testleri ger\u00e7ekle\u015ftirilmektedir. Detayl\u0131 Bilgi \u0130\u00e7in \u0130leti\u015fime Ge\u00e7ebilirsiniz","og_url":"https:\/\/www.chemtoxbiolab.com\/tr\/urunlerimiz\/","og_site_name":"Chemtox Biolab","article_modified_time":"2024-01-01T11:10:13+00:00","og_image":[{"url":"https:\/\/www.chemtoxbiolab.com\/tr\/wp-content\/uploads\/2023\/12\/Adsiz-tasarim-2.png","type":"","width":"","height":""}],"twitter_card":"summary_large_image","twitter_misc":{"Tahmini okuma s\u00fcresi":"5 dakika"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.chemtoxbiolab.com\/tr\/urunlerimiz\/","url":"https:\/\/www.chemtoxbiolab.com\/tr\/urunlerimiz\/","name":"\u00dcr\u00fcnlerimiz - Chemtox Biolab","isPartOf":{"@id":"https:\/\/www.chemtoxbiolab.com\/tr\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.chemtoxbiolab.com\/tr\/urunlerimiz\/#primaryimage"},"image":{"@id":"https:\/\/www.chemtoxbiolab.com\/tr\/urunlerimiz\/#primaryimage"},"thumbnailUrl":"https:\/\/www.chemtoxbiolab.com\/tr\/wp-content\/uploads\/2023\/12\/Adsiz-tasarim-2.png","datePublished":"2020-12-16T01:36:01+00:00","dateModified":"2024-01-01T11:10:13+00:00","breadcrumb":{"@id":"https:\/\/www.chemtoxbiolab.com\/tr\/urunlerimiz\/#breadcrumb"},"inLanguage":"tr","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.chemtoxbiolab.com\/tr\/urunlerimiz\/"]}]},{"@type":"ImageObject","inLanguage":"tr","@id":"https:\/\/www.chemtoxbiolab.com\/tr\/urunlerimiz\/#primaryimage","url":"https:\/\/www.chemtoxbiolab.com\/tr\/wp-content\/uploads\/2023\/12\/Adsiz-tasarim-2.png","contentUrl":"https:\/\/www.chemtoxbiolab.com\/tr\/wp-content\/uploads\/2023\/12\/Adsiz-tasarim-2.png","width":240,"height":240},{"@type":"BreadcrumbList","@id":"https:\/\/www.chemtoxbiolab.com\/tr\/urunlerimiz\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.chemtoxbiolab.com\/tr\/"},{"@type":"ListItem","position":2,"name":"\u00dcr\u00fcnlerimiz"}]},{"@type":"WebSite","@id":"https:\/\/www.chemtoxbiolab.com\/tr\/#website","url":"https:\/\/www.chemtoxbiolab.com\/tr\/","name":"Chemtox Biolab","description":"chemtoxbiolab.com","publisher":{"@id":"https:\/\/www.chemtoxbiolab.com\/tr\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.chemtoxbiolab.com\/tr\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"tr"},{"@type":"Organization","@id":"https:\/\/www.chemtoxbiolab.com\/tr\/#organization","name":"Chemtox Biolab","url":"https:\/\/www.chemtoxbiolab.com\/tr\/","logo":{"@type":"ImageObject","inLanguage":"tr","@id":"https:\/\/www.chemtoxbiolab.com\/tr\/#\/schema\/logo\/image\/","url":"https:\/\/www.chemtoxbiolab.com\/tr\/wp-content\/uploads\/2023\/12\/logo-1.png","contentUrl":"https:\/\/www.chemtoxbiolab.com\/tr\/wp-content\/uploads\/2023\/12\/logo-1.png","width":221,"height":97,"caption":"Chemtox Biolab"},"image":{"@id":"https:\/\/www.chemtoxbiolab.com\/tr\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/www.chemtoxbiolab.com\/tr\/wp-json\/wp\/v2\/pages\/442","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.chemtoxbiolab.com\/tr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.chemtoxbiolab.com\/tr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.chemtoxbiolab.com\/tr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.chemtoxbiolab.com\/tr\/wp-json\/wp\/v2\/comments?post=442"}],"version-history":[{"count":52,"href":"https:\/\/www.chemtoxbiolab.com\/tr\/wp-json\/wp\/v2\/pages\/442\/revisions"}],"predecessor-version":[{"id":2105,"href":"https:\/\/www.chemtoxbiolab.com\/tr\/wp-json\/wp\/v2\/pages\/442\/revisions\/2105"}],"wp:attachment":[{"href":"https:\/\/www.chemtoxbiolab.com\/tr\/wp-json\/wp\/v2\/media?parent=442"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}