{"id":9419,"date":"2025-10-10T11:44:36","date_gmt":"2025-10-10T11:44:36","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/?p=9419"},"modified":"2025-10-10T11:44:48","modified_gmt":"2025-10-10T11:44:48","slug":"%f0%9f%94%ac-tibbi-cihaz-biyouyumluluk-standardi-yenileniyor-en-iso-10993-1-guncellemesi-yakinda-yayinlaniyor","status":"publish","type":"post","link":"https:\/\/www.kalitekit.com.tr\/en\/%f0%9f%94%ac-tibbi-cihaz-biyouyumluluk-standardi-yenileniyor-en-iso-10993-1-guncellemesi-yakinda-yayinlaniyor\/","title":{"rendered":"\ud83d\udd2c T\u0131bbi Cihaz Biyouyumluluk Standard\u0131 Yenileniyor: EN ISO 10993-1 G\u00fcncellemesi Yak\u0131nda Yay\u0131nlan\u0131yor"},"content":{"rendered":"<p class=\"wp-block-paragraph\">T\u0131bbi cihazlar\u0131n g\u00fcvenli\u011fini ve insan sa\u011fl\u0131\u011f\u0131yla uyumunu belirleyen en \u00f6nemli referanslardan biri olan <strong>EN ISO 10993-1<\/strong> standard\u0131, <strong>6 Kas\u0131m 2025<\/strong> tarihinde g\u00fcncellenmi\u015f versiyonuyla yay\u0131nlan\u0131yor.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Bu standart, t\u0131bbi cihazlar\u0131n <strong>biyolojik de\u011ferlendirmesi<\/strong> ve <strong>risk y\u00f6netimi s\u00fcreci<\/strong> a\u00e7\u0131s\u0131ndan \u00fcreticiler i\u00e7in kritik bir rehber niteli\u011finde.<br>Yeni versiyonla birlikte:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Test protokollerinde yenilikler<\/strong>,<\/li>\n\n\n\n<li><strong>Risk de\u011ferlendirme yakla\u015f\u0131mlar\u0131nda g\u00fcncellemeler<\/strong>,<\/li>\n\n\n\n<li><strong>Dok\u00fcmantasyon gereksinimlerinde de\u011fi\u015fiklikler<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">bekleniyor.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Onay s\u00fcreci <strong>15 Eyl\u00fcl 2025\u2019te<\/strong> tamamland\u0131 ve art\u0131k yay\u0131n tarihi resmen <strong>6 Kas\u0131m 2025<\/strong> olarak duyuruldu.<br>Bu g\u00fcncelleme, \u00fcreticilerin hem <strong>reg\u00fclasyon uyumunu<\/strong> s\u00fcrd\u00fcrmesi hem de <strong>\u00fcr\u00fcn g\u00fcvenli\u011fini<\/strong> en \u00fcst seviyede sa\u011flamas\u0131 a\u00e7\u0131s\u0131ndan b\u00fcy\u00fck \u00f6nem ta\u015f\u0131yor.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Kalitekit<\/strong> olarak, yeni standarda ge\u00e7i\u015f s\u00fcrecinde \u00fcreticilere rehberlik etmeye devam ediyoruz.<br>Biyouyumluluk testleri, risk de\u011ferlendirme stratejileri ve dok\u00fcmantasyon deste\u011fiyle, yeni gerekliliklere h\u0131zl\u0131 ve do\u011fru \u015fekilde uyum sa\u011flaman\u0131za yard\u0131mc\u0131 oluyoruz.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udce9 Yeni gereksinimlere haz\u0131rl\u0131k s\u00fcrecinde destek almak i\u00e7in bizimle ileti\u015fime ge\u00e7ebilirsiniz.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">#Kalitekit #T\u0131bbiCihaz #ISO10993 #Biyouyumluluk #MedicalDevices #RiskDe\u011ferlendirme #LaboratuvarHizmetleri #RegulatoryCompliance<\/p>","protected":false},"excerpt":{"rendered":"<p>T\u0131bbi cihazlar\u0131n g\u00fcvenli\u011fini ve insan sa\u011fl\u0131\u011f\u0131yla uyumunu belirleyen en \u00f6nemli referanslardan biri olan EN ISO 10993-1 standard\u0131, 6 Kas\u0131m 2025 tarihinde g\u00fcncellenmi\u015f versiyonuyla yay\u0131nlan\u0131yor<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","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":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","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":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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