Etiket ve IFU, \u00fcr\u00fcn\u00fcn g\u00fcvenli kullan\u0131m\u0131n\u0131 sa\u011flayan reg\u00fclasyon kontrol noktalar\u0131d\u0131r. \u00dcr\u00fcn ad\u0131, kullan\u0131m amac\u0131, kullan\u0131c\u0131 grubu, uyar\u0131lar, kontrendikasyonlar, saklama ko\u015fullar\u0131, \u00fcretici bilgisi, UDI ve semboller teknik dosya ile uyumlu olmal\u0131d\u0131r. \u00c7eviri, eIFU veya k\u0131sa kullan\u0131m kart\u0131 gibi uygulamalar yap\u0131l\u0131rken \u00fclke dili gereklilikleri, kullan\u0131c\u0131 eri\u015fimi, risk azaltma rol\u00fc ve g\u00fcncel revizyon kontrol\u00fc de\u011ferlendirilmelidir. Yanl\u0131\u015f veya eksik IFU bilgisi hem PMS \u015fikayeti hem de piyasa g\u00f6zetimi uygunsuzlu\u011fu do\u011furabilir. Denetimde g\u00fc\u00e7l\u00fc bir cevap verebilmek i\u00e7in karar\u0131n dayand\u0131\u011f\u0131 prosed\u00fcr, kay\u0131t ve revizyon ge\u00e7mi\u015fi birlikte g\u00f6sterilmelidir.<\/p>","protected":false},"excerpt":{"rendered":"
Etiket ve IFU de\u011ferlendirmesi, kullan\u0131m amac\u0131, kullan\u0131c\u0131 grubu, risk bilgisi, dil gereklili\u011fi ve MDR\/IVDR Ek I bilgi h\u00fck\u00fcmlerine g\u00f6re yap\u0131l\u0131r.<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","template":"","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 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-4)","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-4)","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-4)","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":""},"kkqa_category":[454],"kkqa_letter":[473],"class_list":["post-13731","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-etiket-ifu","kkqa_letter-i"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13731","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question"}],"about":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/types\/kkqa_question"}],"author":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/comments?post=13731"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13731\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13731"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13731"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13731"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}