T\u0131bbi cihaz etiketi MDR\/IVDR kapsam\u0131nda cihaz\u0131n g\u00fcvenli kullan\u0131m\u0131n\u0131 desteklemelidir. \u00dcretici ad\u0131\/adresi, cihaz ad\u0131, lot\/seri, UDI, CE i\u015fareti, saklama ko\u015fullar\u0131, sterilite, tek kullan\u0131ml\u0131k bilgi ve gerekli semboller \u00fcr\u00fcn\u00fcn niteli\u011fine g\u00f6re de\u011ferlendirilir. Etiket bilgileri teknik dosya, uygunluk beyan\u0131, \u00dcTS\/EUDAMED kay\u0131tlar\u0131 ve IFU ile uyumlu olmal\u0131d\u0131r.<\/p>\n\n\n
T\u0131bbi cihaz etiketi; cihaz\u0131n \u00fczerinde, her bir cihaz\u0131n ambalaj\u0131nda veya birden fazla cihaz\u0131 i\u00e7eren ambalaj \u00fczerinde yer alan yaz\u0131l\u0131, bas\u0131l\u0131 ya da grafik bilgileri ifade eder. Etiketin amac\u0131 yaln\u0131zca \u00fcr\u00fcn\u00fc tan\u0131tmak de\u011fildir. Cihaz\u0131n do\u011fru tan\u0131mlanmas\u0131n\u0131, g\u00fcvenli kullan\u0131lmas\u0131n\u0131, \u00fcretim serisinin izlenmesini ve piyasadaki ekonomik operat\u00f6rlerin belirlenmesini sa\u011flar.<\/p>\n\n\n\n
Etikette bulunmas\u0131 gereken bilgiler cihaz\u0131n kullan\u0131m amac\u0131na, s\u0131n\u0131f\u0131na, steril olup olmamas\u0131na, tek kullan\u0131ml\u0131k veya tekrar kullan\u0131labilir olmas\u0131na, \u00f6l\u00e7\u00fcm fonksiyonu ta\u015f\u0131mas\u0131na ve raf \u00f6mr\u00fcne g\u00f6re de\u011fi\u015fir. Genel olarak \u00fcr\u00fcn\u00fcn veya cihaz\u0131n ad\u0131, kullan\u0131c\u0131 taraf\u0131ndan cihaz\u0131 tan\u0131mlamaya yarayan bilgiler, \u00fcreticinin ad\u0131 ve adresi, AB d\u0131\u015f\u0131ndaki \u00fcreticiler i\u00e7in yetkili temsilci bilgisi, lot veya seri numaras\u0131, UDI ta\u015f\u0131y\u0131c\u0131s\u0131, \u00fcretim veya son kullanma tarihi, saklama ko\u015fullar\u0131, sterilite bilgisi, tek kullan\u0131ml\u0131k cihaz uyar\u0131s\u0131 ve g\u00fcvenli kullan\u0131m i\u00e7in gerekli uyar\u0131lar de\u011ferlendirilmelidir.<\/p>\n\n\n\n
UDI, yaln\u0131zca barkod g\u00f6r\u00fcnt\u00fcs\u00fcnden ibaret de\u011fildir. Etiket \u00fczerindeki UDI-DI ve varsa UDI-PI bilgileri; \u00fcr\u00fcn modeli, ambalaj seviyesi, lot veya seri numaras\u0131, \u00fcretim tarihi ve son kullanma tarihiyle uyumlu olmal\u0131d\u0131r. Etiketteki bilgiler ile EUDAMED veya \u00dcTS kay\u0131tlar\u0131, uygunluk beyan\u0131, Basic UDI-DI yap\u0131s\u0131, teknik dosya ve firma stok sistemi aras\u0131nda \u00e7eli\u015fki bulunmamal\u0131d\u0131r.<\/p>\n\n\n\n
AB ithalat\u00e7\u0131s\u0131n\u0131n bilgileri MDR Madde 13 kapsam\u0131nda cihaz, ambalaj veya cihazla birlikte verilen bir belge \u00fczerinde g\u00f6sterilebilir. \u0130thalat\u00e7\u0131 taraf\u0131ndan eklenen bilgi, \u00fcreticinin haz\u0131rlad\u0131\u011f\u0131 etiketteki zorunlu bilgileri kapatmamal\u0131 veya okunamaz h\u00e2le getirmemelidir. Distrib\u00fct\u00f6r\u00fcn yapt\u0131\u011f\u0131 \u00e7eviri, yeniden etiketleme veya ambalaj de\u011fi\u015fikli\u011fi ise MDR Madde 16 kapsam\u0131nda ayr\u0131ca de\u011ferlendirilmelidir.<\/p>\n\n\n\n
Semboller kullan\u0131ld\u0131\u011f\u0131nda bunlar\u0131n anlam\u0131 hedef kullan\u0131c\u0131 taraf\u0131ndan anla\u015f\u0131labilir olmal\u0131d\u0131r. ISO 15223-1\u2019de tan\u0131mlanan semboller \u00fcretici, yetkili temsilci, ithalat\u00e7\u0131, \u00fcretim tarihi, son kullanma tarihi, lot, seri numaras\u0131, sterilizasyon y\u00f6ntemi ve saklama \u015fartlar\u0131 gibi bilgilerin standart bi\u00e7imde sunulmas\u0131na yard\u0131mc\u0131 olur. Standartta bulunmayan yeni veya \u00fcr\u00fcn \u00f6zelindeki sembollerin anlam\u0131 kullan\u0131m k\u0131lavuzunda veya \u00fcr\u00fcnle birlikte verilen bilgilerde a\u00e7\u0131klanmal\u0131d\u0131r.<\/p>\n\n\n\n
Etiket tasar\u0131m\u0131 yaln\u0131zca mevzuat metninin yerle\u015ftirilmesi olarak g\u00f6r\u00fclmemelidir. Yaz\u0131 b\u00fcy\u00fckl\u00fc\u011f\u00fc, kontrast, bask\u0131 dayan\u0131kl\u0131l\u0131\u011f\u0131, barkodun okunabilirli\u011fi, ambalaj a\u00e7\u0131ld\u0131ktan sonra bilginin korunmas\u0131, \u00e7eviri kontrol\u00fc ve farkl\u0131 ambalaj seviyelerindeki bilgi tutarl\u0131l\u0131\u011f\u0131 do\u011frulanmal\u0131d\u0131r. K\u00fc\u00e7\u00fck etiket alan\u0131, zorunlu bilgilerin kald\u0131r\u0131lmas\u0131 i\u00e7in tek ba\u015f\u0131na gerek\u00e7e de\u011fildir; bilgi mimarisi, sembol kullan\u0131m\u0131 ve e\u015flik eden dok\u00fcmanlar \u00fcr\u00fcn \u00f6zelinde planlanmal\u0131d\u0131r.<\/p>\n\n\n\n
Etiket de\u011fi\u015fiklikleri kontroll\u00fc dok\u00fcman s\u00fcrecine tabi olmal\u0131d\u0131r. \u00dcr\u00fcn ad\u0131, \u00fcretici adresi, UDI-DI, ambalaj miktar\u0131, sterilizasyon y\u00f6ntemi, raf \u00f6mr\u00fc veya kullan\u0131m amac\u0131n\u0131 etkileyen bir de\u011fi\u015fiklikte teknik dosya, risk y\u00f6netimi, uygunluk beyan\u0131, kay\u0131t sistemleri ve stoktaki mevcut etiketlerin etkisi birlikte de\u011ferlendirilmelidir. Onays\u0131z veya eski revizyonlu etiketlerin \u00fcretimde kullan\u0131lmas\u0131 ciddi izlenebilirlik ve piyasa g\u00f6zetimi riski olu\u015fturur.<\/p>","protected":false},"excerpt":{"rendered":"
Etiket, cihaz\u0131n kimli\u011fi, \u00fcreticisi, kullan\u0131m ko\u015fullar\u0131, uyar\u0131lar\u0131 ve izlenebilirlik bilgilerini kullan\u0131c\u0131ya aktaran zorunlu bilgi alan\u0131d\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":[518],"kkqa_letter":[483],"class_list":["post-12632","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-genel-mevzuat","kkqa_letter-t"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/12632","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=12632"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/12632\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=12632"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=12632"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=12632"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}