
{"id":13793,"date":"2026-05-19T07:14:21","date_gmt":"2026-05-19T07:14:21","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/soru-cevap\/class-i-urunlerde-gspr-tablosu-ne-kadar-detayli-olmali\/"},"modified":"2026-07-16T12:19:19","modified_gmt":"2026-07-16T12:19:19","slug":"class-i-urunlerde-gspr-tablosu-ne-kadar-detayli-olmali","status":"publish","type":"kkqa_question","link":"https:\/\/www.kalitekit.com.tr\/en\/soru-cevap\/class-i-urunlerde-gspr-tablosu-ne-kadar-detayli-olmali\/","title":{"rendered":"Class I \u00fcr\u00fcnlerde GSPR tablosu ne kadar detayl\u0131 olmal\u0131?"},"content":{"rendered":"<p>GSPR matrisi, teknik dosyan\u0131n omurgalar\u0131ndan biridir. Her uygulanabilir gereklilik i\u00e7in hangi dok\u00fcman, test raporu, risk analizi, etiket bilgisi, validasyon kayd\u0131 veya klinik kan\u0131t\u0131n uygunlu\u011fu destekledi\u011fi a\u00e7\u0131k\u00e7a g\u00f6sterilmelidir. Uygulanamaz denilen maddelerde \u201c\u00fcr\u00fcn i\u00e7in ge\u00e7erli de\u011fil\u201d yazmak tek ba\u015f\u0131na yeterli de\u011fildir. \u00dcr\u00fcn\u00fcn kullan\u0131m amac\u0131, temas tipi, enerji kayna\u011f\u0131, sterilite durumu, yaz\u0131l\u0131m i\u00e7erip i\u00e7ermedi\u011fi ve kullan\u0131c\u0131 profili dikkate al\u0131narak k\u0131sa ama mant\u0131kl\u0131 gerek\u00e7e verilmelidir. Dosyada ayn\u0131 bilgi etiket, IFU, risk analizi, GSPR matrisi ve uygunluk beyan\u0131nda tutarl\u0131 g\u00f6r\u00fcnmelidir.<\/p>","protected":false},"excerpt":{"rendered":"<p>GSPR kan\u0131t\u0131, her uygulanabilir gereklilik i\u00e7in somut dok\u00fcman, test, analiz, etiket veya risk y\u00f6netimi referans\u0131yla desteklenmelidir.<\/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":[459],"kkqa_letter":[471],"class_list":["post-13793","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-gspr","kkqa_letter-g"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13793","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=13793"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13793\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13793"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13793"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13793"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}