
{"id":13679,"date":"2026-05-19T07:14:20","date_gmt":"2026-05-19T07:14:20","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/soru-cevap\/double-sterilisation-uygulanirsa-teknik-dosyada-ne-gosterilmelidir\/"},"modified":"2026-05-19T07:14:20","modified_gmt":"2026-05-19T07:14:20","slug":"double-sterilisation-uygulanirsa-teknik-dosyada-ne-gosterilmelidir","status":"publish","type":"kkqa_question","link":"https:\/\/www.kalitekit.com.tr\/en\/soru-cevap\/double-sterilisation-uygulanirsa-teknik-dosyada-ne-gosterilmelidir\/","title":{"rendered":"Double sterilisation uygulan\u0131rsa teknik dosyada ne g\u00f6sterilmelidir?"},"content":{"rendered":"<p>Sterilite iddias\u0131 y\u00fcksek riskli bir beyan oldu\u011fu i\u00e7in proses validasyonu, steril bariyer sistemi, raf \u00f6mr\u00fc, nakliye sim\u00fclasyonu, \u00e7evresel kontrol ve tedarik\u00e7i y\u00f6netimi birlikte ele al\u0131nmal\u0131d\u0131r. Sadece sterilizasyon sertifikas\u0131 almak yeterli de\u011fildir. Sterilizasyon y\u00f6ntemi, \u00fcr\u00fcn malzemesi, ambalaj yap\u0131s\u0131, biyolojik y\u00fck, kal\u0131nt\u0131 riski ve tekrar i\u015fleme olas\u0131l\u0131\u011f\u0131 teknik dosyada gerek\u00e7elendirilmelidir. De\u011fi\u015fiklik oldu\u011funda yeniden validasyon veya etki analizi yap\u0131lmal\u0131 ve etiket\/IFU bilgileri g\u00fcncellenmelidir. Bu nedenle \u00fcretici, ticari karar ile reg\u00fclasyon karar\u0131n\u0131 ay\u0131rmal\u0131 ve karar mant\u0131\u011f\u0131n\u0131 yaz\u0131l\u0131 hale getirmelidir.<\/p>","protected":false},"excerpt":{"rendered":"<p>Sterilite iddias\u0131 y\u00fcksek riskli bir beyan oldu\u011fu i\u00e7in proses validasyonu, steril bariyer sistemi, raf \u00f6mr\u00fc, nakliye sim\u00fclasyonu, \u00e7evresel kontrol ve [&hellip;]<\/p>\n","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":[463],"kkqa_letter":[482],"class_list":["post-13679","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-sterilizasyon","kkqa_letter-s"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13679","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=13679"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13679\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13679"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13679"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13679"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}