
{"id":13689,"date":"2026-05-19T07:14:20","date_gmt":"2026-05-19T07:14:20","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/soru-cevap\/biyouyumluluk-icin-literatur-ve-malzeme-esdegerligi-yeterli-olabilir-mi\/"},"modified":"2026-05-19T07:14:20","modified_gmt":"2026-05-19T07:14:20","slug":"biyouyumluluk-icin-literatur-ve-malzeme-esdegerligi-yeterli-olabilir-mi","status":"publish","type":"kkqa_question","link":"http:\/\/www.kalitekit.com.tr\/en\/soru-cevap\/biyouyumluluk-icin-literatur-ve-malzeme-esdegerligi-yeterli-olabilir-mi\/","title":{"rendered":"Biyouyumluluk i\u00e7in literat\u00fcr ve malzeme e\u015fde\u011ferli\u011fi yeterli olabilir mi?"},"content":{"rendered":"<p>Risk y\u00f6netimi, tehlikelerin listelenmesinden ibaret de\u011fildir. Kullan\u0131m amac\u0131, beklenen kullan\u0131c\u0131 hatalar\u0131, hasta profili, maruziyet s\u00fcresi, temas tipi ve \u00fcr\u00fcn\u00fcn hatal\u0131 \u00e7al\u0131\u015fmas\u0131 halinde olu\u015fabilecek zarar birlikte analiz edilmelidir. Her risk i\u00e7in risk kontrol \u00f6nleminin tasar\u0131m \u00f6nlemi, koruyucu \u00f6nlem veya bilgi\/uyar\u0131 olarak nerede uyguland\u0131\u011f\u0131 g\u00f6sterilmelidir. Art\u0131k risk kabul\u00fc, klinik fayda-risk de\u011ferlendirmesi ve IFU\/etiket uyar\u0131lar\u0131 teknik dosya i\u00e7inde izlenebilir olmal\u0131d\u0131r. 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>Risk y\u00f6netimi, tehlikelerin listelenmesinden ibaret de\u011fildir. Kullan\u0131m amac\u0131, beklenen kullan\u0131c\u0131 hatalar\u0131, hasta profili, maruziyet s\u00fcresi, temas tipi ve \u00fcr\u00fcn\u00fcn hatal\u0131 [&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":[460],"kkqa_letter":[466],"class_list":["post-13689","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-risk-yonetimi","kkqa_letter-b"],"_links":{"self":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13689","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question"}],"about":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/types\/kkqa_question"}],"author":[{"embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/comments?post=13689"}],"version-history":[{"count":0,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13689\/revisions"}],"wp:attachment":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13689"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13689"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13689"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}