
{"id":13773,"date":"2026-05-19T07:14:21","date_gmt":"2026-05-19T07:14:21","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/soru-cevap\/fmea-tek-basina-iso-14971-icin-yeterli-midir\/"},"modified":"2026-07-16T12:18:17","modified_gmt":"2026-07-16T12:18:17","slug":"fmea-tek-basina-iso-14971-icin-yeterli-midir","status":"publish","type":"kkqa_question","link":"http:\/\/www.kalitekit.com.tr\/en\/soru-cevap\/fmea-tek-basina-iso-14971-icin-yeterli-midir\/","title":{"rendered":"FMEA tek ba\u015f\u0131na ISO 14971 i\u00e7in yeterli midir?"},"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. Konu d\u00fc\u015f\u00fck riskli g\u00f6r\u00fcnse bile yanl\u0131\u015f s\u0131n\u0131fland\u0131rma veya yanl\u0131\u015f rol atamas\u0131 daha sonra kay\u0131t ve piyasa g\u00f6zetimi problemi olu\u015fturabilir.<\/p>","protected":false},"excerpt":{"rendered":"<p>Risk de\u011ferlendirmesi yaln\u0131zca tehlike listesi de\u011fil; kullan\u0131m amac\u0131, kullan\u0131c\u0131 profili, risk kontrol\u00fc ve art\u0131k risk ileti\u015fimiyle birlikte yap\u0131lmal\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":[460],"kkqa_letter":[481],"class_list":["post-13773","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-risk-yonetimi","kkqa_letter-r"],"_links":{"self":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13773","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=13773"}],"version-history":[{"count":0,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13773\/revisions"}],"wp:attachment":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13773"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13773"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13773"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}