{"id":9433,"date":"2025-10-10T13:18:52","date_gmt":"2025-10-10T13:18:52","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/?p=9433"},"modified":"2025-10-10T13:19:00","modified_gmt":"2025-10-10T13:19:00","slug":"iso-14971-tibbi-cihazlarda-risk-yonetimi-sureci","status":"publish","type":"post","link":"https:\/\/www.kalitekit.com.tr\/en\/iso-14971-tibbi-cihazlarda-risk-yonetimi-sureci\/","title":{"rendered":"ISO 14971 \u2013 T\u0131bbi Cihazlarda Risk Y\u00f6netimi S\u00fcreci"},"content":{"rendered":"<h3 class=\"wp-block-heading\">\ud83d\udd0d ISO 14971 Nedir?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">T\u0131bbi cihaz \u00fcretiminde kalite ve g\u00fcvenlik, sadece cihaz\u0131n performans\u0131na de\u011fil; <strong>risklerin etkin bi\u00e7imde y\u00f6netilmesine<\/strong> de ba\u011fl\u0131d\u0131r.<br><strong>ISO 14971<\/strong>, \u00fcreticilerin cihaz ya\u015fam d\u00f6ng\u00fcs\u00fc boyunca biyolojik, mekanik, yaz\u0131l\u0131msal ve klinik riskleri tan\u0131mlay\u0131p y\u00f6netmeleri i\u00e7in olu\u015fturulmu\u015f uluslararas\u0131 bir standartt\u0131r.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Bu standart, <strong>MDR 2017\/745<\/strong> ve <strong>IVDR 2017\/746<\/strong> y\u00f6netmeliklerinin temelinde yer al\u0131r. Avrupa\u2019da cihaz CE belgesi almak isteyen \u00fcreticiler, bu standarda uygun bir <strong>Risk Y\u00f6netim Dosyas\u0131<\/strong> haz\u0131rlamak zorundad\u0131r.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u2699\ufe0f Risk Y\u00f6netimi S\u00fcreci Ad\u0131mlar\u0131<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">ISO 14971, risk y\u00f6netimini sistematik bir \u00e7er\u00e7evede ele al\u0131r:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Risk Y\u00f6netim Plan\u0131 Olu\u015fturma<\/strong><br>Her cihaz i\u00e7in risk y\u00f6netimi kapsam\u0131, sorumluluklar, y\u00f6ntemler ve kabul kriterleri belirlenir.<\/li>\n\n\n\n<li><strong>Tehlikelerin Tan\u0131mlanmas\u0131 (Hazard Identification)<\/strong><br>Cihaz\u0131n tasar\u0131m\u0131, malzemeleri, kullan\u0131c\u0131 etkile\u015fimi gibi t\u00fcm a\u015famalarda olu\u015fabilecek potansiyel tehlikeler belirlenir.<\/li>\n\n\n\n<li><strong>Risk Analizi<\/strong><br>Her tehlikenin olas\u0131l\u0131\u011f\u0131 ve \u015fiddeti de\u011ferlendirilir. Bu ad\u0131mda genellikle <strong>risk matrisi<\/strong> kullan\u0131l\u0131r.<\/li>\n\n\n\n<li><strong>Risk De\u011ferlendirme ve Kabul Edilebilirlik Analizi<\/strong><br>Analiz edilen riskler, belirlenen kabul edilebilirlik kriterlerine g\u00f6re s\u0131n\u0131fland\u0131r\u0131l\u0131r.<\/li>\n\n\n\n<li><strong>Risk Kontrol \u00d6nlemleri<\/strong><br>Uygun tasar\u0131m de\u011fi\u015fiklikleri, koruyucu \u00f6nlemler veya kullan\u0131c\u0131 talimatlar\u0131 ile riskler azalt\u0131l\u0131r.<\/li>\n\n\n\n<li><strong>Art\u0131k Risk De\u011ferlendirmesi<\/strong><br>T\u00fcm kontrol \u00f6nlemleri sonras\u0131 kalan riskler (residual risks) yeniden de\u011ferlendirilir ve gerekirse risk\/yarar oran\u0131 analiz edilir.<\/li>\n\n\n\n<li><strong>Risk Y\u00f6netim Raporu ve \u0130zleme<\/strong><br>S\u00fcre\u00e7 sonunda elde edilen t\u00fcm sonu\u00e7lar dok\u00fcmante edilir. \u00dcr\u00fcn pazardayken de post-market veriler izlenmeye devam eder.<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\ud83d\udcc4 MDR ile ISO 14971 Aras\u0131ndaki \u0130li\u015fki<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Avrupa Birli\u011fi\u2019nin <strong>MDR 2017\/745<\/strong> y\u00f6netmeli\u011fi, risk y\u00f6netimini sadece bir gereklilik de\u011fil, <strong>tasar\u0131m\u0131n ayr\u0131lmaz bir par\u00e7as\u0131<\/strong> olarak tan\u0131mlar.<br>Bu nedenle \u00fcreticiler, ISO 14971\u2019in ad\u0131mlar\u0131n\u0131 <strong>MDR\u2019nin Ek I \u2013 Genel G\u00fcvenlik ve Performans Gereklilikleri (GSPR)<\/strong> ile ili\u015fkilendirmelidir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ayr\u0131ca <strong>EN ISO 14971:2019 + A11:2021 (Annex Z)<\/strong> s\u00fcr\u00fcm\u00fc, MDR ile tam uyum sa\u011flayan versiyondur.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\ud83e\udde0 Risk Y\u00f6netimi Dok\u00fcmantasyonu<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Bir risk y\u00f6netim sistemi; sadece analiz tablolar\u0131ndan ibaret de\u011fildir. A\u015fa\u011f\u0131daki dok\u00fcmanlar izlenebilirli\u011fin anahtar\u0131d\u0131r:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Risk Y\u00f6netim Plan\u0131<\/strong><\/li>\n\n\n\n<li><strong>Risk Analizi Formu<\/strong><\/li>\n\n\n\n<li><strong>Risk De\u011ferlendirme Matrisi<\/strong><\/li>\n\n\n\n<li><strong>Risk Kontrol Tablosu<\/strong><\/li>\n\n\n\n<li><strong>Risk Y\u00f6netim Raporu<\/strong><\/li>\n\n\n\n<li><strong>Post-Market Veri Raporlar\u0131<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Her dok\u00fcman, cihaz ya\u015fam d\u00f6ng\u00fcs\u00fc boyunca g\u00fcncel tutulmal\u0131d\u0131r.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u26a0\ufe0f S\u0131k Yap\u0131lan Hatalar<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udeab T\u00fcm tehlikelerin kapsaml\u0131 \u015fekilde tan\u0131mlanmamas\u0131<br>\ud83d\udeab Art\u0131k risklerin yanl\u0131\u015f de\u011ferlendirilmesi<br>\ud83d\udeab Risk kontrol \u00f6nlemlerinin etkinli\u011finin do\u011frulanmamas\u0131<br>\ud83d\udeab Dok\u00fcmantasyonun yetersiz tutulmas\u0131<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Bu hatalar, denetimlerde <strong>uygunsuzluk (NC)<\/strong> olarak de\u011ferlendirilir ve CE belgelendirme s\u00fcrecini geciktirebilir.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\u2705 En \u0130yi Uygulamalar<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Risk y\u00f6netimini <strong>tasar\u0131m a\u015famas\u0131ndan<\/strong> itibaren ba\u015flat\u0131n.<\/li>\n\n\n\n<li>Her g\u00fcncellemede <strong>risk analizi<\/strong> belgelerini g\u00f6zden ge\u00e7irin.<\/li>\n\n\n\n<li>Risk de\u011ferlendirmesini <strong>klinik verilerle destekleyin<\/strong>.<\/li>\n\n\n\n<li>S\u00fcre\u00e7 boyunca <strong>kalite y\u00f6netim sistemi (ISO 13485)<\/strong> ile entegrasyonu sa\u011flay\u0131n.<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\ud83e\udde9 Sonu\u00e7<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">ISO 14971 standard\u0131, yaln\u0131zca bir teknik zorunluluk de\u011fil, ayn\u0131 zamanda <strong>hasta g\u00fcvenli\u011fini merkeze alan bir yakla\u015f\u0131m\u0131n<\/strong> g\u00f6stergesidir.<br>Etkin bir risk y\u00f6netim sistemi, \u00fcreticilere hem <strong>reg\u00fclasyon uyumu<\/strong> hem de <strong>s\u00fcrd\u00fcr\u00fclebilir kalite g\u00fcvence yap\u0131s\u0131<\/strong> kazand\u0131r\u0131r.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h3 class=\"wp-block-heading\">\ud83d\udccc Hashtag \u00d6nerileri (LinkedIn i\u00e7in)<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">#ISO14971 #RiskY\u00f6netimi #T\u0131bbiCihaz #KaliteY\u00f6netimi #MDR #CEBelgelendirme #Kalitekit<\/p>","protected":false},"excerpt":{"rendered":"<p>ISO 14971 standard\u0131 ile t\u0131bbi cihazlarda risk analizi, kontrol ve izleme s\u00fcre\u00e7leri nas\u0131l kurulmal\u0131? Uygulama rehberi.<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","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":""},"categories":[122],"tags":[176,298,299,297],"class_list":["post-9433","post","type-post","status-publish","format-standard","hentry","category-blog","tag-iso-14971","tag-risk-analizi","tag-risk-kontrol","tag-tibbi-cihaz-risk-yonetimi"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts\/9433","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/types\/post"}],"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=9433"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts\/9433\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=9433"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/categories?post=9433"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/tags?post=9433"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}