Belgelendirme karar\u0131nda ilk kontrol, cihaz\u0131n do\u011fru s\u0131n\u0131fta ve do\u011fru uygunluk de\u011ferlendirme yolu alt\u0131nda ele al\u0131n\u0131p al\u0131nmad\u0131\u011f\u0131d\u0131r. CE i\u015fareti, uygunluk beyan\u0131, notified body sertifikas\u0131 ve \u00fcr\u00fcn etiketi ayn\u0131 kapsam\u0131 desteklemelidir. Uygunluk beyan\u0131 veya sertifika \u00fczerinde yer alan \u00fcr\u00fcn ad\u0131, model, Basic UDI-DI, y\u00f6netmelik, standart ve \u00fcretici bilgileri teknik dosya ile \u00e7eli\u015fmemelidir. Bir \u00fcr\u00fcn varyant\u0131 sertifika kapsam\u0131 d\u0131\u015f\u0131nda kal\u0131yorsa sat\u0131\u015f veya kay\u0131t \u00f6ncesi kapsam de\u011ferlendirmesi yap\u0131lmal\u0131d\u0131r. Dosyada ayn\u0131 bilgi etiket, IFU, risk analizi, GSPR matrisi ve uygunluk beyan\u0131nda tutarl\u0131 g\u00f6r\u00fcnmelidir.<\/p>","protected":false},"excerpt":{"rendered":"
CE ve uygunluk beyan\u0131 kararlar\u0131, cihaz s\u0131n\u0131f\u0131, notified body kapsam\u0131, teknik dosya ve \u00fcr\u00fcn etiketinin ayn\u0131 kapsam\u0131 desteklemesine ba\u011fl\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":[498],"kkqa_letter":[467],"class_list":["post-13658","kkqa_question","type-kkqa_question","status-publish","hentry","kkqa_category-onaylanmis-kurulus","kkqa_letter-c"],"_links":{"self":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13658","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=13658"}],"version-history":[{"count":0,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_question\/13658\/revisions"}],"wp:attachment":[{"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=13658"}],"wp:term":[{"taxonomy":"kkqa_category","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_category?post=13658"},{"taxonomy":"kkqa_letter","embeddable":true,"href":"http:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/kkqa_letter?post=13658"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}