{"id":22009,"date":"2026-02-25T09:54:06","date_gmt":"2026-02-25T08:54:06","guid":{"rendered":"https:\/\/www.cai.cz\/?p=22009"},"modified":"2026-02-26T15:29:29","modified_gmt":"2026-02-26T14:29:29","slug":"spolecne-stanovisko-cia-czedma-cls-jep","status":"publish","type":"post","link":"https:\/\/www.cai.cz\/?p=22009","title":{"rendered":"Spole\u010dn\u00e9 stanovisko \u010cIA, CZEDMA, \u010cLS JEP","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"\n

k rozsahu dokumentace dodavatele IVD a laboratorn\u00edch p\u0159\u00edstroj\u016f v kontextu po\u017eadavk\u016f
\u010cSN EN ISO 15189 ed. 3:2023 a na\u0159\u00edzen\u00ed (EU) 2017\/746 (IVDR)<\/p>\n\n\n\n

\u010cesk\u00fdm institutem pro akreditaci, o.p.s., \u010ceskou asociac\u00ed v\u00fdrobc\u016f a dodavatel\u016f diagnostik in vitro a zainteresovan\u00fdmi odborn\u00fdmi spole\u010dnostmi \u010cesk\u00e9 l\u00e9ka\u0159sk\u00e9 spole\u010dnosti J. E. Purkyn\u011b bylo odsouhlaseno stanovisko navazuj\u00edc\u00ed na p\u0159edchoz\u00ed dokumenty z let 2015 a 2017. Reaguje na revizi normy ISO 15189 a nabyt\u00ed pln\u00e9 \u00fa\u010dinnosti na\u0159\u00edzen\u00ed IVDR. Je ur\u010deno jako doporu\u010den\u00ed pro zdravotnick\u00e9 laborato\u0159e i jejich dodavatele p\u0159i pln\u011bn\u00ed legislativn\u00edch a normativn\u00edch po\u017eadavk\u016f t\u00fdkaj\u00edc\u00edch se laboratorn\u00edho za\u0159\u00edzen\u00ed, reagenci\u00ed a po\u017eadavk\u016f souvisej\u00edc\u00edch.<\/p>\n\n\n\n

Stanovisko_IVDR_ISO_15189_ed.3<\/a><\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"excerpt":{"rendered":"

k rozsahu dokumentace dodavatele IVD a laboratorn\u00edch p\u0159\u00edstroj\u016f v kontextu po\u017eadavk\u016f \u010cSN EN ISO 15189 ed. 3:2023 a na\u0159\u00edzen\u00ed (EU) 2017\/746 (IVDR) \u010cesk\u00fdm institutem pro…<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":21,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_price":"","_stock":"","_tribe_ticket_header":"","_tribe_default_ticket_provider":"","_tribe_ticket_capacity":"","_ticket_start_date":"","_ticket_end_date":"","_tribe_ticket_show_description":"","_tribe_ticket_show_not_going":false,"_tribe_ticket_use_global_stock":"","_tribe_ticket_global_stock_level":"","_global_stock_mode":"","_global_stock_cap":"","_tribe_rsvp_for_event":"","_tribe_ticket_going_count":"","_tribe_ticket_not_going_count":"","_tribe_tickets_list":"[]","_tribe_ticket_has_attendee_info_fields":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-22009","post","type-post","status-publish","format-standard","hentry","category-oznameni-cs"],"acf":[],"gt_translate_keys":[{"key":"link","format":"url"}],"_links":{"self":[{"href":"https:\/\/www.cai.cz\/index.php?rest_route=\/wp\/v2\/posts\/22009","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.cai.cz\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.cai.cz\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.cai.cz\/index.php?rest_route=\/wp\/v2\/users\/21"}],"replies":[{"embeddable":true,"href":"https:\/\/www.cai.cz\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=22009"}],"version-history":[{"count":4,"href":"https:\/\/www.cai.cz\/index.php?rest_route=\/wp\/v2\/posts\/22009\/revisions"}],"predecessor-version":[{"id":22013,"href":"https:\/\/www.cai.cz\/index.php?rest_route=\/wp\/v2\/posts\/22009\/revisions\/22013"}],"wp:attachment":[{"href":"https:\/\/www.cai.cz\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=22009"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.cai.cz\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=22009"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.cai.cz\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=22009"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}