{"id":918,"date":"2020-07-07T09:54:22","date_gmt":"2020-07-07T09:54:22","guid":{"rendered":"https:\/\/ardenneiratherm.com\/certifications\/"},"modified":"2026-01-20T16:23:15","modified_gmt":"2026-01-20T16:23:15","slug":"certifikati","status":"publish","type":"page","link":"https:\/\/ardenneiratherm.com\/hr\/certifikati\/","title":{"rendered":"Certifikati"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"918\" class=\"elementor elementor-918 elementor-291\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c610dbd e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"c610dbd\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;slideInDown&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7a118e9e elementor-widget elementor-widget-heading\" data-id=\"7a118e9e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Slu\u017ebeni Certifikati Iratherm 1000: Dokaz Kvalitete i Autoritet (E-E-A-T) za Hipertermiju Cijelog Tijela (WBH wIRA)<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1acf5629 elementor-widget elementor-widget-text-editor\" data-id=\"1acf5629\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Von Ardenne Iratherm 1000 ure\u0111aj za Hipertermiju Cijelog Tijela (WBH wIRA) rezultat je na\u0161e Stru\u010dnosti (E) i Iskustva (E). Podvrgnut rigoroznom i neovisnom testiranju, ovaj je ure\u0111aj dobio sveobuhvatne certifikate koji ne samo da zadovoljavaju, ve\u0107 i nadilaze me\u0111unarodne standarde. Ovi dokumenti jam\u010de Sigurnost, Kvalitetu i U\u010dinkovitost Iratherma 1000, \u0161to je klju\u010dno za na\u0161 Autoritet (A) i Pouzdranost (T) u onkolo\u0161kom podru\u010dju.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3a695dd7 e-flex e-con-boxed e-con e-parent\" data-id=\"3a695dd7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-23424373 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"23424373\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;slideInUp&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Detaljan Pregled: Certifikati kao Dokazi Klini\u010dkog Autoriteteta<\/h2>\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-26befc31 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"26befc31\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;slideInUp&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1d2266a8 elementor-widget elementor-widget-heading\" data-id=\"1d2266a8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Me\u0111unarodni Certifikat Kvalitete UNI CEI EN ISO 13485: Temelj Na\u0161eg Sustava Upravljanja Kvalitetom (QMS)<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5e38d712 elementor-widget elementor-widget-text-editor\" data-id=\"5e38d712\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Von Ardenne Iratherm 1000 WBH wIRA ure\u0111aj za hipertermiju ponosno posjeduje\u00a0<a href=\"https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/Certificate_ISO13485_2025-von-Ardenne-Iratherm-1000-WBH-wIRA-hyperthermia-device.pdf\" target=\"_blank\" rel=\"noopener\">certifikat sustava kvalitete UNI EN ISO 13485<\/a>.<\/p><p>Certifikat potvr\u0111uje da je Von Ardenne Institut f\u00fcr Angewandte Medizinische Forschung GmbH implementirao i odr\u017eava Sustav Upravljanja Kvalitetom (QMS) koji ispunjava zahtjeve norme DIN EN ISO 13485:2021-12 (ISO 13485:2016).<br \/>ISO 13485 je me\u0111unarodno priznati standard koji specificira zahtjeve za sustav upravljanja kvalitetom. Osigurava da organizacija mo\u017ee dosljedno pru\u017eati medicinske proizvode i povezane usluge koje zadovoljavaju zahtjeve kupaca i primjenjive regulatorne zahtjeve.<\/p><p>Za Institut Von Ardenne, ova certifikacija nagla\u0161ava na\u0161u predanost pedantnoj kontroli kvalitete tijekom cijelog \u017eivotnog ciklusa Iratherm 1000 WBH wIRA ure\u0111aja, od dizajna i razvoja do proizvodnje, instalacije i servisiranja. To je temeljno jamstvo na\u0161e posve\u0107enosti sigurnosti pacijenata i izvrsnosti proizvoda.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6ef86f7b elementor-widget elementor-widget-image\" data-id=\"6ef86f7b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"635\" height=\"906\" src=\"https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/ISO-13485-certificate-von-Ardenne-Medical-Institute-Dresden.jpg\" class=\"attachment-large size-large wp-image-2824\" alt=\"ISO 13485 certificate von Ardenne Medical Institute Dresden\" srcset=\"https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/ISO-13485-certificate-von-Ardenne-Medical-Institute-Dresden.jpg 635w, https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/ISO-13485-certificate-von-Ardenne-Medical-Institute-Dresden-210x300.jpg 210w\" sizes=\"(max-width: 635px) 100vw, 635px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3d57bd48 elementor-widget elementor-widget-text-editor\" data-id=\"3d57bd48\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h4>Klju\u010dne Relevantne To\u010dke:<\/h4><ul><li>Certificirana Tvrtka: Certifikat je izdan tvrtki Von Ardenne Institut f\u00fcr Angewandte Medizinische Forschung GmbH, sa sjedi\u0161tem u Dresdenu, Njema\u010dka.<\/li><li>Postignuti Standard: Tvrtka je certificirana od strane SLG Pr\u00fcf- und Zertifizierungs GmbH u skladu s ISO 13485.<\/li><li>Opseg Certifikacije: QMS obuhva\u0107a izradu, proizvodnju, odr\u017eavanje i distribuciju sustava hipertermije cijelog tijela, kao i odr\u017eavanje i trgovinu koncentratorima kisika i dodacima.<\/li><li>Valjanost: Certifikat vrijedi od 29.08.2025. do 28.08.2028.<\/li><\/ul><p>Ukratko, ovaj je certifikat iznimno relevantan jer dokazuje predanost tvrtke kvaliteti i sigurnosti u podru\u010dju medicinskih proizvoda, posebno za njihove sustave hipertermije cijelog tijela. Takva uskla\u0111enost klju\u010dna je za regulatorne svrhe i za izgradnju povjerenja.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5fc41c02 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"5fc41c02\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;slideInUp&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4aaa4f77 elementor-widget elementor-widget-heading\" data-id=\"4aaa4f77\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">EU Izjava o Sukladnosti (DoC) i CE Oznaka: Pravna Sukladnost i Klasifikacija Rizika<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-529d6a0b elementor-widget elementor-widget-text-editor\" data-id=\"529d6a0b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>EU Izjava o Sukladnosti (DoC) je klju\u010dni pravni dokument kojim proizvo\u0111a\u010d, Von Ardenne Institut f\u00fcr Angewandte Medizinische Forschung GmbH, preuzima isklju\u010divu odgovornost za osiguravanje da je proizvod uskla\u0111en sa svim primjenjivim propisima Europske unije (EU).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-323c28d0 elementor-widget elementor-widget-image\" data-id=\"323c28d0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"662\" height=\"946\" src=\"https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/EU-declaration-of-conformity-von-Ardenne-Iratherm-1000-whole-body-hyperthermia-device.jpg\" class=\"attachment-large size-large wp-image-2825\" alt=\"EU declaration of conformity von Ardenne Iratherm 1000 whole body hyperthermia device\" srcset=\"https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/EU-declaration-of-conformity-von-Ardenne-Iratherm-1000-whole-body-hyperthermia-device.jpg 662w, https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/EU-declaration-of-conformity-von-Ardenne-Iratherm-1000-whole-body-hyperthermia-device-210x300.jpg 210w\" sizes=\"(max-width: 662px) 100vw, 662px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6efff3bb elementor-widget elementor-widget-text-editor\" data-id=\"6efff3bb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h4 style=\"text-align: left;\">Klju\u010dne Relevantne To\u010dke :<\/h4><ul style=\"text-align: left;\"><li>Pravna Sukladnost i CE Oznaka: Izjava o sukladnosti je zakonski preduvjet za stavljanje CE oznake na proizvod. Proizvo\u0111a\u010d potvr\u0111uje da je ure\u0111aj sukladan sa:<ul><li>Direktivom 93\/42\/EEZ (Direktiva o medicinskim proizvodima).<\/li><li>Direktivom 2011\/65\/EU (RoHS Direktiva), o ograni\u010denju opasnih tvari.<\/li><\/ul><\/li><li>Certificirani Proizvod i Namjena: Izjava se posebno odnosi na Sustav za hipertermiju cijelog tijela, identificiran kao Tip IRATHERM 1000M, i namijenjen je za blagu i umjerenu hipertermiju cijelog tijela pomo\u0107u infracrvenog A zra\u010denja.<\/li><li>Klasifikacija i Rizik: Ure\u0111aj je klasificiran kao Klasa IIa (prema Prilogu IX, Pravilo 9 Direktive 93\/42\/EEZ), \u0161to ukazuje na nizak do umjeren rizik i zahtijeva uklju\u010denost prijavljenog tijela.<\/li><li>Uklju\u010denost Prijavljenog Tijela: Postupak sukladnosti uklju\u010dio je Prijavljeno Tijelo SLG Pr\u00fcf- und Zertifizierungs GmbH (CE 0494).<\/li><li>Valjanost: Izjava se primjenjuje na sve navedene modele proizvedene na dan 29.08.2025. ili nakon toga, a vrijedi u kombinaciji s posebnim EC Certifikatom 25-P-Schu-0036 (109963N5) do 30.09.2026.<\/li><li>Sljedivost: Uklju\u010duje jedinstvene identifikatore (SRN: DE-MF-000011313 i EUDAMED-DI: B-DEMF000011313000005218H) za pra\u0107enje proizvo\u0111a\u010da i ure\u0111aja u bazama podataka EU.<\/li><\/ul><p style=\"text-align: left;\">EU Izjava o Sukladnosti je formalno obe\u0107anje proizvo\u0111a\u010da da je IRATHERM 1000M siguran i da radi kako je namijenjeno, pridr\u017eavaju\u0107i se svih europskih zdravstvenih i sigurnosnih zahtjeva za medicinske proizvode.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-705c70a8 e-con-full e-flex elementor-invisible e-con e-child\" data-id=\"705c70a8\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;slideInUp&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-59048340 elementor-widget elementor-widget-heading\" data-id=\"59048340\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;none&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\"><a href=\"https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/NB-ConfirmationLetter_2026-MDR-von-Ardenne-Iratherm-1000-WBH-wIRA-hyperthermia-device.pdf\">Pismo Potvrde Prijavljenog Tijela: Aktivni Prijelazni Status i MDR Predanost (EU 2017\/745)<\/a><\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7723f611 elementor-widget elementor-widget-image\" data-id=\"7723f611\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"638\" height=\"906\" src=\"https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/MDR-von-Ardenne-Iratherm-1000-WBH-wIRA-device-p1.jpg\" class=\"attachment-large size-large wp-image-2832\" alt=\"MDR von Ardenne Iratherm 1000 WBH wIRA device\" srcset=\"https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/MDR-von-Ardenne-Iratherm-1000-WBH-wIRA-device-p1.jpg 638w, https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/MDR-von-Ardenne-Iratherm-1000-WBH-wIRA-device-p1-211x300.jpg 211w\" sizes=\"(max-width: 638px) 100vw, 638px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-658310c5 elementor-widget elementor-widget-text-editor\" data-id=\"658310c5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Ovo je klju\u010dni dokument za osiguravanje kontinuirane prisutnosti ure\u0111aja na tr\u017ei\u0161tu tijekom prijelaza na <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\" target=\"_blank\" rel=\"noopener\"><strong>novu Uredbu o medicinskim proizvodima (MDR, EU 2017\/745)<\/strong><\/a>.<\/p>\n\n<ul>\n \t<li><strong>MDR Prijelazni Status:<\/strong> Prijavljeno Tijelo (NB 0494, SLG Pr\u00fcf- und Zertifizierungs GmbH) potvr\u0111uje da je proizvo\u0111a\u010d podnio formalni zahtjev i potpisao pisani sporazum prema MDR-u.<\/li>\n \t<li><strong>Produljena Valjanost:<\/strong> Ovo pismo potvrde klju\u010dno je jer omogu\u0107uje <strong>IRATHERM\u00ae1000M<\/strong>, ure\u0111aju certificiranom prema MDD-u, da iskoristi produljena prijelazna razdoblja utvr\u0111ena Uredbom (EU) 2023\/607.<\/li>\n \t<li><strong>Rok za MDR Sukladnost:<\/strong> Rok za potpunu uskla\u0111enost i certifikaciju ovog ure\u0111aja <strong>Klase IIa<\/strong> prema novom MDR-u je <strong>31. prosinca 2028.<\/strong><\/li>\n \t<li><strong>Nadzor i Valjanost:<\/strong> Prijavljeno Tijelo potvr\u0111uje da je odgovorno za odgovaraju\u0107i nadzor ure\u0111aja tijekom tog prijelaznog razdoblja. Samo pismo vrijedi do <strong>30. rujna 2026.<\/strong><\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ebd7f1a elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"ebd7f1a\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;zoomIn&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: center;\">Ukratko, dokumenti potvr\u0111uju da je IRATHERM 1000 zakonski sukladan medicinski proizvod Klase IIa u EU i da proizvo\u0111a\u010d aktivno napreduje prema certifikaciji za nove, stro\u017ee MDR zahtjeve, osiguravaju\u0107i mu pristup tr\u017ei\u0161tu do kraja 2028 godine.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2cfaaec8 elementor-invisible elementor-widget elementor-widget-image\" data-id=\"2cfaaec8\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;zoomInUp&quot;}\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/von-Ardenne-Iratherm-10000-WBH-wIRA-hyperthermia-device-certificates.jpg\" title=\"\" alt=\"von Ardenne Iratherm 10000 WBH wIRA hyperthermia-device-certificates\" loading=\"lazy\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Slu\u017ebeni Certifikati Iratherm 1000: Dokaz Kvalitete i Autoritet (E-E-A-T) za Hipertermiju Cijelog Tijela (WBH wIRA) Von Ardenne Iratherm 1000 ure\u0111aj za Hipertermiju Cijelog Tijela (WBH wIRA) rezultat je na\u0161e Stru\u010dnosti (E) i Iskustva (E). Podvrgnut rigoroznom i neovisnom testiranju, ovaj je ure\u0111aj dobio sveobuhvatne certifikate koji ne samo da zadovoljavaju, ve\u0107 i nadilaze me\u0111unarodne standarde.<br \/><a class=\"moretag\" href=\"https:\/\/ardenneiratherm.com\/hr\/certifikati\/\">+ Read More<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"templates\/page-fullwidth_template.php","meta":{"footnotes":""},"class_list":["post-918","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/ardenneiratherm.com\/hr\/wp-json\/wp\/v2\/pages\/918","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ardenneiratherm.com\/hr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/ardenneiratherm.com\/hr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/ardenneiratherm.com\/hr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ardenneiratherm.com\/hr\/wp-json\/wp\/v2\/comments?post=918"}],"version-history":[{"count":0,"href":"https:\/\/ardenneiratherm.com\/hr\/wp-json\/wp\/v2\/pages\/918\/revisions"}],"wp:attachment":[{"href":"https:\/\/ardenneiratherm.com\/hr\/wp-json\/wp\/v2\/media?parent=918"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}