{"id":950,"date":"2020-07-07T09:54:22","date_gmt":"2020-07-07T09:54:22","guid":{"rendered":"https:\/\/ardenneiratherm.com\/certifications\/"},"modified":"2026-01-20T17:06:44","modified_gmt":"2026-01-20T17:06:44","slug":"certifikati-naprave-za-hipertermijo","status":"publish","type":"page","link":"https:\/\/ardenneiratherm.com\/sl\/certifikati-naprave-za-hipertermijo\/","title":{"rendered":"Certifikati"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"950\" class=\"elementor elementor-950 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\">Uradni Certifikati Iratherm 1000: Dokaz Kakovosti in Avtoritete (E-E-A-T) za Hipertermijo Celega Telesa (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>Naprava za Hipertermijo Celega Telesa (WBH wIRA) von Ardenne Iratherm 1000 je rezultat na\u0161ih Izku\u0161enj (Experience, E) in Strokovnosti (Expertise, E). Po prestanem strogem in neodvisnem testiranju je ta oprema pridobila celovite certifikate, ki ne le izpolnjujejo, ampak presegajo mednarodne standarde. Ti dokumenti zagotavljajo Varnost, Kakovost in U\u010dinkovitost Iratherm 1000, kar je klju\u010dno za na\u0161o Avtoriteto (Authority, A) in Zanesljivost (Trustworthiness, T) na podro\u010dju onkologije.<\/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\">Podroben Pregled: Certifikati kot Dokaz Klini\u010dne Avtoritete<\/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\">Mednarodni Certifikat Kakovosti UNI CEI EN ISO 13485: Osnova Na\u0161ega Sistema Vodenja Kakovosti (SVK)<\/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>Naprava za hipertermijo Iratherm 1000 WBH wIRA se ponosno pona\u0161a s\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\">certifikatom sistema kakovosti UNI EN ISO 13485<\/a>.<\/p><p>Certifikat potrjuje, da je Von Ardenne Institut f\u00fcr Angewandte Medicinske Raziskave GmbH vzpostavil in vzdr\u017euje Sistem Vodenja Kakovosti (SVK), ki izpolnjuje zahteve standarda DIN EN ISO 13485:2021-12 (ISO 13485:2016).<br \/>ISO 13485 je mednarodno priznan standard, ki dolo\u010da zahteve za sistem vodenja kakovosti. Zagotavlja, da je organizacija sposobna dosledno zagotavljati medicinske pripomo\u010dke in z njimi povezane storitve, ki ustrezajo zahtevam strank in veljavnim regulativnim zahtevam.<\/p><p>Za In\u0161titut Von Ardenne ta certifikat poudarja na\u0161o zavezanost natan\u010dnemu nadzoru kakovosti skozi celoten \u017eivljenjski cikel enote Iratherm 1000 WBH wIRA, od zasnove in razvoja do proizvodnje, namestitve in servisa. To je temeljna garancija na\u0161e predanosti varnosti bolnikov in izjemnosti izdelka.<\/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-3066\" 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>Certificirano Podjetje: Certifikat je bil izdan Von Ardenne Institut f\u00fcr Angewandte Medicinske Raziskave GmbH s sede\u017eem v Dresdnu, Nem\u010dija.<\/li><li>Dose\u017een Standard: Podjetje je certificirano s strani SLG Pr\u00fcf- und Zertifizierungs GmbH za skladnost z ISO 13485.<\/li><li>Podro\u010dje Certificiranja: SVK zajema izdelavo, proizvodnjo, vzdr\u017eevanje in distribucijo sistemov celotelesne hipertermije, kot tudi vzdr\u017eevanje in prodajo koncentratorjev kisika in dodatkov.<\/li><li>Veljavnost: Certifikat velja od 29.08.2025 do 28.08.2028.<\/li><\/ul><p>\u010ce povzamemo, je ta certifikat izjemno pomemben, saj dokazuje zavezanost podjetja kakovosti in varnosti na podro\u010dju medicinskih pripomo\u010dkov, zlasti za njihove sisteme celotelesne hipertermije. Ta skladnost je klju\u010dna za regulativne namene in za vzpostavljanje zaupanja.<\/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\">Izjava EU o Skladnosti (DoC) in Oznaka CE: Pravna Skladnost in Klasifikacija Tveganja<\/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>Izjava EU o Skladnosti (DoC) je klju\u010den pravni dokument, s katerim proizvajalec, Von Ardenne Institut f\u00fcr Angewandte Medicinske Raziskave GmbH, prevzema izklju\u010dno odgovornost za zagotovitev, da izdelek ustreza vsem veljavnim predpisom Evropske 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-3067\" 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>Klju\u010dne Relevantne To\u010dke :<\/h4><ul><li>Pravna Skladnost in Oznaka CE: Izjava o skladnosti je pravna predpostavka za namestitev Oznake CE na izdelek. Proizvajalec potrjuje, da oprema ustreza:<ul><li>Direktivi 93\/42\/EEC (Direktiva o Medicinskih Pripomo\u010dkih).<\/li><li>Direktivi 2011\/65\/EU (Direktiva RoHS), glede omejitve nevarnih snovi.<\/li><\/ul><\/li><li>Certificiran Izdelek in Namen: Izjava posebej zajema Sistem Celotelesne Hipertermije, identificiran kot Tip IRATHERM 1000M, in je namenjen blagi in zmerni celotelesni hipertermiji z uporabo infrarde\u010dega A sevanja.<\/li><li>Klasifikacija in Tveganje: Naprava je razvr\u0161\u010dena kot Razred IIa (v skladu z Prilogo IX Pravilo 9 Direktive 93\/42\/EEC), kar ka\u017ee na nizko do zmerno tveganje in zahteva vpletenost prigla\u0161enega organa.<\/li><li>Vpletenost Prigla\u0161enega Organa: Postopek ocenjevanja skladnosti je vklju\u010deval Prigla\u0161eni Organ SLG Pr\u00fcf- und Zertifizierungs GmbH (CE 0494).<\/li><li>Veljavnost: Ta izjava velja za vse navedene modele, izdelane 29.08.2025 ali pozneje, in je veljavna skupaj s specifi\u010dnim Certifikatom EC 25-P-Schu-0036 (109963N5) do 30.09.2026.<\/li><li>Sledljivost: Vklju\u010duje edinstvene identifikatorje (SRN: DE-MF-000011313 in EUDAMED-DI: B-DEMF000011313000005218H) za sledenje proizvajalca in naprave v podatkovnih bazah EU.<\/li><\/ul><p>Izjava EU o skladnosti je v bistvu formalna obljuba proizvajalca, da je IRATHERM 1000M varen in deluje, kot je predvideno, v skladu z vsemi evropskimi zahtevami za zdravje in varnost za medicinske pripomo\u010dke.<\/p><p>\u00a0<\/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\">Potrditveno Pismo Prigla\u0161enega Organa: Aktiven Prehodni Status in Zaveza MDR (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-3074\" 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>Ta dokument je klju\u010dnega pomena za zagotovitev neprekinjene prisotnosti naprave na trgu med prehodom na <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\" target=\"_blank\" rel=\"noopener\"><strong>novo Uredbo o Medicinskih Pripomo\u010dkih (MDR, EU 2017\/745)<\/strong><\/a>.<\/p>\n\n<ul>\n \t<li><strong>Prehodni Status MDR:<\/strong> Prigla\u0161eni Organ (NB 0494, SLG Pr\u00fcf- und Zertifizierungs GmbH) potrjuje, da je proizvajalec vlo\u017eil uradno vlogo in podpisal pisni sporazum v skladu z MDR.<\/li>\n \t<li><strong>Podalj\u0161ana Veljavnost:<\/strong> To Potrditveno Pismo je klju\u010dno, saj omogo\u010da napravi, certificirani po MDD, <strong>IRATHERM\u00ae1000M<\/strong>, da izkoristi podalj\u0161ana prehodna obdobja, dolo\u010dena z Uredbo (EU) 2023\/607.<\/li>\n \t<li><strong>Rok za Skladnost z MDR:<\/strong> Rok za popolno skladnost in certificiranje te naprave <strong>Razreda IIa<\/strong> po novem MDR je <strong>31. december 2028<\/strong>.<\/li>\n \t<li><strong>Nadzor in Veljavnost:<\/strong> Prigla\u0161eni Organ potrjuje, da je odgovoren za ustrezen nadzor nad napravo v tem prehodnem obdobju. Samo pismo velja do <strong>30. septembra 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;\">\u010ce povzamemo, dokumenti potrjujejo, da je IRATHERM 1000 pravno skladna medicinska naprava razreda IIa v EU in da proizvajalec aktivno napreduje k certificiranju v skladu z novimi, stro\u017ejimi zahtevami MDR, s \u010dimer je zagotovljen njen dostop na trg do konca leta 2028.<\/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>Uradni Certifikati Iratherm 1000: Dokaz Kakovosti in Avtoritete (E-E-A-T) za Hipertermijo Celega Telesa (WBH wIRA) Naprava za Hipertermijo Celega Telesa (WBH wIRA) von Ardenne Iratherm 1000 je rezultat na\u0161ih Izku\u0161enj (Experience, E) in Strokovnosti (Expertise, E). Po prestanem strogem in neodvisnem testiranju je ta oprema pridobila celovite certifikate, ki ne le izpolnjujejo, ampak presegajo mednarodne<br \/><a class=\"moretag\" href=\"https:\/\/ardenneiratherm.com\/sl\/certifikati-naprave-za-hipertermijo\/\">+ 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-950","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/ardenneiratherm.com\/sl\/wp-json\/wp\/v2\/pages\/950","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ardenneiratherm.com\/sl\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/ardenneiratherm.com\/sl\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/ardenneiratherm.com\/sl\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ardenneiratherm.com\/sl\/wp-json\/wp\/v2\/comments?post=950"}],"version-history":[{"count":0,"href":"https:\/\/ardenneiratherm.com\/sl\/wp-json\/wp\/v2\/pages\/950\/revisions"}],"wp:attachment":[{"href":"https:\/\/ardenneiratherm.com\/sl\/wp-json\/wp\/v2\/media?parent=950"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}