{"id":922,"date":"2020-07-07T09:54:22","date_gmt":"2020-07-07T09:54:22","guid":{"rendered":"https:\/\/ardenneiratherm.com\/certifications\/"},"modified":"2026-01-20T16:26:43","modified_gmt":"2026-01-20T16:26:43","slug":"certificeringer","status":"publish","type":"page","link":"https:\/\/ardenneiratherm.com\/da\/certificeringer\/","title":{"rendered":"Certificeringer"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"922\" class=\"elementor elementor-922 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\">Officielle Iratherm 1000 Certificeringer: Bevis for Kvalitet og Autoritet (E-E-A-T) for Helkrops Hypertermi (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 Helkrops Hypertermiapparatet (WBH wIRA) er resultatet af vores Erfaring (E) og Ekspertise (E). Efter at have gennemg\u00e5et strenge og uafh\u00e6ngige tests har dette udstyr opn\u00e5et omfattende certificeringer, der ikke kun opfylder, men ogs\u00e5 overg\u00e5r internationale standarder. Disse dokumenter garanterer Sikkerheden, Kvaliteten og Effektiviteten af Iratherm 1000, hvilket er afg\u00f8rende for vores Autoritet (A) og Trov\u00e6rdighed (T) inden for det onkologiske felt.<\/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\">Detaljeret Oversigt: Certificeringer som Bevis p\u00e5 Klinisk Autoritet<\/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\">International Kvalitetscertificering UNI CEI EN ISO 13485: Grundlaget for Vores Kvalitetsstyringssystem (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>Iratherm 1000 WBH wIRA hypertermiapparatet er stolt af at besidde\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\">UNI EN ISO 13485 kvalitetssystemcertificeringen<\/a>.<\/p><p>Certifikatet bekr\u00e6fter, at Von Ardenne Institut f\u00fcr Angewandte Medizinische Forschung GmbH har implementeret og vedligeholder et Kvalitetsstyringssystem (QMS), der opfylder kravene i DIN EN ISO 13485:2021-12 (ISO 13485:2016).<br \/>ISO 13485 er en internationalt anerkendt standard, der specificerer kravene til et kvalitetsstyringssystem. Den sikrer, at en organisation er i stand til konsekvent at levere medicinsk udstyr og relaterede tjenester, der opfylder kundekrav og g\u00e6ldende lovm\u00e6ssige krav.<\/p><p>For Von Ardenne Instituttet understreger denne certificering vores engagement i omhyggelig kvalitetskontrol gennem hele Iratherm 1000 WBH wIRA-enhedens livscyklus, fra design og udvikling til produktion, installation og service. Det er en grundl\u00e6ggende garanti for vores dedikation til patientsikkerhed og produktkvalitet.<\/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-2874\" 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>N\u00f8gle relevante punkter<\/h4><ul><li>Certificeret Virksomhed: Certifikatet blev udstedt til Von Ardenne Institut f\u00fcr Angewandte Medizinische Forschung GmbH, baseret i Dresden, Tyskland.<\/li><li>Opn\u00e5et Standard: Virksomheden er certificeret af SLG Pr\u00fcf- und Zertifizierungs GmbH for overholdelse af ISO 13485.<\/li><li>Certificeringens Omfang: QMS d\u00e6kker fremstilling, produktion, vedligeholdelse og distribution af helkrops hypertermisystemer, samt vedligeholdelse og handel med iltkoncentratorer og tilbeh\u00f8r.<\/li><li>Gyldighed: Certifikatet er gyldigt fra 29-08-2025 til 28-08-2028.<\/li><\/ul><p>Kort sagt er dette certifikat yderst relevant, da det demonstrerer virksomhedens engagement i kvalitet og sikkerhed inden for medicinsk udstyr, is\u00e6r for deres helkrops hypertermisystemer. Denne overholdelse er afg\u00f8rende for lovm\u00e6ssige form\u00e5l og for at opbygge tillid.<\/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 Overensstemmelseserkl\u00e6ring (DoC) og CE-M\u00e6rkning: Lovm\u00e6ssig Overholdelse og Risikoklassificering<\/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 style=\"text-align: left;\">EU Overensstemmelseserkl\u00e6ringen (DoC) er det afg\u00f8rende juridiske dokument, hvormed producenten, Von Ardenne Institut f\u00fcr Angewandte Medizinische Forschung GmbH, p\u00e5tager sig det eneste ansvar for at sikre, at produktet overholder alle g\u00e6ldende bestemmelser i Den Europ\u00e6iske Union (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-2875\" 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>N\u00f8gle relevante punkter<\/h4><ul><li>Lovm\u00e6ssig Overholdelse og CE-M\u00e6rkning: Overensstemmelseserkl\u00e6ringen er den lovm\u00e6ssige foruds\u00e6tning for at s\u00e6tte CE-m\u00e6rket p\u00e5 produktet. Producenten bekr\u00e6fter, at udstyret overholder:<ul><li>Direktiv 93\/42\/E\u00d8F (Direktivet om medicinsk udstyr).<\/li><li>Direktiv 2011\/65\/EU (RoHS-direktivet), vedr\u00f8rende begr\u00e6nsning af farlige stoffer.<\/li><\/ul><\/li><li>Certificeret Produkt og Form\u00e5l: Erkl\u00e6ringen d\u00e6kker specifikt Helkrops Hypertermisystemet, identificeret som Type IRATHERM 1000M, og er beregnet til mild og moderat helkrops hypertermi ved brug af infrar\u00f8d A-str\u00e5ling.<\/li><li>Klassificering og Risiko: Enheden er klassificeret som Klasse IIa (i henhold til Bilag IX Regel 9 i Direktiv 93\/42\/E\u00d8F), hvilket indikerer lav til moderat risiko og kr\u00e6ver involvering af et bemyndiget organ.<\/li><li>Involvering af Bemyndiget Organ: Overensstemmelsesproceduren involverede det Bemyndigede Organ SLG Pr\u00fcf- und Zertifizierungs GmbH (CE 0494).<\/li><li>Gyldighed: Erkl\u00e6ringen g\u00e6lder for alle anf\u00f8rte modeller produceret p\u00e5 eller efter 29-08-2025 og er gyldig i forbindelse med det specifikke EF-certifikat 25-P-Schu-0036 (109963N5) indtil 30-09-2026.<\/li><li>Sporbarhed: Den inkluderer unikke identifikatorer (SRN: DE-MF-000011313 og EUDAMED-DI: B-DEMF000011313000005218H) for sporing af producenten og enheden i EU-databaser.<\/li><\/ul><p>EU-overensstemmelseserkl\u00e6ringen er i det v\u00e6sentlige producentens formelle l\u00f8fte om, at IRATHERM 1000M er sikkert og fungerer efter hensigten, idet det overholder alle europ\u00e6iske sundheds- og sikkerhedskrav til medicinsk udstyr.<\/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\">Bemyndiget Organs Bekr\u00e6ftelsesbrev: Aktiv Overgangsstatus og MDR-Forpligtelse (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-2882\" 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>Dette brev er et afg\u00f8rende dokument for at sikre enhedens fortsatte markedstilstedev\u00e6relse under overgangen til <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\" target=\"_blank\" rel=\"noopener\"><strong>den nye Forordning om Medicinsk Udstyr (MDR, EU 2017\/745)<\/strong><\/a>.<\/p>\n\n<ul>\n\u00a0\t<li><strong>MDR Overgangsstatus:<\/strong> Det Bemyndigede Organ (NB 0494, SLG Pr\u00fcf- und Zertifizierungs GmbH) bekr\u00e6fter, at producenten har indgivet en formel ans\u00f8gning og underskrevet en skriftlig aftale i henhold til MDR.<\/li>\n\u00a0\t<li><strong>Forl\u00e6nget Gyldighed:<\/strong> Dette bekr\u00e6ftelsesbrev er n\u00f8glen, da det giver <strong>IRATHERM\u00ae1000M<\/strong>, en MDD-certificeret enhed, mulighed for at udnytte de forl\u00e6ngede overgangsperioder fastsat i Forordning (EU) 2023\/607.<\/li>\n\u00a0\t<li><strong>Frist for MDR-Overholdelse:<\/strong> Fristen for, at dette <strong>Klasse IIa<\/strong> udstyr fuldt ud skal overholde og certificeres under den nye MDR, er <strong>31. december 2028<\/strong>.<\/li>\n\u00a0\t<li><strong>Overv\u00e5gning og Gyldighed:<\/strong> Det Bemyndigede Organ bekr\u00e6fter, at det er ansvarligt for passende overv\u00e5gning af enheden i denne overgangsperiode. Selve brevet er gyldigt indtil <strong>30. september 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>Kort sagt bekr\u00e6fter dokumenterne, at IRATHERM 1000 er et lovligt overensstemmende <b>medicinsk udstyr i klasse IIa i EU,<\/b> og at producenten aktivt bev\u00e6ger sig mod certificering i henhold til de nye, strengere MDR-krav, hvilket sikrer dets markedsadgang indtil udgangen af 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>Officielle Iratherm 1000 Certificeringer: Bevis for Kvalitet og Autoritet (E-E-A-T) for Helkrops Hypertermi (WBH wIRA) Von Ardenne Iratherm 1000 Helkrops Hypertermiapparatet (WBH wIRA) er resultatet af vores Erfaring (E) og Ekspertise (E). Efter at have gennemg\u00e5et strenge og uafh\u00e6ngige tests har dette udstyr opn\u00e5et omfattende certificeringer, der ikke kun opfylder, men ogs\u00e5 overg\u00e5r internationale standarder.<br \/><a class=\"moretag\" href=\"https:\/\/ardenneiratherm.com\/da\/certificeringer\/\">+ 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-922","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/ardenneiratherm.com\/da\/wp-json\/wp\/v2\/pages\/922","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ardenneiratherm.com\/da\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/ardenneiratherm.com\/da\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/ardenneiratherm.com\/da\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ardenneiratherm.com\/da\/wp-json\/wp\/v2\/comments?post=922"}],"version-history":[{"count":0,"href":"https:\/\/ardenneiratherm.com\/da\/wp-json\/wp\/v2\/pages\/922\/revisions"}],"wp:attachment":[{"href":"https:\/\/ardenneiratherm.com\/da\/wp-json\/wp\/v2\/media?parent=922"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}