{"id":926,"date":"2020-07-07T09:54:22","date_gmt":"2020-07-07T09:54:22","guid":{"rendered":"https:\/\/ardenneiratherm.com\/certifications\/"},"modified":"2026-01-20T16:30:12","modified_gmt":"2026-01-20T16:30:12","slug":"sertifikaadid-hupertermia-seadmed","status":"publish","type":"page","link":"https:\/\/ardenneiratherm.com\/et\/sertifikaadid-hupertermia-seadmed\/","title":{"rendered":"Sertifikaadid"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"926\" class=\"elementor elementor-926 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\">Iratherm 1000 Ametlikud Sertifikaadid: T\u00f5end Kvaliteedist ja Autoriteedist (E-E-A-T) Kogu Keha H\u00fcpertermia (WBH wIRA) jaoks<\/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 Kogu Keha H\u00fcpertermia Seade (WBH wIRA) on meie Kogemuse (E) ja Ekspertiisi (E) tulemus. P\u00e4rast rangeid ja s\u00f5ltumatuid katseid on see seade saanud ulatuslikud sertifikaadid, mis mitte ainult ei vasta, vaid \u00fcletavad rahvusvahelisi standardeid. Need dokumendid tagavad Iratherm 1000 Ohutuse, Kvaliteedi ja T\u00f5hususe, mis on meie Autoriteedi (A) ja Usaldusv\u00e4\u00e4rsuse (T) jaoks onkoloogia valdkonnas \u00fclioluline.<\/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\">Detailne \u00dclevaade: Sertifikaadid kui Kliinilise Autoriteedi T\u00f5endid<\/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\">Rahvusvaheline Kvaliteedisertifikaat UNI CEI EN ISO 13485: Meie Kvaliteedijuhtimiss\u00fcsteemi (QMS) Alus<\/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 h\u00fcpertermia seade on uhke\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 kvaliteedis\u00fcsteemi sertifikaadi<\/a>\u00a0omamise \u00fcle.<\/p><p>Sertifikaat kinnitab, et Von Ardenne Institut f\u00fcr Angewandte Medizinische Forschung GmbH on rakendanud ja s\u00e4ilitab Kvaliteedijuhtimiss\u00fcsteemi (QMS), mis vastab standardi DIN EN ISO 13485:2021-12 (ISO 13485:2016) n\u00f5uetele.<br \/>ISO 13485 on rahvusvaheliselt tunnustatud standard, mis m\u00e4\u00e4ratleb kvaliteedijuhtimiss\u00fcsteemi n\u00f5uded. See tagab, et organisatsioon on v\u00f5imeline j\u00e4rjepidevalt pakkuma meditsiiniseadmeid ja nendega seotud teenuseid, mis vastavad kliendi ja kohaldatavatele regulatiivsetele n\u00f5uetele.<\/p><p>Von Ardenne Instituudi jaoks r\u00f5hutab see sertifikaat meie p\u00fchendumist p\u00f5hjalikule kvaliteedikontrollile Terve Iratherm 1000 WBH wIRA seadme eluts\u00fckli jooksul, alates projekteerimisest ja arendamisest kuni tootmise, paigaldamise ja hoolduseni. See on p\u00f5hiline garantii meie p\u00fchendumisele patsientide ohutusele ja toote tipptasele.<\/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-2885\" 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>Peamised Olulised Punktid<\/h4><ul><li>Sertifitseeritud Ettev\u00f5te: Sertifikaat v\u00e4ljastati ettev\u00f5ttele Von Ardenne Institut f\u00fcr Angewandte Medizinische Forschung GmbH, mis asub Dresdenis, Saksamaal.<\/li><li>Saavutatud Standard: Ettev\u00f5te on sertifitseeritud SLG Pr\u00fcf- und Zertifizierungs GmbH poolt vastavalt ISO 13485 standardile.<\/li><li>Sertifitseerimise Ulatus: QMS h\u00f5lmab Kogu keha h\u00fcpertermia s\u00fcsteemide tootmist, valmistamist, hooldust ja turustamist, samuti hapnikukontsentraatorite ja tarvikute hooldust ja kaubandust.<\/li><li>Kehtivus: Sertifikaat kehtib 29.08.2025 kuni 28.08.2028.<\/li><\/ul><p>Kokkuv\u00f5ttes on see sertifikaat \u00e4\u00e4rmiselt oluline, kuna see demonstreerib ettev\u00f5tte p\u00fchendumist kvaliteedile ja ohutusele meditsiiniseadmete valdkonnas, eriti nende Kogu keha h\u00fcpertermia s\u00fcsteemide osas. Selline vastavus on reguleerivate eesm\u00e4rkide ja usalduse loomise seisukohalt \u00fclioluline.<\/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\">EL-i Vastavusdeklaratsioon (DoC) ja CE-m\u00e4rgistus: \u00d5iguslik Vastavus ja Riskiklassifikatsioon<\/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;\">EL-i Vastavusdeklaratsioon (DoC) on \u00fclioluline juriidiline dokument, millega tootja, Von Ardenne Institut f\u00fcr Angewandte Medizinische Forschung GmbH, v\u00f5tab ainuvastutuse toote vastavuse eest k\u00f5igile kehtivatele Euroopa Liidu (EL) eeskirjadele.<\/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-2886\" 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>Peamised Olulised Punktid :<\/h4><ul><li>\u00d5iguslik Vastavus ja CE-m\u00e4rgistus: Vastavusdeklaratsioon on seaduslik eeltingimus CE-m\u00e4rgise paigaldamiseks tootele. Tootja kinnitab, et seade vastab:<ul><li>Direktiivile 93\/42\/EM\u00dc (Meditsiiniseadmete direktiiv).<\/li><li>Direktiivile 2011\/65\/EL (RoHS-direktiiv), mis k\u00e4sitleb ohtlike ainete piiramist.<\/li><\/ul><\/li><li>Sertifitseeritud Toode ja Otstarve: Deklaratsioon h\u00f5lmab spetsiaalselt Kogu Keha H\u00fcpertermia S\u00fcsteemi, mis on identifitseeritud kui T\u00fc\u00fcp IRATHERM 1000M, ja on ette n\u00e4htud kerge ja m\u00f5\u00f5duka Kogu keha h\u00fcpertermia jaoks infrapuna A-kiirguse abil.<\/li><li>Klassifikatsioon ja Risk: Seade on klassifitseeritud IIa klassi (vastavalt direktiivi 93\/42\/EM\u00dc IX lisa reeglile 9), mis n\u00e4itab madalat kuni m\u00f5\u00f5dukat riski ja n\u00f5uab teavitatud asutuse kaasamist.<\/li><li>Teavitatud Asutuse Kaasamine: Vastavusmenetlus h\u00f5lmas teavitatud asutust SLG Pr\u00fcf- und Zertifizierungs GmbH (CE 0494).<\/li><li>Kehtivus: Deklaratsioon kehtib k\u00f5ikidele loetletud mudelitele, mis on toodetud 29.08.2025 v\u00f5i hiljem, ja kehtib koos spetsiifilise E\u00dc Sertifikaadiga 25-P-Schu-0036 (109963N5) kuni 30.09.2026.<\/li><li>J\u00e4lgitavus: See sisaldab unikaalseid identifikaatoreid (SRN: DE-MF-000011313 ja EUDAMED-DI: B-DEMF000011313000005218H) tootja ja seadme j\u00e4lgimiseks EL-i andmebaasides.<\/li><\/ul><p>EL-i vastavusdeklaratsioon on sisuliselt tootja ametlik lubadus, et IRATHERM 1000M on ohutu ja t\u00f6\u00f6tab etten\u00e4htud viisil, j\u00e4rgides k\u00f5iki Euroopa tervise- ja ohutusn\u00f5udeid meditsiiniseadmetele.<\/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\">Teavitatud Asutuse Kinnituskiri: Aktiivne \u00dclemineku Olek ja MDR-kohustus (EL 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-2893\" 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>See kiri on \u00fclioluline dokument, et tagada seadme j\u00e4tkuv turulolek \u00fcleminekul <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\" target=\"_blank\" rel=\"noopener\"><strong>uuele Meditsiiniseadmete M\u00e4\u00e4rusele (MDR, EL 2017\/745)<\/strong><\/a>.<\/p>\n\n<ul>\n \t<li><strong>MDR \u00dclemineku Olek:<\/strong> Teavitatud Asutus (NB 0494, SLG Pr\u00fcf- und Zertifizierungs GmbH) kinnitab, et tootja on esitanud ametliku taotluse ja allkirjastanud MDR-i kohase kirjaliku lepingu.<\/li>\n \t<li><strong>Pikendatud Kehtivus:<\/strong> See kinnituskiri on v\u00f5tmet\u00e4htsusega, kuna see v\u00f5imaldab <strong>IRATHERM\u00ae1000M<\/strong>, MDD-sertifitseeritud seadmel, kasutada m\u00e4\u00e4rusega (EL) 2023\/607 kehtestatud pikendatud \u00fcleminekuperioode.<\/li>\n \t<li><strong>T\u00e4htaeg MDR-vastavusele:<\/strong> T\u00e4htaeg, mil see <strong>IIa klassi<\/strong> seade peab uue MDR-i j\u00e4rgi t\u00e4ielikult vastama ja olema sertifitseeritud, on <strong>31. detsember 2028<\/strong>.<\/li>\n \t<li><strong>J\u00e4relevalve ja Kehtivus:<\/strong> Teavitatud Asutus kinnitab, et vastutab seadme asjakohase j\u00e4relevalve eest selle \u00fcleminekuperioodi jooksul. Kiri ise kehtib <strong>30. septembrini 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;\">Kokkuv\u00f5ttes kinnitavad dokumendid, et IRATHERM 1000 on seaduslikult vastav IIa klassi meditsiiniseade EL-is ja et tootja liigub aktiivselt uute, rangemate MDR-n\u00f5uete kohase sertifitseerimise suunas, tagades selle turulep\u00e4\u00e4su kuni 2028. aasta l\u00f5puni.<\/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>Iratherm 1000 Ametlikud Sertifikaadid: T\u00f5end Kvaliteedist ja Autoriteedist (E-E-A-T) Kogu Keha H\u00fcpertermia (WBH wIRA) jaoks Von Ardenne Iratherm 1000 Kogu Keha H\u00fcpertermia Seade (WBH wIRA) on meie Kogemuse (E) ja Ekspertiisi (E) tulemus. P\u00e4rast rangeid ja s\u00f5ltumatuid katseid on see seade saanud ulatuslikud sertifikaadid, mis mitte ainult ei vasta, vaid \u00fcletavad rahvusvahelisi standardeid. Need dokumendid<br \/><a class=\"moretag\" href=\"https:\/\/ardenneiratherm.com\/et\/sertifikaadid-hupertermia-seadmed\/\">+ 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-926","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/ardenneiratherm.com\/et\/wp-json\/wp\/v2\/pages\/926","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ardenneiratherm.com\/et\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/ardenneiratherm.com\/et\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/ardenneiratherm.com\/et\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ardenneiratherm.com\/et\/wp-json\/wp\/v2\/comments?post=926"}],"version-history":[{"count":0,"href":"https:\/\/ardenneiratherm.com\/et\/wp-json\/wp\/v2\/pages\/926\/revisions"}],"wp:attachment":[{"href":"https:\/\/ardenneiratherm.com\/et\/wp-json\/wp\/v2\/media?parent=926"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}