{"id":944,"date":"2020-07-07T09:54:22","date_gmt":"2020-07-07T09:54:22","guid":{"rendered":"https:\/\/ardenneiratherm.com\/certifications\/"},"modified":"2026-01-20T16:58:16","modified_gmt":"2026-01-20T16:58:16","slug":"certificari-dispoziv-hipertermie","status":"publish","type":"page","link":"https:\/\/ardenneiratherm.com\/ro\/certificari-dispoziv-hipertermie\/","title":{"rendered":"Certific\u0103ri dispozitiv Hipertermie Corporala Totala von Ardenne Iratherm 1000"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"944\" class=\"elementor elementor-944 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\">Certificari pentru dispozitivele de hipertermie Von Ardenne Iratherm 1000 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>Dispozitivul von Ardenne Iratherm 1000 Whole Body Hyperthermia WBH wIRA a fost supus unor teste riguroase \u0219i a primit certific\u0103ri complete pentru a respecta standardele \u0219i reglement\u0103rile interna\u021bionale \u0219i locale, asigur\u00e2ndu-i siguran\u021ba, calitatea \u0219i eficacitatea pentru tratamentul integrativ al cancerului.<\/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\" data-settings=\"{&quot;animation&quot;:&quot;none&quot;}\">\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\">Detalii despre certific\u0103rile dispozitivului de hipertermie von Ardenne Iratherm 1000 WBH wIRA<\/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\">Certificare de calitate UNI CEI EN ISO 13485 pentru dispozitive medicale<\/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><span dir=\"auto\">Dispozitivul de hipertermie von Ardenne Iratherm 1000 WBH wIRA de\u021bine cu m\u00e2ndrie\u00a0<\/span><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\"><span dir=\"auto\">certificarea sistemului de calitate UNI EN ISO 13485<\/span><\/a><span dir=\"auto\">\u00a0.<\/span><\/p><p><span dir=\"auto\">Certificatul confirm\u0103 faptul c\u0103\u00a0<\/span><strong><span dir=\"auto\">Von Ardenne Institut f\u00fcr Angewandte Medizinische Forschung GmbH<\/span><\/strong><span dir=\"auto\">\u00a0a implementat \u0219i men\u021bine un\u00a0<\/span><strong><span dir=\"auto\">Sistem de Management al Calit\u0103\u021bii (QMS)<\/span><\/strong><span dir=\"auto\">\u00a0care \u00eendepline\u0219te cerin\u021bele\u00a0<\/span><strong><span dir=\"auto\">DIN EN ISO 13485:2021-12 (ISO 13485:2016)<\/span><\/strong><span dir=\"auto\">\u00a0.<\/span><\/p><p><span dir=\"auto\">ISO 13485 este un standard recunoscut la nivel interna\u021bional care specific\u0103 cerin\u021bele pentru un sistem de management al calit\u0103\u021bii \u00een cadrul c\u0103ruia o organiza\u021bie trebuie s\u0103 \u00ee\u0219i demonstreze capacitatea de a furniza dispozitive medicale \u0219i servicii conexe care s\u0103 \u00eendeplineasc\u0103 \u00een mod constant cerin\u021bele clien\u021bilor \u0219i reglement\u0103rile aplicabile.<\/span><\/p><p><span dir=\"auto\">Pentru Institutul von Ardenne, aceast\u0103 certificare subliniaz\u0103 angajamentul nostru fa\u021b\u0103 de un control meticulos al calit\u0103\u021bii pe tot parcursul ciclului de via\u021b\u0103 al dispozitivului de hipertermie Iratherm 1000 WBH wIRA, de la proiectare \u0219i dezvoltare p\u00e2n\u0103 la produc\u021bie, instalare \u0219i service. Este o garan\u021bie fundamental\u0103 a dedic\u0103rii noastre fa\u021b\u0103 de siguran\u021ba pacientului \u0219i excelen\u021ba produselor, stabilind un cadru robust pentru procesele noastre opera\u021bionale.<\/span><\/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-958\" 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><span dir=\"auto\">Puncte cheie relevante:<\/span><\/h4><ul><li><strong><span dir=\"auto\">Companie certificat\u0103:<\/span><\/strong><span dir=\"auto\">\u00a0Certificatul a fost eliberat\u00a0<\/span><strong><span dir=\"auto\">Von Ardenne Institut f\u00fcr Angewandte Medizinische Forschung GmbH<\/span><\/strong><span dir=\"auto\">\u00a0cu sediul \u00een Dresda, Germania.<\/span><\/li><li><strong><span dir=\"auto\">Standard atins:<\/span><\/strong><span dir=\"auto\">\u00a0Compania a fost certificat\u0103 de\u00a0<\/span><strong><span dir=\"auto\">SLG Pr\u00fcf- und Zertifizierungs GmbH<\/span><\/strong><span dir=\"auto\">\u00a0ca fiind conform\u0103 cu\u00a0<\/span><strong><span dir=\"auto\">ISO 13485<\/span><\/strong><\/li><li><strong><span dir=\"auto\">Domeniul de aplicare al certific\u0103rii:<\/span><\/strong><span dir=\"auto\">\u00a0SMC acoper\u0103\u00a0<\/span><strong><span dir=\"auto\">fabricarea, produc\u021bia, \u00eentre\u021binerea \u0219i distribu\u021bia sistemelor de hipertermie corporal\u0103 integral\u0103<\/span><\/strong><span dir=\"auto\">\u00a0, precum \u0219i\u00a0<\/span><strong><span dir=\"auto\">\u00eentre\u021binerea \u0219i comercializarea concentratoarelor de oxigen \u0219i a accesoriilor<\/span><\/strong><span dir=\"auto\">\u00a0.<\/span><\/li><li><strong><span dir=\"auto\">Valabilitate:<\/span><\/strong><span dir=\"auto\">\u00a0Certificatul este valabil de la\u00a0<\/span><strong><span dir=\"auto\">29.08.2025<\/span><\/strong><span dir=\"auto\">\u00a0p\u00e2n\u0103\u00a0<\/span><strong><span dir=\"auto\">la 28.08.2028<\/span><\/strong><span dir=\"auto\">\u00a0.<\/span><\/li><\/ul><p><span dir=\"auto\">\u00cen concluzie, acest certificat este extrem de relevant, deoarece demonstreaz\u0103 angajamentul companiei fa\u021b\u0103 de\u00a0<\/span><strong><span dir=\"auto\">calitate \u0219i siguran\u021b\u0103<\/span><\/strong><span dir=\"auto\">\u00a0\u00een domeniul dispozitivelor medicale, \u00een special pentru sistemele lor de hipertermie a \u00eentregului corp. Aceast\u0103 conformitate este esen\u021bial\u0103 \u00een scopuri de reglementare \u0219i pentru consolidarea \u00eencrederii \u00een r\u00e2ndul clien\u021bilor \u0219i al furnizorilor de servicii medicale.<\/span><\/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\">Declara\u021bie de conformitate CE-UE (IRATHERM 1000M)<\/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<div class=\"elementor-element elementor-element-529d6a0b elementor-widget elementor-widget-text-editor\" data-id=\"529d6a0b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><p><span dir=\"auto\">Declara\u021bia\u00a0\u00a0<\/span><a href=\"https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/EU-Konformitaetserklaerung_MDD_signed_2025-von-Ardenne-Iratherm-1000-WBH-wIRA-hyperthermia-device.pdf\"><strong><span dir=\"auto\">UE de conformitate (DoC)<\/span><\/strong><\/a><span dir=\"auto\">\u00a0pentru un dispozitiv medical. Acesta este un document juridic esen\u021bial \u00een care produc\u0103torul,\u00a0<\/span><strong><span dir=\"auto\">Von Ardenne Institut f\u00fcr Angewandte Medizinische Forschung GmbH<\/span><\/strong><span dir=\"auto\">\u00a0, \u00ee\u0219i asum\u0103\u00a0<\/span><strong><span dir=\"auto\">responsabilitatea exclusiv\u0103<\/span><\/strong><span dir=\"auto\">\u00a0pentru asigurarea faptului c\u0103 produsul respect\u0103 toate reglement\u0103rile aplicabile ale Uniunii Europene (UE).<\/span><\/p><\/div>\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-959\" 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><span dir=\"auto\">Puncte cheie relevante:<\/span><\/h4><ul><li><strong><span dir=\"auto\">Conformitate legal\u0103 \u0219i marcaj CE:<\/span><\/strong><span dir=\"auto\">\u00a0Declara\u021bia de Conformitate (DoC) este condi\u021bia legal\u0103 prealabil\u0103 pentru aplicarea\u00a0<\/span><strong><span dir=\"auto\">marcajului CE<\/span><\/strong><span dir=\"auto\">\u00a0pe produs, care este obligatorie pentru introducerea unui dispozitiv medical pe pia\u021ba UE. Prin semnarea acesteia, produc\u0103torul certific\u0103 faptul c\u0103 dispozitivul respect\u0103:<\/span><ul><li><strong><span dir=\"auto\">Directiva 93\/42\/CEE (Directiva privind dispozitivele medicale)<\/span><\/strong><span dir=\"auto\">\u00a0.<\/span><\/li><li><strong><span dir=\"auto\">Directiva 2011\/65\/UE (Directiva RoHS)<\/span><\/strong><span dir=\"auto\">\u00a0privind restric\u021bionarea substan\u021belor periculoase.<\/span><\/li><\/ul><\/li><li><strong><span dir=\"auto\">Produs certificat:<\/span><\/strong><span dir=\"auto\">\u00a0Declara\u021bia acoper\u0103 \u00een mod specific\u00a0<\/span><strong><span dir=\"auto\">sistemul de hipertermie corporala totala<\/span><\/strong><span dir=\"auto\">\u00a0, identificat ca fiind\u00a0<\/span><strong><span dir=\"auto\">de tip IRATHERM 1000M<\/span><\/strong><span dir=\"auto\">\u00a0.<\/span><\/li><li><strong><span dir=\"auto\">Scopul preconizat:<\/span><\/strong><span dir=\"auto\">\u00a0Dispozitivul este destinat\u00a0<\/span><strong><span dir=\"auto\">hipertermiei corporale totale u\u0219oare \u0219i moderate utiliz\u00e2nd radia\u021bii infraro\u0219ii<\/span><\/strong><span dir=\"auto\">\u00a0A.<\/span><\/li><li><strong><span dir=\"auto\">Clasificare:<\/span><\/strong><span dir=\"auto\">\u00a0Dispozitivul este clasificat \u00een\u00a0<\/span><strong><span dir=\"auto\">clasa IIa<\/span><\/strong><span dir=\"auto\">\u00a0(conform anexei IX, regula 9 a Directivei 93\/42\/CEE).<\/span><ul><li><em><span dir=\"auto\">Dispozitivele din clasa IIa sunt considerate a prezenta un\u00a0<\/span><strong><span dir=\"auto\">risc sc\u0103zut spre mediu<\/span><\/strong><span dir=\"auto\">\u00a0\u0219i necesit\u0103 implicarea unui organism notificat (o organiza\u021bie ter\u021b\u0103 independent\u0103) pentru evaluarea conformit\u0103\u021bii.<\/span><\/em><\/li><\/ul><\/li><li><strong><span dir=\"auto\">Implicarea organismului notificat:<\/span><\/strong><span dir=\"auto\">\u00a0Procedura de conformitate a implicat organismul notificat\u00a0<\/span><strong><span dir=\"auto\">SLG Pr\u00fcf- und Zertifizierungs GmbH (CE 0494)<\/span><\/strong><span dir=\"auto\">\u00a0.<\/span><\/li><li><strong><span dir=\"auto\">Valabilitate:<\/span><\/strong><span dir=\"auto\">\u00a0Declara\u021bia se aplic\u0103 tuturor modelelor listate, produse la sau dup\u0103\u00a0<\/span><strong><span dir=\"auto\">29.08.2025<\/span><\/strong><span dir=\"auto\">\u00a0\u0219i este valabil\u0103 \u00een leg\u0103tur\u0103 cu\u00a0<\/span><strong><span dir=\"auto\">certificatul CE specific 25-P-Schu-0036 (109963N5)<\/span><\/strong><span dir=\"auto\">\u00a0p\u00e2n\u0103 la\u00a0<\/span><strong><span dir=\"auto\">30.09.2026<\/span><\/strong><span dir=\"auto\">\u00a0.<\/span><\/li><li><strong><span dir=\"auto\">Trasabilitate \u0219i standarde:<\/span><\/strong><span dir=\"auto\">\u00a0Confirm\u0103 utilizarea diverselor standarde aplicabile (cum ar fi EN ISO 13485:2021) \u0219i include identificatori unici (\u00a0<\/span><strong><span dir=\"auto\">SRN: DE-MF-000011313<\/span><\/strong><span dir=\"auto\">\u00a0\u0219i\u00a0<\/span><strong><span dir=\"auto\">EUDAMED-DI: B-DEMF000011313000005218H<\/span><\/strong><span dir=\"auto\">\u00a0) pentru urm\u0103rirea produc\u0103torului \u0219i a dispozitivului \u00een bazele de date ale UE.<\/span><\/li><\/ul><p><span dir=\"auto\">\u00cen esen\u021b\u0103, Declara\u021bia UE de conformitate este promisiunea oficial\u0103 a produc\u0103torului c\u0103\u00a0<\/span><strong><span dir=\"auto\">IRATHERM 1000M<\/span><\/strong><span dir=\"auto\">\u00a0este sigur \u0219i func\u021bioneaz\u0103 conform destina\u021biei, respect\u00e2nd toate cerin\u021bele europene de s\u0103n\u0103tate \u0219i siguran\u021b\u0103 pentru dispozitivele medicale.<\/span><\/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\">\nScrisoare de confirmare din partea organismului notificat (ON) (tranzi\u021bie MDR)<\/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-965\" 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 dir=\"auto\">Aceast\u0103 scrisoare este un document esen\u021bial pentru asigurarea prezen\u021bei continue a dispozitivului pe pia\u021b\u0103 \u00een perioada de tranzi\u021bie la noul <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\" target=\"_blank\" rel=\"noopener\"><strong>Regulament privind dispozitivele medicale (MDR, UE 2017\/745)<\/strong><\/a>.<\/p>\n\n<ul>\n \t<li><strong><span dir=\"auto\">Status de tranzi\u021bie MDR:<\/span><\/strong><span dir=\"auto\"> Organismul notificat (NB 0494, SLG Pr\u00fcf- und Zertifizierungs GmbH) confirm\u0103 c\u0103 produc\u0103torul a depus o cerere formal\u0103 \u0219i a semnat un acord scris \u00een temeiul MDR.<\/span><\/li>\n \t<li><strong><span dir=\"auto\">Valabilitate extins\u0103:<\/span><\/strong><span dir=\"auto\"> Aceast\u0103 scrisoare de confirmare este esen\u021bial\u0103 deoarece permite <\/span><strong><span dir=\"auto\">IRATHERM\u00ae1000M<\/span><\/strong><span dir=\"auto\">, un dispozitiv certificat MDD, s\u0103 beneficieze de perioadele de tranzi\u021bie extinse stabilite de Regulamentul (UE) 2023\/607.<\/span><\/li>\n \t<li><strong><span dir=\"auto\">Termen limit\u0103 pentru conformitatea MDR:<\/span><\/strong><span dir=\"auto\"> Termenul limit\u0103 pentru ca acest dispozitiv <\/span><strong><span dir=\"auto\">din clasa IIa<\/span><\/strong><span dir=\"auto\"> s\u0103 se conformeze pe deplin \u0219i s\u0103 fie certificat \u00een conformitate cu noul MDR este <\/span><strong><span dir=\"auto\">31 decembrie 2028<\/span><\/strong><span dir=\"auto\">.<\/span><\/li>\n \t<li><strong><span dir=\"auto\">Supraveghere:<\/span><\/strong><span dir=\"auto\"> ON confirm\u0103 c\u0103 este responsabil pentru supravegherea corespunz\u0103toare a dispozitivului \u00een temeiul directivei aplicabile pe parcursul acestei perioade de tranzi\u021bie.<\/span><\/li>\n \t<li><strong><span dir=\"auto\">Valabilitate:<\/span><\/strong><span dir=\"auto\"> Scrisoarea \u00een sine este valabil\u0103 p\u00e2n\u0103 la <\/span><strong><span dir=\"auto\">30 septembrie 2026<\/span><\/strong><span dir=\"auto\">.<\/span><\/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;\"><span dir=\"auto\">\u00cen concluzie, documentele confirm\u0103 faptul c\u0103 IRATHERM 1000 este un\u00a0<\/span><strong><span dir=\"auto\">dispozitiv medical de clasa IIa<\/span><\/strong><span dir=\"auto\">\u00a0conform legal \u00een UE \u0219i c\u0103 produc\u0103torul \u00ee\u0219i continu\u0103 \u00een mod activ certificarea \u00een conformitate cu noile cerin\u021be MDR, mai stricte, asigur\u00e2ndu-i accesul pe pia\u021b\u0103 p\u00e2n\u0103 la sf\u00e2r\u0219itul anului 2028.<\/span><\/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>Certificari pentru dispozitivele de hipertermie Von Ardenne Iratherm 1000 WBH wIRA Dispozitivul von Ardenne Iratherm 1000 Whole Body Hyperthermia WBH wIRA a fost supus unor teste riguroase \u0219i a primit certific\u0103ri complete pentru a respecta standardele \u0219i reglement\u0103rile interna\u021bionale \u0219i locale, asigur\u00e2ndu-i siguran\u021ba, calitatea \u0219i eficacitatea pentru tratamentul integrativ al cancerului. Detalii despre certific\u0103rile dispozitivului<br \/><a class=\"moretag\" href=\"https:\/\/ardenneiratherm.com\/ro\/certificari-dispoziv-hipertermie\/\">+ 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-944","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/ardenneiratherm.com\/ro\/wp-json\/wp\/v2\/pages\/944","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ardenneiratherm.com\/ro\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/ardenneiratherm.com\/ro\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/ardenneiratherm.com\/ro\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ardenneiratherm.com\/ro\/wp-json\/wp\/v2\/comments?post=944"}],"version-history":[{"count":0,"href":"https:\/\/ardenneiratherm.com\/ro\/wp-json\/wp\/v2\/pages\/944\/revisions"}],"wp:attachment":[{"href":"https:\/\/ardenneiratherm.com\/ro\/wp-json\/wp\/v2\/media?parent=944"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}