{"id":1940,"date":"2020-07-07T09:54:22","date_gmt":"2020-07-07T09:54:22","guid":{"rendered":"https:\/\/ardenneiratherm.com\/certifications\/"},"modified":"2026-01-20T17:14:39","modified_gmt":"2026-01-20T17:14:39","slug":"chung-nhan-thiet-bi-tang-than-nhiet","status":"publish","type":"page","link":"https:\/\/ardenneiratherm.com\/vi\/chung-nhan-thiet-bi-tang-than-nhiet\/","title":{"rendered":"Ch\u1ee9ng nh\u1eadn"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1940\" class=\"elementor elementor-1940 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\">Ch\u1ee9ng nh\u1eadn cho Thi\u1ebft b\u1ecb Nhi\u1ec7t tr\u1ecb 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>Thi\u1ebft b\u1ecb nhi\u1ec7t tr\u1ecb to\u00e0n th\u00e2n von Ardenne Iratherm 1000 WBH wIRA \u0111\u00e3 tr\u1ea3i qua c\u00e1c quy tr\u00ecnh ki\u1ec3m \u0111\u1ecbnh nghi\u00eam ng\u1eb7t v\u00e0 nh\u1eadn \u0111\u01b0\u1ee3c c\u00e1c ch\u1ee9ng nh\u1eadn to\u00e0n di\u1ec7n nh\u1eb1m tu\u00e2n th\u1ee7 c\u00e1c ti\u00eau chu\u1ea9n v\u00e0 quy \u0111\u1ecbnh qu\u1ed1c t\u1ebf c\u0169ng nh\u01b0 \u0111\u1ecba ph\u01b0\u01a1ng, \u0111\u1ea3m b\u1ea3o t\u00ednh an to\u00e0n, ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 hi\u1ec7u qu\u1ea3 trong \u0111i\u1ec1u tr\u1ecb ung th\u01b0 t\u00edch h\u1ee3p<\/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\">Ch\u1ee9ng nh\u1eadn chi ti\u1ebft c\u1ee7a Thi\u1ebft b\u1ecb Nhi\u1ec7t tr\u1ecb 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\">Ch\u1ee9ng nh\u1eadn Ch\u1ea5t l\u01b0\u1ee3ng UNI CEI EN ISO 13485 cho Thi\u1ebft b\u1ecb Y t\u1ebf<\/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 style=\"text-align: left;\">Thi\u1ebft b\u1ecb nhi\u1ec7t tr\u1ecb von Ardenne Iratherm 1000 WBH wIRA t\u1ef1 h\u00e0o s\u1edf h\u1eefu <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\">ch\u1ee9ng nh\u1eadn h\u1ec7 th\u1ed1ng ch\u1ea5t l\u01b0\u1ee3ng UNI EN ISO 13485<\/a>.<\/p> <p style=\"text-align: left;\">Ch\u1ee9ng ch\u1ec9 n\u00e0y x\u00e1c nh\u1eadn r\u1eb1ng <strong>Von Ardenne Institut f\u00fcr Angewandte Medizinische Forschung GmbH<\/strong> \u0111\u00e3 tri\u1ec3n khai v\u00e0 duy tr\u00ec <strong>H\u1ec7 th\u1ed1ng Qu\u1ea3n l\u00fd Ch\u1ea5t l\u01b0\u1ee3ng (QMS)<\/strong> \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u c\u1ee7a <strong>DIN EN ISO 13485:2021-12 (ISO 13485:2016)<\/strong>.<\/p> <p style=\"text-align: left;\">ISO 13485 l\u00e0 ti\u00eau chu\u1ea9n \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn qu\u1ed1c t\u1ebf, quy \u0111\u1ecbnh c\u00e1c y\u00eau c\u1ea7u \u0111\u1ed1i v\u1edbi h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng m\u00e0 t\u1ea1i \u0111\u00f3 m\u1ed9t t\u1ed5 ch\u1ee9c c\u1ea7n ch\u1ee9ng minh kh\u1ea3 n\u0103ng cung c\u1ea5p c\u00e1c thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 d\u1ecbch v\u1ee5 li\u00ean quan nh\u1eb1m \u0111\u00e1p \u1ee9ng nh\u1ea5t qu\u00e1n c\u00e1c y\u00eau c\u1ea7u c\u1ee7a kh\u00e1ch h\u00e0ng v\u00e0 c\u00e1c quy \u0111\u1ecbnh hi\u1ec7n h\u00e0nh.<\/p> <p style=\"text-align: left;\">\u0110\u1ed1i v\u1edbi Vi\u1ec7n von Ardenne, ch\u1ee9ng nh\u1eadn n\u00e0y nh\u1ea5n m\u1ea1nh cam k\u1ebft c\u1ee7a ch\u00fang t\u00f4i \u0111\u1ed1i v\u1edbi vi\u1ec7c ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng t\u1ec9 m\u1ec9 trong su\u1ed1t to\u00e0n b\u1ed9 v\u00f2ng \u0111\u1eddi c\u1ee7a thi\u1ebft b\u1ecb nhi\u1ec7t tr\u1ecb Iratherm 1000 WBH wIRA, t\u1eeb thi\u1ebft k\u1ebf v\u00e0 ph\u00e1t tri\u1ec3n \u0111\u1ebfn s\u1ea3n xu\u1ea5t, l\u1eafp \u0111\u1eb7t v\u00e0 d\u1ecbch v\u1ee5. \u0110\u00e2y l\u00e0 s\u1ef1 \u0111\u1ea3m b\u1ea3o c\u01a1 b\u1ea3n cho s\u1ef1 t\u1eadn t\u00e2m c\u1ee7a ch\u00fang t\u00f4i \u0111\u1ed1i v\u1edbi an to\u00e0n c\u1ee7a b\u1ec7nh nh\u00e2n v\u00e0 s\u1ef1 \u01b0u vi\u1ec7t c\u1ee7a s\u1ea3n ph\u1ea9m, thi\u1ebft l\u1eadp m\u1ed9t khung v\u1eadn h\u00e0nh v\u1eefng ch\u1eafc cho c\u00e1c quy tr\u00ecnh ho\u1ea1t \u0111\u1ed9ng c\u1ee7a ch\u00fang t\u00f4i.<\/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-3121\" 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>C\u00e1c \u0111i\u1ec3m tr\u1ecdng y\u1ebfu li\u00ean quan:<\/h4> <ul> <li><strong>C\u00f4ng ty \u0111\u01b0\u1ee3c c\u1ea5p ch\u1ee9ng nh\u1eadn:<\/strong> Ch\u1ee9ng ch\u1ec9 \u0111\u01b0\u1ee3c c\u1ea5p cho <strong>Von Ardenne Institut f\u00fcr Angewandte Medizinische Forschung GmbH<\/strong> c\u00f3 tr\u1ee5 s\u1edf t\u1ea1i Dresden, \u0110\u1ee9c.<\/li> <li><strong>Ti\u00eau chu\u1ea9n \u0111\u1ea1t \u0111\u01b0\u1ee3c:<\/strong> C\u00f4ng ty \u0111\u00e3 \u0111\u01b0\u1ee3c <strong>SLG Pr\u00fcf- und Zertifizierungs GmbH<\/strong> ch\u1ee9ng nh\u1eadn tu\u00e2n th\u1ee7 ti\u00eau chu\u1ea9n <strong>ISO 13485<\/strong>.<\/li> <li><strong>Ph\u1ea1m vi ch\u1ee9ng nh\u1eadn:<\/strong> H\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng (QMS) bao g\u1ed3m vi\u1ec7c <strong>S\u1ea3n xu\u1ea5t, ch\u1ebf t\u1ea1o, b\u1ea3o tr\u00ec v\u00e0 ph\u00e2n ph\u1ed1i c\u00e1c h\u1ec7 th\u1ed1ng nhi\u1ec7t tr\u1ecb to\u00e0n th\u00e2n<\/strong>, c\u0169ng nh\u01b0 <strong>b\u1ea3o tr\u00ec v\u00e0 kinh doanh c\u00e1c m\u00e1y t\u1ea1o oxy v\u00e0 ph\u1ee5 ki\u1ec7n<\/strong>.<\/li> <li><strong>Th\u1eddi h\u1ea1n hi\u1ec7u l\u1ef1c:<\/strong> Ch\u1ee9ng ch\u1ec9 c\u00f3 gi\u00e1 tr\u1ecb t\u1eeb ng\u00e0y <strong>29-08-2025<\/strong> \u0111\u1ebfn h\u1ebft ng\u00e0y <strong>28-08-2028<\/strong>.<\/li> <\/ul> T\u00f3m l\u1ea1i, ch\u1ee9ng ch\u1ec9 n\u00e0y c\u1ef1c k\u1ef3 quan tr\u1ecdng v\u00ec n\u00f3 minh ch\u1ee9ng cho cam k\u1ebft c\u1ee7a c\u00f4ng ty v\u1ec1 <strong>ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 an to\u00e0n<\/strong> trong l\u0129nh v\u1ef1c thi\u1ebft b\u1ecb y t\u1ebf, \u0111\u1eb7c bi\u1ec7t l\u00e0 \u0111\u1ed1i v\u1edbi c\u00e1c h\u1ec7 th\u1ed1ng nhi\u1ec7t tr\u1ecb to\u00e0n th\u00e2n c\u1ee7a h\u1ecd. Vi\u1ec7c tu\u00e2n th\u1ee7 n\u00e0y l\u00e0 \u0111i\u1ec1u ki\u1ec7n then ch\u1ed1t cho c\u00e1c m\u1ee5c \u0111\u00edch ph\u00e1p l\u00fd v\u00e0 \u0111\u1ec3 x\u00e2y d\u1ef1ng ni\u1ec1m tin n\u01a1i kh\u00e1ch h\u00e0ng c\u0169ng nh\u01b0 c\u00e1c \u0111\u01a1n v\u1ecb cung c\u1ea5p d\u1ecbch v\u1ee5 y t\u1ebf.\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\">CE - Tuy\u00ean b\u1ed1 H\u1ee3p chu\u1ea9n c\u1ee7a Li\u00ean minh Ch\u00e2u \u00c2u (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<p style=\"text-align: left;\"><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>Tuy\u00ean b\u1ed1 H\u1ee3p chu\u1ea9n c\u1ee7a Li\u00ean minh Ch\u00e2u \u00c2u (DoC)<\/strong><\/a> d\u00e0nh cho thi\u1ebft b\u1ecb y t\u1ebf. \u0110\u00e2y l\u00e0 m\u1ed9t v\u0103n b\u1ea3n ph\u00e1p l\u00fd quan tr\u1ecdng, trong \u0111\u00f3 nh\u00e0 s\u1ea3n xu\u1ea5t, <strong>Von Ardenne Institut f\u00fcr Angewandte Medizinische Forschung GmbH<\/strong>, ch\u1ecbu <strong>tr\u00e1ch nhi\u1ec7m duy nh\u1ea5t<\/strong> trong vi\u1ec7c \u0111\u1ea3m b\u1ea3o r\u1eb1ng s\u1ea3n ph\u1ea9m \u0111\u00e1p \u1ee9ng t\u1ea5t c\u1ea3 c\u00e1c quy \u0111\u1ecbnh hi\u1ec7n h\u00e0nh c\u1ee7a Li\u00ean minh Ch\u00e2u \u00c2u (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-3122\" 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;\">C\u00e1c \u0111i\u1ec3m tr\u1ecdng y\u1ebfu li\u00ean quan:<\/h4> <ul style=\"text-align: left;\"> <li><strong>Tu\u00e2n th\u1ee7 ph\u00e1p l\u00fd v\u00e0 D\u1ea5u CE:<\/strong> DoC l\u00e0 \u0111i\u1ec1u ki\u1ec7n ti\u00ean quy\u1ebft v\u1ec1 m\u1eb7t ph\u00e1p l\u00fd \u0111\u1ec3 d\u00e1n <strong>d\u1ea5u CE<\/strong> l\u00ean s\u1ea3n ph\u1ea9m, \u0111\u00e2y l\u00e0 y\u00eau c\u1ea7u b\u1eaft bu\u1ed9c \u0111\u1ec3 l\u01b0u h\u00e0nh thi\u1ebft b\u1ecb y t\u1ebf tr\u00ean th\u1ecb tr\u01b0\u1eddng EU. B\u1eb1ng c\u00e1ch k\u00fd v\u0103n b\u1ea3n n\u00e0y, nh\u00e0 s\u1ea3n xu\u1ea5t ch\u1ee9ng nh\u1eadn r\u1eb1ng thi\u1ebft b\u1ecb tu\u00e2n th\u1ee7: <ul> <li><strong>Ch\u1ec9 th\u1ecb 93\/42\/EEC (Ch\u1ec9 th\u1ecb v\u1ec1 Thi\u1ebft b\u1ecb Y t\u1ebf)<\/strong>.<\/li> <li><strong>Ch\u1ec9 th\u1ecb 2011\/65\/EU (Ch\u1ec9 th\u1ecb RoHS)<\/strong>, li\u00ean quan \u0111\u1ebfn vi\u1ec7c h\u1ea1n ch\u1ebf c\u00e1c ch\u1ea5t \u0111\u1ed9c h\u1ea1i.<\/li> <\/ul> <\/li> <li><strong>S\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn:<\/strong> Tuy\u00ean b\u1ed1 n\u00e0y \u0111\u1eb7c bi\u1ec7t \u00e1p d\u1ee5ng cho <strong>H\u1ec7 th\u1ed1ng nhi\u1ec7t tr\u1ecb to\u00e0n th\u00e2n<\/strong>, \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh l\u00e0 <strong>Lo\u1ea1i IRATHERM 1000M<\/strong>.<\/li> <li><strong>M\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng:<\/strong> Thi\u1ebft b\u1ecb \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh cho <strong>nhi\u1ec7t tr\u1ecb to\u00e0n th\u00e2n m\u1ee9c \u0111\u1ed9 nh\u1eb9 v\u00e0 trung b\u00ecnh s\u1eed d\u1ee5ng b\u1ee9c x\u1ea1 h\u1ed3ng ngo\u1ea1i A<\/strong>.<\/li> <li><strong>Ph\u00e2n lo\u1ea1i:<\/strong> Thi\u1ebft b\u1ecb \u0111\u01b0\u1ee3c ph\u00e2n lo\u1ea1i l\u00e0 <strong>Nh\u00f3m IIa<\/strong> (theo Ph\u1ee5 l\u1ee5c IX Quy t\u1eafc 9 c\u1ee7a Ch\u1ec9 th\u1ecb 93\/42\/EEC). <ul> <li><em>C\u00e1c thi\u1ebft b\u1ecb thu\u1ed9c Nh\u00f3m IIa \u0111\u01b0\u1ee3c coi l\u00e0 c\u00f3 <strong>r\u1ee7i ro th\u1ea5p \u0111\u1ebfn trung b\u00ecnh<\/strong> v\u00e0 y\u00eau c\u1ea7u s\u1ef1 tham gia c\u1ee7a T\u1ed5 ch\u1ee9c Th\u00f4ng b\u00e1o (m\u1ed9t t\u1ed5 ch\u1ee9c b\u00ean th\u1ee9 ba \u0111\u1ed9c l\u1eadp) \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 s\u1ef1 ph\u00f9 h\u1ee3p.<\/em><\/li> <\/ul> <\/li> <li><strong>S\u1ef1 tham gia c\u1ee7a T\u1ed5 ch\u1ee9c Th\u00f4ng b\u00e1o (Notified Body):<\/strong> Quy tr\u00ecnh \u0111\u00e1nh gi\u00e1 s\u1ef1 ph\u00f9 h\u1ee3p c\u00f3 s\u1ef1 tham gia c\u1ee7a T\u1ed5 ch\u1ee9c Th\u00f4ng b\u00e1o <strong>SLG Pr\u00fcf- und Zertifizierungs GmbH (CE 0494)<\/strong>.<\/li> <li><strong>Th\u1eddi h\u1ea1n hi\u1ec7u l\u1ef1c:<\/strong> Tuy\u00ean b\u1ed1 \u00e1p d\u1ee5ng cho t\u1ea5t c\u1ea3 c\u00e1c m\u1eabu m\u00e1y \u0111\u01b0\u1ee3c li\u1ec7t k\u00ea s\u1ea3n xu\u1ea5t v\u00e0o ho\u1eb7c sau ng\u00e0y <strong>29-08-2025<\/strong> v\u00e0 c\u00f3 gi\u00e1 tr\u1ecb li\u00ean quan \u0111\u1ebfn <strong>Ch\u1ee9ng ch\u1ec9 EC s\u1ed1 25-P-Schu-0036 (109963N5)<\/strong> c\u1ee5 th\u1ec3 cho \u0111\u1ebfn ng\u00e0y <strong>30-09-2026<\/strong>.<\/li> <li><strong>Kh\u1ea3 n\u0103ng truy xu\u1ea5t ngu\u1ed3n g\u1ed1c v\u00e0 Ti\u00eau chu\u1ea9n:<\/strong> V\u0103n b\u1ea3n x\u00e1c nh\u1eadn vi\u1ec7c s\u1eed d\u1ee5ng c\u00e1c ti\u00eau chu\u1ea9n \u00e1p d\u1ee5ng kh\u00e1c nhau (nh\u01b0 EN ISO 13485:2021) v\u00e0 bao g\u1ed3m c\u00e1c m\u00e3 \u0111\u1ecbnh danh duy nh\u1ea5t (<strong>SRN: DE-MF-000011313<\/strong> v\u00e0 <strong>EUDAMED-DI: B-DEMF000011313000005218H<\/strong>) \u0111\u1ec3 theo d\u00f5i nh\u00e0 s\u1ea3n xu\u1ea5t v\u00e0 thi\u1ebft b\u1ecb trong c\u01a1 s\u1edf d\u1eef li\u1ec7u c\u1ee7a EU.<\/li> <\/ul> <p style=\"text-align: left;\">V\u1ec1 b\u1ea3n ch\u1ea5t, Tuy\u00ean b\u1ed1 H\u1ee3p chu\u1ea9n EU l\u00e0 l\u1eddi h\u1ee9a ch\u00ednh th\u1ee9c c\u1ee7a nh\u00e0 s\u1ea3n xu\u1ea5t r\u1eb1ng <strong>IRATHERM 1000M<\/strong> an to\u00e0n v\u00e0 ho\u1ea1t \u0111\u1ed9ng \u0111\u00fang nh\u01b0 thi\u1ebft k\u1ebf, tu\u00e2n th\u1ee7 t\u1ea5t c\u1ea3 c\u00e1c y\u00eau c\u1ea7u v\u1ec1 s\u1ee9c kh\u1ecfe v\u00e0 an to\u00e0n c\u1ee7a Ch\u00e2u \u00c2u \u0111\u1ed1i v\u1edbi thi\u1ebft b\u1ecb y t\u1ebf.<\/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\">Th\u01b0 X\u00e1c nh\u1eadn c\u1ee7a T\u1ed5 ch\u1ee9c Th\u00f4ng b\u00e1o (NB) (Qu\u00e1 tr\u00ecnh chuy\u1ec3n \u0111\u1ed5i 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-3129\" 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>Th\u01b0 n\u00e0y l\u00e0 m\u1ed9t t\u00e0i li\u1ec7u then ch\u1ed1t \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o thi\u1ebft b\u1ecb ti\u1ebfp t\u1ee5c hi\u1ec7n di\u1ec7n tr\u00ean th\u1ecb tr\u01b0\u1eddng trong qu\u00e1 tr\u00ecnh chuy\u1ec3n \u0111\u1ed5i sang <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\" target=\"_blank\" rel=\"noopener\"><strong>Quy \u0111\u1ecbnh v\u1ec1 Thi\u1ebft b\u1ecb Y t\u1ebf m\u1edbi (MDR, EU 2017\/745)<\/strong><\/a>.<\/p>\n\n<ul>\n \t<li><strong>Tr\u1ea1ng th\u00e1i chuy\u1ec3n \u0111\u1ed5i MDR:<\/strong> T\u1ed5 ch\u1ee9c Th\u00f4ng b\u00e1o (NB 0494, SLG Pr\u00fcf- und Zertifizierungs GmbH) x\u00e1c nh\u1eadn r\u1eb1ng nh\u00e0 s\u1ea3n xu\u1ea5t \u0111\u00e3 n\u1ed9p \u0111\u01a1n \u0111\u0103ng k\u00fd ch\u00ednh th\u1ee9c v\u00e0 k\u00fd th\u1ecfa thu\u1eadn b\u1eb1ng v\u0103n b\u1ea3n theo MDR.<\/li>\n \t<li><strong>Gia h\u1ea1n hi\u1ec7u l\u1ef1c:<\/strong> Th\u01b0 x\u00e1c nh\u1eadn n\u00e0y r\u1ea5t quan tr\u1ecdng v\u00ec n\u00f3 cho ph\u00e9p <strong>IRATHERM\u00ae1000M<\/strong>, m\u1ed9t thi\u1ebft b\u1ecb \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn MDD, \u0111\u01b0\u1ee3c h\u01b0\u1edfng l\u1ee3i t\u1eeb c\u00e1c giai \u0111o\u1ea1n chuy\u1ec3n \u0111\u1ed5i k\u00e9o d\u00e0i \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp b\u1edfi Quy \u0111\u1ecbnh (EU) 2023\/607.<\/li>\n \t<li><strong>Th\u1eddi h\u1ea1n tu\u00e2n th\u1ee7 MDR:<\/strong> Th\u1eddi h\u1ea1n \u0111\u1ec3 thi\u1ebft b\u1ecb <strong>Nh\u00f3m IIa<\/strong> n\u00e0y tu\u00e2n th\u1ee7 \u0111\u1ea7y \u0111\u1ee7 v\u00e0 \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn theo MDR m\u1edbi l\u00e0 ng\u00e0y <strong>31 th\u00e1ng 12 n\u0103m 2028<\/strong>.<\/li>\n \t<li><strong>Gi\u00e1m s\u00e1t:<\/strong> T\u1ed5 ch\u1ee9c Th\u00f4ng b\u00e1o (NB) x\u00e1c nh\u1eadn h\u1ecd ch\u1ecbu tr\u00e1ch nhi\u1ec7m gi\u00e1m s\u00e1t th\u00edch h\u1ee3p \u0111\u1ed1i v\u1edbi thi\u1ebft b\u1ecb theo Ch\u1ec9 th\u1ecb hi\u1ec7n h\u00e0nh trong giai \u0111o\u1ea1n chuy\u1ec3n \u0111\u1ed5i n\u00e0y.<\/li>\n \t<li><strong>Th\u1eddi h\u1ea1n hi\u1ec7u l\u1ef1c:<\/strong> B\u1ea3n th\u00e2n th\u01b0 n\u00e0y c\u00f3 gi\u00e1 tr\u1ecb \u0111\u1ebfn ng\u00e0y <strong>30 th\u00e1ng 09 n\u0103m 2026<\/strong>.<\/li>\n<\/ul>\n<h3 style=\"text-align: center;\"><\/h3>\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;\">T\u00f3m l\u1ea1i, c\u00e1c t\u00e0i li\u1ec7u n\u00e0y x\u00e1c nh\u1eadn r\u1eb1ng IRATHERM 1000 l\u00e0 m\u1ed9t thi\u1ebft b\u1ecb y t\u1ebf Nh\u00f3m IIa tu\u00e2n th\u1ee7 \u0111\u1ea7y \u0111\u1ee7 v\u1ec1 m\u1eb7t ph\u00e1p l\u00fd t\u1ea1i EU v\u00e0 nh\u00e0 s\u1ea3n xu\u1ea5t \u0111ang t\u00edch c\u1ef1c ti\u1ebfn h\u00e0nh quy tr\u00ecnh ch\u1ee9ng nh\u1eadn theo c\u00e1c y\u00eau c\u1ea7u MDR m\u1edbi nghi\u00eam ng\u1eb7t h\u01a1n, \u0111\u1ea3m b\u1ea3o quy\u1ec1n ti\u1ebfp c\u1eadn th\u1ecb tr\u01b0\u1eddng cho thi\u1ebft b\u1ecb cho \u0111\u1ebfn cu\u1ed1i n\u0103m 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>Ch\u1ee9ng nh\u1eadn cho Thi\u1ebft b\u1ecb Nhi\u1ec7t tr\u1ecb Von Ardenne Iratherm 1000 WBH wIRA Thi\u1ebft b\u1ecb nhi\u1ec7t tr\u1ecb to\u00e0n th\u00e2n von Ardenne Iratherm 1000 WBH wIRA \u0111\u00e3 tr\u1ea3i qua c\u00e1c quy tr\u00ecnh ki\u1ec3m \u0111\u1ecbnh nghi\u00eam ng\u1eb7t v\u00e0 nh\u1eadn \u0111\u01b0\u1ee3c c\u00e1c ch\u1ee9ng nh\u1eadn to\u00e0n di\u1ec7n nh\u1eb1m tu\u00e2n th\u1ee7 c\u00e1c ti\u00eau chu\u1ea9n v\u00e0 quy \u0111\u1ecbnh qu\u1ed1c t\u1ebf c\u0169ng<br \/><a class=\"moretag\" href=\"https:\/\/ardenneiratherm.com\/vi\/chung-nhan-thiet-bi-tang-than-nhiet\/\">+ 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-1940","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/ardenneiratherm.com\/vi\/wp-json\/wp\/v2\/pages\/1940","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ardenneiratherm.com\/vi\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/ardenneiratherm.com\/vi\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/ardenneiratherm.com\/vi\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ardenneiratherm.com\/vi\/wp-json\/wp\/v2\/comments?post=1940"}],"version-history":[{"count":0,"href":"https:\/\/ardenneiratherm.com\/vi\/wp-json\/wp\/v2\/pages\/1940\/revisions"}],"wp:attachment":[{"href":"https:\/\/ardenneiratherm.com\/vi\/wp-json\/wp\/v2\/media?parent=1940"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}