{"id":1932,"date":"2020-07-07T09:54:22","date_gmt":"2020-07-07T09:54:22","guid":{"rendered":"https:\/\/ardenneiratherm.com\/certifications\/"},"modified":"2026-01-20T16:41:05","modified_gmt":"2026-01-20T16:41:05","slug":"certificates","status":"publish","type":"page","link":"https:\/\/ardenneiratherm.com\/ja\/certificates\/","title":{"rendered":"\u8a8d\u8a3c"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1932\" class=\"elementor elementor-1932 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\">\u30d5\u30a9\u30f3\u30fb\u30a2\u30eb\u30c7\u30f3\u30cc Iratherm 1000 WBH wIRA \u30cf\u30a4\u30d1\u30fc\u30b5\u30fc\u30df\u30a2\u88c5\u7f6e\u306b\u95a2\u3059\u308b\u8a8d\u8a3c\u66f8<\/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<div id=\"model-response-message-contentr_77bc0472511bfe49\" class=\"markdown markdown-main-panel stronger enable-updated-hr-color\" dir=\"ltr\" aria-live=\"polite\" aria-busy=\"false\"><p data-path-to-node=\"0\"><span class=\"citation-1 citation-end-1\">\u30d5\u30a9\u30f3\u30fb\u30a2\u30eb\u30c7\u30f3\u30cc\u7814\u7a76\u6240\u306e\u5168\u8eab\u30cf\u30a4\u30d1\u30fc\u30b5\u30fc\u30df\u30a2\uff08WBH\uff09\u88c5\u7f6e\u300cIratherm 1000 wIRA\u300d\u306f\u3001\u53b3\u683c\u306a\u8a66\u9a13\u3092\u7d4c\u3066\u3001\u56fd\u969b\u304a\u3088\u3073\u73fe\u5730\u306e\u57fa\u6e96\u3068\u898f\u5236\u306b\u6e96\u62e0\u3057\u305f\u5305\u62ec\u7684\u306a\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u96c6\u5b66\u7684\u304c\u3093\u6cbb\u7642\u306b\u304a\u3051\u308b\u5b89\u5168\u6027\u3001\u54c1\u8cea\u3001\u304a\u3088\u3073\u6709\u52b9\u6027\u304c\u4fdd\u8a3c\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/span><\/p><\/div>\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\">\u30d5\u30a9\u30f3\u30fb\u30a2\u30eb\u30c7\u30f3\u30cc Iratherm 1000 WBH wIRA \u30cf\u30a4\u30d1\u30fc\u30b5\u30fc\u30df\u30a2\u88c5\u7f6e\u306b\u95a2\u3059\u308b\u8a73\u7d30\u306a\u8a8d\u8a3c\u60c5\u5831<\/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\">\u533b\u7642\u6a5f\u5668\u306b\u304a\u3051\u308b\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u898f\u683c UNI CEI EN ISO 13485 \u8a8d\u8a3c<\/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;\">\u30d5\u30a9\u30f3\u30fb\u30a2\u30eb\u30c7\u30f3\u30cc\u306e\u5168\u8eab\u30cf\u30a4\u30d1\u30fc\u30b5\u30fc\u30df\u30a2\u88c5\u7f6e\u300cIratherm 1000 wIRA\u300d\u306f\u3001<a href=\"[https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/Certificate_ISO13485_2025-von-Ardenne-Iratherm-1000-WBH-wIRA-hyperthermia-device.pdf](https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/Certificate_ISO13485_2025-von-Ardenne-Iratherm-1000-WBH-wIRA-hyperthermia-device.pdf)\" target=\"_blank\" rel=\"noopener\"><strong>UNI EN ISO 13485\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u8a8d\u8a3c<\/strong><\/a>\u3092\u53d6\u5f97\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p style=\"text-align: left;\">\u3053\u306e\u8a8d\u8a3c\u306f\u3001<strong>Von Ardenne Institut f\u00fcr Angewandte Medizinische Forschung GmbH<\/strong>\u304c\u3001<strong>DIN EN ISO 13485:2021-12 (ISO 13485:2016)<\/strong>\u306e\u8981\u6c42\u4e8b\u9805\u3092\u6e80\u305f\u3059<strong>\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09<\/strong>\u3092\u69cb\u7bc9\u3057\u3001\u7dad\u6301\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u3082\u306e\u3067\u3059\u3002<\/p>\n<p style=\"text-align: left;\">ISO 13485\u306f\u3001\u9867\u5ba2\u8981\u6c42\u4e8b\u9805\u304a\u3088\u3073\u9069\u7528\u3055\u308c\u308b\u898f\u5236\u8981\u6c42\u4e8b\u9805\u3092\u4e00\u8cab\u3057\u3066\u6e80\u305f\u3059\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073\u95a2\u9023\u30b5\u30fc\u30d3\u30b9\u3092\u63d0\u4f9b\u3059\u308b\u80fd\u529b\u3092\u7d44\u7e54\u304c\u5b9f\u8a3c\u3059\u308b\u305f\u3081\u306e\u3001\u56fd\u969b\u7684\u306b\u8a8d\u3081\u3089\u308c\u305f\u6a19\u6e96\u898f\u683c\u3067\u3059\u3002<\/p>\n<p style=\"text-align: left;\">\u30d5\u30a9\u30f3\u30fb\u30a2\u30eb\u30c7\u30f3\u30cc\u7814\u7a76\u6240\u306b\u3068\u3063\u3066\u3001\u3053\u306e\u8a8d\u8a3c\u306f\u3001Iratherm 1000 WBH wIRA \u30cf\u30a4\u30d1\u30fc\u30b5\u30fc\u30df\u30a2\u88c5\u7f6e\u306e\u8a2d\u8a08\u30fb\u958b\u767a\u304b\u3089\u88fd\u9020\u3001\u8a2d\u7f6e\u3001\u30a2\u30d5\u30bf\u30fc\u30b5\u30fc\u30d3\u30b9\u306b\u81f3\u308b\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u3092\u901a\u3058\u305f\u3001\u53b3\u683c\u306a\u54c1\u8cea\u7ba1\u7406\u3078\u306e\u53d6\u308a\u7d44\u307f\u3092\u5f37\u8abf\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u3053\u308c\u306f\u3001\u60a3\u8005\u306e\u5b89\u5168\u6027\u3068\u88fd\u54c1\u306e\u5353\u8d8a\u6027\u306b\u5bfe\u3059\u308b\u5f53\u793e\u306e\u732e\u8eab\u7684\u306a\u59ff\u52e2\u3092\u4fdd\u8a3c\u3059\u308b\u57fa\u76e4\u3067\u3042\u308a\u3001\u696d\u52d9\u30d7\u30ed\u30bb\u30b9\u306e\u305f\u3081\u306e\u5f37\u56fa\u306a\u67a0\u7d44\u307f\u3092\u69cb\u7bc9\u3057\u3066\u3044\u307e\u3059\u3002<\/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-2952\" 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>\u4e3b\u306a\u95a2\u9023\u30dd\u30a4\u30f3\u30c8\uff1a<\/h4>\n<ul>\n\u00a0\t<li><strong>\u8a8d\u8a3c\u53d6\u5f97\u4f01\u696d\uff1a<\/strong> \u672c\u8a8d\u8a3c\u306f\u3001\u30c9\u30a4\u30c4\u30fb\u30c9\u30ec\u30b9\u30c7\u30f3\u306b\u6240\u5728\u3059\u308b <strong>Von Ardenne Institut f\u00fcr Angewandte Medizinische Forschung GmbH<\/strong> \u306b\u5bfe\u3057\u3066\u767a\u884c\u3055\u308c\u307e\u3057\u305f\u3002<\/li>\n\u00a0\t<li><strong>\u6e96\u62e0\u898f\u683c\uff1a<\/strong> \u540c\u793e\u306f\u3001<strong>SLG Pr\u00fcf- und Zertifizierungs GmbH<\/strong> \u306b\u3088\u308a\u3001<strong>ISO 13485<\/strong> \u898f\u683c\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u304c\u8a8d\u8a3c\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/li>\n\u00a0\t<li><strong>\u8a8d\u8a3c\u7bc4\u56f2\uff1a<\/strong> \u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u306f\u3001<strong>\u5168\u8eab\u30cf\u30a4\u30d1\u30fc\u30b5\u30fc\u30df\u30a2\u30b7\u30b9\u30c6\u30e0\u306e\u88fd\u9020\u3001\u751f\u7523\u3001\u4fdd\u5b88\u3001\u304a\u3088\u3073\u8ca9\u58f2<\/strong>\u3001\u306a\u3089\u3073\u306b<strong>\u9178\u7d20\u6fc3\u7e2e\u5668\u304a\u3088\u3073\u4ed8\u5c5e\u54c1\u306e\u4fdd\u5b88\u3068\u53d6\u5f15<\/strong>\u3092\u5bfe\u8c61\u3068\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n\u00a0\t<li><strong>\u6709\u52b9\u671f\u9593\uff1a<\/strong> \u672c\u8a8d\u8a3c\u306e\u6709\u52b9\u671f\u9593\u306f <strong>2025\u5e748\u670829\u65e5<\/strong> \u304b\u3089 <strong>2028\u5e748\u670828\u65e5<\/strong> \u307e\u3067\u3067\u3059\u3002<\/li>\n<\/ul>\n\u8981\u7d04\u3059\u308b\u3068\u3001\u672c\u8a8d\u8a3c\u306f\u3001\u533b\u7642\u6a5f\u5668\u5206\u91ce\u3001\u7279\u306b\u5168\u8eab\u30cf\u30a4\u30d1\u30fc\u30b5\u30fc\u30df\u30a2\u30b7\u30b9\u30c6\u30e0\u306b\u304a\u3051\u308b\u5f53\u793e\u306e<strong>\u54c1\u8cea\u3068\u5b89\u5168\u6027<\/strong>\u3078\u306e\u53d6\u308a\u7d44\u307f\u3092\u8a3c\u660e\u3059\u308b\u3082\u306e\u3067\u3042\u308a\u3001\u6975\u3081\u3066\u9ad8\u3044\u91cd\u8981\u6027\u3092\u6301\u3061\u307e\u3059\u3002\u3053\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306f\u3001\u898f\u5236\u4e0a\u306e\u76ee\u7684\u306e\u307f\u306a\u3089\u305a\u3001\u9867\u5ba2\u3084\u533b\u7642\u5f93\u4e8b\u8005\u304b\u3089\u306e\u4fe1\u983c\u3092\u7bc9\u304f\u4e0a\u3067\u3082\u4e0d\u53ef\u6b20\u306a\u3082\u306e\u3067\u3059\u3002\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 - EU\u9069\u5408\u5ba3\u8a00\u66f8\uff08IRATHERM 1000M\uff09<\/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;\">\u3053\u308c\u306f\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b<a href=\"[https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/EU-Konformitaetserklaerung_MDD_signed_2025-von-Ardenne-Iratherm-1000-WBH-wIRA-hyperthermia-device.pdf](https:\/\/ardenneiratherm.com\/wp-content\/uploads\/2025\/10\/EU-Konformitaetserklaerung_MDD_signed_2025-von-Ardenne-Iratherm-1000-WBH-wIRA-hyperthermia-device.pdf)\"><strong>EU\u9069\u5408\u5ba3\u8a00\u66f8\uff08DoC\uff09<\/strong><\/a>\u3067\u3059\u3002\u3053\u306e\u6587\u66f8\u306f\u3001\u88fd\u9020\u696d\u8005\u3067\u3042\u308b <strong>Von Ardenne Institut f\u00fcr Angewandte Medizinische Forschung GmbH<\/strong> \u304c\u3001\u5f53\u8a72\u88fd\u54c1\u304c\u9069\u7528\u3055\u308c\u308b\u3059\u3079\u3066\u306e\u6b27\u5dde\u9023\u5408\uff08EU\uff09\u898f\u5236\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u306b\u5bfe\u3057\u3001<strong>\u5358\u72ec\u3067\u8cac\u4efb\u3092\u8ca0\u3046<\/strong>\u3053\u3068\u3092\u8868\u660e\u3059\u308b\u6975\u3081\u3066\u91cd\u8981\u306a\u6cd5\u7684\u66f8\u985e\u3067\u3059\u3002<\/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-2953\" 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;\">\u4e3b\u306a\u95a2\u9023\u30dd\u30a4\u30f3\u30c8\uff1a<\/h4>\n<ul style=\"text-align: left;\">\n\u00a0\t<li><strong>\u6cd5\u7684\u9075\u5b88\u3068CE\u30de\u30fc\u30af\uff1a<\/strong> \u9069\u5408\u5ba3\u8a00\u66f8\uff08DoC\uff09\u306f\u3001\u88fd\u54c1\u306b<strong>CE\u30de\u30fc\u30af<\/strong>\u3092\u4ed8\u4e0e\u3059\u308b\u305f\u3081\u306e\u6cd5\u7684\u524d\u63d0\u6761\u4ef6\u3067\u3042\u308a\u3001EU\u5e02\u5834\u306b\u533b\u7642\u6a5f\u5668\u3092\u6d41\u901a\u3055\u305b\u308b\u305f\u3081\u306b\u5fc5\u9808\u3068\u306a\u308a\u307e\u3059\u3002\u3053\u308c\u306b\u7f72\u540d\u3059\u308b\u3053\u3068\u3067\u3001\u88fd\u9020\u696d\u8005\u306f\u88c5\u7f6e\u304c\u4ee5\u4e0b\u306e\u6307\u4ee4\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u8a3c\u660e\u3057\u307e\u3059\u3002\n<ul>\n\u00a0\t<li><strong>\u6307\u4ee4 93\/42\/EEC\uff08\u533b\u7642\u6a5f\u5668\u6307\u4ee4\uff1aMDD\uff09<\/strong><\/li>\n\u00a0\t<li><strong>\u6307\u4ee4 2011\/65\/EU\uff08RoHS\u6307\u4ee4\uff09<\/strong>\uff1a\u6709\u5bb3\u7269\u8cea\u306e\u4f7f\u7528\u5236\u9650\u306b\u95a2\u3059\u308b\u898f\u5236<\/li>\n<\/ul>\n<\/li>\n\u00a0\t<li><strong>\u8a8d\u8a3c\u5bfe\u8c61\u88fd\u54c1\uff1a<\/strong> \u672c\u5ba3\u8a00\u306f\u3001<strong>IRATHERM 1000M<\/strong> \u578b\u3068\u3057\u3066\u8b58\u5225\u3055\u308c\u308b<strong>\u5168\u8eab\u30cf\u30a4\u30d1\u30fc\u30b5\u30fc\u30df\u30a2\u30b7\u30b9\u30c6\u30e0<\/strong>\u3092\u7279\u306b\u5bfe\u8c61\u3068\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n\u00a0\t<li><strong>\u4f7f\u7528\u76ee\u7684\uff1a<\/strong> \u672c\u88c5\u7f6e\u306f\u3001<strong>\u8d64\u5916\u7ddaA\u6ce2\uff08wIRA\uff09\u3092\u7528\u3044\u305f\u8efd\u5ea6\u304a\u3088\u3073\u4e2d\u7b49\u5ea6\u306e\u5168\u8eab\u30cf\u30a4\u30d1\u30fc\u30b5\u30fc\u30df\u30a2<\/strong>\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n\u00a0\t<li><strong>\u30af\u30e9\u30b9\u5206\u985e\uff1a<\/strong> \u672c\u88c5\u7f6e\u306f <strong>\u30af\u30e9\u30b9IIa<\/strong>\uff08\u6307\u4ee4 93\/42\/EEC \u9644\u5c5e\u66f8IX \u898f\u52479\u306b\u3088\u308b\uff09\u306b\u5206\u985e\u3055\u308c\u3066\u3044\u307e\u3059\u3002\n<ul>\n\u00a0\t<li><em>\u30af\u30e9\u30b9IIa\u306e\u6a5f\u5668\u306f<strong>\u4f4e\uff5e\u4e2d\u30ea\u30b9\u30af<\/strong>\u3068\u307f\u306a\u3055\u308c\u3001\u9069\u5408\u6027\u8a55\u4fa1\u306e\u305f\u3081\u306b\u516c\u8a8d\u6a5f\u95a2\uff08\u72ec\u7acb\u3057\u305f\u7b2c\u4e09\u8005\u6a5f\u95a2\uff09\u306e\u95a2\u4e0e\u304c\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002<\/em><\/li>\n<\/ul>\n<\/li>\n\u00a0\t<li><strong>\u516c\u8a8d\u6a5f\u95a2\uff08\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\uff09\u306e\u95a2\u4e0e\uff1a<\/strong> \u9069\u5408\u6027\u8a55\u4fa1\u624b\u7d9a\u304d\u306b\u306f\u3001\u516c\u8a8d\u6a5f\u95a2 <strong>SLG Pr\u00fcf- und Zertifizierungs GmbH (CE 0494)<\/strong> \u304c\u95a2\u4e0e\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n\u00a0\t<li><strong>\u6709\u52b9\u671f\u9593\uff1a<\/strong> \u672c\u5ba3\u8a00\u306f <strong>2025\u5e748\u670829\u65e5<\/strong> \u4ee5\u964d\u306b\u88fd\u9020\u3055\u308c\u305f\u3059\u3079\u3066\u306e\u8a18\u8f09\u30e2\u30c7\u30eb\u306b\u9069\u7528\u3055\u308c\u3001\u7279\u5b9a\u306e <strong>EC\u8a3c\u660e\u66f8 25-P-Schu-0036 (109963N5)<\/strong> \u3068\u95a2\u9023\u3057\u3066 <strong>2026\u5e749\u670830\u65e5<\/strong> \u307e\u3067\u6709\u52b9\u3067\u3059\u3002<\/li>\n\u00a0\t<li><strong>\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3068\u898f\u683c\uff1a<\/strong> \u5404\u7a2e\u9069\u7528\u898f\u683c\uff08EN ISO 13485:2021\u306a\u3069\uff09\u306e\u4f7f\u7528\u3092\u88cf\u4ed8\u3051\u308b\u3068\u3068\u3082\u306b\u3001EU\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3067\u88fd\u9020\u696d\u8005\u304a\u3088\u3073\u88c5\u7f6e\u3092\u8ffd\u8de1\u3059\u308b\u305f\u3081\u306e\u56fa\u6709\u8b58\u5225\u5b50\uff08<strong>SRN: DE-MF-000011313<\/strong> \u304a\u3088\u3073 <strong>EUDAMED-DI: B-DEMF000011313000005218H<\/strong>\uff09\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002<\/li>\n<\/ul>\n<p style=\"text-align: left;\">\u672c\u8cea\u7684\u306b\u3001EU\u9069\u5408\u5ba3\u8a00\u66f8\u306f\u3001<strong>IRATHERM 1000M<\/strong> \u304c\u5b89\u5168\u3067\u3042\u308a\u3001\u610f\u56f3\u3055\u308c\u305f\u901a\u308a\u306b\u6a5f\u80fd\u3057\u3001\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u3059\u3079\u3066\u306e\u6b27\u5dde\u306e\u5065\u5eb7\u304a\u3088\u3073\u5b89\u5168\u8981\u4ef6\u3092\u9075\u5b88\u3057\u3066\u3044\u308b\u3068\u3044\u3046\u88fd\u9020\u696d\u8005\u306e\u6b63\u5f0f\u306a\u8a93\u7d04\u3067\u3059\u3002<\/p>\n\n\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\">\u516c\u8a8d\u6a5f\u95a2\uff08NB\uff09\u78ba\u8a8d\u66f8\uff08MDR\u79fb\u884c\u306b\u95a2\u3059\u308b\u78ba\u8a8d\u66f8\uff09<\/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-2960\" 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>\u3053\u306e\u66f8\u9762\u306f\u3001\u65b0\u3057\u3044<a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\" target=\"_blank\" rel=\"noopener\"><strong>\u6b27\u5dde\u533b\u7642\u6a5f\u5668\u898f\u5247\uff08MDR, EU 2017\/745\uff09<\/strong><\/a>\u3078\u306e\u79fb\u884c\u671f\u9593\u4e2d\u306b\u304a\u3044\u3066\u3001\u88c5\u7f6e\u304c\u7d99\u7d9a\u7684\u306b\u5e02\u5834\u306b\u6d41\u901a\u3059\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306e\u91cd\u8981\u306a\u6587\u66f8\u3067\u3059\u3002<\/p>\n\n<ul>\n \t<li><strong>MDR\u79fb\u884c\u30b9\u30c6\u30fc\u30bf\u30b9\uff1a<\/strong> \u516c\u8a8d\u6a5f\u95a2\uff08NB 0494, SLG Pr\u00fcf- und Zertifizierungs GmbH\uff09\u306f\u3001\u88fd\u9020\u696d\u8005\u304cMDR\u306b\u57fa\u3065\u3044\u305f\u6b63\u5f0f\u306a\u7533\u8acb\u3092\u63d0\u51fa\u3057\u3001\u66f8\u9762\u306b\u3088\u308b\u5408\u610f\u3092\u7de0\u7d50\u3057\u305f\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n \t<li><strong>\u6709\u52b9\u671f\u9593\u306e\u5ef6\u9577\uff1a<\/strong> \u3053\u306e\u78ba\u8a8d\u66f8\u306f\u3001MDD\u8a8d\u8a3c\u3092\u53d7\u3051\u3066\u3044\u308b<strong>IRATHERM\u00ae1000M<\/strong>\u304c\u3001\u898f\u5247\uff08EU\uff092023\/607\u306b\u3088\u3063\u3066\u8a2d\u5b9a\u3055\u308c\u305f\u5ef6\u9577\u79fb\u884c\u671f\u9593\u306e\u9069\u7528\u3092\u53d7\u3051\u308b\u305f\u3081\u306b\u4e0d\u53ef\u6b20\u306a\u3082\u306e\u3067\u3059\u3002<\/li>\n \t<li><strong>MDR\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u671f\u9650\uff1a<\/strong> \u3053\u306e<strong>\u30af\u30e9\u30b9IIa<\/strong>\u6a5f\u5668\u304c\u65b0\u3057\u3044MDR\u306b\u5b8c\u5168\u306b\u6e96\u62e0\u3057\u3001\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u305f\u3081\u306e\u671f\u9650\u306f<strong>2028\u5e7412\u670831\u65e5<\/strong>\u3067\u3059\u3002<\/li>\n \t<li><strong>\u30b5\u30fc\u30d9\u30a4\u30e9\u30f3\u30b9\uff08\u76e3\u8996\uff09\uff1a<\/strong> \u516c\u8a8d\u6a5f\u95a2\uff08NB\uff09\u306f\u3001\u3053\u306e\u79fb\u884c\u671f\u9593\u4e2d\u3001\u9069\u7528\u3055\u308c\u308b\u6307\u4ee4\u306b\u57fa\u3065\u304d\u88c5\u7f6e\u306e\u9069\u5207\u306a\u76e3\u8996\u3092\u884c\u3046\u8cac\u4efb\u3092\u8ca0\u3046\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n \t<li><strong>\u6709\u52b9\u671f\u9650\uff1a<\/strong> \u672c\u78ba\u8a8d\u66f8\u81ea\u4f53\u306e\u6709\u52b9\u671f\u9650\u306f<strong>2026\u5e749\u670830\u65e5<\/strong>\u307e\u3067\u3067\u3059\u3002<\/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;\">\u8981\u7d04\u3059\u308b\u3068\u3001\u3053\u308c\u3089\u306e\u6587\u66f8\u306f IRATHERM 1000 \u304cEU\u306b\u304a\u3051\u308b\u6cd5\u898f\u5236\u306b\u6e96\u62e0\u3057\u305f<strong>\u30af\u30e9\u30b9IIa\u533b\u7642\u6a5f\u5668<\/strong>\u3067\u3042\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u307e\u305f\u3001\u88fd\u9020\u696d\u8005\u304c\u3088\u308a\u53b3\u683c\u306a\u65b0MDR\uff08\u6b27\u5dde\u533b\u7642\u6a5f\u5668\u898f\u5247\uff09\u306e\u8981\u4ef6\u306b\u5411\u3051\u305f\u8a8d\u8a3c\u624b\u7d9a\u304d\u3092\u7a4d\u6975\u7684\u306b\u9032\u3081\u3066\u304a\u308a\u30012028\u5e74\u672b\u307e\u3067\u306e\u5e02\u5834\u6d41\u901a\u304c\u78ba\u4fdd\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u88cf\u4ed8\u3051\u3066\u3044\u307e\u3059\u3002<\/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>\u30d5\u30a9\u30f3\u30fb\u30a2\u30eb\u30c7\u30f3\u30cc Iratherm 1000 WBH wIRA \u30cf\u30a4\u30d1\u30fc\u30b5\u30fc\u30df\u30a2\u88c5\u7f6e\u306b\u95a2\u3059\u308b\u8a8d\u8a3c\u66f8 \u30d5\u30a9\u30f3\u30fb\u30a2\u30eb\u30c7\u30f3\u30cc\u7814\u7a76\u6240\u306e\u5168\u8eab\u30cf\u30a4\u30d1\u30fc\u30b5\u30fc\u30df\u30a2\uff08WBH\uff09\u88c5\u7f6e\u300cIratherm 1000 wIRA\u300d\u306f\u3001\u53b3\u683c\u306a\u8a66\u9a13\u3092\u7d4c<br \/><a class=\"moretag\" href=\"https:\/\/ardenneiratherm.com\/ja\/certificates\/\">+ 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-1932","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/ardenneiratherm.com\/ja\/wp-json\/wp\/v2\/pages\/1932","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ardenneiratherm.com\/ja\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/ardenneiratherm.com\/ja\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/ardenneiratherm.com\/ja\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ardenneiratherm.com\/ja\/wp-json\/wp\/v2\/comments?post=1932"}],"version-history":[{"count":0,"href":"https:\/\/ardenneiratherm.com\/ja\/wp-json\/wp\/v2\/pages\/1932\/revisions"}],"wp:attachment":[{"href":"https:\/\/ardenneiratherm.com\/ja\/wp-json\/wp\/v2\/media?parent=1932"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}