{"id":17359,"date":"2025-09-30T22:52:56","date_gmt":"2025-09-30T14:52:56","guid":{"rendered":"https:\/\/weecke.com\/?p=17359"},"modified":"2025-09-30T22:54:04","modified_gmt":"2025-09-30T14:54:04","slug":"%e5%8c%bb%e7%99%82%e3%82%b0%e3%83%ac%e3%83%bc%e3%83%89%e5%90%b8%e5%85%a5%e5%99%a8-%e5%ae%89%e5%85%a8%e3%82%ac%e3%82%a4%e3%83%89-%e8%aa%8d%e8%a8%bc%e6%b8%88%e3%81%bf%e3%83%a1%e3%83%bc%e3%82%ab%e3%83%bc","status":"publish","type":"post","link":"https:\/\/weecke.com\/ja\/%e5%8c%bb%e7%99%82%e3%82%b0%e3%83%ac%e3%83%bc%e3%83%89%e5%90%b8%e5%85%a5%e5%99%a8-%e5%ae%89%e5%85%a8%e3%82%ac%e3%82%a4%e3%83%89-%e8%aa%8d%e8%a8%bc%e6%b8%88%e3%81%bf%e3%83%a1%e3%83%bc%e3%82%ab%e3%83%bc\/","title":{"rendered":"\u533b\u7642\u7528\u30b0\u30ec\u30fc\u30c9\u30d9\u30a4\u30d1\u30e9\u30a4\u30b6\u30fc\u8a8d\u8a3c\u306e\u89e3\u8aac\uff1a\u3059\u3079\u3066\u306e\u30d6\u30e9\u30f3\u30c9\u304c\u77e5\u3063\u3066\u304a\u304f\u3079\u304d\u3053\u3068"},"content":{"rendered":"

\u533b\u7642\u5c02\u9580\u5bb6\u306f\u3001\u6cbb\u7642\u76ee\u7684\u3067\u30d9\u30a4\u30dd\u30e9\u30a4\u30b6\u30fc\uff08\u5438\u5165\u5668\uff09\u306e\u4f7f\u7528\u3092\u5897\u3084\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u305d\u308c\u306f\u53b3\u683c\u306a\u533b\u7642\u57fa\u6e96\u3092\u6e80\u305f\u3059\u5834\u5408\u306b\u9650\u3089\u308c\u307e\u3059\u3002 \u53b3\u683c\u306a\u533b\u7642\u57fa\u6e96<\/strong>. \u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u3001\u3053\u306e\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u3053\u3068\u306f\u5bb9\u6613\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u6642\u9593\u3068\u6295\u8cc7\u304c\u5fc5\u8981\u3067\u3042\u308a\u3001\u8907\u96d1\u306a\u56fd\u969b\u898f\u5236\u306e\u7db2\u3092\u304f\u3050\u308a\u629c\u3051\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n

\u533b\u7642\u7528\u307e\u305f\u306f\u81e8\u5e8a\u7528\u306e\u30d9\u30a4\u30dd\u30e9\u30a4\u30b6\u30fc\u3092\u958b\u767a\u3059\u308b\u8a08\u753b\u3092\u304a\u6301\u3061\u306e\u5834\u5408\u3001 \u533b\u7642\u7528\u307e\u305f\u306f\u81e8\u5e8a\u7528<\/strong>, \u3053\u306e\u30ac\u30a4\u30c9\u3067\u306f\u3001\u300c\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u300d\u306e\u771f\u306e\u610f\u5473\u3001\u4e3b\u8981\u306a\u8a8d\u8a3c\u30b9\u30c6\u30c3\u30d7\u3001\u5e02\u5834\u53c2\u5165\u3092\u9045\u3089\u305b\u308b\u4e00\u822c\u7684\u306a\u30df\u30b9\u3092\u56de\u907f\u3059\u308b\u65b9\u6cd5\u306b\u3064\u3044\u3066\u3054\u8aac\u660e\u3057\u307e\u3059\u3002.<\/p>\n

\u5b9f\u8df5\u7684\u3067\u5206\u304b\u308a\u3084\u3059\u3044\u65b9\u6cd5\u3067\u89e3\u8aac\u3057\u3066\u3044\u304d\u307e\u3057\u3087\u3046\u3002.<\/p>\n

\u30d9\u30a4\u30dd\u30e9\u30a4\u30b6\u30fc\u304c\u300c\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u300d\u3068\u3055\u308c\u308b\u8981\u4ef6\u3068\u306f\uff1f<\/h2>\n

\u30d9\u30a4\u30dd\u30e9\u30a4\u30b6\u30fc\u304c \u533b\u7642\u30b0\u30ec\u30fc\u30c9\u306e\u30d9\u30a4\u30dd\u30e9\u30a4\u30b6\u30fc<\/strong>, \u3068\u3057\u3066\u5206\u985e\u3055\u308c\u308b\u305f\u3081\u306b\u306f\u3001\u60a3\u8005\u306e\u5b89\u5168\u3092\u4fdd\u8b77\u3057\u6cbb\u7642\u52b9\u679c\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u8a2d\u8a08\u3055\u308c\u305f\u53b3\u683c\u306a\u898f\u5236\u8981\u4ef6\u3092\u6e80\u305f\u3055\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002.<\/p>\n

\u4ee5\u4e0b\u304c\u305d\u306e\u4e3b\u8981\u306a\u67f1\u3067\u3059\uff1a<\/p>\n

\u898f\u5236\u4e0a\u306e\u5206\u985e<\/h3>\n

\u7c73\u56fd\u3067\u306f\u3001FDA\u306f\u307b\u3068\u3093\u3069\u306e\u533b\u7642\u7528\u30d9\u30a4\u30dd\u30e9\u30a4\u30b6\u30fc\u3092 \u30af\u30e9\u30b9II\u533b\u7642\u6a5f\u5668<\/strong>. \u306b\u5206\u985e\u3057\u3066\u3044\u307e\u3059\u3002\u3064\u307e\u308a\u3001\u88fd\u54c1\u306f 510(k)\u627f\u8a8d<\/strong>, \u3092\u7d4c\u3066\u3001\u3059\u3067\u306b\u627f\u8a8d\u3055\u308c\u3066\u3044\u308b\u6a5f\u5668\u3068\u540c\u7b49\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u8a3c\u660e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n

\u30e8\u30fc\u30ed\u30c3\u30d1\u3067\u306f\u3001 CE\u30de\u30fc\u30ad\u30f3\u30b0<\/strong> \uff08MDR\uff1a\u533b\u7642\u6a5f\u5668\u898f\u5247\u306b\u57fa\u3065\u304f\uff09\u304c\u5fc5\u8981\u3067\u3042\u308a\u3001\u3053\u308c\u306b\u306f\u81e8\u5e8a\u8a55\u4fa1\u3068\u30ea\u30b9\u30af\u7ba1\u7406\u304c\u542b\u307e\u308c\u307e\u3059\u3002.<\/p>\n

\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u3067\u306f\u3001 TGA\uff08\u6cbb\u7642\u7528\u54c1\u5c40\uff09\u9069\u5408\u6027\u8a55\u4fa1\u8a8d\u8a3c<\/strong>, \u304c\u5fc5\u8981\u3067\u3042\u308a\u3001\u3053\u308c\u306b\u3088\u308a\u30d9\u30a4\u30dd\u30e9\u30a4\u30b6\u30fc\u304c \u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u306e\u533b\u7642\u6a5f\u5668\u57fa\u6e96<\/strong>. \u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3053\u3068\u304c\u4fdd\u8a3c\u3055\u308c\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u3001\u6587\u66f8\u5316\u3055\u308c\u305f\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3001\u81e8\u5e8a\u7684\u8a3c\u62e0\u3001\u304a\u3088\u3073TGA\u5be9\u67fb\u306b\u63d0\u51fa\u3059\u308b\u88fd\u54c1\u56fa\u6709\u306e\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u304c\u542b\u307e\u308c\u307e\u3059\u3002.<\/p>\n

\u751f\u4f53\u9069\u5408\u6027\u6750\u6599<\/h3>\n

\u4eba\u4f53\u3078\u306e\u66dd\u9732\u306b\u5bfe\u3057\u3066\u5b89\u5168\u306a\u6750\u6599\u3092\u4f7f\u7528\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u3053\u308c\u3089\u306e\u6750\u6599\u306f\u3001 USP\u30af\u30e9\u30b9VI\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13<\/strong> \u306b\u5408\u683c\u3057\u3001\u5438\u5165\u307e\u305f\u306f\u63a5\u89e6\u6642\u306b\u30a2\u30ec\u30eb\u30ae\u30fc\u53cd\u5fdc\u3084\u6bd2\u6027\u3092\u5f15\u304d\u8d77\u3053\u3055\u306a\u3044\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n

ISO 13485\u8a8d\u8a3c<\/h3>\n

\u3053\u306e\u533b\u7642\u6a5f\u5668\u306e\u56fd\u969b\u54c1\u8cea\u898f\u683c\u306f\u3001\u5de5\u5834\u304c\u53b3\u683c\u306a\u88fd\u9020\u304a\u3088\u3073\u54c1\u8cea\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9\u306b\u5f93\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n\n\n\n\n\n
\u8981\u4ef6<\/th>\n\u5185\u5bb9<\/th>\n\u8981\u6c42\u3059\u308b\u4e3b\u4f53<\/th>\n<\/tr>\n<\/thead>\n
FDA 510(k)<\/td>\n\u5b89\u5168\u6027\u30fb\u6027\u80fd\u8a66\u9a13<\/td>\n\u7c73\u56fd\u5e02\u5834<\/td>\n<\/tr>\n
CE\u30de\u30fc\u30ad\u30f3\u30b0 (MDR)<\/td>\n\u81e8\u5e8a\u8a55\u4fa1\u3001\u30ea\u30b9\u30af\u7ba1\u7406<\/td>\nEU\u5e02\u5834<\/td>\n<\/tr>\n
ISO 13485<\/td>\n\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0<\/td>\n\u30b0\u30ed\u30fc\u30d0\u30eb<\/td>\n<\/tr>\n
USP\u30af\u30e9\u30b9VI<\/td>\n\u6750\u6599\u306e\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13<\/td>\n\u3059\u3079\u3066\u306e\u533b\u7642\u7528\u9014<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u533b\u7642\u7528\u30d9\u30a4\u30dd\u30e9\u30a4\u30b6\u30fc\u3092\u898f\u5236\u3059\u308b\u306e\u306f\u8ab0\u304b\uff1f<\/h2>\n

\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u30d9\u30a4\u30dd\u30e9\u30a4\u30b6\u30fc\u306e\u627f\u8a8d\u3092\u76e3\u7763\u3059\u308b\u4e3b\u8981\u306a\u6a5f\u95a2\u306f\u8907\u6570\u3042\u308a\u3001\u305d\u308c\u305e\u308c\u72ec\u81ea\u306e\u30d7\u30ed\u30bb\u30b9\u304c\u3042\u308a\u307e\u3059\uff1a<\/p>\n\n\n\n\n\n\n\n\n
\u898f\u5236\u6a5f\u95a2<\/th>\n\u5730\u57df<\/th>\n\u4e3b\u8981\u8981\u4ef6<\/th>\n\u627f\u8a8d\u307e\u3067\u306e\u6a19\u6e96\u671f\u9593<\/th>\n<\/tr>\n<\/thead>\n
FDA (\u7c73\u56fd)<\/td>\n\u30a2\u30e1\u30ea\u30ab\u5408\u8846\u56fd<\/td>\n510(k)\u3001ISO 13485\u3001QMS<\/td>\n6\uff5e12\u30f6\u6708<\/td>\n<\/tr>\n
EMA (\u6b27\u5dde)<\/td>\n\u6b27\u5dde\u9023\u5408<\/td>\nCE\u30de\u30fc\u30ad\u30f3\u30b0\u3001\u81e8\u5e8a\u7684\u691c\u8a3c<\/td>\n8\uff5e18\u30f6\u6708<\/td>\n<\/tr>\n
\u30d8\u30eb\u30b9\u30ab\u30ca\u30c0<\/td>\n\u30ab\u30ca\u30c0<\/td>\nISO 13485\u3001CMDCAS<\/td>\n6\uff5e15\u30f6\u6708<\/td>\n<\/tr>\n
TGA\uff08\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\uff09<\/td>\n\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2<\/td>\n\u9069\u5408\u6027\u8a55\u4fa1\u3001\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0<\/td>\n4\uff5e12\u30f6\u6708<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u3059\u3079\u3066\u306e\u898f\u5236\u5f53\u5c40\u304c\u8981\u6c42\u3059\u308b\u4e8b\u9805\uff1a<\/p>\n

    \n
  • \u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\uff08ISO 14971\uff09 <\/li>\n
  • \u88fd\u54c1\u8a66\u9a13\u304a\u3088\u3073\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3 <\/li>\n
  • \u81e8\u5e8a\u7684\u8a3c\u62e0\uff08CE\u3001FDA\u5411\u3051\uff09<\/li>\n<\/ul>\n

    \u305d\u306e\u305f\u3081 ISO 13485<\/strong> \u3053\u308c\u306f\u666e\u904d\u7684\u306a\u6a19\u6e96\u3068\u898b\u306a\u3055\u308c\u3066\u304a\u308a\u3001\u3053\u308c\u3089\u3059\u3079\u3066\u306e\u8a8d\u8a3c\u53d6\u5f97\u7d4c\u8def\u306b\u5bfe\u5fdc\u3059\u308b\u6e96\u5099\u304c\u6574\u3044\u307e\u3059\u3002.<\/p>\n

    ISO 13485\u8a8d\u8a3c\u304c\u4e0d\u53ef\u6b20\u306a\u7406\u7531<\/h2>\n

    ISO 13485\u304c\u306a\u3051\u308c\u3070\u3001\u4e3b\u8981\u306a\u533b\u7642\u6a5f\u5668\u5e02\u5834\u306b\u53c2\u5165\u3059\u308b\u3053\u3068\u306f\u56f0\u96e3\u3067\u3059\u3002\u3053\u306e\u8a8d\u8a3c\u306f\u3001\u8cb4\u793e\u306e\u5de5\u5834\u304c\u4ee5\u4e0b\u3092\u6709\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3057\u307e\u3059\uff1a<\/p>\n

      \n
    • \u5b8c\u5168\u306a\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0 <\/li>\n
    • \u8ffd\u8de1\u53ef\u80fd\u306a\u6587\u66f8\u7ba1\u7406\u304a\u3088\u3073\u30d0\u30c3\u30c1\u7ba1\u7406 <\/li>\n
    • \u691c\u8a3c\u6e08\u307f\u306e\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8 <\/li>\n
    • \u9069\u683c\u306a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u30de\u30cd\u30b8\u30e1\u30f3\u30c8<\/li>\n<\/ul>\n

      \u3053\u308c\u304c\u3001\u8cb4\u793e\u306e\u30d9\u30fc\u30d1\u30e9\u30a4\u30b6\u30fc\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306b\u76f4\u63a5\u7684\u306b\u4e0e\u3048\u308b\u5f71\u97ff\u3067\u3059\uff1a<\/p>\n\n\n\n\n\n\n\n\n
      \u9818\u57df<\/th>\nISO 13485\u8981\u4ef6<\/th>\n\u30d9\u30fc\u30d1\u30e9\u30a4\u30b6\u30fc\u958b\u767a\u3078\u306e\u30e1\u30ea\u30c3\u30c8<\/th>\n<\/tr>\n<\/thead>\n
      \u8a2d\u8a08\u7ba1\u7406<\/td>\n\u691c\u8a3c\u6e08\u307f\u8a2d\u8a08\u30d7\u30ed\u30bb\u30b9<\/td>\n\u3088\u308a\u5b89\u5168\u3067\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u88fd\u54c1<\/td>\n<\/tr>\n
      \u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u7ba1\u7406<\/td>\n\u30d9\u30f3\u30c0\u30fc\u9069\u683c\u6027\u8a55\u4fa1\u30d7\u30ed\u30c8\u30b3\u30eb<\/td>\n\u4e0d\u826f\u90e8\u54c1\u306e\u9632\u6b62<\/td>\n<\/tr>\n
      \u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8<\/td>\nISO 14971\u6e96\u62e0<\/td>\n\u5371\u967a\u6e90\u306e\u7279\u5b9a\u3068\u7ba1\u7406<\/td>\n<\/tr>\n
      \u6587\u66f8\u7ba1\u7406<\/td>\nQMS\u8a18\u9332\u7ba1\u7406<\/td>\n\u898f\u5236\u5f53\u5c40\u3078\u306e\u7533\u8acb\u3092\u5bb9\u6613\u5316<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
      \n

      \u88fd\u9020\u696d\u8005\u3068\u5354\u696d\u3059\u308b\u5834\u5408\u306f\u3001 \u305d\u306e\u696d\u8005\u304c<\/strong> ISO 13485\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u3055\u3082\u306a\u3051\u308c\u3070\u3001\u9045\u5ef6\u3084\u76e3\u67fb\u4e0d\u5408\u683c\u306e\u30ea\u30b9\u30af\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n<\/blockquote>\n

      \u9069\u5408\u6027\u3092\u5f97\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u6587\u66f8\u306f\uff1f<\/h2>\n

      \u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u306b\u306f\u3001\u88fd\u54c1\u4ed5\u69d8\u66f8\u3060\u3051\u3067\u306f\u4e0d\u5341\u5206\u3067\u3059\u3002\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u5b8c\u5168\u306a\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u6587\u66f8\u304c\u5fc5\u8981\u3067\u3059\uff1a<\/p>\n\n\n\n\n\n\n\n\n
      \u6587\u66f8\u30bf\u30a4\u30d7<\/th>\n\u8aac\u660e<\/th>\n\u95a2\u9023\u898f\u683c<\/th>\n<\/tr>\n<\/thead>\n
      \u8a2d\u8a08\u5c65\u6b74\u30d5\u30a1\u30a4\u30eb<\/td>\n\u30b3\u30f3\u30bb\u30d7\u30c8\u304b\u3089\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u307e\u3067<\/td>\nFDA 21 CFR 820.30<\/td>\n<\/tr>\n
      \u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d5\u30a1\u30a4\u30eb<\/td>\n\u5371\u967a\u6e90\u3001\u7ba1\u7406\u7b56\u3001\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0<\/td>\nISO 14971<\/td>\n<\/tr>\n
      \u6280\u8853\u30d5\u30a1\u30a4\u30eb<\/td>\n\u6750\u6599\u3001\u88fd\u9020\u3001\u8a66\u9a13<\/td>\nEU MDR<\/td>\n<\/tr>\n
      \u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u6587\u66f8<\/td>\n\u88fd\u9020\u304a\u3088\u3073\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30d7\u30ed\u30bb\u30b9<\/td>\nISO 13485<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
      \n

      \u5f37\u56fa\u306a\u6587\u66f8\u306e\u8ecc\u8de1\u3053\u305d\u304c\u3001\u6a5f\u80fd\u3059\u308b\u88fd\u54c1\u3092 \u8a8d\u8a3c\u3055\u308c\u305f\u533b\u7642\u6a5f\u5668\u3078\u3068\u5909\u3048\u308b\u306e\u3067\u3059\u3002<\/strong>.<\/p>\n<\/blockquote>\n

      \u914d\u9001\u30d7\u30ed\u30c8\u30b3\u30eb\u3082\u91cd\u8981\u306a\u7406\u7531<\/h2>\n

      \u88fd\u54c1\u304c\u5de5\u5834\u3092\u51fa\u305f\u6642\u70b9\u3067\u3001\u8a8d\u8a3c\u306e\u8981\u4ef6\u306f\u7d42\u308f\u308a\u307e\u305b\u3093\u3002.<\/p>\n

      \u4ee5\u4e0b\u306e\u9075\u5b88\u304c\u5fc5\u9808\u3067\u3059\uff1a \u533b\u7642\u6a5f\u5668\u30b0\u30ec\u30fc\u30c9\u306e\u6d41\u901a\u30d7\u30ed\u30c8\u30b3\u30eb<\/strong>:<\/p>\n

        \n
      • \u4fdd\u7ba1\u8a18\u9332\u9023\u9396 <\/li>\n
      • \u6e29\u5ea6\u7ba1\u7406\u3055\u308c\u305f\u7269\u6d41 <\/li>\n
      • \u6539\u3056\u3093\u9632\u6b62\u5305\u88c5 <\/li>\n
      • \u30d0\u30c3\u30c1\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3<\/li>\n<\/ul>\n

        \u3053\u308c\u3089\u306f\u5358\u306a\u308b\u512a\u308c\u305f\u6163\u884c\u3067\u306f\u306a\u304f\u3001ISO 13485\u306e\u4e0b\u3067\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3001\u307b\u3068\u3093\u3069\u306e\u898f\u5236\u5f53\u5c40\u306b\u3088\u3063\u3066\u8981\u6c42\u3055\u308c\u308b\u3082\u306e\u3067\u3059\u3002.<\/p>\n

        \u6700\u7d42\u7684\u306a\u8003\u5bdf<\/h2>\n

        \u5438\u5165\u5668\u88fd\u54c1\u3067\u533b\u7642\u6a5f\u5668\u5e02\u5834\u306b\u53c2\u5165\u3059\u308b\u306e\u306f\u5bb9\u6613\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3057\u304b\u3057\u3001\u9069\u5207\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u3068\u9069\u5207\u306a\u30d1\u30fc\u30c8\u30ca\u30fc\u304c\u3042\u308c\u3070\u3001\u6210\u529f\u306f\u53ef\u80fd\u3067\u3059\u3002.<\/p>\n

        \u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u306b\u306f\u3001\u4ee5\u4e0b\u304c\u5fc5\u8981\u3067\u3059\uff1a<\/p>\n

          \n
        • \u898f\u5236\u306b\u6e96\u62e0\u3057\u305f\u88fd\u54c1\u8a2d\u8a08 <\/li>\n
        • ISO 13485\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u305f\u88fd\u9020 <\/li>\n
        • \u5b8c\u5168\u306a\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u6587\u66f8<\/li>\n<\/ul>\n

          \u8a8d\u8a3c\u53d6\u5f97\u306b\u306f 6\uff5e18\u304b\u6708<\/strong>, \u3092\u8981\u3059\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u304c\u3001\u533b\u7642\u5c02\u9580\u5bb6\u3001\u898f\u5236\u5f53\u5c40\u3001\u60a3\u8005\u304b\u3089\u306e\u6bd4\u985e\u306a\u3044\u4fe1\u983c\u6027\u3092\u7372\u5f97\u3067\u304d\u307e\u3059\u3002.<\/p>\n

          \u4e0d\u78ba\u5b9f\u6027\u3084\u66f8\u985e\u4e0d\u5099\u304c\u6210\u529f\u3092\u9045\u3089\u305b\u308b\u306e\u3092\u8a31\u3057\u3066\u306f\u3044\u3051\u307e\u305b\u3093\u3002.
          \n\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u304b\u3089\u59cb\u3081\u3001\u78ba\u4fe1\u3092\u6301\u3063\u3066\u69cb\u7bc9\u3057\u3001\u4fe1\u983c\u3092\u3082\u3063\u3066\u767a\u58f2\u3057\u307e\u3057\u3087\u3046\u3002.<\/strong><\/p>\n

          \n

          \u3088\u304f\u3042\u308b\u8cea\u554f<\/h2>\n

          1. \u533b\u7642\u7528\u5438\u5165\u5668\u306b\u306f\u3069\u306e\u3088\u3046\u306a\u8a8d\u8a3c\u304c\u5fc5\u8981\u3067\u3059\u304b\uff1f<\/h3>\n

          \u533b\u7642\u30b0\u30ec\u30fc\u30c9\u306e\u5438\u5165\u5668\u306b\u306f\u3001 ISO 13485\u8a8d\u8a3c<\/strong>, FDA 510(k)<\/strong> \uff08\u7c73\u56fd\u5411\u3051\u306b\u306f\uff09\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u3001\u304a\u3088\u3073 CE\u30de\u30fc\u30ad\u30f3\u30b0<\/strong> \uff08\u6b27\u5dde\u5411\u3051\u306b\u306f\uff09CE\u30de\u30fc\u30ad\u30f3\u30b0\u304c\u5fc5\u8981\u3067\u3059\u3002\u8ca9\u58f2\u3092\u8a08\u753b\u3059\u308b\u5730\u57df\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u3002.<\/p>\n

          2. \u533b\u7642\u7528\u5438\u5165\u5668\u3068\u4e00\u822c\u5411\u3051\u5438\u5165\u5668\u306e\u9055\u3044\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h3>\n

          \u533b\u7642\u7528\u5438\u5165\u5668\u306f\u3001 \u751f\u4f53\u9069\u5408\u6027\u6750\u6599\u3092\u4f7f\u7528\u3057\u3001<\/strong>, \u63d0\u4f9b\u3057\u307e\u3059 \u7cbe\u5bc6\u306a\u6e29\u5ea6\u5236\u5fa1\u3092\u3001<\/strong>, \u305d\u3057\u3066\u6e80\u305f\u3057\u307e\u3059 \u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306b\u95a2\u3059\u308b\u898f\u5236\u57fa\u6e96\u3092<\/strong> \u3002.<\/p>\n

          3. \u8a8d\u8a3c\u6e08\u307f\u533b\u7642\u7528\u5438\u5165\u5668\u306e\u4e3b\u306a\u5b89\u5168\u6a5f\u80fd\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h3>\n

          \u6a5f\u80fd\u306b\u306f\u4ee5\u4e0b\u304c\u542b\u307e\u308c\u307e\u3059\uff1a <\/p>\n

            \n
          • \u00b11\u00b0C\u4ee5\u5185\u306e\u6e29\u5ea6\u7cbe\u5ea6 <\/li>\n
          • \u904e\u71b1\u4fdd\u8b77 <\/li>\n
          • \u533b\u7642\u30b0\u30ec\u30fc\u30c9\u6750\u6599 <\/li>\n
          • \u5206\u96e2\u3055\u308c\u305f\u84b8\u6c17\u7d4c\u8def <\/li>\n
          • \u4e00\u8cab\u3057\u305f\u6295\u85ac\u91cf\u306e\u63d0\u4f9b<\/li>\n<\/ul>\n

            4. ISO 13485\u306f\u5438\u5165\u5668\u88fd\u9020\u306b\u304a\u3044\u3066\u4f55\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u304b\uff1f<\/h3>\n

            \u305d\u308c\u306f\u88fd\u9020\u696d\u8005\u304c\u4ee5\u4e0b\u3092\u6709\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u307e\u3059\uff1a <\/p>\n

              \n
            • \u5b8c\u5168\u306a\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0 <\/li>\n
            • \u30ea\u30b9\u30af\u7ba1\u7406 <\/li>\n
            • \u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3 <\/li>\n
            • \u898f\u5236\u9075\u5b88\u624b\u9806<\/li>\n<\/ul>\n

              5. \u8a8d\u8a3c\u6a5f\u5668\u306e\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306b\u306f\u4f55\u304c\u5fc5\u8981\u3067\u3059\u304b\uff1f<\/h3>\n

              \u4ee5\u4e0b\u304c\u5fc5\u8981\u306b\u306a\u308a\u307e\u3059\uff1a <\/p>\n

                \n
              • \u4fdd\u7ba1\u8a18\u9332\u9023\u9396 <\/li>\n
              • \u6e29\u5ea6\u7ba1\u7406\u3055\u308c\u305f\u914d\u9001 <\/li>\n
              • \u6539\u3056\u3093\u9632\u6b62\u5305\u88c5 <\/li>\n
              • ISO\u306b\u6e96\u62e0\u3057\u305f\u5009\u5eab\u4fdd\u7ba1<\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"

                \u533b\u7642\u5c02\u9580\u5bb6\u306f\u3001\u6cbb\u7642\u76ee\u7684\u3067\u30d9\u30a4\u30dd\u30e9\u30a4\u30b6\u30fc\uff08\u5438\u5165\u5668\uff09\u306e\u4f7f\u7528\u3092\u5897\u3084\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u53b3\u683c\u306a\u533b\u7642\u57fa\u6e96\u3092\u6e80\u305f\u3059\u5834\u5408\u306b\u9650\u308a\u307e\u3059\u3002\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u3001\u3053\u306e\u8a8d\u8a3c\u3092\u53d6\u5f97\u3059\u308b\u3053\u3068\u306f\u5bb9\u6613\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u6642\u9593\u3068\u6295\u8cc7\u304c\u5fc5\u8981\u3067\u3042\u308a\u3001\u4e16\u754c\u5404\u56fd\u306e\u8907\u96d1\u306a\u898f\u5236\u3092\u4e57\u308a\u8d8a\u3048\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u533b\u7642\u7528\u307e\u305f\u306f\u81e8\u5e8a\u7528\u306e\u30d9\u30a4\u30dd\u30e9\u30a4\u30b6\u30fc\u958b\u767a\u3092\u8a08\u753b\u3055\u308c\u3066\u3044\u308b\u65b9\u3078\u3001\u672c\u30ac\u30a4\u30c9\u3067\u306f\u300c\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u300d\u306e\u771f\u306e\u610f\u5473\u3001\u4e3b\u8981\u306a\u8a8d\u8a3c\u30b9\u30c6\u30c3\u30d7\u3001\u5e02\u5834\u53c2\u5165\u3092\u9045\u3089\u305b\u308b\u4e00\u822c\u7684\u306a\u5931\u6557\u3092\u56de\u907f\u3059\u308b\u65b9\u6cd5\u3092\u89e3\u8aac\u3057\u307e\u3059\u3002\u5b9f\u8df5\u7684\u3067\u5206\u304b\u308a\u3084\u3059\u3044\u65b9\u6cd5\u3067\u8aac\u660e\u3057\u3066\u3044\u304d\u307e\u3057\u3087\u3046\u3002\u30d9\u30a4\u30dd\u30e9\u30a4\u30b6\u30fc\u304c\u300c\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u300d\u3068\u3055\u308c\u308b\u8981\u4ef6\u3068\u306f\uff1f\u30d9\u30a4\u30dd\u30e9\u30a4\u30b6\u30fc\u304c\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u306b\u5206\u985e\u3055\u308c\u308b\u305f\u3081\u306b\u306f\u3001\u60a3\u8005\u306e\u5b89\u5168\u3092\u4fdd\u8b77\u3057\u6cbb\u7642\u6027\u80fd\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u8a2d\u8a08\u3055\u308c\u305f\u53b3\u683c\u306a\u898f\u5236\u8981\u4ef6\u3092\u6e80\u305f\u3055\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u4ee5\u4e0b\u306b[\u2026]<\/p>","protected":false},"author":2,"featured_media":16965,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[241],"tags":[],"class_list":["post-17359","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-quality-compliance"],"views":162,"_links":{"self":[{"href":"https:\/\/weecke.com\/ja\/wp-json\/wp\/v2\/posts\/17359","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/weecke.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/weecke.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/weecke.com\/ja\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/weecke.com\/ja\/wp-json\/wp\/v2\/comments?post=17359"}],"version-history":[{"count":4,"href":"https:\/\/weecke.com\/ja\/wp-json\/wp\/v2\/posts\/17359\/revisions"}],"predecessor-version":[{"id":17365,"href":"https:\/\/weecke.com\/ja\/wp-json\/wp\/v2\/posts\/17359\/revisions\/17365"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/weecke.com\/ja\/wp-json\/wp\/v2\/media\/16965"}],"wp:attachment":[{"href":"https:\/\/weecke.com\/ja\/wp-json\/wp\/v2\/media?parent=17359"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/weecke.com\/ja\/wp-json\/wp\/v2\/categories?post=17359"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/weecke.com\/ja\/wp-json\/wp\/v2\/tags?post=17359"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}