{"id":59619,"date":"2026-05-17T13:03:08","date_gmt":"2026-05-17T13:03:08","guid":{"rendered":"https:\/\/tpumedical.com\/?p=59619"},"modified":"2026-05-17T13:04:19","modified_gmt":"2026-05-17T13:04:19","slug":"not-all-tpu-is-created-equal-understanding-biocompatibility-and-iso-10993","status":"publish","type":"post","link":"https:\/\/tpumedical.com\/ja\/not-all-tpu-is-created-equal-understanding-biocompatibility-and-iso-10993\/","title":{"rendered":"TPU\u306f\u3059\u3079\u3066\u540c\u3058\u3067\u306f\u3042\u308a\u307e\u305b\u3093\uff1a\u751f\u4f53\u9069\u5408\u6027\u3068ISO 10993\u3092\u7406\u89e3\u3059\u308b"},"content":{"rendered":"<h2 class=\"wp-block-heading\">\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u300dTPU\u306b\u6f5c\u3080\u5371\u967a\u306a\u8aa4\u89e3<\/h2>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668\u696d\u754c\u3067\u306f\u3001\u300c\u533b\u7642\u30b0\u30ec\u30fc\u30c9TPU\u300d\u3068\u3044\u3046\u8a00\u8449\u304c\u3001\u5e83\u7fa9\u306e\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u7528\u8a9e\u3068\u3057\u3066\u983b\u7e41\u306b\u4f7f\u308f\u308c\u3066\u3044\u308b\u3002\u73fe\u5b9f\u306b\u306f\u3001\u6c4e\u7528\u306eTPU\u3068\u771f\u306b\u751f\u4f53\u9069\u5408\u6027\u306e\u3042\u308bTPU\u30b7\u30b9\u30c6\u30e0\u3068\u306e\u9593\u306b\u306f\u5927\u304d\u306a\u9694\u305f\u308a\u304c\u3042\u308a\u307e\u3059\u3002\u8840\u5727\u30ab\u30d5\u30fb\u30d6\u30e9\u30c0\u30fc\u3001\u30ea\u30cf\u30d3\u30ea\u7528\u30a8\u30a2\u30bb\u30eb\u3001\u8925\u7621\u9632\u6b62\u30de\u30c3\u30c8\u30ec\u30b9\u30fb\u30c1\u30e3\u30f3\u30d0\u30fc\u3001\u5727\u8feb\u30b9\u30ea\u30fc\u30d6\u3001\u6b62\u8840\u30ab\u30d5\u306a\u3069\u306e\u81a8\u5f35\u5f0f\u533b\u7642\u88fd\u54c1\u3092\u88fd\u9020\u3059\u308b\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u3001\u3053\u306e\u9055\u3044\u3092\u8aa4\u89e3\u3059\u308b\u3053\u3068\u306f\u3001\u898f\u5236\u306e\u5931\u6557\u3001\u60a3\u8005\u306e\u5b89\u5168\u30ea\u30b9\u30af\u3001\u627f\u8a8d\u306e\u9045\u308c\u3001\u9ad8\u4fa1\u306a\u88fd\u54c1\u30ea\u30b3\u30fc\u30eb\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u71b1\u53ef\u5851\u6027\u30dd\u30ea\u30a6\u30ec\u30bf\u30f3\u306f\u3001\u67d4\u8edf\u6027\u304c\u3042\u308a\u3001\u8010\u4e45\u6027\u306b\u512a\u308c\u3001\u5e83\u304f\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u3068\u3044\u3046\u3060\u3051\u3067\u3001\u81ea\u52d5\u7684\u306b\u533b\u7642\u7528\u9014\u306b\u9069\u3059\u308b\u3068\u3044\u3046\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u533b\u7642\u7528\u9014\u306b\u9069\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u306f\u3001\u3082\u3063\u3068\u6df1\u3044\u8981\u56e0\u306e\u7d44\u307f\u5408\u308f\u305b\u306b\u5de6\u53f3\u3055\u308c\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30dd\u30ea\u30de\u30fc\u7d14\u5ea6<\/li>\n\n\n\n<li>\u6dfb\u52a0\u7269\u306e\u9078\u629e<\/li>\n\n\n\n<li>\u88fd\u9020\u7ba1\u7406<\/li>\n\n\n\n<li>\u30d0\u30c3\u30c1\u4e00\u8cab\u6027<\/li>\n\n\n\n<li>\u62bd\u51fa\u6027\u304a\u3088\u3073\u6d78\u51fa\u6027\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb<\/li>\n\n\n\n<li>\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u6587\u66f8<\/li>\n\n\n\n<li>\u5b9f\u8a3c\u6e08\u307f\u306e\u751f\u7269\u5b66\u7684\u5b89\u5168\u6027\u691c\u8a3c<\/li>\n<\/ul>\n\n\n\n<p>\u6700\u3082\u91cd\u8981\u306a\u3053\u3068\u306f\u3001\u771f\u306e\u533b\u7642\u8cc7\u683c\u306f\u3001\u56fd\u969b\u7684\u306b\u8a8d\u3081\u3089\u308c\u305f\u751f\u7269\u5b66\u7684\u8a55\u4fa1\u57fa\u6e96\u3001\u7279\u306bISO 10993\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u306b\u304b\u304b\u3063\u3066\u3044\u308b\u3068\u3044\u3046\u3053\u3068\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<p>\u9577\u6642\u9593\u306e\u76ae\u819a\u63a5\u89e6\u3084\u7e70\u308a\u8fd4\u3057\u60a3\u8005\u3078\u306e\u66dd\u9732\u3092\u7dad\u6301\u3059\u308b\u533b\u7642\u7528\u81a8\u5f35\u30b7\u30b9\u30c6\u30e0\u306b\u3068\u3063\u3066\u3001\u6750\u6599\u306e\u9078\u629e\u306f\u3082\u306f\u3084\u5358\u306a\u308b\u6a5f\u68b0\u5de5\u5b66\u7684\u306a\u6c7a\u5b9a\u3067\u306f\u306a\u3044\u3002\u305d\u308c\u306f\u898f\u5236\u3084\u6bd2\u7269\u5b66\u7684\u306a\u6c7a\u5b9a\u3067\u3082\u3042\u308b\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u751f\u4f53\u9069\u5408\u6027\u306f\u300c\u7121\u5bb3\u300d\u3060\u3051\u3067\u306f\u306a\u3044<\/h2>\n\n\n\n<p>ISO 10993\u306f\u751f\u4f53\u9069\u5408\u6027\u3092\u6b21\u306e\u3088\u3046\u306b\u5b9a\u7fa9\u3057\u3066\u3044\u308b\uff1a<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>\"\u7279\u5b9a\u306e\u7528\u9014\u306b\u304a\u3044\u3066\u3001\u9069\u5207\u306a\u5bbf\u4e3b\u53cd\u5fdc\u3092\u793a\u3059\u6750\u6599\u306e\u80fd\u529b\"<\/p>\n<\/blockquote>\n\n\n\n<p>\u751f\u4f53\u9069\u5408\u6027\u306f\u786c\u5ea6\u3084\u5f15\u5f35\u5f37\u5ea6\u3001\u5bc6\u5ea6\u306e\u3088\u3046\u306a\u56fa\u6709\u306e\u7279\u6027\u3067\u306f\u306a\u3044\u305f\u3081\u3001\u3053\u306e\u5b9a\u7fa9\u306f\u6c7a\u5b9a\u7684\u306b\u91cd\u8981\u3067\u3059\u3002\u3042\u308b\u88c5\u7f6e\u3067\u306f\u5b89\u5168\u306b\u6a5f\u80fd\u3059\u308bTPU\u914d\u5408\u3067\u3082\u3001\u63a5\u89e6\u6761\u4ef6\u306e\u7570\u306a\u308b\u5225\u306e\u7528\u9014\u3067\u306f\u9069\u3055\u306a\u3044\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u3042\u308b\u7d20\u6750\u304c\u751f\u4f53\u9069\u5408\u6027\u304c\u3042\u308b\u3068\u307f\u306a\u3055\u308c\u308b\u306e\u306f\u3001\u305d\u306e\u7d20\u6750\u304c\u610f\u56f3\u3059\u308b\u533b\u7642\u7528\u9014\u306e\u7bc4\u56f2\u5185\u306b\u304a\u3044\u3066\u306e\u307f\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"886\" height=\"1024\" src=\"https:\/\/tpumedical.com\/wp-content\/uploads\/2024\/04\/service-image16-copyright-886x1024.jpg\" alt=\"TPU\u306f\u3059\u3079\u3066\u540c\u3058\u3067\u306f\u3042\u308a\u307e\u305b\u3093\uff1a\u751f\u4f53\u9069\u5408\u6027\u3068ISO 10993\u3092\u7406\u89e3\u3059\u308b \" class=\"wp-image-57828\" srcset=\"https:\/\/tpumedical.com\/wp-content\/uploads\/2024\/04\/service-image16-copyright-886x1024.jpg 886w, https:\/\/tpumedical.com\/wp-content\/uploads\/2024\/04\/service-image16-copyright-630x728.jpg 630w, https:\/\/tpumedical.com\/wp-content\/uploads\/2024\/04\/service-image16-copyright-600x693.jpg 600w, https:\/\/tpumedical.com\/wp-content\/uploads\/2024\/04\/service-image16-copyright-260x300.jpg 260w, https:\/\/tpumedical.com\/wp-content\/uploads\/2024\/04\/service-image16-copyright-768x888.jpg 768w, https:\/\/tpumedical.com\/wp-content\/uploads\/2024\/04\/service-image16-copyright-1329x1536.jpg 1329w, https:\/\/tpumedical.com\/wp-content\/uploads\/2024\/04\/service-image16-copyright-1772x2048.jpg 1772w, https:\/\/tpumedical.com\/wp-content\/uploads\/2024\/04\/service-image16-copyright-370x428.jpg 370w, https:\/\/tpumedical.com\/wp-content\/uploads\/2024\/04\/service-image16-copyright-840x971.jpg 840w, https:\/\/tpumedical.com\/wp-content\/uploads\/2024\/04\/service-image16-copyright-410x474.jpg 410w, https:\/\/tpumedical.com\/wp-content\/uploads\/2024\/04\/service-image16-copyright.jpg 1920w\" sizes=\"(max-width: 886px) 100vw, 886px\" \/><figcaption class=\"wp-element-caption\">TPU\u306f\u3059\u3079\u3066\u540c\u3058\u3067\u306f\u3042\u308a\u307e\u305b\u3093\uff1a\u751f\u4f53\u9069\u5408\u6027\u3068ISO 10993\u3092\u7406\u89e3\u3059\u308b <\/figcaption><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">\u751f\u4f53\u9069\u5408\u6027\u8a55\u4fa1\u306e3\u3064\u306e\u30b3\u30a2\u5909\u6570<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1.\u30dc\u30c7\u30a3\u30b3\u30f3\u30bf\u30af\u30c8\u306e\u6027\u8cea<\/h3>\n\n\n\n<p>\u898f\u5236\u5f53\u5c40\u306e\u8a55\u4fa1\u306f\u3001\u6a5f\u5668\u304c\u8eab\u4f53\u3068\u3069\u306e\u3088\u3046\u306b\u76f8\u4e92\u4f5c\u7528\u3059\u308b\u304b\u306b\u3088\u3063\u3066\u5927\u304d\u304f\u5de6\u53f3\u3055\u308c\u308b\u3002<\/p>\n\n\n\n<p>\u4ee3\u8868\u7684\u306a\u5206\u985e\u306b\u306f\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u3082\u306e\u304c\u3042\u308b\uff1a<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u30b3\u30f3\u30bf\u30af\u30c8\u30bf\u30a4\u30d7<\/th><th>\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u4f8b<\/th><th>\u30ea\u30b9\u30af\u30ec\u30d9\u30eb<\/th><\/tr><\/thead><tbody><tr><td>\u9593\u63a5\u7684\u306a\u63a5\u89e6<\/td><td>\u5916\u90e8\u6a5f\u5668\u30cf\u30a6\u30b8\u30f3\u30b0<\/td><td>\u3088\u308a\u4f4e\u3044<\/td><\/tr><tr><td>\u8868\u9762\u63a5\u89e6<\/td><td>\u8840\u5727\u8a08\u3001\u81a8\u5f35\u5f0f\u30ea\u30cf\u30d3\u30ea\u7528\u30e9\u30c3\u30d7<\/td><td>\u4e2d\u7a0b\u5ea6<\/td><\/tr><tr><td>\u7c98\u819c\u63a5\u89e6<\/td><td>\u547c\u5438\u5668\u7528\u307e\u305f\u306f\u6ccc\u5c3f\u5668\u7528\u6a5f\u5668<\/td><td>\u3088\u308a\u9ad8\u3044<\/td><\/tr><tr><td>\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u30b3\u30f3\u30bf\u30af\u30c8<\/td><td>\u690d\u8fbc\u307f\u578b\u30d0\u30eb\u30fc\u30f3\u307e\u305f\u306f\u30ea\u30b6\u30fc\u30d0\u30fc<\/td><td>\u6700\u9ad8<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>\u307b\u3068\u3093\u3069\u306eTPU\u81a8\u5f35\u5f0f\u533b\u7642\u7528\u30d5\u30a1\u30d6\u30ea\u30c3\u30af\u306f\u3001\u8868\u9762\u306b\u63a5\u89e6\u3059\u308b\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u5206\u985e\u3055\u308c\u3001\u307e\u3060\u5b9f\u8cea\u7684\u306a\u751f\u7269\u5b66\u7684\u8a55\u4fa1\u304c\u5fc5\u8981\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2.\u63a5\u89e6\u671f\u9593<\/h3>\n\n\n\n<p>ISO 10993\u3067\u306f\u3001\u9732\u5149\u6642\u9593\u3092\u5927\u304d\u304f3\u3064\u306e\u30b0\u30eb\u30fc\u30d7\u306b\u5206\u985e\u3057\u3066\u3044\u308b\uff1a<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u9023\u7d61\u671f\u9593<\/th><th>\u6642\u9593\u7bc4\u56f2<\/th><th>\u4ee3\u8868\u7684\u306a\u4f8b<\/th><\/tr><\/thead><tbody><tr><td>\u9650\u5b9a<\/td><td>24\u6642\u9593\u4ee5\u5185<\/td><td>\u7dca\u6025\u7528\u624b\u9320<\/td><\/tr><tr><td>\u9577\u671f\u5316<\/td><td>24\u6642\u9593\uff5e30\u65e5<\/td><td>\u5727\u8feb\u7642\u6cd5\u30b7\u30b9\u30c6\u30e0<\/td><\/tr><tr><td>\u9577\u671f \/ \u6b63\u793e\u54e1<\/td><td>30\u65e5\u4ee5\u4e0a<\/td><td>\u6162\u6027\u671f\u533b\u7642\u652f\u63f4\u30b7\u30b9\u30c6\u30e0<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>\u60a3\u8005\u306e\u88ab\u66dd\u671f\u9593\u304c\u9577\u3051\u308c\u3070\u9577\u3044\u307b\u3069\u3001\u751f\u7269\u5b66\u7684\u691c\u67fb\u306e\u8981\u4ef6\u306f\u3088\u308a\u5e83\u7bc4\u306b\u306a\u308b\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3.\u610f\u56f3\u3059\u308b\u30c7\u30d0\u30a4\u30b9\u306e\u6a5f\u80fd<\/h3>\n\n\n\n<p>\u6a5f\u5668\u306e\u6a5f\u80fd\u306f\u3001\u898f\u5236\u5f53\u5c40\u306e\u671f\u5f85\u306b\u76f4\u63a5\u5f71\u97ff\u3059\u308b\u3002<\/p>\n\n\n\n<p>\u4f8b\u3048\u3070\u3001\u81a8\u5f35\u5f0f\u6b62\u8840\u30ab\u30d5\u306f\u3001\u4e00\u6642\u7684\u306a\u5727\u8feb\u3068\u9650\u5b9a\u3055\u308c\u305f\u66dd\u9732\u3092\u751f\u3058\u3055\u305b\u308b\u3002\u5727\u8feb\u75db\u9632\u6b62\u30de\u30c3\u30c8\u30ec\u30b9\u30c1\u30e3\u30f3\u30d0\u30fc\u306f\u3001\u6570\u9031\u9593\u304b\u3089\u6570\u30f6\u6708\u9593\u3001\u60a3\u8005\u3068\u306e\u63a5\u89e6\u3092\u7e70\u308a\u8fd4\u3059\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u4e21\u8005\u304cTPU\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u3055\u308c\u305f\u81a8\u5f35\u6027\u751f\u5730\u3092\u4f7f\u7528\u3057\u3066\u3044\u308b\u5834\u5408\u3067\u3082\u3001\u751f\u7269\u5b66\u7684\u8a55\u4fa1\u8981\u4ef6\u306f\u307e\u3063\u305f\u304f\u7570\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u751f\u4f53\u9069\u5408\u6027\u304c\u5e38\u306b\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u3067\u3042\u308a\u3001\u7528\u9014\u306b\u7279\u5316\u3057\u3066\u3044\u308b\u306e\u306f\u3053\u306e\u305f\u3081\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u81a8\u5f35\u5f0f\u533b\u7642\u6a5f\u5668\u306b\u7279\u5225\u306a\u6ce8\u610f\u304c\u5fc5\u8981\u306a\u7406\u7531<\/h2>\n\n\n\n<p>\u81a8\u5f35\u5f0f\u533b\u7642\u7528\u90e8\u54c1\u306f\u3001\u305d\u306e\u7d44\u307f\u5408\u308f\u305b\u304b\u3089\u3001\u6750\u6599\u306b\u95a2\u3059\u308b\u72ec\u7279\u306e\u8ab2\u984c\u304c\u3042\u308b\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u76ae\u819a\u3078\u306e\u53cd\u5fa9\u66b4\u9732<\/li>\n\n\n\n<li>\u6a5f\u68b0\u7684\u30b9\u30c8\u30ec\u30b9\u3068\u5c48\u66f2\u75b2\u52b4<\/li>\n\n\n\n<li>\u71b1\u3068\u6e7f\u6c17\u3078\u306e\u66b4\u9732<\/li>\n\n\n\n<li>\u9023\u7d9a\u5727\u529b\u30b5\u30a4\u30af\u30eb<\/li>\n\n\n\n<li>\u9577\u671f\u719f\u6210\u306e\u8981\u4ef6<\/li>\n\n\n\n<li>\u6f5c\u5728\u7684\u306a\u5316\u5b66\u7269\u8cea\u79fb\u884c\u30ea\u30b9\u30af<\/li>\n<\/ul>\n\n\n\n<p>\u786c\u8cea\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u90e8\u54c1\u3068\u306f\u7570\u306a\u308a\u3001\u67d4\u8edf\u306aTPU\u30b7\u30b9\u30c6\u30e0\u306b\u306f\u3001\u30bd\u30d5\u30c8\u30bb\u30b0\u30e1\u30f3\u30c8\u3001\u52a0\u5de5\u52a9\u5264\u3001\u89e6\u5a92\u3001\u5b89\u5b9a\u5264\u3001\u9854\u6599\u3001\u63a5\u7740\u5264\u306a\u3069\u304c\u542b\u307e\u308c\u3066\u3044\u308b\u5834\u5408\u304c\u3042\u308a\u3001\u3053\u308c\u3089\u306f\u5b9f\u969b\u306e\u4f7f\u7528\u6761\u4ef6\u4e0b\u3067\u79fb\u884c\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u3053\u306e\u305f\u3081\u898f\u5236\u5f53\u5c40\u306f\u3001\u57fa\u672c\u7684\u306a\u6bd2\u6027\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u3060\u3051\u306b\u983c\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u62bd\u51fa\u7269\u3084\u6eb6\u51fa\u7269\u306e\u5206\u6790\u306b\u307e\u3059\u307e\u3059\u91cd\u70b9\u3092\u7f6e\u304f\u3088\u3046\u306b\u306a\u3063\u3066\u3044\u308b\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">ISO 10993\uff1a\u5358\u4e00\u306e\u8a66\u9a13\u3067\u306f\u306a\u304f\u3001\u751f\u7269\u5b66\u7684\u5b89\u5168\u6027\u306e\u67a0\u7d44\u307f<\/h2>\n\n\n\n<p>\u696d\u754c\u3067\u3088\u304f\u3042\u308b\u8aa4\u89e3\u306f\u3001ISO 10993\u3092\u4e00\u3064\u306e\u8a8d\u8a3c\u3068\u3057\u3066\u6271\u3046\u3053\u3068\u3067\u3042\u308b\u3002\u5b9f\u969b\u306b\u306f\u3001ISO 10993\u306f\u7570\u306a\u308b\u751f\u7269\u5b66\u7684\u8a55\u4fa1\u7d4c\u8def\u3092\u30ab\u30d0\u30fc\u3059\u308b\u898f\u683c\u7fa4\u5168\u4f53\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<p>\u3053\u306e\u898f\u683c\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306e\u4f53\u7cfb\u7684\u306a\u67a0\u7d44\u307f\u3068\u3057\u3066\u6a5f\u80fd\u3059\u308b\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">ISO 10993-1\uff1a\u898f\u5236\u30ed\u30fc\u30c9\u30de\u30c3\u30d7<\/h3>\n\n\n\n<p>ISO 10993-1\u3067\u306f\u3001\u3069\u306e\u751f\u7269\u5b66\u7684\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u306b\u57fa\u3065\u3044\u3066\u8a55\u4fa1\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u304b\u3092\u5b9a\u3081\u3066\u3044\u308b\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30b3\u30f3\u30bf\u30af\u30c8\u30bf\u30a4\u30d7<\/li>\n\n\n\n<li>\u66dd\u9732\u671f\u9593<\/li>\n\n\n\n<li>\u30c7\u30d0\u30a4\u30b9\u30ab\u30c6\u30b4\u30ea\u30fc<\/li>\n\n\n\n<li>\u7d20\u6750\u7279\u6027<\/li>\n\n\n\n<li>\u81e8\u5e8a\u4f7f\u7528\u30b7\u30ca\u30ea\u30aa<\/li>\n<\/ul>\n\n\n\n<p>\u9577\u671f\u7684\u306b\u8868\u9762\u306b\u63a5\u89e6\u3059\u308b\u81a8\u5f35\u5f0fTPU\u30d5\u30a1\u30d6\u30ea\u30c3\u30af\u306e\u5834\u5408\u3001\u5178\u578b\u7684\u306a\u751f\u7269\u5b66\u7684\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u306b\u306f\u6b21\u306e\u3088\u3046\u306a\u3082\u306e\u304c\u542b\u307e\u308c\u308b\u3053\u3068\u304c\u591a\u3044\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u7d30\u80de\u6bd2\u6027<\/li>\n\n\n\n<li>\u76ae\u819a\u523a\u6fc0<\/li>\n\n\n\n<li>\u76ae\u819a\u611f\u4f5c\u6027<\/li>\n\n\n\n<li>\u6025\u6027\u5168\u8eab\u6bd2\u6027<\/li>\n\n\n\n<li>\u5316\u5b66\u7684\u7279\u6027<\/li>\n\n\n\n<li>\u62bd\u51fa\u7269\u304a\u3088\u3073\u6d78\u51fa\u7269\u306e\u8a55\u4fa1<\/li>\n<\/ul>\n\n\n\n<p>\u3053\u306e\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u69cb\u9020\u306f\u3001FDA\u30ac\u30a4\u30c0\u30f3\u30b9\u3001EU MDR\u3001\u305d\u306e\u4ed6\u306e\u56fd\u969b\u7684\u67a0\u7d44\u307f\u306e\u3082\u3068\u3067\u3001\u73fe\u4ee3\u306e\u533b\u7642\u6a5f\u5668\u898f\u5236\u306e\u4e2d\u5fc3\u3068\u306a\u3063\u3066\u3044\u308b\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u6838\u3068\u306a\u308bISO 10993\u8a66\u9a13\u3068\u305d\u306e\u5b9f\u969b\u306e\u610f\u5473\u7d30\u80de\u6bd2\u6027\u8a66\u9a13 - ISO 10993-5<\/h3>\n\n\n\n<p>\u3053\u308c\u306f\u901a\u5e38\u3001\u751f\u7269\u5b66\u7684\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u306e\u6700\u521d\u306e\u30b9\u30c6\u30c3\u30d7\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<p>\u3053\u306e\u8a66\u9a13\u306f\u3001\u7269\u8cea\u62bd\u51fa\u7269\u304c\u751f\u304d\u305f\u7d30\u80de\u306b\u30c0\u30e1\u30fc\u30b8\u3092\u4e0e\u3048\u308b\u304b\u3069\u3046\u304b\u3092\u8a55\u4fa1\u3059\u308b\u3082\u306e\u3067\u3001\u4e00\u822c\u7684\u306b\u306fL929\u30de\u30a6\u30b9\u7dda\u7dad\u82bd\u7d30\u80de\u3092\u4f7f\u7528\u3059\u308b\u3002<\/p>\n\n\n\n<p>\u5408\u683c\u306f\u3001\u305d\u306e\u7269\u8cea\u304c\u62bd\u51fa\u6761\u4ef6\u4e0b\u3067\u6025\u6027\u7d30\u80de\u6bd2\u6027\u3092\u793a\u3055\u306a\u3044\u3053\u3068\u3092\u793a\u3059\u3002<\/p>\n\n\n\n<p>TPU\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u3092\u65bd\u3057\u305f\u533b\u7642\u7528\u30a4\u30f3\u30d5\u30ec\u30fc\u30bf\u30d6\u30eb\u751f\u5730\u3067\u306f\u3001\u7d30\u80de\u6bd2\u6027\u8a66\u9a13\u306b\u3088\u308a\u3001\u95a2\u9023\u3059\u308b\u554f\u984c\u3092\u7279\u5b9a\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6b8b\u7559\u30e2\u30ce\u30de\u30fc<\/li>\n\n\n\n<li>\u89e6\u5a92\u6b8b\u6e23<\/li>\n\n\n\n<li>\u6eb6\u5264\u6b8b\u6e23<\/li>\n\n\n\n<li>\u5206\u89e3\u526f\u7523\u7269<\/li>\n\n\n\n<li>\u4e0d\u5b89\u5b9a\u306a\u6dfb\u52a0\u7269<\/li>\n<\/ul>\n\n\n\n<p>\u533b\u7642\u7528\u3068\u3057\u3066\u8ca9\u58f2\u3055\u308c\u308bTPU\u7d20\u6750\u306f\u3001\u8a8d\u5b9a\u3092\u53d7\u3051\u305f\u7b2c\u4e09\u8005\u8a66\u9a13\u6240\u306b\u3088\u308b\u691c\u8a3c\u6e08\u307f\u306e\u7d30\u80de\u6bd2\u6027\u30c7\u30fc\u30bf\u3092\u63d0\u4f9b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002\u76ae\u819a\u523a\u6fc0\u6027\u3068\u611f\u4f5c\u6027 - ISO 10993-10<\/p>\n\n\n\n<p>\u3053\u308c\u3089\u306e\u691c\u67fb\u306f\u3001\u53cd\u5fa9\u66b4\u9732\u304c\u5f15\u304d\u91d1\u306b\u306a\u308b\u304b\u3069\u3046\u304b\u3092\u8a55\u4fa1\u3059\u308b\u3082\u306e\u3067\u3042\u308b\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5c40\u6240\u708e\u75c7\u53cd\u5fdc<\/li>\n\n\n\n<li>\u8d64\u307f\u3084\u708e\u75c7<\/li>\n\n\n\n<li>\u30a2\u30ec\u30eb\u30ae\u30fc\u6027\u63a5\u89e6\u76ae\u819a\u708e<\/li>\n\n\n\n<li>\u9045\u5ef6\u578b\u904e\u654f\u53cd\u5fdc<\/li>\n<\/ul>\n\n\n\n<p>\u3053\u308c\u306f\u7279\u306b\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u6a5f\u5668\u306b\u3068\u3063\u3066\u91cd\u8981\u3067\u3042\u308b\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30b3\u30f3\u30d7\u30ec\u30c3\u30b7\u30e7\u30f3\u30fb\u30b9\u30ea\u30fc\u30d6<\/li>\n\n\n\n<li>\u30a4\u30f3\u30d5\u30ec\u30fc\u30bf\u30d6\u30eb\u30fb\u30ea\u30cf\u30d3\u30ea\u30fb\u30d6\u30fc\u30c4<\/li>\n\n\n\n<li>\u30de\u30c3\u30c8\u30ec\u30b9\u30b7\u30b9\u30c6\u30e0<\/li>\n\n\n\n<li>\u7e70\u308a\u8fd4\u3057\u4f7f\u7528\u3059\u308b\u5727\u529b\u30ab\u30d5<\/li>\n<\/ul>\n\n\n\n<p>\u3053\u308c\u3089\u306e\u88fd\u54c1\u306f\u9577\u6642\u9593\u76ae\u819a\u3068\u63a5\u89e6\u3057\u3066\u3044\u308b\u305f\u3081\u3001\u305f\u3068\u3048\u4f4e\u30ec\u30d9\u30eb\u306e\u5316\u5b66\u7269\u8cea\u306e\u79fb\u884c\u3067\u3042\u3063\u3066\u3082\u3001\u6642\u9593\u306e\u7d4c\u904e\u3068\u3068\u3082\u306b\u81e8\u5e8a\u7684\u306a\u610f\u5473\u3092\u6301\u3064\u3088\u3046\u306b\u306a\u308b\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u5316\u5b66\u7684\u7279\u6027\u8a55\u4fa1\u3068\u6eb6\u51fa\u7269 - ISO 10993-18 \u304a\u3088\u3073 10993-19<\/h3>\n\n\n\n<p>\u73fe\u4ee3\u306e\u533b\u7642\u898f\u5236\u3067\u306f\u3001\u751f\u7269\u5b66\u7684\u30ea\u30b9\u30af\u8a55\u4fa1\u306e\u57fa\u790e\u3068\u3057\u3066\u5316\u5b66\u7684\u7279\u6027\u8a55\u4fa1\u304c\u307e\u3059\u307e\u3059\u91cd\u8996\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u3063\u3066\u3044\u308b\u3002<\/p>\n\n\n\n<p>\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u3067\u306f\u3001\u5b9f\u969b\u306e\u4f7f\u7528\u6761\u4ef6\u4e0b\u3067TPU\u30b7\u30b9\u30c6\u30e0\u304b\u3089\u79fb\u884c\u3059\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u7269\u8cea\u3092\u7279\u5b9a\u3057\u3001\u5b9a\u91cf\u5316\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u6f5c\u5728\u7684\u306a\u62bd\u51fa\u7269\u306b\u306f\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u3082\u306e\u304c\u3042\u308b\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6b8b\u7559\u30b8\u30a4\u30bd\u30b7\u30a2\u30cd\u30fc\u30c8<\/li>\n\n\n\n<li>\u30dd\u30ea\u30aa\u30fc\u30eb\u65ad\u7247<\/li>\n\n\n\n<li>\u89e6\u5a92<\/li>\n\n\n\n<li>\u6297\u9178\u5316\u7269\u8cea<\/li>\n\n\n\n<li>\u7740\u8272\u6599<\/li>\n\n\n\n<li>\u52a0\u5de5\u7528\u6f64\u6ed1\u6cb9<\/li>\n\n\n\n<li>\u30dc\u30f3\u30c7\u30a3\u30f3\u30b0\u5264\u306e\u6b8b\u7559\u7269<\/li>\n\n\n\n<li>\u71b1\u52a3\u5316\u751f\u6210\u7269<\/li>\n<\/ul>\n\n\n\n<p>\u30c6\u30b9\u30c8\u6761\u4ef6\u306f\u30b7\u30df\u30e5\u30ec\u30fc\u30c8\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u9ad8\u6e29<\/li>\n\n\n\n<li>\u9577\u6642\u9593\u306e\u63a5\u89e6<\/li>\n\n\n\n<li>\u6e7f\u6c17\u3078\u306e\u66b4\u9732<\/li>\n\n\n\n<li>\u6a5f\u68b0\u7684\u30b9\u30c8\u30ec\u30b9<\/li>\n\n\n\n<li>\u5316\u5b66\u7684\u76f8\u4e92\u4f5c\u7528\u74b0\u5883<\/li>\n<\/ul>\n\n\n\n<p>\u540c\u5b9a\u5f8c\u3001\u6bd2\u6027\u5b66\u7684\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306b\u3088\u308a\u3001\u691c\u51fa\u3055\u308c\u305f\u7269\u8cea\u304c\u8a31\u5bb9\u66b4\u9732\u95be\u5024\u3092\u8d85\u3048\u308b\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u3002<\/p>\n\n\n\n<p>EU MDR\u3067\u306f\u3001\u5305\u62ec\u7684\u306a\u6eb6\u51fa\u7269\u306e\u7279\u6027\u8a55\u4fa1\u304c\u898f\u5236\u5f53\u5c40\u3078\u306e\u7533\u8acb\u306b\u304a\u3044\u3066\u307e\u3059\u307e\u3059\u91cd\u8981\u306b\u306a\u3063\u3066\u304d\u3066\u3044\u308b\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u5de5\u696d\u7528TPU\u3068\u533b\u7642\u7528TPU\uff1a\u672c\u5f53\u306e\u9055\u3044<\/h2>\n\n\n\n<p>\u5de5\u696d\u7528TPU\u3068\u533b\u7642\u7528TPU\u306e\u9055\u3044\u306f\u3001\u5358\u306a\u308b\u30d6\u30e9\u30f3\u30c9\u540d\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u5316\u5b66\u3001\u5de5\u7a0b\u898f\u5f8b\u3001\u6587\u66f8\u5316\u3001\u898f\u5236\u5bfe\u5fdc\u306b\u6839\u3056\u3057\u3066\u3044\u308b\u3002<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u30a2\u30b9\u30da\u30af\u30c8<\/th><th>\u5de5\u696d\u7528\/\u4e00\u822cTPU<\/th><th>\u30e1\u30c7\u30a3\u30ab\u30eb\u30b0\u30ec\u30fc\u30c9TPU<\/th><\/tr><\/thead><tbody><tr><td>\u539f\u6750\u6599<\/td><td>\u30b3\u30b9\u30c8\u91cd\u8996\u3001\u5de5\u696d\u7528\u539f\u6599\u3092\u542b\u3080\u5834\u5408\u3082\u3042\u308b<\/td><td>\u9ad8\u7d14\u5ea6\u306b\u7ba1\u7406\u3055\u308c\u305f\u539f\u6599<\/td><\/tr><tr><td>\u6dfb\u52a0\u7269<\/td><td>\u672a\u8a55\u4fa1\u306e\u5b89\u5b9a\u5264\u3084\u53ef\u5851\u5264\u304c\u542b\u307e\u308c\u3066\u3044\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002<\/td><td>\u751f\u7269\u5b66\u7684\u306b\u8a55\u4fa1\u3055\u308c\u305f\u6dfb\u52a0\u5264\u30b7\u30b9\u30c6\u30e0<\/td><\/tr><tr><td>\u751f\u7523\u74b0\u5883<\/td><td>\u4e00\u822c\u88fd\u9020\u30e9\u30a4\u30f3<\/td><td>\u7ba1\u7406\u3055\u308c\u305f\u88fd\u9020\u30b7\u30b9\u30c6\u30e0<\/td><\/tr><tr><td>\u30d0\u30c3\u30c1\u4e00\u8cab\u6027<\/td><td>\u53ef\u5909<\/td><td>\u9ad8\u5ea6\u306b\u7ba1\u7406\u3055\u308c\u3001\u8ffd\u8de1\u53ef\u80fd<\/td><\/tr><tr><td>\u898f\u5236\u95a2\u9023\u6587\u66f8<\/td><td>\u6700\u5c0f\u9650<\/td><td>\u30c6\u30af\u30cb\u30ab\u30eb\u30fb\u30b5\u30dd\u30fc\u30c8<\/td><\/tr><tr><td>\u751f\u7269\u5b66\u7684\u8a66\u9a13<\/td><td>\u3057\u3070\u3057\u3070\u5229\u7528\u3067\u304d\u306a\u3044<\/td><td>ISO 10993\u30c6\u30b9\u30c8\u63d0\u4f9b<\/td><\/tr><tr><td>\u6eb6\u51fa\u7269\u306e\u7279\u6027\u8a55\u4fa1<\/td><td>\u5e0c\u5c11<\/td><td>\u307e\u3059\u307e\u3059\u30b9\u30bf\u30f3\u30c0\u30fc\u30c9\u306b<\/td><\/tr><tr><td>\u898f\u5236\u652f\u63f4<\/td><td>\u9650\u5b9a<\/td><td>FDA\u304a\u3088\u3073MDR\u306e\u7533\u8acb\u3092\u30b5\u30dd\u30fc\u30c8<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">ISO13485\u304cTPU\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306b\u3068\u3063\u3066\u91cd\u8981\u306a\u7406\u7531<\/h2>\n\n\n\n<p>\u7d20\u6750\u306e\u5b89\u5168\u6027\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306f\u3001\u305d\u306e\u80cc\u5f8c\u306b\u3042\u308b\u88fd\u9020\u30b7\u30b9\u30c6\u30e0\u306e\u4fe1\u983c\u6027\u306b\u3088\u3063\u3066\u306e\u307f\u6c7a\u307e\u308b\u3002<\/p>\n\n\n\n<p>\u3053\u308c\u304c\u3001\u771f\u9762\u76ee\u306a\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304cISO13485\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306e\u4e0b\u3067\u64cd\u696d\u3059\u308b\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u512a\u5148\u3059\u308b\u7406\u7531\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<p>ISO13485\u306e\u8a8d\u8a3c\u306f\u3001\u305d\u306e\u4fdd\u8a3c\u306b\u5f79\u7acb\u3061\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30d7\u30ed\u30bb\u30b9\u306e\u4e00\u8cab\u6027<\/li>\n\n\n\n<li>\u5909\u66f4\u7ba1\u7406<\/li>\n\n\n\n<li>\u6750\u6599\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3<\/li>\n\n\n\n<li>\u6587\u66f8\u7ba1\u7406<\/li>\n\n\n\n<li>\u6c5a\u67d3\u30ea\u30b9\u30af\u306e\u4f4e\u6e1b<\/li>\n\n\n\n<li>\u30d0\u30c3\u30c1\u518d\u73fe\u6027<\/li>\n<\/ul>\n\n\n\n<p>\u81a8\u5f35\u5f0f\u533b\u7642\u7528\u30d5\u30a1\u30d6\u30ea\u30c3\u30af\u3067\u306f\u3001\u308f\u305a\u304b\u306a\u914d\u5408\u306e\u5909\u66f4\u3067\u3082\u751f\u7269\u5b66\u7684\u6027\u80fd\u304c\u5909\u5316\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u305f\u3081\u3001\u88fd\u9020\u306e\u4e00\u8cab\u6027\u304c\u7279\u306b\u91cd\u8981\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u62bd\u51fa\u7269\u3068\u6d78\u51fa\u7269\uff08E&amp;L\uff09\u306e\u91cd\u8981\u6027\u306e\u9ad8\u307e\u308a<\/h2>\n\n\n\n<p>\u6b74\u53f2\u7684\u306b\u3001\u591a\u304f\u306e\u30e1\u30fc\u30ab\u30fc\u306f\u4e3b\u306b\u751f\u7269\u5b66\u7684\u8a66\u9a13\u306e\u5408\u5426\u306b\u983c\u3063\u3066\u3044\u305f\u3002\u898f\u5236\u5f53\u5c40\u306e\u671f\u5f85\u306f\u5927\u304d\u304f\u9032\u5316\u3057\u3066\u3044\u308b\u3002<\/p>\n\n\n\n<p>\u4eca\u65e5\u3001\u5f53\u5c40\u306f\u307e\u3059\u307e\u3059\u30e1\u30fc\u30ab\u30fc\u306b\u7406\u89e3\u3092\u6c42\u3081\u3066\u3044\u308b\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u3069\u306e\u3088\u3046\u306a\u5316\u5b66\u7269\u8cea\u304c\u5b58\u5728\u3059\u308b\u304b<\/li>\n\n\n\n<li>\u79fb\u884c\u53ef\u80fd\u306a\u7269\u8cea<\/li>\n\n\n\n<li>\u3069\u306e\u3088\u3046\u306a\u6761\u4ef6\u3067\u79fb\u52d5\u304c\u8d77\u3053\u308b\u304b<\/li>\n\n\n\n<li>\u5404\u7269\u8cea\u304c\u3069\u306e\u3088\u3046\u306a\u6bd2\u6027\u5b66\u7684\u30ea\u30b9\u30af\u3092\u3082\u305f\u3089\u3059\u304b<\/li>\n<\/ul>\n\n\n\n<p>\u3053\u306e\u5909\u5316\u306f\u3001EU\u306eMDR\u306e\u67a0\u7d44\u307f\u306e\u3082\u3068\u3067\u7279\u306b\u9855\u8457\u306b\u8868\u308c\u3066\u3044\u308b\u3002<\/p>\n\n\n\n<p>TPU\u306e\u30a4\u30f3\u30d5\u30ec\u30fc\u30bf\u30d6\u30eb\u30fb\u30b7\u30b9\u30c6\u30e0\u3067\u306f\u3001\u67d4\u8edf\u306a\u30dd\u30ea\u30de\u30fc\u306f\u672c\u6765\u3001\u786c\u3044\u6750\u6599\u3088\u308a\u3082\u79fb\u52d5\u6027\u306e\u5316\u5b66\u7a2e\u3092\u591a\u304f\u542b\u3080\u305f\u3081\u3001E&amp;L\u7814\u7a76\u304c\u4e0d\u53ef\u6b20\u306b\u306a\u3063\u3066\u3044\u308b\u3002<\/p>\n\n\n\n<p>\u5305\u62ec\u7684\u306aE&amp;L\u30ec\u30dd\u30fc\u30c8\u306f\u3001\u6210\u719f\u3057\u305f\u533b\u7642\u6750\u6599\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u306e\u5f37\u529b\u306a\u6307\u6a19\u306e\u3072\u3068\u3064\u3068\u306a\u308b\u3053\u3068\u304c\u591a\u3044\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">TPU\u533b\u7642\u6750\u6599\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u8a55\u4fa1\u3059\u308b\u969b\u306e\u4e00\u822c\u7684\u306a\u30ec\u30c3\u30c9\u30d5\u30e9\u30c3\u30b0<\/h2>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u91cd\u8981\u306a\u96fb\u5b50\u90e8\u54c1\u3084\u533b\u85ac\u54c1\u90e8\u54c1\u306b\u9069\u7528\u3055\u308c\u308b\u306e\u3068\u540c\u3058\u53b3\u5bc6\u3055\u3067TPU\u8abf\u9054\u306b\u53d6\u308a\u7d44\u3080\u3079\u304d\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u8b66\u544a\u306e\u30b5\u30a4\u30f3<\/h3>\n\n\n\n<h4 class=\"wp-block-heading\">\u88cf\u4ed8\u3051\u306e\u306a\u3044\u4e00\u822c\u7684\u306a\u300c\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u300d\u306e\u4e3b\u5f35<\/h4>\n\n\n\n<p>\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f\u3001\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u30fb\u30b9\u30c6\u30fc\u30c8\u30e1\u30f3\u30c8\u3060\u3051\u3067\u306a\u304f\u3001\u5b9f\u969b\u306e\u30c6\u30b9\u30c8\u30fb\u30ec\u30dd\u30fc\u30c8\u3092\u63d0\u4f9b\u3059\u3079\u304d\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">ISO 10993-18 \u5316\u5b66\u7684\u7279\u6027\u306e\u6b20\u843d<\/h4>\n\n\n\n<p>\u62bd\u51fa\u7269\u3068\u6eb6\u51fa\u7269\u306e\u8a55\u4fa1\u306b\u95a2\u3059\u308b\u3042\u3044\u307e\u3044\u306a\u56de\u7b54\u306f\u3001\u73fe\u4ee3\u306e\u898f\u5236\u5f53\u5c40\u306e\u671f\u5f85\u306e\u4e0b\u3067\u306e\u5927\u304d\u306a\u61f8\u5ff5\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">ISO13485\u8a8d\u8a3c\u306e\u6b20\u5982<\/h4>\n\n\n\n<p>\u7ba1\u7406\u3055\u308c\u305f\u533b\u7642\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u304c\u306a\u3051\u308c\u3070\u3001\u4e00\u8cab\u6027\u306e\u30ea\u30b9\u30af\u306f\u5927\u5e45\u306b\u5897\u5927\u3059\u308b\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">\u5909\u66f4\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9\u306a\u3057<\/h4>\n\n\n\n<p>\u9867\u5ba2\u306b\u901a\u77e5\u3059\u308b\u3053\u3068\u306a\u304f\u6750\u6599\u306e\u914d\u5408\u3092\u5909\u66f4\u3057\u305f\u5834\u5408\u3001\u6a5f\u5668\u898f\u5236\u306e\u627f\u8a8d\u304c\u7121\u52b9\u306b\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">\u6642\u4ee3\u9045\u308c\u306e\u751f\u7269\u5b66\u7684\u691c\u67fb<\/h4>\n\n\n\n<p>\u8a66\u9a13\u306f\u6700\u65b0\u306e\u3082\u306e\u3067\u3001\u6b63\u78ba\u306aTPU\u30b0\u30ec\u30fc\u30c9\u3068\u6700\u7d42\u88fd\u54c1\u306e\u69cb\u6210\u306b\u95a2\u9023\u3057\u305f\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304cTPU\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306b\u8981\u6c42\u3059\u3079\u304d\u3053\u3068<\/h2>\n\n\n\n<p>TPU\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u3055\u308c\u305f\u533b\u7642\u7528\u30d5\u30a1\u30d6\u30ea\u30c3\u30af\u3084\u30a4\u30f3\u30d5\u30ec\u30fc\u30bf\u30d6\u30eb\u30b7\u30b9\u30c6\u30e0\u3092\u8a8d\u5b9a\u3059\u308b\u5834\u5408\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u4ee5\u4e0b\u3092\u542b\u3080\u5b8c\u5168\u306a\u6280\u8853\u30d1\u30c3\u30b1\u30fc\u30b8\u3092\u8981\u6c42\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\uff1a<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u5fc5\u9808\u6587\u66f8\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ISO13485\u8a8d\u8a3c<\/li>\n\n\n\n<li>\u5b8c\u5168\u306aISO 10993\u751f\u7269\u5b66\u7684\u8a66\u9a13\u5831\u544a\u66f8<\/li>\n\n\n\n<li>\u7d30\u80de\u6bd2\u6027\u5831\u544a<\/li>\n\n\n\n<li>\u523a\u6fc0\u6027\u304a\u3088\u3073\u611f\u4f5c\u6027\u306e\u5831\u544a<\/li>\n\n\n\n<li>\u62bd\u51fa\u7269\u304a\u3088\u3073\u6d78\u51fa\u7269\u306e\u7814\u7a76<\/li>\n\n\n\n<li>\u88fd\u54c1\u5b89\u5168\u30c7\u30fc\u30bf\u30b7\u30fc\u30c8<\/li>\n\n\n\n<li>\u539f\u6750\u6599\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u60c5\u5831<\/li>\n\n\n\n<li>\u7269\u7406\u7684\u7279\u6027\u306e\u691c\u8a3c\u30ec\u30dd\u30fc\u30c8<\/li>\n\n\n\n<li>\u5909\u66f4\u901a\u77e5\u30dd\u30ea\u30b7\u30fc<\/li>\n\n\n\n<li>\u898f\u5236\u652f\u63f4\u6587\u66f8<\/li>\n<\/ul>\n\n\n\n<p>\u6210\u719f\u3057\u305f\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f\u307e\u305f\u3001\u4ee5\u4e0b\u306e\u3053\u3068\u306b\u7cbe\u901a\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3059\u3079\u304d\u3067\u3042\u308b\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>FDA\u63d0\u51fa\u3078\u306e\u671f\u5f85<\/li>\n\n\n\n<li>EU MDR\u9069\u5408\u30d1\u30b9\u30a6\u30a7\u30a4<\/li>\n\n\n\n<li>\u30ea\u30b9\u30af\u7ba1\u7406\u306e\u7d71\u5408<\/li>\n\n\n\n<li>\u7d20\u6750\u306e\u540c\u7b49\u6027\u306b\u95a2\u3059\u308b\u8b70\u8ad6<\/li>\n\n\n\n<li>\u9577\u671f\u4f9b\u7d66\u306e\u4e00\u8cab\u6027<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">\u30de\u30c6\u30ea\u30a2\u30eb\u30fb\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u304c\u7af6\u4e89\u512a\u4f4d\u306b\u306a\u308b\u7406\u7531<\/h2>\n\n\n\n<p>\u73fe\u4ee3\u306e\u533b\u7642\u88fd\u9020\u306b\u304a\u3044\u3066\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306f\u3082\u306f\u3084\u30aa\u30d7\u30b7\u30e7\u30f3\u3067\u306f\u306a\u3044\u3002<\/p>\n\n\n\n<p>\u30c7\u30d0\u30a4\u30b9\u30fb\u30e1\u30fc\u30ab\u30fc\u306e\u30cb\u30fc\u30ba\u306f\u307e\u3059\u307e\u3059\u9ad8\u307e\u3063\u3066\u3044\u308b\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30d0\u30c3\u30c1\u30ec\u30d9\u30eb\u306e\u6750\u6599\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3<\/li>\n\n\n\n<li>\u7ba1\u7406\u3055\u308c\u305f\u539f\u6750\u6599\u8abf\u9054<\/li>\n\n\n\n<li>\u9577\u671f\u88fd\u5264\u5b89\u5b9a\u6027<\/li>\n\n\n\n<li>\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u5909\u66f4\u901a\u77e5\u30b7\u30b9\u30c6\u30e0<\/li>\n\n\n\n<li>\u904e\u53bb\u306e\u88fd\u9020\u8a18\u9332<\/li>\n<\/ul>\n\n\n\n<p>\u3053\u308c\u306f\u3001\u81a8\u5f35\u5f0f\u533b\u7642\u6a5f\u5668\u3067\u306f\u7279\u306b\u91cd\u8981\u3067\u3042\u308b\u3002\u5316\u5b66\u7684\u52a3\u5316\u3001\u79fb\u52d5\u3001\u6750\u6599\u306e\u4e0d\u5b89\u5b9a\u6027\u306f\u3001\u9577\u671f\u9593\u306e\u81e8\u5e8a\u4f7f\u7528\u5f8c\u306b\u521d\u3081\u3066\u73fe\u308c\u308b\u3053\u3068\u304c\u3042\u308b\u3002<\/p>\n\n\n\n<p>\u5f37\u56fa\u306a\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30fb\u30b7\u30b9\u30c6\u30e0\u3092\u7dad\u6301\u3059\u308b\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f\u3001OEM\u9867\u5ba2\u306e\u9577\u671f\u7684\u306a\u898f\u5236\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3059\u308b\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u751f\u4f53\u9069\u5408\u6027\u306f\u5171\u6709\u306e\u8cac\u4efb<\/h2>\n\n\n\n<p>\u73fe\u5728\u306e\u533b\u7642\u898f\u5236\u306e\u67a0\u7d44\u307f\u3067\u306f\u3001\u751f\u7269\u5b66\u7684\u5b89\u5168\u6027\u306e\u8cac\u4efb\u306f\u4e21\u8005\u306e\u9593\u3067\u5206\u62c5\u3055\u308c\u3066\u3044\u308b\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6750\u6599\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc<\/li>\n\n\n\n<li>\u90e8\u54c1\u30e1\u30fc\u30ab\u30fc<\/li>\n\n\n\n<li>\u5b8c\u6210\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc<\/li>\n<\/ul>\n\n\n\n<p>\u3069\u306eTPU\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3082\u3001\u30c7\u30d0\u30a4\u30b9\u30ec\u30d9\u30eb\u306e\u627f\u8a8d\u3092\u5b8c\u5168\u306b\u4fdd\u8a3c\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u306a\u3044\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u88fd\u54c1\u30c7\u30b6\u30a4\u30f3<\/li>\n\n\n\n<li>\u88fd\u9020\u5de5\u7a0b<\/li>\n\n\n\n<li>\u6ec5\u83cc\u65b9\u6cd5<\/li>\n\n\n\n<li>\u4f7f\u7528\u76ee\u7684<\/li>\n\n\n\n<li>\u81e8\u5e8a\u66b4\u9732\u6761\u4ef6<\/li>\n<\/ul>\n\n\n\n<p>\u3057\u304b\u3057\u3001\u9069\u683c\u306aTPU\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f\u3001\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304c\u751f\u7269\u5b66\u7684\u30ea\u30b9\u30af\u8a55\u4fa1\u3092\u52b9\u7387\u7684\u306b\u5b8c\u4e86\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u79d1\u5b66\u7684\u57fa\u76e4\u3092\u63d0\u4f9b\u3059\u308b\u306f\u305a\u3067\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u533b\u7642\u7528TPU\u7d20\u6750\u306e\u672a\u6765<\/h2>\n\n\n\n<p>\u533b\u7642\u7528TPU\u696d\u754c\u306f\u3001\u4e16\u754c\u7684\u306a\u898f\u5236\u306e\u5f37\u5316\u3084\u60a3\u8005\u306e\u5b89\u5168\u6027\u3078\u306e\u671f\u5f85\u306e\u9ad8\u307e\u308a\u3068\u3068\u3082\u306b\u3001\u6025\u901f\u306b\u9032\u5316\u3057\u3066\u3044\u308b\u3002<\/p>\n\n\n\n<p>\u4e3b\u306a\u30c8\u30ec\u30f3\u30c9\u306f\u4ee5\u4e0b\u306e\u901a\u308a\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5316\u5b66\u7684\u7279\u6027\u3092\u3088\u308a\u91cd\u8996<\/li>\n\n\n\n<li>\u30d5\u30bf\u30eb\u9178\u30a8\u30b9\u30c6\u30eb\u30d5\u30ea\u30fc\u51e6\u65b9<\/li>\n\n\n\n<li>\u4f4e\u62bd\u51fa\u6027TPU\u30b7\u30b9\u30c6\u30e0<\/li>\n\n\n\n<li>\u3088\u308a\u30af\u30ea\u30fc\u30f3\u306a\u6dfb\u52a0\u5264\u5316\u5b66<\/li>\n\n\n\n<li>\u8010\u52a0\u6c34\u5206\u89e3\u6027\u306e\u5411\u4e0a<\/li>\n\n\n\n<li>\u9577\u671f\u719f\u6210\u5b89\u5b9a\u6027\u306e\u5411\u4e0a<\/li>\n\n\n\n<li>\u6301\u7d9a\u53ef\u80fd\u306a\u533b\u7642\u7528\u30dd\u30ea\u30de\u30fc\u306e\u958b\u767a<\/li>\n\n\n\n<li>MDR\u306e\u6587\u66f8\u5316\u8981\u4ef6\u306e\u5897\u52a0<\/li>\n<\/ul>\n\n\n\n<p>\u533b\u7642\u7528\u30a4\u30f3\u30d5\u30ec\u30fc\u30bf\u30d6\u30eb\u6a5f\u5668\u304c\u3088\u308a\u9ad8\u5ea6\u306b\u306a\u308b\u306b\u3064\u308c\u3066\u3001\u6750\u6599\u8a8d\u5b9a\u57fa\u6e96\u306f\u4e0a\u6607\u3057\u7d9a\u3051\u308b\u3060\u308d\u3046\u3002<\/p>\n\n\n\n<p>EU MDR\u3001FDA\u306e\u7cbe\u67fb\u3001\u305d\u3057\u3066\u307e\u3059\u307e\u3059\u9ad8\u5ea6\u5316\u3059\u308b\u751f\u7269\u5b66\u7684\u30ea\u30b9\u30af\u8a55\u4fa1\u306e\u6642\u4ee3\u306b\u304a\u3044\u3066\u3001\u751f\u4f53\u9069\u5408\u6027\u306f\u3082\u306f\u3084\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u30e9\u30d9\u30eb\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u305d\u308c\u306f\u6587\u66f8\u5316\u3055\u308c\u3001\u8a66\u9a13\u4e3b\u5c0e\u3067\u3001\u7d99\u7d9a\u7684\u306b\u7ba1\u7406\u3055\u308c\u308b\u8cac\u4efb\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u5358\u306b\u300c\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u300d\u3068\u5ba3\u4f1d\u3055\u308c\u3066\u3044\u308b\u304b\u3089\u3068\u3044\u3046\u7406\u7531\u3067TPU\u751f\u5730\u3092\u9078\u3076\u3053\u3068\u306f\u3001\u3082\u306f\u3084\u5341\u5206\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u88fd\u9020\u696d\u8005\u306f\u3001\u51e6\u65b9\u7ba1\u7406\u3001\u88fd\u9020\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3001\u62bd\u51fa\u7269\u306e\u7279\u6027\u8a55\u4fa1\u3001\u898f\u5236\u6587\u66f8\u3001\u9577\u671f\u7684\u306a\u4e00\u8cab\u6027\u306a\u3069\u3001\u7d20\u6750\u30b7\u30b9\u30c6\u30e0\u5168\u4f53\u3092\u8a55\u4fa1\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u771f\u306e\u533b\u7642\u30b0\u30ec\u30fc\u30c9TPU\u306f\u5358\u306a\u308b\u30dd\u30ea\u30de\u30fc\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u60a3\u8005\u306e\u5b89\u5168\u6027\u3001\u898f\u5236\u4e0a\u306e\u4fe1\u983c\u6027\u3001\u81e8\u5e8a\u6027\u80fd\u306e\u305f\u3081\u306b\u8a2d\u8a08\u3055\u308c\u305f\u3001\u5b8c\u5168\u306b\u5de5\u5b66\u7684\u306b\u8a2d\u8a08\u3055\u308c\u305f\u751f\u4f53\u9069\u5408\u6027\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u6cbb\u7642\u3001\u30ea\u30cf\u30d3\u30ea\u30c6\u30fc\u30b7\u30e7\u30f3\u3001\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3001\u56de\u5fa9\u6642\u306b\u60a3\u8005\u304c\u983c\u308a\u306b\u3059\u308b\u81a8\u5f35\u5f0f\u533b\u7642\u88fd\u54c1\u306b\u3068\u3063\u3066\u3001\u3053\u306e\u30ec\u30d9\u30eb\u306e\u4fdd\u8a3c\u306f\u30aa\u30d7\u30b7\u30e7\u30f3\u3067\u306f\u306a\u3044\u3002\u3053\u308c\u306f\u671f\u5f85\u3055\u308c\u308b\u6a19\u6e96\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>The Dangerous Misunderstanding Behind \u201cMedical-Grade\u201d TPU In the medical device industry, the phrase \u201cmedical-grade TPU\u201d is frequently used as a broad marketing term. In reality, the gap between a general-purpose&hellip;<\/p>","protected":false},"author":1,"featured_media":58762,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[227],"tags":[],"class_list":["post-59619","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-quality-compliance"],"acf":[],"_links":{"self":[{"href":"https:\/\/tpumedical.com\/ja\/wp-json\/wp\/v2\/posts\/59619","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/tpumedical.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/tpumedical.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/tpumedical.com\/ja\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/tpumedical.com\/ja\/wp-json\/wp\/v2\/comments?post=59619"}],"version-history":[{"count":2,"href":"https:\/\/tpumedical.com\/ja\/wp-json\/wp\/v2\/posts\/59619\/revisions"}],"predecessor-version":[{"id":59622,"href":"https:\/\/tpumedical.com\/ja\/wp-json\/wp\/v2\/posts\/59619\/revisions\/59622"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/tpumedical.com\/ja\/wp-json\/wp\/v2\/media\/58762"}],"wp:attachment":[{"href":"https:\/\/tpumedical.com\/ja\/wp-json\/wp\/v2\/media?parent=59619"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/tpumedical.com\/ja\/wp-json\/wp\/v2\/categories?post=59619"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/tpumedical.com\/ja\/wp-json\/wp\/v2\/tags?post=59619"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}