{"id":6628,"date":"2025-02-20T16:05:07","date_gmt":"2025-02-20T08:05:07","guid":{"rendered":"https:\/\/www.thy-precision.com\/%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%ae%e5%93%81%e8%b3%aa%e3%82%92%e6%94%af%e3%81%88%e3%82%8b%e3%82%af%e3%83%aa%e3%83%bc%e3%83%b3%e3%83%ab%e3%83%bc%e3%83%a0%e8%a3%bd%e9%80%a0\/"},"modified":"2025-03-14T18:23:10","modified_gmt":"2025-03-14T10:23:10","slug":"clean-room-manufacturing-key-to-medical-device-quality","status":"publish","type":"post","link":"https:\/\/www.thy-precision.com\/ja\/clean-room-manufacturing-key-to-medical-device-quality\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u3092\u652f\u3048\u308b\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020"},"content":{"rendered":"\n<p>\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u306f\u3001\u7a7a\u6c17\u4e2d\u306e\u5fae\u7c92\u5b50\u3084\u6c5a\u67d3\u7269\u8cea\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u305f\u3081\u306b\u3001\u53b3\u5bc6\u306b\u7ba1\u7406\u3055\u308c\u305f\u74b0\u5883\u3067\u884c\u308f\u308c\u307e\u3059\u3002\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u3068\u547c\u3070\u308c\u308b\u3053\u308c\u3089\u306e\u7279\u6b8a\u65bd\u8a2d\u306f\u3001\u5fae\u7d30\u306a\u4e0d\u7d14\u7269\u304c\u88fd\u54c1\u306e\u54c1\u8cea\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u696d\u754c\u306b\u304a\u3044\u3066\u4e0d\u53ef\u6b20\u306a\u5b58\u5728\u3067\u3059\u3002 <\/p>\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.thy-precision.com\/ja\/clean-room-manufacturing-key-to-medical-device-quality\/#%E3%82%AF%E3%83%AA%E3%83%BC%E3%83%B3%E3%83%AB%E3%83%BC%E3%83%A0%E3%81%A8%E3%81%AF%EF%BC%9F\" >\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u3068\u306f\uff1f<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.thy-precision.com\/ja\/clean-room-manufacturing-key-to-medical-device-quality\/#%E2%80%A2_ISO_7%E3%82%AF%E3%83%AA%E3%83%BC%E3%83%B3%E3%83%AB%E3%83%BC%E3%83%A0%E3%81%AE%E5%9F%BA%E6%BA%96\" >\u2022 ISO 7\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u306e\u57fa\u6e96<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.thy-precision.com\/ja\/clean-room-manufacturing-key-to-medical-device-quality\/#%E2%80%A2_ISO_8%E3%82%AF%E3%83%AA%E3%83%BC%E3%83%B3%E3%83%AB%E3%83%BC%E3%83%A0%E3%81%AE%E5%9F%BA%E6%BA%96\" >\u2022 ISO 8\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u306e\u57fa\u6e96<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.thy-precision.com\/ja\/clean-room-manufacturing-key-to-medical-device-quality\/#%E3%82%AF%E3%83%AA%E3%83%BC%E3%83%B3%E3%83%AB%E3%83%BC%E3%83%A0%E8%A3%BD%E9%80%A0%E3%81%8C%E9%87%8D%E8%A6%81%E3%81%AA%E7%90%86%E7%94%B1\" >\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u304c\u91cd\u8981\u306a\u7406\u7531<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.thy-precision.com\/ja\/clean-room-manufacturing-key-to-medical-device-quality\/#%E3%82%AF%E3%83%AA%E3%83%BC%E3%83%B3%E3%83%AB%E3%83%BC%E3%83%A0%E8%A3%BD%E9%80%A0%E3%81%AE%E4%B8%BB%E8%A6%81%E3%81%AA%E7%89%B9%E5%BE%B4\" >\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u306e\u4e3b\u8981\u306a\u7279\u5fb4<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.thy-precision.com\/ja\/clean-room-manufacturing-key-to-medical-device-quality\/#1_%E5%8C%BB%E7%99%82%E3%82%B0%E3%83%AC%E3%83%BC%E3%83%89%E3%81%AE%E6%96%BD%E8%A8%AD%E8%A8%AD%E8%A8%88\" >1. \u533b\u7642\u30b0\u30ec\u30fc\u30c9\u306e\u65bd\u8a2d\u8a2d\u8a08<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.thy-precision.com\/ja\/clean-room-manufacturing-key-to-medical-device-quality\/#2_%E9%AB%98%E7%B2%BE%E5%BA%A6%E3%81%AA%E7%A9%BA%E6%B0%97%E7%AE%A1%E7%90%86\" >2. \u9ad8\u7cbe\u5ea6\u306a\u7a7a\u6c17\u7ba1\u7406<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.thy-precision.com\/ja\/clean-room-manufacturing-key-to-medical-device-quality\/#3_%E6%88%A6%E7%95%A5%E7%9A%84%E3%81%AA%E5%9C%A7%E5%8A%9B%E5%88%B6%E5%BE%A1\" >3. \u6226\u7565\u7684\u306a\u5727\u529b\u5236\u5fa1<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.thy-precision.com\/ja\/clean-room-manufacturing-key-to-medical-device-quality\/#4_%E5%8E%B3%E6%A0%BC%E3%81%AA%E5%93%81%E8%B3%AA%E7%9B%A3%E8%A6%96\" >4. \u53b3\u683c\u306a\u54c1\u8cea\u76e3\u8996<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.thy-precision.com\/ja\/clean-room-manufacturing-key-to-medical-device-quality\/#5_%E6%9F%94%E8%BB%9F%E3%81%AA%E8%A3%BD%E9%80%A0%E3%82%B9%E3%83%9A%E3%83%BC%E3%82%B9\" >5. \u67d4\u8edf\u306a\u88fd\u9020\u30b9\u30da\u30fc\u30b9<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.thy-precision.com\/ja\/clean-room-manufacturing-key-to-medical-device-quality\/#6_%E7%B2%BE%E5%AF%86%E3%81%AA%E8%87%AA%E5%8B%95%E5%8C%96%E3%82%B7%E3%82%B9%E3%83%86%E3%83%A0\" >6. \u7cbe\u5bc6\u306a\u81ea\u52d5\u5316\u30b7\u30b9\u30c6\u30e0<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.thy-precision.com\/ja\/clean-room-manufacturing-key-to-medical-device-quality\/#7_%E3%82%B9%E3%83%9E%E3%83%BC%E3%83%88%E3%83%A2%E3%83%8B%E3%82%BF%E3%83%AA%E3%83%B3%E3%82%B0%E3%81%AE%E7%B5%B1%E5%90%88\" >7. \u30b9\u30de\u30fc\u30c8\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306e\u7d71\u5408<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.thy-precision.com\/ja\/clean-room-manufacturing-key-to-medical-device-quality\/#%E5%8C%BB%E7%99%82%E5%88%86%E9%87%8E%E3%81%AB%E3%81%8A%E3%81%91%E3%82%8B%E3%82%AF%E3%83%AA%E3%83%BC%E3%83%B3%E3%83%AB%E3%83%BC%E3%83%A0%E8%A3%BD%E9%80%A0%E3%81%AE3%E3%81%A4%E3%81%AE%E5%88%A9%E7%82%B9\" >\u533b\u7642\u5206\u91ce\u306b\u304a\u3051\u308b\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u306e3\u3064\u306e\u5229\u70b9<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/www.thy-precision.com\/ja\/clean-room-manufacturing-key-to-medical-device-quality\/#1_%E6%B1%9A%E6%9F%93%E3%81%AE%E3%81%AA%E3%81%84%E8%A3%BD%E9%80%A0%E7%92%B0%E5%A2%83\" >1. \u6c5a\u67d3\u306e\u306a\u3044\u88fd\u9020\u74b0\u5883<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/www.thy-precision.com\/ja\/clean-room-manufacturing-key-to-medical-device-quality\/#2_%E5%8E%B3%E6%A0%BC%E3%81%AA%E5%93%81%E8%B3%AA%E7%AE%A1%E7%90%86%E3%81%A8%E8%A6%8F%E5%88%B6%E9%81%B5%E5%AE%88\" >2. \u53b3\u683c\u306a\u54c1\u8cea\u7ba1\u7406\u3068\u898f\u5236\u9075\u5b88<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/www.thy-precision.com\/ja\/clean-room-manufacturing-key-to-medical-device-quality\/#3_%E6%82%A3%E8%80%85%E3%81%AE%E5%AE%89%E5%85%A8%E6%80%A7%E3%81%A8%E8%A3%BD%E5%93%81%E3%81%AE%E4%BF%A1%E9%A0%BC%E6%80%A7%E3%81%AE%E5%90%91%E4%B8%8A\" >3. \u60a3\u8005\u306e\u5b89\u5168\u6027\u3068\u88fd\u54c1\u306e\u4fe1\u983c\u6027\u306e\u5411\u4e0a<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-17\" href=\"https:\/\/www.thy-precision.com\/ja\/clean-room-manufacturing-key-to-medical-device-quality\/#THY%E7%B2%BE%E5%AF%86%E5%B7%A5%E6%A5%AD%E3%81%A7%E3%81%AE%E3%82%AF%E3%83%AA%E3%83%BC%E3%83%B3%E3%83%AB%E3%83%BC%E3%83%A0%E8%A3%BD%E9%80%A0%EF%BC%9A%E6%8F%90%E4%BE%9B%E3%81%95%E3%82%8C%E3%82%8B%E5%8D%93%E8%B6%8A%E6%80%A7\" >THY\u7cbe\u5bc6\u5de5\u696d\u3067\u306e\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\uff1a\u63d0\u4f9b\u3055\u308c\u308b\u5353\u8d8a\u6027<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E3%82%AF%E3%83%AA%E3%83%BC%E3%83%B3%E3%83%AB%E3%83%BC%E3%83%A0%E3%81%A8%E3%81%AF%EF%BC%9F\"><\/span><strong>\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u3068\u306f\uff1f <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n<p>\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u3067\u306f\u3001\u9ad8\u5ea6\u306a\u74b0\u5883\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u7528\u3044\u3066\u53b3\u683c\u306a\u5236\u5fa1\u3092\u884c\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u6e29\u5ea6\u30fb\u6e7f\u5ea6\u30fb\u6c17\u6d41\u3092\u7cbe\u5bc6\u306b\u8abf\u6574\u3057\u3001HEPA\uff08\u9ad8\u52b9\u7387\u5fae\u7c92\u5b50\u30a8\u30a2\u30d5\u30a3\u30eb\u30bf\u30fc\uff09\u3084ULPA\uff08\u8d85\u4f4e\u7c92\u5b50\u30a8\u30a2\u30d5\u30a3\u30eb\u30bf\u30fc\uff09\u3092\u4f7f\u7528\u3057\u3066\u6700\u9069\u306a\u74b0\u5883\u3092\u7dad\u6301\u3057\u307e\u3059\u3002 <\/p>\n\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1000\" height=\"550\" src=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2025\/03\/2025_\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u3092\u652f\u3048\u308b\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u65e5\u6587-07.webp\" alt=\"&#x30AF;&#x30EA;&#x30FC;&#x30F3;&#x30EB;&#x30FC;&#x30E0;&#x306F;&#x3001;&#x9AD8;&#x5EA6;&#x306A;&#x74B0;&#x5883;&#x7BA1;&#x7406;&#x30B7;&#x30B9;&#x30C6;&#x30E0;&#x3092;&#x901A;&#x3058;&#x3066;&#x53B3;&#x683C;&#x306A;&#x7BA1;&#x7406;&#x3092;&#x5B9F;&#x65BD;&#x3057;&#x3066;&#x3044;&#x307E;&#x3059;&#x3002;\" class=\"wp-image-6561\" srcset=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2025\/03\/2025_\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u3092\u652f\u3048\u308b\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u65e5\u6587-07.webp 1000w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2025\/03\/2025_\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u3092\u652f\u3048\u308b\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u65e5\u6587-07-768x422.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n<p>\u3055\u3089\u306b\u3001\u967d\u5727\uff08\u30dd\u30b8\u30c6\u30a3\u30d6\u30d7\u30ec\u30c3\u30b7\u30e3\u30fc\uff09\u30b7\u30b9\u30c6\u30e0\u306b\u3088\u308a\u5916\u90e8\u304b\u3089\u306e\u6c5a\u67d3\u3092\u9632\u304e\u3001\u58c1\u30fb\u5e8a\u30fb\u5929\u4e95\u306b\u306f\u30a8\u30dd\u30ad\u30b7\u6a39\u8102\u306a\u3069\u306e\u7279\u6b8a\u306a\u7d20\u6750\u3092\u63a1\u7528\u3059\u308b\u3053\u3068\u3067\u3001\u5fb9\u5e95\u3057\u305f\u6e05\u6383\u3084\u52b9\u7387\u7684\u306a\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u304c\u53ef\u80fd\u306b\u306a\u308a\u307e\u3059\u3002<br\/><br\/>\u56fd\u969b\u6a19\u6e96\u5316\u6a5f\u69cb\uff08ISO\uff09\u306f\u3001\u7a7a\u6c17\u4e2d\u306e\u5fae\u7c92\u5b50\u6fc3\u5ea6\u306b\u57fa\u3065\u3044\u3066\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u3092\u5206\u985e\u3057\u3066\u3044\u307e\u3059\u3002\u305d\u306e\u4e2d\u3067\u3082\u4ee3\u8868\u7684\u306aISO 7\u304a\u3088\u3073<a href=\"https:\/\/www.thy-precision.com\/ja\/what-is-an-iso-8-cleanroom-principles-requirements\/\">ISO 8<\/a>\u306e\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u306e\u4ed5\u69d8\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\u3002  <\/p>\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E2%80%A2_ISO_7%E3%82%AF%E3%83%AA%E3%83%BC%E3%83%B3%E3%83%AB%E3%83%BC%E3%83%A0%E3%81%AE%E5%9F%BA%E6%BA%96\"><\/span><strong>\u2022<\/strong> <strong>ISO 7\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u306e\u57fa\u6e96<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p>\u7c92\u5b50\u6570\uff08\u22650.5 \u00b5m\uff09\uff1a1\u7acb\u65b9\u30e1\u30fc\u30c8\u30eb\u3042\u305f\u308a\u6700\u5927352,000\u500b<br\/>\u7c92\u5b50\u6570\uff08\u22651 \u00b5m\uff09\uff1a1\u7acb\u65b9\u30e1\u30fc\u30c8\u30eb\u3042\u305f\u308a\u6700\u592783,200\u500b<br\/>\u7c92\u5b50\u6570\uff08\u22655 \u00b5m\uff09\uff1a1\u7acb\u65b9\u30e1\u30fc\u30c8\u30eb\u3042\u305f\u308a\u6700\u59272,930\u500b<\/p>\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E2%80%A2_ISO_8%E3%82%AF%E3%83%AA%E3%83%BC%E3%83%B3%E3%83%AB%E3%83%BC%E3%83%A0%E3%81%AE%E5%9F%BA%E6%BA%96\"><\/span><strong>\u2022<\/strong> <strong>ISO 8\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u306e\u57fa\u6e96<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p>\u7c92\u5b50\u6570\uff08\u22650.5 \u00b5m\uff09\uff1a1\u7acb\u65b9\u30e1\u30fc\u30c8\u30eb\u3042\u305f\u308a\u6700\u59273,520,000\u500b<br\/>\u7c92\u5b50\u6570\uff08\u22651 \u00b5m\uff09\uff1a1\u7acb\u65b9\u30e1\u30fc\u30c8\u30eb\u3042\u305f\u308a\u6700\u5927832,000\u500b<br\/>\u7c92\u5b50\u6570\uff08\u22655 \u00b5m\uff09\uff1a1\u7acb\u65b9\u30e1\u30fc\u30c8\u30eb\u3042\u305f\u308a\u6700\u592729,300\u500b<\/p>\n\n<p>\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u306f\u3055\u307e\u3056\u307e\u306a\u696d\u754c\u3067\u4e0d\u53ef\u6b20\u3067\u3042\u308a\u3001\u7279\u306b\u533b\u7642\u6a5f\u5668\u88fd\u9020\u306b\u304a\u3044\u3066\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3057\u307e\u3059\u3002\u624b\u8853\u5668\u5177\u306e\u5916\u88c5\u3001\u70b9\u6ef4\u30bb\u30c3\u30c8\u306e\u90e8\u54c1\u3001\u57cb\u3081\u8fbc\u307f\u578b\u533b\u7642\u6a5f\u5668\u306a\u3069\u306e\u7121\u83cc\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306e\u88fd\u9020\u3092\u53ef\u80fd\u306b\u3057\u307e\u3059\u3002  <\/p>\n\n<p>\u307e\u305f\u3001\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u6280\u8853\u306f\u533b\u7642\u5206\u91ce\u4ee5\u5916\u306b\u3082\u3001\u96fb\u5b50\u6a5f\u5668\u88fd\u9020\u3001\u822a\u7a7a\u5b87\u5b99\u90e8\u54c1\u306e\u751f\u7523\u3001\u533b\u85ac\u54c1\u306e\u88fd\u9020\u306a\u3069\u3001\u53b3\u5bc6\u306a\u74b0\u5883\u7ba1\u7406\u304c\u6c42\u3081\u3089\u308c\u308b\u696d\u754c\u3067\u5e83\u304f\u6d3b\u7528\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E3%82%AF%E3%83%AA%E3%83%BC%E3%83%B3%E3%83%AB%E3%83%BC%E3%83%A0%E8%A3%BD%E9%80%A0%E3%81%8C%E9%87%8D%E8%A6%81%E3%81%AA%E7%90%86%E7%94%B1\"><\/span><strong>\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u304c\u91cd\u8981\u306a\u7406\u7531<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n<p>\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u74b0\u5883\u306f\u3001\u91cd\u8981\u306a\u533b\u7642\u6a5f\u5668\u3084\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u3092\u88fd\u9020\u3059\u308b\u305f\u3081\u306b\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u3053\u308c\u3089\u306e\u533b\u7642\u6a5f\u5668\u306f\u3001\u60a3\u8005\u306e\u5b89\u5168\u3068\u78ba\u5b9f\u306a\u6a5f\u80fd\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u3001\u7121\u83cc\u74b0\u5883\u3067\u306e\u7cbe\u5bc6\u306a\u88fd\u9020\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002  <\/p>\n\n<p>\u305d\u306e\u4ee3\u8868\u4f8b\u304c\u767d\u8840\u7403\u9664\u53bb\u30d5\u30a3\u30eb\u30bf\u30fc\u3067\u3059\u3002\u3053\u308c\u306f\u8f38\u8840\u88fd\u54c1\u304b\u3089\u767d\u8840\u7403\u3092\u9664\u53bb\u3059\u308b\u305f\u3081\u306e\u30d5\u30a3\u30eb\u30bf\u30fc\u3067\u3042\u308a\u3001\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u3067\u306f\u6e05\u6f54\u306a\u74b0\u5883\u3092\u5fb9\u5e95\u7684\u306b\u7ba1\u7406\u3059\u308b\u3053\u3068\u3067\u3001\u60a3\u8005\u306e\u514d\u75ab\u53cd\u5fdc\u3092\u9632\u3050\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002 <\/p>\n\n<p>\u307e\u305f\u3001\u591a\u304f\u306e\u533b\u7642\u6a5f\u5668\u3082\u3001\u6c5a\u67d3\u306e\u306a\u3044\u53b3\u683c\u306a\u88fd\u9020\u74b0\u5883\u3067\u751f\u7523\u3055\u308c\u308b\u3053\u3068\u3067\u3001\u305d\u306e\u4fe1\u983c\u6027\u3068\u6709\u52b9\u6027\u3092\u78ba\u4fdd\u3057\u3066\u3044\u307e\u3059\u3002\u305f\u3068\u3048\u3070\u3001\u7cbe\u5bc6\u306a\u308d\u904e\u88c5\u7f6e\u3001\u624b\u8853\u5668\u5177\u306e\u30b1\u30fc\u30b9\u3001\u70b9\u6ef4\u30bb\u30c3\u30c8\u306e\u90e8\u54c1\u3001\u5185\u8996\u93e1\u306a\u3069\u306f\u3001\u305d\u306e\u6a5f\u80fd\u3068\u7cbe\u5ea6\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u9ad8\u3044\u6e05\u6d44\u5ea6\u3092\u5fc5\u8981\u3068\u3057\u307e\u3059\u3002 <\/p>\n\n<p>\u3055\u3089\u306b\u3001\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u306f\u3001\u533b\u7642\u6a5f\u5668\u5411\u3051\u306e\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u5c04\u51fa\u6210\u5f62\u306b\u304a\u3044\u3066\u3082\u91cd\u8981\u306a\u5f79\u5272\u3092\u62c5\u3063\u3066\u3044\u307e\u3059\u3002\u7121\u83cc\u74b0\u5883\u3067\u306e\u88fd\u9020\u306b\u3088\u308a\u3001\u88fd\u54c1\u306e\u6b20\u9665\u3092\u6e1b\u3089\u3057\u3001\u6700\u7d42\u88fd\u54c1\u306e\u4fe1\u983c\u6027\u3092\u5927\u5e45\u306b\u5411\u4e0a\u3055\u305b\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u7279\u306b\u3001\u57cb\u3081\u8fbc\u307f\u578b\u533b\u7642\u6a5f\u5668\u3084\u8a3a\u65ad\u6a5f\u5668\u306a\u3069\u306e\u9ad8\u7cbe\u5ea6\u306a\u533b\u7642\u6a5f\u5668\u3067\u306f\u3001FDA\uff08\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff09\u306e\u53b3\u683c\u306a\u57fa\u6e96\u3084\u3001<a href=\"https:\/\/www.thy-precision.com\/ja\/iso-standards-for-medical-devices-the-meaning-of-iso-13485\/\">ISO 13485<\/a>\uff08\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff09\u306e\u898f\u683c\u306b\u6e96\u62e0\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002  <\/p>\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E3%82%AF%E3%83%AA%E3%83%BC%E3%83%B3%E3%83%AB%E3%83%BC%E3%83%A0%E8%A3%BD%E9%80%A0%E3%81%AE%E4%B8%BB%E8%A6%81%E3%81%AA%E7%89%B9%E5%BE%B4\"><\/span><strong>\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u306e\u4e3b\u8981\u306a\u7279\u5fb4<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n<p>\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u306f\u3001\u5148\u9032\u7684\u306a\u5236\u5fa1\u30b7\u30b9\u30c6\u30e0\u3068\u9769\u65b0\u7684\u306a\u6280\u8853\u306b\u3088\u308a\u3001\u4e00\u8cab\u6027\u3068\u7cbe\u5bc6\u3055\u3092\u78ba\u4fdd\u3059\u308b\u70b9\u3067\u969b\u7acb\u3063\u3066\u3044\u307e\u3059\u3002\u4ee5\u4e0b\u306b\u4e3b\u8981\u306a\u7279\u5fb4\u3092\u7d39\u4ecb\u3057\u307e\u3059\u3002 <\/p>\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"1_%E5%8C%BB%E7%99%82%E3%82%B0%E3%83%AC%E3%83%BC%E3%83%89%E3%81%AE%E6%96%BD%E8%A8%AD%E8%A8%AD%E8%A8%88\"><\/span><strong>1. \u533b\u7642\u30b0\u30ec\u30fc\u30c9\u306e\u65bd\u8a2d\u8a2d\u8a08<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p>\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u306f\u3001\u3055\u307e\u3056\u307e\u306a\u533b\u7642\u6a5f\u5668\u3092\u540c\u6642\u306b\u88fd\u9020\u3057\u306a\u304c\u3089\u3001\u4ea4\u5dee\u6c5a\u67d3\u3092\u9632\u3050\u305f\u3081\u306b\u5c02\u9580\u7684\u306a\u30be\u30fc\u30f3\u306b\u5206\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"1000\" height=\"550\" src=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2025\/03\/2025_\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u3092\u652f\u3048\u308b\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u65e5\u6587-08.webp\" alt=\"&#x30AF;&#x30EA;&#x30FC;&#x30F3;&#x30EB;&#x30FC;&#x30E0;&#x306B;&#x306F;&#x533B;&#x7642;&#x30B0;&#x30EC;&#x30FC;&#x30C9;&#x306E;&#x65BD;&#x8A2D;&#x8A2D;&#x8A08;&#x304C;&#x5FC5;&#x8981;&#x3067;&#x3059;&#x3002;\" class=\"wp-image-6564\" srcset=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2025\/03\/2025_\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u3092\u652f\u3048\u308b\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u65e5\u6587-08.webp 1000w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2025\/03\/2025_\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u3092\u652f\u3048\u308b\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u65e5\u6587-08-768x422.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"2_%E9%AB%98%E7%B2%BE%E5%BA%A6%E3%81%AA%E7%A9%BA%E6%B0%97%E7%AE%A1%E7%90%86\"><\/span><strong>2. \u9ad8\u7cbe\u5ea6\u306a\u7a7a\u6c17\u7ba1\u7406<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p>\u9ad8\u5ea6\u306aHVAC\uff08\u6696\u623f\u30fb\u63db\u6c17\u30fb\u7a7a\u8abf\uff09\u30b7\u30b9\u30c6\u30e0\u3068\u5c64\u6d41\uff08\u30e9\u30df\u30ca\u30fc\u30d5\u30ed\u30fc\uff09\u6280\u8853\u306b\u3088\u308a\u3001\u7121\u83cc\u533b\u7642\u88fd\u9020\u306b\u5fc5\u8981\u306a\u74b0\u5883\u3092\u7dad\u6301\u3057\u307e\u3059\u3002\u7279\u306b\u3001\u547c\u5438\u5668\u95a2\u9023\u6a5f\u5668\u3084\u624b\u8853\u5668\u5177\u306e\u88fd\u9020\u3067\u306f\u3001\u7a7a\u6c17\u306e\u6e05\u6d44\u5ea6\u304c\u88fd\u54c1\u306e\u5b89\u5168\u6027\u306b\u76f4\u63a5\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u305f\u3081\u91cd\u8981\u3067\u3059\u3002 <\/p>\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"3_%E6%88%A6%E7%95%A5%E7%9A%84%E3%81%AA%E5%9C%A7%E5%8A%9B%E5%88%B6%E5%BE%A1\"><\/span><strong>3. \u6226\u7565\u7684\u306a\u5727\u529b\u5236\u5fa1<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p>\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u4e2d\u306b\u7570\u306a\u308b\u533b\u7642\u6a5f\u5668\u3092\u4fdd\u8b77\u3059\u308b\u305f\u3081\u3001\u30de\u30eb\u30c1\u30be\u30fc\u30f3\u306e\u5727\u529b\u52fe\u914d\u3092\u63a1\u7528\u3002\u7279\u306b\u3001\u91cd\u8981\u306a\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3084\u8a3a\u65ad\u90e8\u54c1\u3092\u88fd\u9020\u3059\u308b\u30a8\u30ea\u30a2\u3067\u306f\u6700\u3082\u9ad8\u3044\u967d\u5727\u3092\u7dad\u6301\u3057\u3001\u6c5a\u67d3\u3092\u9632\u304e\u307e\u3059\u3002<\/p>\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"4_%E5%8E%B3%E6%A0%BC%E3%81%AA%E5%93%81%E8%B3%AA%E7%9B%A3%E8%A6%96\"><\/span><strong>4. \u53b3\u683c\u306a\u54c1\u8cea\u76e3\u8996<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p>\u74b0\u5883\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3092\u7d99\u7d9a\u7684\u306b\u884c\u3044\u3001\u533b\u7642\u6a5f\u5668\u88fd\u9020\u306e\u57fa\u6e96\u3092\u9075\u5b88\u3002\u60a3\u8005\u306e\u5b89\u5168\u3068\u88fd\u54c1\u306e\u6709\u52b9\u6027\u306b\u95a2\u308f\u308b\u91cd\u8981\u306a\u8981\u7d20\u3092\u91cd\u70b9\u7684\u306b\u76e3\u8996\u3057\u307e\u3059\u3002<\/p>\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"5_%E6%9F%94%E8%BB%9F%E3%81%AA%E8%A3%BD%E9%80%A0%E3%82%B9%E3%83%9A%E3%83%BC%E3%82%B9\"><\/span><strong>5. \u67d4\u8edf\u306a\u88fd\u9020\u30b9\u30da\u30fc\u30b9<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p>\u6700\u65b0\u306e\u8a2d\u5099\u306f\u3001\u6025\u901f\u306b\u9032\u5316\u3059\u308b\u533b\u7642\u6280\u8853\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u3088\u3046\u8a2d\u8a08\u3055\u308c\u3066\u304a\u308a\u3001\u65b0\u305f\u306a\u30c7\u30d0\u30a4\u30b9\u306e\u88fd\u9020\u8981\u4ef6\u3084\u898f\u5236\u5909\u66f4\u306b\u8fc5\u901f\u306b\u9069\u5fdc\u3067\u304d\u307e\u3059\u3002<\/p>\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"6_%E7%B2%BE%E5%AF%86%E3%81%AA%E8%87%AA%E5%8B%95%E5%8C%96%E3%82%B7%E3%82%B9%E3%83%86%E3%83%A0\"><\/span><strong>6. \u7cbe\u5bc6\u306a\u81ea\u52d5\u5316\u30b7\u30b9\u30c6\u30e0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p>\u30ed\u30dc\u30c3\u30c8\u6280\u8853\u3092\u6d3b\u7528\u3057\u305f\u81ea\u52d5\u7d44\u7acb\u30b7\u30b9\u30c6\u30e0\u306b\u3088\u308a\u3001\u7121\u83cc\u74b0\u5883\u3067\u306e\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3051\u308b\u4e00\u8cab\u3057\u305f\u54c1\u8cea\u7ba1\u7406\u3092\u5b9f\u73fe\u3057\u3001\u6c5a\u67d3\u30ea\u30b9\u30af\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u307e\u3059\u3002<\/p>\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"1000\" height=\"550\" src=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2025\/03\/2025_\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u3092\u652f\u3048\u308b\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u65e5\u6587-10.webp\" alt=\"&#x30B9;&#x30DE;&#x30FC;&#x30C8;&#x30EB;&#x30FC;&#x30E0;&#x306B;&#x306F;&#x7CBE;&#x5BC6;&#x306A;&#x81EA;&#x52D5;&#x5316;&#x30B7;&#x30B9;&#x30C6;&#x30E0;&#x304C;&#x5FC5;&#x8981;&#x3067;&#x3059;&#x3002;\" class=\"wp-image-6570\" srcset=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2025\/03\/2025_\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u3092\u652f\u3048\u308b\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u65e5\u6587-10.webp 1000w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2025\/03\/2025_\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u3092\u652f\u3048\u308b\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u65e5\u6587-10-768x422.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"7_%E3%82%B9%E3%83%9E%E3%83%BC%E3%83%88%E3%83%A2%E3%83%8B%E3%82%BF%E3%83%AA%E3%83%B3%E3%82%B0%E3%81%AE%E7%B5%B1%E5%90%88\"><\/span>7. <strong>\u30b9\u30de\u30fc\u30c8\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306e\u7d71\u5408<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p>AI\u304a\u3088\u3073IoT\u6280\u8853\u3092\u6d3b\u7528\u3057\u3001<a href=\"https:\/\/www.thy-precision.com\/ja\/plastic-injection-moulding-for-medical-devices-a-basic-overview\/\">\u533b\u7642\u6a5f\u5668<\/a>\u88fd\u9020\u4e2d\u306e\u91cd\u8981\u30d1\u30e9\u30e1\u30fc\u30bf\u3092\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u3067\u76e3\u8996\u3002\u898f\u683c\u304b\u3089\u306e\u9038\u8131\u3092\u5373\u5ea7\u306b\u691c\u51fa\u3057\u3001\u8fc5\u901f\u306a\u5bfe\u5fdc\u3092\u53ef\u80fd\u306b\u3057\u307e\u3059\u3002<\/p>\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"1000\" height=\"550\" src=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2025\/03\/2025_\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u3092\u652f\u3048\u308b\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u65e5\u6587-09.webp\" alt=\"&#x30B9;&#x30DE;&#x30FC;&#x30C8;&#x76E3;&#x8996;&#x30B7;&#x30B9;&#x30C6;&#x30E0;&#x3092;&#x7D71;&#x5408;&#x3057;&#x305F;&#x30AF;&#x30EA;&#x30FC;&#x30F3;&#x30EB;&#x30FC;&#x30E0;\" class=\"wp-image-6567\" srcset=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2025\/03\/2025_\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u3092\u652f\u3048\u308b\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u65e5\u6587-09.webp 1000w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2025\/03\/2025_\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u3092\u652f\u3048\u308b\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u65e5\u6587-09-768x422.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"%E5%8C%BB%E7%99%82%E5%88%86%E9%87%8E%E3%81%AB%E3%81%8A%E3%81%91%E3%82%8B%E3%82%AF%E3%83%AA%E3%83%BC%E3%83%B3%E3%83%AB%E3%83%BC%E3%83%A0%E8%A3%BD%E9%80%A0%E3%81%AE3%E3%81%A4%E3%81%AE%E5%88%A9%E7%82%B9\"><\/span><strong>\u533b\u7642\u5206\u91ce\u306b\u304a\u3051\u308b\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u306e3\u3064\u306e\u5229\u70b9<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n<p>\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u306f\u3001\u533b\u7642\u7528\u9014\u306b\u304a\u3044\u3066\u6b20\u304b\u305b\u306a\u3044\u3044\u304f\u3064\u304b\u306e\u5229\u70b9\u3092\u63d0\u4f9b\u3057\u307e\u3059\uff1a<br\/><\/p>\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"1_%E6%B1%9A%E6%9F%93%E3%81%AE%E3%81%AA%E3%81%84%E8%A3%BD%E9%80%A0%E7%92%B0%E5%A2%83\"><\/span><strong>1. \u6c5a\u67d3\u306e\u306a\u3044\u88fd\u9020\u74b0\u5883<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p>\u9ad8\u5ea6\u306b\u7ba1\u7406\u3055\u308c\u305f\u74b0\u5883\u306b\u3088\u308a\u3001\u7cbe\u5bc6\u8a3a\u65ad\u6a5f\u5668\u304b\u3089\u751f\u547d\u7dad\u6301\u88c5\u7f6e\u306b\u81f3\u308b\u307e\u3067\u3001\u91cd\u8981\u306a\u533b\u7642\u90e8\u54c1\u3092\u6700\u9ad8\u30ec\u30d9\u30eb\u3067\u4fdd\u8b77\u3057\u307e\u3059\u3002\u30d0\u30a4\u30aa\u30bb\u30f3\u30b5\u30fc\u3084\u751f\u4f53\u63a5\u89e6\u30c7\u30d0\u30a4\u30b9\u306e\u88fd\u9020\u306b\u304a\u3044\u3066\u3001\u5fae\u7d30\u306a\u6c5a\u67d3\u7269\u8cea\u304c\u6cbb\u7642\u52b9\u679c\u3084\u60a3\u8005\u306e\u5b89\u5168\u6027\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u305f\u3081\u3001\u6e05\u6f54\u306a\u74b0\u5883\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002 <\/p>\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"2_%E5%8E%B3%E6%A0%BC%E3%81%AA%E5%93%81%E8%B3%AA%E7%AE%A1%E7%90%86%E3%81%A8%E8%A6%8F%E5%88%B6%E9%81%B5%E5%AE%88\"><\/span><strong>2. \u53b3\u683c\u306a\u54c1\u8cea\u7ba1\u7406\u3068\u898f\u5236\u9075\u5b88<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p>\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u306f\u3001\u6a19\u6e96\u7684\u306a\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u8d85\u3048\u305f\u5305\u62ec\u7684\u306a\u54c1\u8cea\u691c\u8a3c\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u74b0\u5883\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306e\u8a73\u7d30\u306a\u8a18\u9332\u3092\u4fdd\u6301\u3059\u308b\u3053\u3068\u3067\u3001FDA\uff08\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff09\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3084ISO 13485\u8a8d\u8a3c\u306e\u9075\u5b88\u3092\u5bb9\u6613\u306b\u3057\u3001\u5404\u88fd\u9020\u30d0\u30c3\u30c1\u306e\u691c\u8a3c\u30d7\u30ed\u30bb\u30b9\u3092\u78ba\u7acb\u3057\u307e\u3059\u3002 <\/p>\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"1000\" height=\"550\" src=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2025\/02\/Clean-Room-Manufacturing-Key-to-Medical-Device-Quality-6.webp\" alt=\"&#x30AF;&#x30EA;&#x30FC;&#x30F3;&#x30EB;&#x30FC;&#x30E0;&#x306F;&#x53B3;&#x683C;&#x306A;&#x54C1;&#x8CEA;&#x7BA1;&#x7406;&#x3068;&#x898F;&#x5236;&#x9075;&#x5B88;&#x3092;&#x5FC5;&#x8981;&#x3068;&#x3057;&#x307E;&#x3059;\" class=\"wp-image-6571\" srcset=\"https:\/\/www.thy-precision.com\/wp-content\/uploads\/2025\/02\/Clean-Room-Manufacturing-Key-to-Medical-Device-Quality-6.webp 1000w, https:\/\/www.thy-precision.com\/wp-content\/uploads\/2025\/02\/Clean-Room-Manufacturing-Key-to-Medical-Device-Quality-6-768x422.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"3_%E6%82%A3%E8%80%85%E3%81%AE%E5%AE%89%E5%85%A8%E6%80%A7%E3%81%A8%E8%A3%BD%E5%93%81%E3%81%AE%E4%BF%A1%E9%A0%BC%E6%80%A7%E3%81%AE%E5%90%91%E4%B8%8A\"><\/span><strong>3. \u60a3\u8005\u306e\u5b89\u5168\u6027\u3068\u88fd\u54c1\u306e\u4fe1\u983c\u6027\u306e\u5411\u4e0a<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n<p>\u53b3\u683c\u306b\u7ba1\u7406\u3055\u308c\u305f\u88fd\u9020\u6761\u4ef6\u306f\u3001\u81e8\u5e8a\u7684\u306a\u6210\u529f\u7387\u306b\u76f4\u63a5\u8ca2\u732e\u3057\u307e\u3059\u3002\u7279\u306b\u3001\u7cbe\u5bc6\u533b\u7642\u6a5f\u5668\u3084\u751f\u547d\u7dad\u6301\u88c5\u7f6e\u306e\u88fd\u9020\u3067\u306f\u3001\u4e00\u8cab\u3057\u305f\u6027\u80fd\u304c\u6cbb\u7642\u7d50\u679c\u306b\u5927\u304d\u304f\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u305f\u3081\u3001\u3053\u306e\u7ba1\u7406\u4f53\u5236\u304c\u6975\u3081\u3066\u91cd\u8981\u3067\u3059\u3002\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u5168\u4f53\u3092\u5fb9\u5e95\u7684\u306b\u76e3\u8996\u3059\u308b\u3053\u3068\u3067\u3001\u5404\u30c7\u30d0\u30a4\u30b9\u304c\u533b\u7642\u7528\u9014\u306b\u9069\u5408\u3057\u3001\u6700\u5927\u9650\u306e\u4fe1\u983c\u6027\u3092\u78ba\u4fdd\u3067\u304d\u307e\u3059\u3002  <\/p>\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"THY%E7%B2%BE%E5%AF%86%E5%B7%A5%E6%A5%AD%E3%81%A7%E3%81%AE%E3%82%AF%E3%83%AA%E3%83%BC%E3%83%B3%E3%83%AB%E3%83%BC%E3%83%A0%E8%A3%BD%E9%80%A0%EF%BC%9A%E6%8F%90%E4%BE%9B%E3%81%95%E3%82%8C%E3%82%8B%E5%8D%93%E8%B6%8A%E6%80%A7\"><\/span><strong>THY\u7cbe\u5bc6\u5de5\u696d\u3067\u306e\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\uff1a\u63d0\u4f9b\u3055\u308c\u308b\u5353\u8d8a\u6027<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n<p><a href=\"https:\/\/www.thy-precision.com\/ja\/\">THY\u7cbe\u5bc6\u5de5\u696d<\/a>\u306f\u3001\u91cd\u8981\u306a\u533b\u7642\u7528\u9014\u5411\u3051\u306e\u30ab\u30b9\u30bf\u30e0\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u5c04\u51fa\u6210\u5f62\u306b\u304a\u3044\u3066\u8c4a\u5bcc\u306a\u7d4c\u9a13\u3092\u6301\u3064\u3001\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u306e\u30ea\u30fc\u30c7\u30a3\u30f3\u30b0\u30ab\u30f3\u30d1\u30cb\u30fc\u3067\u3059\u3002\u7cbe\u5bc6\u306a\u624b\u8853\u5668\u5177\u3084\u9ad8\u5ea6\u306a\u8a3a\u65ad\u6a5f\u5668\u90e8\u54c1\u306e\u88fd\u9020\u306b\u304a\u3044\u3066\u3001\u9ad8\u7cbe\u5ea6\u306a\u91d1\u578b\u52a0\u5de5\u304a\u3088\u3073OEM\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u90e8\u54c1\u88fd\u9020\u30b5\u30fc\u30d3\u30b9\u3092\u63d0\u4f9b\u3057\u3001\u533b\u7642\u6a5f\u5668\u3001\u5149\u5b66\u3001\u96fb\u5b50\u6a5f\u5668\u306e\u5404\u5206\u91ce\u3067\u6700\u9ad8\u54c1\u8cea\u306e\u88fd\u54c1\u3092\u5b9f\u73fe\u3057\u3066\u3044\u307e\u3059\u3002 <\/p>\n\n<p>\u5f53\u793e\u306e\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u306f\u3001ISO 13485\u304a\u3088\u3073ISO 9001\u306e\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u3066\u304a\u308a\u3001\u56fd\u969b\u57fa\u6e96\u3092\u6e80\u305f\u3057\u305f\u533b\u7642\u6a5f\u5668\u88fd\u9020\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002<\/p>\n\n<p>\u6b21\u306e\u30b9\u30c6\u30c3\u30d7\u3078\u9032\u307f\u307e\u305b\u3093\u304b\uff1f<br\/>\u5f53\u793e\u306e\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u306b\u3064\u3044\u3066\u8a73\u3057\u304f\u77e5\u308a\u305f\u3044\u65b9\u3001\u307e\u305f\u306f\u304a\u898b\u7a4d\u3082\u308a\u3092\u3054\u5e0c\u671b\u306e\u65b9\u306f\u3001\u304a\u6c17\u8efd\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002\u8a73\u7d30\u60c5\u5831\u306f\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u3092\u3054\u89a7\u3044\u305f\u3060\u304f\u304b\u3001\u304a\u6c17\u8efd\u306b<a href=\"https:\/\/www.thy-precision.com\/ja\/contact\/\">\u304a\u554f\u3044\u5408\u308f\u305b<\/a>\u304f\u3060\u3055\u3044\uff01  <\/p>\n\n<p>\u95a2\u9023\u8a18\u4e8b\uff1a<br\/><a href=\"https:\/\/www.thy-precision.com\/ja\/a-guide-to-clean-room-plastic-injection-molding-2024\/\">\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u5c04\u51fa\u6210\u5f62\u306e\u696d\u754c\u6d3b\u7528\u30ac\u30a4\u30c9 [2024] [2024]<\/a> 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