{"id":5606,"date":"2026-06-26T06:27:47","date_gmt":"2026-06-26T06:27:47","guid":{"rendered":"https:\/\/xinyangmfg.com\/?p=5606"},"modified":"2026-06-28T06:32:46","modified_gmt":"2026-06-28T06:32:46","slug":"%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%ae%e3%83%97%e3%83%ad%e3%83%88%e3%82%bf%e3%82%a4%e3%83%97%e8%a3%bd%e4%bd%9c%e3%81%8a%e3%82%88%e3%81%b3%e9%87%8f%e7%94%a3","status":"publish","type":"post","link":"https:\/\/xinyangmfg.com\/ja\/medical-device-prototyping-and-production\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u306e\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u88fd\u4f5c\u3068\u91cf\u7523\uff1aCNC\u52a0\u5de5\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3001\u305d\u3057\u3066\u30a8\u30f3\u30b8\u30cb\u30a2\u304c\u77e5\u3063\u3066\u304a\u304f\u3079\u304d\u3053\u3068"},"content":{"rendered":"

\u533b\u7642\u6a5f\u5668\u306e\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u4f5c\u6210\u304a\u3088\u3073\u751f\u7523\u3068\u306f\u3001\u533b\u7642\u88fd\u54c1\u306e\u30b3\u30f3\u30bb\u30d7\u30c8\u3092\u3001\u8a2d\u8a08\u691c\u8a3c\u3001\u898f\u5236\u5f53\u5c40\u3078\u306e\u7533\u8acb\u3001\u305d\u3057\u3066\u5546\u696d\u751f\u7523\u3078\u3068\u5c0e\u304f\u591a\u6bb5\u968e\u306e\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u3067\u3042\u308a\u3001\u305d\u306e\u3059\u3079\u3066\u306e\u6bb5\u968e\u306b\u304a\u3044\u3066\u751f\u4f53\u9069\u5408\u6027\u3001\u5bf8\u6cd5\u7cbe\u5ea6\u3001\u304a\u3088\u3073\u6587\u66f8\u5316\u3055\u308c\u305f\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u7dad\u6301\u3059\u308b\u3082\u306e\u3067\u3059\u3002 2026\u5e742\u67082\u65e5\u3092\u3082\u3063\u3066\u3001FDA\u306e\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u898f\u5247\uff08QMSR\uff09\u304c\u65bd\u884c\u3055\u308c\u300121 CFR Part 820\u304cISO 13485:2016\u5e74\u7248\u3068\u6574\u5408\u3055\u305b\u307e\u3057\u305f\u3002\u3053\u308c\u306b\u3088\u308a\u3001ISO 13485\u8a8d\u8a3c\u306f\u3001\u7c73\u56fd\u306e\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u88fd\u9020\u306b\u304a\u3051\u308b\u4e8b\u5b9f\u4e0a\u306e\u57fa\u6e96\u3068\u306a\u3063\u3066\u3044\u307e\u3059\uff08Criterion Precision\u30012026\u5e74\uff09\u3002.<\/p>\n\n\n\n

CNC\u52a0\u5de5\u306f\u3001\u624b\u8853\u5668\u5177\u3001\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u90e8\u54c1\u3001\u8a3a\u65ad\u6a5f\u5668\u306e\u90e8\u54c1\u3001\u533b\u7642\u7528\u5927\u578b\u6a5f\u5668\u306e\u7b50\u4f53\u306a\u3069\u3001\u91d1\u5c5e\u88fd\u306e\u533b\u7642\u6a5f\u5668\u90e8\u54c1\u306e\u88fd\u9020\u306b\u304a\u3044\u3066\u4e3b\u6d41\u306e\u88fd\u9020\u624b\u6cd5\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u60a3\u8005\u306e\u5b89\u5168\u78ba\u4fdd\u306b\u5fc5\u8981\u306a\u30df\u30af\u30ed\u30f3\u30ec\u30d9\u30eb\u306e\u516c\u5dee\u3092\u5b9f\u73fe\u3067\u304d\u308b\u3053\u3068\u3001\u751f\u4f53\u9069\u5408\u6027\u306e\u3042\u308b\u5408\u91d1\u3084\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u306a\u3069\u5e45\u5e83\u3044\u6750\u6599\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u67d4\u8edf\u6027\u3001\u305d\u3057\u3066FDA\u306e\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306b\u5fc5\u8981\u306a\u30d7\u30ed\u30bb\u30b9\u306e\u518d\u73fe\u6027\u3092\u5099\u3048\u3066\u3044\u308b\u305f\u3081\u3067\u3059\u3002.<\/p>\n\n\n\n

\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\uff1a\u8a66\u4f5c\u304b\u3089\u91cf\u7523\u307e\u3067<\/h2>\n\n\n\n

\u30b3\u30f3\u30bb\u30d7\u30c8\u304a\u3088\u3073\u5b9f\u73fe\u53ef\u80fd\u6027\u306e\u691c\u8a3c\u3092\u76ee\u7684\u3068\u3057\u305f\u30d7\u30ed\u30c8\u30bf\u30a4\u30d4\u30f3\u30b0\u3067\u306f\u3001\u57fa\u672c\u7684\u306a\u8a2d\u8a08\u30b3\u30f3\u30bb\u30d7\u30c8\u3092\u691c\u8a3c\u3059\u308b\u305f\u3081\u306e\u5f62\u72b6\u3001\u5d4c\u5408\u3001\u6a5f\u80fd\u306e\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u304c\u4f5c\u6210\u3055\u308c\u307e\u3059\u3002\u3053\u306e\u6bb5\u968e\u306e\u90e8\u54c1\u306b\u306f\u3001\u6a5f\u80fd\u7684\u306a\u63a5\u5408\u90e8\u306b\u304a\u3051\u308b\u5bf8\u6cd5\u7cbe\u5ea6\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u304c\u3001\u5b8c\u5168\u306a\u751f\u4f53\u9069\u5408\u6027\u306e\u691c\u8a3c\u3001\u6750\u6599\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u304a\u3088\u3073\u751f\u7523\u95a2\u9023\u6587\u66f8\u306f\u3001\u73fe\u6642\u70b9\u3067\u306f\u5fc5\u8981\u3068\u3055\u308c\u307e\u305b\u3093\u3002\u53cd\u5fa9\u306e\u30b9\u30d4\u30fc\u30c9\u304c\u6700\u512a\u5148\u3055\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n

\u8a2d\u8a08\u306e\u691c\u8a3c\u304a\u3088\u3073\u59a5\u5f53\u6027\u78ba\u8a8d\uff08V&V\uff09\u306b\u306f\u3001\u6240\u5b9a\u306e\u751f\u7523\u6750\u6599\u3092\u7528\u3044\u3066\u3001\u8a08\u753b\u3055\u308c\u305f\u751f\u7523\u30d7\u30ed\u30bb\u30b9\u3092\u4ee3\u8868\u3059\u308b\u88fd\u9020\u65b9\u6cd5\u3067\u88fd\u9020\u3055\u308c\u3001\u8a2d\u8a08\u8981\u4ef6\u306b\u5f93\u3063\u3066\u691c\u67fb\u3055\u308c\u305f\u90e8\u54c1\u304c\u5fc5\u8981\u3067\u3059\u3002 V&V\u8a66\u9a13\u306b\u4f7f\u7528\u3055\u308c\u308b\u90e8\u54c1\u306f\u3001\u3069\u306e\u6750\u6599\u30ed\u30c3\u30c8\u3001\u3069\u306e\u6a5f\u68b0\u3001\u3069\u306e\u4f5c\u696d\u8005\u3001\u3069\u306e\u691c\u67fb\u7d50\u679c\u3067\u3042\u308b\u304b\u3068\u3044\u3063\u305f\u8ffd\u8de1\u53ef\u80fd\u6027\u304c\u78ba\u4fdd\u3055\u308c\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u3053\u308c\u306f\u3001\u3053\u308c\u3089\u306e\u30c7\u30fc\u30bf\u304cFDA\u306b\u63d0\u51fa\u3055\u308c\u308b\u8a2d\u8a08\u5c65\u6b74\u30d5\u30a1\u30a4\u30eb\uff08DHF\uff09\u306e\u4e00\u90e8\u3092\u69cb\u6210\u3059\u308b\u305f\u3081\u3067\u3059\u3002.<\/p>\n\n\n\n

\u81e8\u5e8a\u8a66\u9a13\u7528\u88fd\u54c1\u306e\u88fd\u9020\u306b\u306f\u3001ISO 13485\u306b\u6e96\u62e0\u3057\u305f\u54c1\u8cea\u7ba1\u7406\u4f53\u5236\u306e\u4e0b\u3067\u88fd\u9020\u3055\u308c\u305f\u90e8\u54c1\u304c\u5fc5\u8981\u3067\u3042\u308a\u3001\u5b8c\u5168\u306a\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u30ed\u30c3\u30c8\u8a18\u9332\u3001\u304a\u3088\u3073\u6587\u66f8\u5316\u3055\u308c\u305f\u5de5\u7a0b\u7ba1\u7406\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n

\u5546\u696d\u751f\u7523\u306f\u6700\u7d42\u6bb5\u968e\u3067\u3042\u308a\u3001\u751f\u7523\u3055\u308c\u308b\u3059\u3079\u3066\u306e\u88fd\u54c1\u306f\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u6e08\u307f\u306e\u30de\u30b9\u30bf\u30fc\u30b5\u30f3\u30d7\u30eb\u3068\u5b8c\u5168\u306b\u540c\u4e00\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u5546\u696d\u751f\u7523\u306e\u30ea\u30ea\u30fc\u30b9\u306b\u5148\u7acb\u3061\u3001\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08IQ\u3001OQ\u3001PQ\uff09\u3092\u5b8c\u4e86\u3057\u3001\u305d\u306e\u8a18\u9332\u3092\u4f5c\u6210\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

\u533b\u7642\u6a5f\u5668\u306e\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u88fd\u4f5c\u306b\u304a\u3051\u308bCNC\u52a0\u5de5\uff1a\u30b9\u30d4\u30fc\u30c9\u3001\u7cbe\u5ea6\u3001\u305d\u3057\u3066\u7d20\u6750\u306e\u5fe0\u5b9f\u5ea6<\/h2>\n\n\n\n

CNC\u52a0\u5de5\u306f\u3001\u6700\u3082\u597d\u307e\u308c\u308b \u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u65b9\u6cd5<\/a> \u91d1\u5c5e\u88fd\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u306f\u3001\u751f\u7523\u3068\u540c\u7b49\u306e\u5bf8\u6cd5\u7cbe\u5ea6\u3001\u6700\u521d\u306e\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u6bb5\u968e\u304b\u3089\u751f\u7523\u7528\u3068\u540c\u7b49\u306e\u751f\u4f53\u9069\u5408\u6027\u6750\u6599\u3092\u81ea\u7531\u306b\u4f7f\u7528\u3067\u304d\u308b\u3053\u3068\u3001\u305d\u3057\u3066\u91d1\u578b\u3078\u306e\u6295\u8cc7\u3092\u5fc5\u8981\u3068\u3057\u306a\u3044\u8fc5\u901f\u306a\u53cd\u5fa9\u30b5\u30a4\u30af\u30eb\u3068\u3044\u30463\u3064\u306e\u7279\u6027\u3092\u540c\u6642\u306b\u5099\u3048\u3066\u3044\u308b\u305f\u3081\u3067\u3059\u3002.<\/p>\n\n\n\n

\u521d\u671f\u6bb5\u968e\u306e\u30b3\u30f3\u30bb\u30d7\u30c8\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u306b\u3064\u3044\u3066\u306f\u3001\u4ee5\u4e0b\u3092\u7528\u3044\u305f\u30e9\u30d4\u30c3\u30c9\u30d7\u30ed\u30c8\u30bf\u30a4\u30d4\u30f3\u30b0\u30b5\u30fc\u30d3\u30b9 CNC\u52a0\u5de5<\/a> \u30a2\u30eb\u30df\u30cb\u30a6\u30e0\u88fd\u307e\u305f\u306f\u30b9\u30c6\u30f3\u30ec\u30b9\u88fd\u306e\u533b\u7642\u7528\u90e8\u54c1\u3092\u30013\uff5e7\u55b6\u696d\u65e5\u3067\u7d0d\u54c1\u53ef\u80fd\u3067\u3059\u3002\u3053\u306e\u30b9\u30d4\u30fc\u30c9\u306b\u3088\u308a\u3001\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u30c1\u30fc\u30e0\u306f2\u9031\u9593\u4ee5\u5185\u306b\u8a2d\u8a08\u306e\u53cd\u5fa9\u30b5\u30a4\u30af\u30eb\u30921\u56de\u5b8c\u4e86\u3055\u305b\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p>\n\n\n\n

V&V\u6bb5\u968e\u306e\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u306b\u3064\u3044\u3066\u306f\u3001\u52a0\u5de5\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u4e88\u5b9a\u3055\u308c\u3066\u3044\u308b\u91cf\u7523\u30d7\u30ed\u30bb\u30b9\u306b\u53ef\u80fd\u306a\u9650\u308a\u8fd1\u3044\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u91cf\u7523\u3067\u306f 5\u8ef8CNC\u52a0\u5de5<\/a> \u30c1\u30bf\u30f3\uff08Ti-6Al-4V\uff09\u306e\u5834\u5408\u3001V&V\u7528\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u306f\u3001\u540c\u4e00\u306e\u6750\u8cea\u30b0\u30ec\u30fc\u30c9\u306e5\u8ef8\u52a0\u5de5\u6a5f\u3067\u52a0\u5de5\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u518d\u8a66\u9a13\u3092\u884c\u308f\u305a\u306b\u3001\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u7528\u306e\u30a2\u30eb\u30df\u30cb\u30a6\u30e0\u304b\u3089\u91cf\u7523\u7528\u306e\u30c1\u30bf\u30f3\u306b\u5207\u308a\u66ff\u3048\u308b\u3053\u3068\u306f\u3001\u898f\u5236\u4e0a\u306e\u3088\u304f\u3042\u308b\u30df\u30b9\u3067\u3042\u308a\u3001\u305d\u306e\u7d50\u679c\u3001V&V\u30d5\u30a7\u30fc\u30ba\u5168\u4f53\u3092\u3084\u308a\u76f4\u3059\u5fc5\u8981\u304c\u751f\u3058\u307e\u3059\u3002.<\/p>\n\n\n\n

\u533b\u7642\u6a5f\u5668\u306e\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u88fd\u4f5c\u306b\u304a\u3044\u3066\u3001\u8868\u9762\u4ed5\u4e0a\u3052\u306f\u691c\u8a3c\u30fb\u59a5\u5f53\u6027\u78ba\u8a8d\uff08V&V\uff09\u6bb5\u968e\u4ee5\u964d\u3082\u91cd\u8981\u306a\u8981\u7d20\u3068\u306a\u308a\u307e\u3059\u3002\u4f53\u5185\u306b\u57cb\u3081\u8fbc\u3080\u90e8\u54c1\u306b\u3064\u3044\u3066\u306f\u3001\u7d44\u7e54\u3068\u63a5\u89e6\u3059\u308b\u8868\u9762\u306e\u8868\u9762\u7c97\u3055\u304cRa 0.4 \u00b5m\u304b\u3089Ra 0.8 \u00b5m\u306e\u7bc4\u56f2\u306b\u3042\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u307e\u305f\u3001\u8a3a\u65ad\u6a5f\u5668\u306e\u6d41\u8def\u90e8\u54c1\u306b\u3064\u3044\u3066\u306f\u3001\u751f\u7269\u5b66\u7684\u6c5a\u67d3\u7269\u8cea\u306e\u84c4\u7a4d\u3092\u9632\u3050\u305f\u3081\u3001Ra 0.8 \u00b5m\u4ee5\u4e0b\u306e\u8868\u9762\u7c97\u3055\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n

ISO 13485 \u304a\u3088\u3073 FDA QMSR\uff1a2026\u5e74\u306b\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304c\u77e5\u3063\u3066\u304a\u304f\u3079\u304d\u3053\u3068<\/h2>\n\n\n\n

2026\u5e742\u67082\u65e5\u3001FDA\u306e\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u898f\u5247\uff08QMSR\uff09\u304c\u65bd\u884c\u3055\u308c\u300121 CFR Part 820\u304c\u6539\u6b63\u3055\u308c\u3066ISO 13485:2016\u304c\u53c2\u7167\u306b\u3088\u308a\u7d44\u307f\u8fbc\u307e\u308c\u305f\u3053\u3068\u3067\u3001\u533b\u7642\u6a5f\u5668\u88fd\u9020\u306b\u95a2\u3059\u308b\u898f\u5236\u74b0\u5883\u306f\u5927\u304d\u304f\u5909\u5316\u3057\u307e\u3057\u305f\u3002 \u7c73\u56fd\u5e02\u5834\u306b\u88fd\u54c1\u3092\u4f9b\u7d66\u3059\u308b\u533b\u7642\u6a5f\u5668\u90e8\u54c1\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306b\u3068\u3063\u3066\u3001\u5358\u306bISO 9001\u306e\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u3066\u3044\u308b\u3060\u3051\u3067\u306f\u3082\u306f\u3084\u4e0d\u5341\u5206\u3067\u3059\u3002.<\/p>\n\n\n\n

ISO 13485:2016 \u3067\u306f\u3001\u88fd\u54c1\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u5168\u4f53\u306b\u308f\u305f\u308b\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\uff08ISO 14971\uff09\u3001\u88fd\u9020\u5de5\u7a0b\u306b\u304a\u3051\u308b\u6c5a\u67d3\u7ba1\u7406\u3001\u8a2d\u8a08\u5c65\u6b74\u30d5\u30a1\u30a4\u30eb\u306e\u7dad\u6301\u7ba1\u7406\u3001\u5404\u30ed\u30c3\u30c8\u3054\u3068\u306e\u539f\u6750\u6599\u8a3c\u660e\u66f8\u304a\u3088\u3073\u691c\u67fb\u5831\u544a\u66f8\u3092\u542b\u3080\u5b8c\u5168\u306a\u30d0\u30c3\u30c1\u8a18\u9332\u3001\u306a\u3089\u3073\u306b\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u306e\u6587\u66f8\u5316\u3055\u308c\u305f\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n

ISO 14971\u306b\u57fa\u3065\u304f\u30ea\u30b9\u30af\u7ba1\u7406\u3067\u306f\u3001\u30cf\u30b6\u30fc\u30c9\u306e\u7279\u5b9a\u3001\u30ea\u30b9\u30af\u306e\u63a8\u5b9a\u304a\u3088\u3073\u8a55\u4fa1\u3001\u30ea\u30b9\u30af\u7ba1\u7406\u63aa\u7f6e\u306e\u5b9f\u65bd\u3001\u306a\u3089\u3073\u306b\u305d\u308c\u3089\u306e\u63aa\u7f6e\u306e\u6709\u52b9\u6027\u306e\u76e3\u8996\u3092\u884c\u3046\u305f\u3081\u306e\u4f53\u7cfb\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002CNC\u52a0\u5de5\u3055\u308c\u305f\u533b\u7642\u7528\u90e8\u54c1\u306e\u5834\u5408\u3001\u3053\u308c\u306f\u3001\u6545\u969c\u30e2\u30fc\u30c9\uff08\u5bf8\u6cd5\u4e0d\u9069\u5408\u3001\u8868\u9762\u6c5a\u67d3\u3001\u6750\u6599\u306e\u6df7\u5165\uff09\u3092\u7279\u5b9a\u3057\u3001\u305d\u308c\u3089\u3092\u9632\u6b62\u3059\u308b\u305f\u3081\u306e\u7ba1\u7406\u63aa\u7f6e\u3092\u6587\u66f8\u5316\u3059\u308b\u3053\u3068\u3092\u610f\u5473\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n

\u60a3\u8005\u3068\u63a5\u89e6\u3059\u308b\u3042\u3089\u3086\u308b\u69cb\u6210\u90e8\u54c1\u306b\u3064\u3044\u3066\u306f\u3001ISO 10993\u306b\u57fa\u3065\u304f\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u751f\u7269\u5b66\u7684\u8a55\u4fa1\u8a08\u753b\u306b\u306f\u3001\u7d30\u80de\u6bd2\u6027\u3001\u611f\u4f5c\u6027\u3001\u523a\u6fc0\u6027\u3001\u304a\u3088\u3073\u5168\u8eab\u6bd2\u6027\u306e\u8a66\u9a13\u304c\u542b\u307e\u308c\u307e\u3059\u3002 ISO 10993\u306b\u57fa\u3065\u304f\u751f\u4f53\u9069\u5408\u6027\u306e\u5b9f\u7e3e\u304c\u78ba\u7acb\u3055\u308c\u3066\u3044\u308b\u6750\u6599\uff08\u533b\u7642\u7528\u30c1\u30bf\u30f3\u3001316L\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u3001\u30b3\u30d0\u30eb\u30c8\u30af\u30ed\u30e0\u3001PEEK\u306a\u3069\uff09\u3092\u4f7f\u7528\u3059\u308b\u3053\u3068\u3067\u3001\u751f\u4f53\u9069\u5408\u6027\u8a55\u4fa1\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u5927\u5e45\u306b\u7c21\u7565\u5316\u3067\u304d\u307e\u3059\u3002.<\/p>\n\n\n\n

CNC\u52a0\u5de5\u3055\u308c\u305f\u533b\u7642\u7528\u90e8\u54c1\u5411\u3051\u306e\u751f\u4f53\u9069\u5408\u6027\u6750\u6599<\/h2>\n\n\n\n
\u7d20\u6750<\/strong><\/td>\u4e3b\u306a\u533b\u7642\u7528\u9014<\/strong><\/td>\u751f\u4f53\u9069\u5408\u6027<\/strong><\/td>\u6ec5\u83cc<\/strong><\/td>\u52a0\u5de5\u6027<\/strong><\/td><\/tr><\/thead>
5\u7d1a Ti-6Al-4V ELI<\/td>\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3001\u624b\u8853\u5668\u5177<\/td>ISO 10993\u304c\u5236\u5b9a\u3055\u308c\u305f<\/td>\u84b8\u6c17\u3001EO\u3001\u30ac\u30f3\u30de\u7dda<\/td>\u96e3\u3057\u3044<\/td><\/tr>
316L\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc<\/td>\u624b\u8853\u5668\u5177\u3001\u518d\u5229\u7528\u53ef\u80fd\u306a\u533b\u7642\u6a5f\u5668<\/td>ISO 10993\u304c\u5236\u5b9a\u3055\u308c\u305f<\/td>Steam\u3001EO<\/td>\u4e2d\u7a0b\u5ea6<\/td><\/tr>
\u30b3\u30d0\u30eb\u30c8\u30fb\u30af\u30ed\u30e0\uff08CoCrMo\uff09<\/td>\u95a2\u7bc0\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3001\u6b6f\u79d1\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8<\/td>ISO 10993\u304c\u5236\u5b9a\u3055\u308c\u305f<\/td>Steam<\/td>\u975e\u5e38\u306b\u96e3\u3057\u3044<\/td><\/tr>
PEEK\uff08\u533b\u7642\u7528\u30b0\u30ec\u30fc\u30c9\uff09<\/td>\u810a\u690e\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3001\u624b\u8853\u5668\u5177<\/td>ISO 10993\u304c\u5236\u5b9a\u3055\u308c\u305f<\/td>EO\u3001\u30ac\u30f3\u30de<\/td>\u3044\u3044\u306d<\/td><\/tr>
\u30a2\u30eb\u30df\u30cb\u30a6\u30e0 6061-T6<\/td>\u8a3a\u65ad\u6a5f\u5668\u306e\u7b50\u4f53<\/td>\u60a3\u8005\u3068\u306e\u63a5\u89e6\u306b\u306f\u4f7f\u7528\u3057\u306a\u3044\u3067\u304f\u3060\u3055\u3044<\/td>\u5834\u5408\u306b\u3088\u308b<\/td>\u7d20\u6674\u3089\u3057\u3044<\/td><\/tr>
\u30c7\u30eb\u30ea\u30f3\uff08\u30a2\u30bb\u30bf\u30fc\u30eb POM\uff09<\/td>\u5668\u5177\u306e\u30cf\u30f3\u30c9\u30eb\u3001\u6cbb\u5177<\/td>\u9650\u5b9a\uff08\u975e\u57cb\u3081\u8fbc\u307f\u578b\uff09<\/td>EO\u3001\u30ac\u30f3\u30de<\/td>\u7d20\u6674\u3089\u3057\u3044<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

\u30c1\u30bf\u30f323\u53f7\uff08Ti-6Al-4V ELI \u2014 \u6975\u4f4e\u9593\u9699\u5143\u7d20\u542b\u6709\uff09\u306f\u3001\u4f53\u5185\u306b\u57cb\u3081\u8fbc\u3080\u91d1\u5c5e\u88fd\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306b\u597d\u3093\u3067\u7528\u3044\u3089\u308c\u308b\u6750\u6599\u3067\u3059\u3002ELI\u30b0\u30ec\u30fc\u30c9\u306f\u3001\u6a19\u6e96\u7684\u306aTi-6Al-4V\u306b\u6bd4\u3079\u3066\u9178\u7d20\u3001\u7a92\u7d20\u3001\u70ad\u7d20\u306e\u542b\u6709\u91cf\u304c\u4f4e\u304f\u3001\u3053\u308c\u306b\u3088\u308a\u3001\u7e70\u8fd4\u3057\u8377\u91cd\u304c\u304b\u304b\u308b\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u7528\u9014\u306b\u304a\u3044\u3066\u7834\u65ad\u976d\u6027\u304c\u5411\u4e0a\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n

316L\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u306f\u3001\u518d\u5229\u7528\u53ef\u80fd\u306a\u624b\u8853\u5668\u5177\u306e\u6a19\u6e96\u6750\u6599\u3067\u3059\u3002\u8d85\u786c\u5de5\u5177\u306b\u3088\u308b\u52a0\u5de5\u6027\u306b\u512a\u308c\u3001\u78ba\u5b9f\u306b\u4e0d\u52d5\u614b\u5316\u51e6\u7406\u304c\u53ef\u80fd\u3067\u3042\u308a\u3001\u7e70\u308a\u8fd4\u3057\u84b8\u6c17\u6ec5\u83cc\u3092\u884c\u3063\u3066\u3082\u5bf8\u6cd5\u5909\u5316\u304c\u751f\u3058\u307e\u305b\u3093\u3002\u624b\u8853\u5668\u5177\u306e\u4e0d\u52d5\u614b\u5316\u51e6\u7406\u5f8c\u306e\u8868\u9762\u7c97\u3055\u306f\u3001\u901a\u5e38\u3001\u63a5\u89e6\u9762\u3067Ra 0.4 \u00b5m\u304b\u3089Ra 0.8 \u00b5m\u306e\u7bc4\u56f2\u306b\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

\u533b\u7642\u7528CNC\u90e8\u54c1\u306e\u516c\u5dee\u304a\u3088\u3073\u8868\u9762\u4ed5\u4e0a\u3052\u8981\u4ef6<\/h2>\n\n\n\n

\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306e\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\uff08\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u304c\u9aa8\u3001\u7d44\u7e54\u3001\u307e\u305f\u306f\u4ed6\u306e\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u90e8\u54c1\u3068\u63a5\u89e6\u3059\u308b\u8868\u9762\uff09\u306b\u306f\u3001\u901a\u5e38\u3001\u00b10.01 mm \u304b\u3089 \u00b10.025 mm \u306e\u516c\u5dee\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u30e2\u30b8\u30e5\u30e9\u30fc\u578b\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306e\u30c6\u30fc\u30d1\u30fc\u4ed8\u304d\u30e2\u30fc\u30b9\u578b\u63a5\u7d9a\u90e8\u3067\u306f\u3001\u30c6\u30fc\u30d1\u30fc\u89d2\uff08\u00b10.05 \u5ea6\u4ee5\u5185\uff09\u3068\u30c6\u30fc\u30d1\u30fc\u5f84\u306e\u4e21\u65b9\u306b\u3064\u3044\u3066\u516c\u5dee\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n

\u5207\u524a\u5203\u3001\u30b8\u30e7\u30fc\u63a5\u5408\u90e8\u3001\u30d2\u30f3\u30b8\u306e\u8ef8\u306a\u3069\u3001\u624b\u8853\u5668\u5177\u306e\u5404\u90e8\u306b\u306f\u3001\u6a5f\u80fd\u9762\u306b\u304a\u3044\u3066\u00b10.025 mm\uff5e\u00b10.05 mm\u306e\u516c\u5dee\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u306f\u3055\u307f\u3084\u30b7\u30a2\u30fc\uff08\u526a\u65ad\u5668\u5177\uff09\u306e\u5207\u524a\u5203\u5f62\u72b6\u306b\u3064\u3044\u3066\u306f\u3001\u5207\u65ad\u52b9\u7387\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u3001\u8868\u9762\u7c97\u3055Ra 0.4 \u00b5m\u4ee5\u4e0b\u304a\u3088\u3073\u898f\u5b9a\u3055\u308c\u305f\u5203\u5148\u534a\u5f84\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n

\u8a3a\u65ad\u6a5f\u5668\u306e\u69cb\u6210\u90e8\u54c1\uff08\u6d41\u8def\u3001\u30bb\u30f3\u30b5\u30fc\u53d6\u308a\u4ed8\u3051\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u3001\u5149\u5b66\u4f4d\u7f6e\u5408\u308f\u305b\u90e8\u306a\u3069\uff09\u3067\u306f\u3001\u901a\u5e38\u3001\u6a5f\u80fd\u9762\u306b\u304a\u3044\u3066\u00b10.025 mm\uff5e\u00b10.05 mm\u306e\u7cbe\u5ea6\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u6d41\u8def\u306e\u6e05\u6d44\u5ea6\u306b\u3064\u3044\u3066\u306f\u3001Ra 0.8 \u00b5m\u4ee5\u4e0a\u304c\u8981\u6c42\u3055\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n

\u9ad8\u7cbe\u5ea6 CNC\u65cb\u76e4\u52a0\u5de5<\/a> \u5c0f\u578b\u533b\u7642\u7528\u90e8\u54c1\u306e\u65cb\u524a\u5f84\u306b\u304a\u3044\u3066\u00b10.005 mm\uff080.0002\u30a4\u30f3\u30c1\uff09\u306e\u516c\u5dee\u3092\u7dad\u6301\u3067\u304d\u308b\u305f\u3081\u3001\u76f4\u5f840.25 mm\u3068\u3044\u3046\u6975\u5c0f\u30b5\u30a4\u30ba\u306e\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u7528\u30cd\u30b8\u3001\u624b\u8853\u7528\u30d7\u30ed\u30fc\u30d6\u672c\u4f53\u3001\u304a\u3088\u3073\u30b3\u30cd\u30af\u30bf\u90e8\u54c1\u306b\u9069\u3057\u3066\u3044\u308b\uff08Criterion Precision, 2026\uff09\u3002.<\/p>\n\n\n\n

\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u304b\u3089\u691c\u8a3c\u6e08\u307f\u306e\u533b\u7642\u7528\u88fd\u54c1\u3078\u306e\u79fb\u884c<\/h2>\n\n\n\n

\u533b\u7642\u6a5f\u5668\u306e\u8a66\u4f5c\u304b\u3089\u91cf\u7523\u3078\u306e\u79fb\u884c\u306b\u304a\u3044\u3066\u3001\u81f4\u547d\u7684\u306a\u904e\u3061\u306f\u3001\u91cf\u7523\u9069\u683c\u6027\u8a55\u4fa1\u3092\u958b\u767a\u5f8c\u306e\u6d3b\u52d5\u3068\u3057\u3066\u6271\u3063\u3066\u3057\u307e\u3046\u3053\u3068\u3067\u3059\u3002 \u691c\u8a3c\u30fb\u59a5\u5f53\u6027\u78ba\u8a8d\uff08V&V\uff09\u30c6\u30b9\u30c8\u304c\u5b8c\u4e86\u3057\u3001\u898f\u5236\u5f53\u5c40\u3078\u306e\u7533\u8acb\u624b\u7d9a\u304d\u304c\u9032\u3081\u3089\u308c\u3066\u3044\u308b\u6bb5\u968e\u3067\u306f\u3001\u3059\u3067\u306b\u88fd\u9020\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3068\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u306f\u90e8\u5206\u7684\u306b\u8a8d\u5b9a\u6e08\u307f\u3067\u3042\u308b\u3079\u304d\u3067\u3059\u3002V&V\u5b8c\u4e86\u5f8c\u306b\u88fd\u9020\u8a8d\u5b9a\u3092\u958b\u59cb\u3059\u308b\u3068\u3001\u88fd\u54c1\u958b\u767a\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u306b\u7d44\u307f\u8fbc\u307e\u308c\u3066\u3044\u306a\u304b\u3063\u305f3\uff5e6\u30f6\u6708\u306e\u5de5\u671f\u304c\u8ffd\u52a0\u3055\u308c\u3066\u3057\u307e\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n

\u6b63\u3057\u3044\u30a2\u30d7\u30ed\u30fc\u30c1\uff1aV&V\u306e\u6bb5\u968e\u3067\u91cf\u7523\u7528CNC\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u7279\u5b9a\u3057\u3001\u5f8c\u671f\u6bb5\u968e\u306eV&V\u7528\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u306b\u3064\u3044\u3066\u3082\u540c\u3058\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u5229\u7528\u3059\u308b\u3002 \u3053\u308c\u306b\u3088\u308a\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c\u3059\u3067\u306b\u90e8\u54c1\u306b\u7cbe\u901a\u3057\u3066\u304a\u308a\u3001\u6cbb\u5177\u3084\u30c4\u30fc\u30eb\u30d1\u30b9\u3082\u958b\u767a\u6e08\u307f\u3067\u3042\u308b\u305f\u3081\u3001\u518d\u5b66\u7fd2\u306e\u30b5\u30a4\u30af\u30eb\u3092\u7d4c\u308b\u3053\u3068\u306a\u304f\u3001\u8a66\u4f5c\u88fd\u9020\u304b\u3089\u751f\u7523\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08IQ\u3001OQ\u3001PQ\uff09\u3078\u3068\u76f4\u63a5\u79fb\u884c\u3067\u304d\u308b\u3001\u81ea\u7136\u306a\u79fb\u884c\u304c\u5b9f\u73fe\u3055\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n

\u533b\u7642\u7528\u88fd\u54c1\u306eCNC\u52a0\u5de5\u306b\u95a2\u3059\u308b\u6587\u66f8\u306f\u3001\u5f53\u8a72\u533b\u7642\u6a5f\u5668\u306e\u5546\u696d\u7684\u8010\u7528\u671f\u9593\u3092\u901a\u3058\u3066\u4fdd\u5b58\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u57cb\u3081\u8fbc\u307f\u578b\u533b\u7642\u6a5f\u5668\u306e\u5834\u5408\u3001\u3053\u306e\u671f\u9593\u306f\u901a\u5e38\u3001\u60a3\u8005\u306e\u4f59\u547d\u306b2\u5e74\u3092\u52a0\u3048\u305f\u671f\u9593\u3068\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

\u533b\u7642\u6a5f\u5668\u306e\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u88fd\u4f5c\u304a\u3088\u3073\u91cf\u7523\u306b\u95a2\u3059\u308b\u3088\u304f\u3042\u308b\u8cea\u554f<\/h2>\n\n\n\n

2026\u5e74\u306b\u304a\u3044\u3066\u3001CNC\u52a0\u5de5\u3055\u308c\u305f\u533b\u7642\u6a5f\u5668\u90e8\u54c1\u306b\u306f\u3069\u306e\u3088\u3046\u306a\u898f\u5236\u8981\u4ef6\u304c\u9069\u7528\u3055\u308c\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1f<\/strong><\/h3>\n\n\n\n

2026\u5e742\u67082\u65e5\u3088\u308a\u3001FDA\u306e\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u898f\u5247\uff08QMSR\uff09\u304c\u65bd\u884c\u3055\u308c\u3001ISO 13485:2016\u304c21 CFR Part 820\u306b\u53c2\u7167\u306b\u3088\u308a\u7d44\u307f\u8fbc\u307e\u308c\u307e\u3057\u305f\u3002 \u7c73\u56fd\u5e02\u5834\u5411\u3051\u306e\u533b\u7642\u6a5f\u5668\u90e8\u54c1\u3092\u88fd\u9020\u3059\u308b\u3059\u3079\u3066\u306e\u65bd\u8a2d\u306f\u3001ISO 13485\u3078\u306e\u6e96\u62e0\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u6b27\u5dde\u3078\u306e\u8f38\u51fa\u306b\u3064\u3044\u3066\u306f\u3001EU MDR\u3078\u306e\u6e96\u62e0\u3082\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002EU MDR\u3067\u306f\u3001\u88fd\u9020\u306b\u95a2\u3057\u3066ISO 13485\u306e\u6e96\u62e0\u3092\u7fa9\u52d9\u4ed8\u3051\u308b\u307b\u304b\u3001\u5e02\u8ca9\u5f8c\u8abf\u67fb\u304a\u3088\u3073\u81e8\u5e8a\u7684\u30a8\u30d3\u30c7\u30f3\u30b9\u306b\u95a2\u3059\u308b\u8ffd\u52a0\u8981\u4ef6\u3092\u8ab2\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n

ISO 13485\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f\u307e\u305f\u3001\u533b\u7642\u7528CNC\u52a0\u5de5\u306b\u304a\u3044\u3066\u306a\u305c\u3053\u308c\u304c\u6c42\u3081\u3089\u308c\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1f<\/strong><\/h3>\n\n\n\n

ISO 13485\u306f\u3001\u533b\u7642\u6a5f\u5668\u306b\u7279\u5316\u3057\u305f\u56fd\u969b\u7684\u306a\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u898f\u683c\u3067\u3059\u3002ISO 9001\u3068\u306f\u7570\u306a\u308a\u3001\u3053\u306e\u898f\u683c\u3067\u306f\u3001ISO 14971\u306b\u57fa\u3065\u304f\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3001\u6c5a\u67d3\u7ba1\u7406\u624b\u9806\u3001\u539f\u6750\u6599\u306e\u9069\u5408\u8a3c\u660e\u66f8\u304a\u3088\u3073\u691c\u67fb\u5831\u544a\u66f8\u3092\u542b\u3080\u5b8c\u5168\u306a\u30ed\u30c3\u30c8\u8a18\u9332\u3001\u88fd\u9020\u5de5\u7a0b\u306e\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3001\u306a\u3089\u3073\u306b\u6587\u66f8\u5316\u3055\u308c\u305f\u8a2d\u8a08\u5c65\u6b74\u30d5\u30a1\u30a4\u30eb\u306e\u7dad\u6301\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n

CNC\u52a0\u5de5\u3055\u308c\u305f\u533b\u7642\u7528\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306b\u304a\u3044\u3066\u3001\u3069\u306e\u3088\u3046\u306a\u6750\u6599\u304c\u751f\u4f53\u9069\u5408\u6027\u3092\u6301\u3064\u306e\u3067\u3057\u3087\u3046\u304b\uff1f<\/strong><\/h3>\n\n\n\n

\u57cb\u3081\u8fbc\u307f\u578b\u90e8\u54c1\u306b\u3064\u3044\u3066\u306f\u3001ISO 10993\u306b\u57fa\u3065\u304d\u5b89\u5168\u6027\u304c\u78ba\u7acb\u3055\u308c\u3066\u3044\u308b\u4e3b\u306a\u751f\u4f53\u9069\u5408\u6027\u6750\u6599\u3068\u3057\u3066\u3001\u30c1\u30bf\u30f3 Ti-6Al-4V ELI\uff08\u30b0\u30ec\u30fc\u30c923\uff09\u3001\u30b3\u30d0\u30eb\u30c8\u30fb\u30af\u30ed\u30e0\u30fb\u30e2\u30ea\u30d6\u30c7\u30f3\u5408\u91d1\uff08CoCrMo\uff09\u3001 316L\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u3001\u304a\u3088\u3073\u533b\u7642\u7528PEEK\u304c\u6319\u3052\u3089\u308c\u308b\u3002\u3059\u3079\u3066\u306e\u57cb\u8fbc\u578b\u6750\u6599\u306f\u3001ISO 10993\u306b\u57fa\u3065\u304f\u751f\u4f53\u9069\u5408\u6027\u8a55\u4fa1\u304c\u5fc5\u8981\u3067\u3042\u308b\u3002\u30a2\u30eb\u30df\u30cb\u30a6\u30e0\u306f\u3001\u4e00\u822c\u7684\u306b\u60a3\u8005\u3068\u63a5\u89e6\u3059\u308b\u7528\u9014\u306b\u304a\u3044\u3066\u306f\u751f\u4f53\u9069\u5408\u6027\u304c\u306a\u3044\u3002.<\/p>\n\n\n\n

CNC\u52a0\u5de5\u3055\u308c\u305f\u533b\u7642\u7528\u90e8\u54c1\u306b\u306f\u3001\u3069\u306e\u3088\u3046\u306a\u8868\u9762\u4ed5\u4e0a\u3052\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u304b\uff1f<\/strong><\/h3>\n\n\n\n

\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306e\u7d44\u7e54\u63a5\u89e6\u9762\u306f\u3001\u901a\u5e38\u3001\u4ed5\u4e0a\u3052\u5f8c\u306bRa 0.4 \u00b5m\uff5eRa 0.8 \u00b5m\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u624b\u8853\u7528\u5668\u5177\u306e\u5207\u524a\u9762\u306b\u306f\u3001Ra 0.4 \u00b5m\u4ee5\u4e0a\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u8a3a\u65ad\u6a5f\u5668\u306e\u6d41\u8def\u9762\u306b\u306f\u3001Ra 0.8 \u00b5m\u4ee5\u4e0a\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002 \u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u88fd\u306e\u533b\u7642\u7528\u90e8\u54c1\u306b\u306f\u3001\u30d1\u30c3\u30b7\u30d9\u30fc\u30b7\u30e7\u30f3\u51e6\u7406\u304c\u6a19\u6e96\u7684\u306b\u884c\u308f\u308c\u307e\u3059\u3002\u96fb\u89e3\u7814\u78e8\u306f\u3001\u8868\u9762\u4ed5\u4e0a\u3052\u3068\u8010\u98df\u6027\u306e\u4e21\u65b9\u3092\u5411\u4e0a\u3055\u305b\u308b\u305f\u3081\u3001\u6d41\u4f53\u63a5\u89e6\u9762\u3084\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306e\u8868\u9762\u306b\u7528\u3044\u3089\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n

\u300c\u8a2d\u8a08\u5c65\u6b74\u30d5\u30a1\u30a4\u30eb\u300d\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f\u307e\u305f\u3001\u306a\u305c\u88fd\u9020\u95a2\u9023\u6587\u66f8\u304c\u5fc5\u8981\u3068\u306a\u308b\u306e\u3067\u3059\u304b\uff1f<\/strong><\/h3>\n\n\n\n

\u8a2d\u8a08\u5c65\u6b74\u30d5\u30a1\u30a4\u30eb\uff08DHF\uff09\u3068\u306f\u3001FDA 21 CFR Part 820 \u304a\u3088\u3073 ISO 13485 \u3067\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u308b\u3001\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u5c65\u6b74\u3092\u8a18\u8f09\u3057\u305f\u8a18\u9332\u306e\u96c6\u7a4d\u3067\u3059\u3002\u3053\u308c\u306b\u306f\u3001\u8a2d\u8a08\u4ed5\u69d8\u66f8\u3001\u8a2d\u8a08\u691c\u8a3c\u304a\u3088\u3073\u59a5\u5f53\u6027\u78ba\u8a8d\u306e\u7d50\u679c\u3001\u30ea\u30b9\u30af\u7ba1\u7406\u306e\u6210\u679c\u7269\u3001\u306a\u3089\u3073\u306b\u691c\u8a3c\u30fb\u59a5\u5f53\u6027\u78ba\u8a8d\uff08V&V\uff09\u6bb5\u968e\u306e\u90e8\u54c1\u306b\u95a2\u3059\u308b\u88fd\u9020\u8a18\u9332\u304c\u542b\u307e\u308c\u307e\u3059\u3002 V&V\u30d7\u30ed\u30c8\u30bf\u30a4\u30d7\u306e\u88fd\u9020\u6587\u66f8\uff08\u6750\u6599\u8a3c\u660e\u66f8\u3001\u5bf8\u6cd5\u691c\u67fb\u5831\u544a\u66f8\u3001\u5de5\u7a0b\u8a18\u9332\u306a\u3069\uff09\u306fDHF\u306e\u4e00\u90e8\u3092\u69cb\u6210\u3057\u3001\u5f53\u8a72\u533b\u7642\u6a5f\u5668\u306e\u8010\u7528\u671f\u9593\u3092\u901a\u3058\u3066\u4fdd\u5b58\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

\u533b\u7642\u7528CNC\u52a0\u5de5\u306b\u304a\u3051\u308b\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306f\u3001\u3069\u306e\u3088\u3046\u306b\u884c\u308f\u308c\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1f<\/strong><\/h3>\n\n\n\n

\u8a2d\u7f6e\u9069\u683c\u6027\u8a55\u4fa1\uff08IQ\uff09\u306f\u3001CNC\u88c5\u7f6e\u304c\u4ed5\u69d8\u901a\u308a\u306b\u8a2d\u7f6e\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u6587\u66f8\u3067\u8a3c\u660e\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u904b\u7528\u9069\u683c\u6027\u8a55\u4fa1\uff08OQ\uff09\u306f\u3001\u52d5\u4f5c\u7bc4\u56f2\u5168\u4f53\u306b\u308f\u305f\u3063\u3066\u30d7\u30ed\u30bb\u30b9\u3092\u8a66\u9a13\u3057\u3001\u4e00\u8cab\u3057\u305f\u51fa\u529b\u304c\u5f97\u3089\u308c\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u6027\u80fd\u9069\u683c\u6027\u8a55\u4fa1\uff08PQ\uff09\u306f\u3001\u901a\u5e38\u306e\u751f\u7523\u6761\u4ef6\u4e0b\u306b\u304a\u3044\u3066\u3001\u4e00\u8cab\u3057\u3066\u898f\u683c\u306b\u9069\u5408\u3057\u305f\u51fa\u529b\u304c\u5f97\u3089\u308c\u308b\u3053\u3068\u3092\u5b9f\u8a3c\u3059\u308b\u3082\u306e\u3067\u3059\u3002 \u30d1\u30c3\u30b7\u30d9\u30fc\u30b7\u30e7\u30f3\u3001\u96fb\u89e3\u7814\u78e8\u3001\u304a\u3088\u3073\u305d\u306e\u4ed6\u306e\u5316\u5b66\u7684\u4ed5\u4e0a\u3052\u30d7\u30ed\u30bb\u30b9\u306b\u3064\u3044\u3066\u306f\u3001\u751f\u7523\u958b\u59cb\u524d\u306b\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u304c\u5fc5\u9808\u3068\u306a\u308a\u307e\u3059\u3002.<\/p>","protected":false},"excerpt":{"rendered":"

Medical device prototyping and production is the multi-stage manufacturing process that takes a medical product concept through design validation, regulatory submission, and commercial manufacturing while maintaining biocompatibility, dimensional accuracy, and documented compliance at every step. As of February 2, 2026, the FDA’s Quality Management System Regulation (QMSR) is now in effect, aligning 21 CFR Part 820 with ISO 13485:2016 by reference \u2014 making ISO 13485 certification the practical standard for all US medical device manufacturing (Criterion Precision, 2026). CNC machining is the dominant manufacturing method for metal medical device components including surgical instruments, implant components, diagnostic equipment parts, and medical capital equipment housings, because it provides the micron-level tolerances required […]<\/p>\n","protected":false},"author":1,"featured_media":5609,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-5606","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"_links":{"self":[{"href":"https:\/\/xinyangmfg.com\/ja\/wp-json\/wp\/v2\/posts\/5606","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/xinyangmfg.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/xinyangmfg.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/xinyangmfg.com\/ja\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/xinyangmfg.com\/ja\/wp-json\/wp\/v2\/comments?post=5606"}],"version-history":[{"count":2,"href":"https:\/\/xinyangmfg.com\/ja\/wp-json\/wp\/v2\/posts\/5606\/revisions"}],"predecessor-version":[{"id":5610,"href":"https:\/\/xinyangmfg.com\/ja\/wp-json\/wp\/v2\/posts\/5606\/revisions\/5610"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/xinyangmfg.com\/ja\/wp-json\/wp\/v2\/media\/5609"}],"wp:attachment":[{"href":"https:\/\/xinyangmfg.com\/ja\/wp-json\/wp\/v2\/media?parent=5606"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/xinyangmfg.com\/ja\/wp-json\/wp\/v2\/categories?post=5606"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/xinyangmfg.com\/ja\/wp-json\/wp\/v2\/tags?post=5606"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}