{"id":3329,"date":"2026-05-24T20:28:28","date_gmt":"2026-05-24T12:28:28","guid":{"rendered":"https:\/\/zscncparts.com\/?p=3329"},"modified":"2026-05-24T20:58:31","modified_gmt":"2026-05-24T12:58:31","slug":"key-requirements-for-cnc-machining-medical-device-components-2","status":"publish","type":"post","link":"https:\/\/zscncparts.com\/ja\/key-requirements-for-cnc-machining-medical-device-components-2\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u90e8\u54c1\u306eCNC\u52a0\u5de5\u306b\u304a\u3051\u308b\u4e3b\u8981\u8981\u4ef6"},"content":{"rendered":"<h2 class=\"wp-block-heading\">CNC\u52a0\u5de5\u533b\u7642\u6a5f\u5668\u90e8\u54c1\u306e\u898f\u5236\u8981\u4ef6<\/h2>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668\u90e8\u54c1\u3092\u52a0\u5de5\u3059\u308b\u969b\u306b\u306f\u3001 <strong>\u898f\u5236\u3055\u308c\u305f\u533b\u7642\u74b0\u5883\u5185\u3067\u64cd\u4f5c\u3057\u307e\u3059<\/strong>\u3060\u3051\u3067\u306a\u304f\u3001\u7cbe\u5bc6\u6a5f\u68b0\u5de5\u5834\u3060\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3042\u306a\u305f\u304c\u5207\u524a\u3059\u308b\u3059\u3079\u3066\u306e\u90e8\u54c1\u306f\u6700\u7d42\u7684\u306b <strong>\u60a3\u8005\u306e\u5b89\u5168\u6027<\/strong>\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u305f\u3081\u3001 <strong>\u533b\u7642\u7528CNC\u52a0\u5de5\u57fa\u6e96<\/strong> \u306f\u53b3\u683c\u3067\u5fb9\u5e95\u7684\u306b\u6587\u66f8\u5316\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u4e3b\u8981\u898f\u5236\uff1aFDA 21 CFR Part 820\u304a\u3088\u3073ISO 13485<\/h3>\n\n\n\n<p>CNC\u52a0\u5de5\u3055\u308c\u305f\u533b\u7642\u6a5f\u5668\u90e8\u54c1\u306b\u306f\u3001\u307b\u3068\u3093\u3069\u306e\u8981\u4ef6\u3092\u30ab\u30d0\u30fc\u3059\u308b2\u3064\u306e\u67a0\u7d44\u307f\u304c\u3042\u308a\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>FDA 21 CFR Part 820\uff08\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u898f\u5247\uff09<\/strong> \u2014 \u65e5\u672c\u3067\u8ca9\u58f2\u3055\u308c\u308b\u533b\u7642\u6a5f\u5668\u306b\u5fc5\u9808\n<ul>\n<li>\u5fc5\u8981\u3068\u3055\u308c\u308b\u306e\u306f <strong>\u7ba1\u7406\u3055\u308c\u305f\u5de5\u7a0b<\/strong>\u3001\u6587\u66f8\u5316\u3055\u308c\u305f\u624b\u9806\u3001\u304a\u3088\u3073\u91cd\u8981\u306a\u5404\u6bb5\u968e\u306e\u8a18\u9332\u3067\u3059<\/li>\n<li>CNC\u52a0\u5de5\u306f\u3001 <strong>\u7279\u6b8a\u5de5\u7a0b<\/strong> \u3068\u307f\u306a\u3055\u308c\u307e\u3059\u3002\u51fa\u529b\u304c\u691c\u67fb\u3060\u3051\u3067\u306f\u5b8c\u5168\u306b\u691c\u8a3c\u3067\u304d\u306a\u3044\u5834\u5408<\/li>\n<\/ul>\n<\/li>\n<li><strong>ISO 13485\uff08\u533b\u7642\u6a5f\u5668 \u2013 \u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u8981\u4ef6\uff09<\/strong> \u2014 \u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u57fa\u6e96\u3068\u306a\u308b <strong>\u533b\u7642CNC\u52a0\u5de5\u8981\u4ef6<\/strong>\n<ul>\n<li>\u304c\u3069\u306e\u3088\u3046\u306b\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u308b\u304b <strong>\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09<\/strong> \u533b\u7642\u88fd\u9020\u306e\u305f\u3081\u306b\u69cb\u7bc9\u3055\u308c\u308b\u5fc5\u8981\u304c\u3042\u308b<\/li>\n<li>\u533b\u7642OEM\u3092\u652f\u63f4\u3059\u308bCNC\u5de5\u5834\u306fISO 13485\u3092\u4f7f\u7528\u3057\u3066\u6e80\u305f\u3059 <strong>\u30c7\u30d0\u30a4\u30b9\u30e1\u30fc\u30ab\u30fc\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/strong> \u304a\u3088\u3073\u76e3\u67fb\u306e\u671f\u5f85\u5024<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p>CNC\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c\u81ea\u793e\u5de5\u5834\u304c <strong>FDA 21 CFR \u30d1\u30fc\u30c8820\u306eCNC\u52a0\u5de5\u306b\u3069\u306e\u3088\u3046\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u304b\u8aac\u660e\u3067\u304d\u306a\u3044\u5834\u5408<\/strong> \u304a\u3088\u3073 <strong>ISO 13485<\/strong>\u672c\u5f53\u306e\u533b\u7642\u4f5c\u696d\u306b\u307e\u3060\u6e96\u5099\u304c\u3067\u304d\u3066\u3044\u306a\u3044\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">QMS\u304cCNC\u5de5\u5834\u306b\u3069\u306e\u3088\u3046\u306b\u9069\u7528\u3055\u308c\u308b\u304b<\/h3>\n\n\n\n<p>\u533b\u7642\u5bfe\u5fdc\u53ef\u80fd\u306aCNC\u5de5\u5834\u306f <strong>\u6b63\u5f0f\u306a\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306e\u4e0b\u3067\u904b\u55b6\u3055\u308c\u3066\u3044\u308b<\/strong>, \u975e\u516c\u5f0f\u306a\u90e8\u65cf\u77e5\u8b58\u3067\u306f\u306a\u3044\u3002\u5b9f\u969b\u306b\u306f\u3001\u3053\u308c\u306f\u6b21\u306e\u3053\u3068\u3092\u610f\u5473\u3059\u308b\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u898b\u7a4d\u3082\u308a\u3001\u30d7\u30ed\u30b0\u30e9\u30df\u30f3\u30b0\u3001\u30bb\u30c3\u30c8\u30a2\u30c3\u30d7\u3001\u52a0\u5de5\u3001\u691c\u67fb\u3001\u30ea\u30ea\u30fc\u30b9\u306e\u305f\u3081\u306e<\/strong> \u6587\u66f8\u5316\u3055\u308c\u305f\u624b\u9806<\/li>\n<li><strong>\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u3001\u30d7\u30ed\u30b0\u30e9\u30de\u30fc\u3001\u691c\u67fb\u54e1\u306e\u305f\u3081\u306e<\/strong> \u8a13\u7df4\u3068\u80fd\u529b\u8a18\u9332<\/li>\n<li><strong>\u5909\u66f4\u7ba1\u7406<\/strong> CNC\u30d7\u30ed\u30b0\u30e9\u30e0\u3001\u56f3\u9762\u3001\u5de5\u7a0b\u30d1\u30e9\u30e1\u30fc\u30bf\u7528<\/li>\n<li><strong>\u4e0d\u9069\u5408\u7ba1\u7406\u3068CAPA\uff08\u662f\u6b63\u63aa\u7f6e\u304a\u3088\u3073\u4e88\u9632\u63aa\u7f6e\uff09<\/strong> \u554f\u984c\u304c\u767a\u751f\u3057\u305f\u5834\u5408<\/li>\n<\/ul>\n\n\n\n<p>\u79c1\u305f\u3061\u306f\u3059\u3079\u3066\u306eCNC\u5de5\u7a0b\u3092 <strong>\u5b9a\u7fa9\u3055\u308c\u3001\u7ba1\u7406\u3055\u308c\u3001\u518d\u73fe\u53ef\u80fd\u306a\u3082\u306e\u3068\u307f\u306a\u3057\u307e\u3059<\/strong>\u8a3c\u62e0\u3092\u660e\u78ba\u306b\u793a\u3057\u3066\u8a3c\u660e\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u30ea\u30b9\u30af\u7ba1\u7406\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3001\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u4f5c\u6210<\/h3>\n\n\n\n<p>\u898f\u5236\u5f53\u5c40\u306f\u671f\u5f85\u3057\u3066\u3044\u307e\u3059 <strong>\u30ea\u30b9\u30af\u306b\u57fa\u3065\u304f\u7ba1\u7406<\/strong> \u30c7\u30d0\u30a4\u30b9\u306e\u5b89\u5168\u6027\u3084\u6027\u80fd\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u52a0\u5de5\u5de5\u7a0b\u306b\u5bfe\u3057\u3066\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u30ea\u30b9\u30af\u7ba1\u7406<\/strong> \uff08ISO 14971\u306e\u539f\u5247\u306b\u57fa\u3065\u304f\uff09\n<ul>\n<li>\u52a0\u5de5\u306b\u95a2\u9023\u3059\u308b\u30ea\u30b9\u30af\u3092\u7279\u5b9a\uff1a\u8aa4\u3063\u305f\u5bf8\u6cd5\u3001\u4e0d\u9069\u5207\u306a\u6750\u6599\u3001\u8868\u9762\u6b20\u9665\u3001\u6c5a\u67d3\u306a\u3069<\/li>\n<li>\u7ba1\u7406\u3092\u9069\u7528\uff1a\u3088\u308a\u53b3\u3057\u3044\u691c\u67fb\u3001\u691c\u8a3c\u6e08\u307f\u30d7\u30ed\u30b0\u30e9\u30e0\u3001\u5de5\u5177\u5bff\u547d\u7ba1\u7406\u3001\u6e05\u6f54\u306a\u53d6\u308a\u6271\u3044<\/li>\n<\/ul>\n<\/li>\n<li><strong>\u5de5\u7a0b\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08IQ\/OQ\/PQ\uff09<\/strong> for critical or &#8220;special&#8221; CNC processes:\n<ul>\n<li><strong>IQ\uff08\u8a2d\u7f6e\u9069\u683c\u6027\uff09<\/strong>: \u6a5f\u68b0\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3001\u30b2\u30fc\u30b8\u304c\u9069\u5207\u306b\u8a2d\u7f6e\u304a\u3088\u3073\u8f03\u6b63\u3055\u308c\u3066\u3044\u308b\u3053\u3068<\/li>\n<li><strong>OQ\uff08\u904b\u7528\u9069\u683c\u6027\u8a55\u4fa1\uff09<\/strong>: \u30d7\u30ed\u30bb\u30b9\u304c\u4e88\u60f3\u3055\u308c\u308b\u904b\u7528\u7bc4\u56f2\u5185\u3067\u4ed5\u69d8\u3092\u6e80\u305f\u3059\u3053\u3068\u304c\u3067\u304d\u308b<\/li>\n<li><strong>PQ\uff08\u6027\u80fd\u9069\u683c\u6027\u8a55\u4fa1\uff09<\/strong>: \u5b9f\u969b\u306e\u751f\u7523\u30d0\u30c3\u30c1\u3067\u4e00\u8cab\u3057\u3066\u3059\u3079\u3066\u306e\u4ed5\u69d8\u3092\u6e80\u305f\u3059<\/li>\n<\/ul>\n<\/li>\n<li><strong>\u7ba1\u7406\u3055\u308c\u305f\u6587\u66f8<\/strong>\n<ul>\n<li>\u305f\u3060\u3057 <strong>\u30ea\u30ea\u30fc\u30b9\u3055\u308c\u305f\u56f3\u9762\u3001CNC\u30d7\u30ed\u30b0\u30e9\u30e0\u3001\u4f5c\u696d\u6307\u793a\u66f8<\/strong> \u73fe\u5834\u3067\u4f7f\u7528\u3055\u308c\u308b<\/li>\n<li>\u3059\u3079\u3066\u306e\u6539\u8a02\u306f\u8ffd\u8de1\u3055\u308c\u308b\uff1b\u6b63\u5f0f\u306a\u30ec\u30d3\u30e5\u30fc\u3068\u627f\u8a8d\u306a\u3057\u306b\u5909\u66f4\u306f\u306a\u3044<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p>\u898f\u5236\u76e3\u67fb\u54e1\u304c\u30ec\u30d3\u30e5\u30fc\u6642\u306b\u78ba\u8a8d\u3059\u308b\u3082\u306e <strong>\u691c\u8a3c\u6e08\u307f\u306e\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u304a\u3088\u3073\u5668\u5177\u306e\u52a0\u5de5\u30d7\u30ed\u30bb\u30b9<\/strong>.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u30d0\u30c3\u30c1\u7ba1\u7406\u3001DHR\u3001DMR<\/h3>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668\u306e\u52a0\u5de5\u306b\u304a\u3044\u3066\u3001 <strong>\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3068\u30d0\u30c3\u30c1\u7ba1\u7406<\/strong> \u306f\u4e0d\u53ef\u6b20\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u30d0\u30c3\u30c1\u7ba1\u7406<\/strong>\n<ul>\n<li>\u3059\u3079\u3066\u306e\u4f5c\u696d\u6307\u793a\u66f8\u307e\u305f\u306f\u30ed\u30c3\u30c8\u306b\u306f <strong>\u30e6\u30cb\u30fc\u30af\u306a\u30ed\u30c3\u30c8\u756a\u53f7<\/strong><\/li>\n<li>\u3092\u8ffd\u8de1\u3059\u308b <strong>\u6750\u6599\u306e\u71b1\u51e6\u7406\u3001\u30d7\u30ed\u30b0\u30e9\u30e0\u3001\u5de5\u5177\u3001\u4f5c\u696d\u8005\u3001\u6a5f\u68b0\u3001\u691c\u67fb\u7d50\u679c<\/strong> \u305d\u306e\u30ed\u30c3\u30c8\u306e\u305f\u3081\u306b<\/li>\n<\/ul>\n<\/li>\n<li><strong>DHR\uff08\u30c7\u30d0\u30a4\u30b9\u5c65\u6b74\u30ec\u30b3\u30fc\u30c9\uff09<\/strong>\n<ul>\n<li>\u88fd\u9020\u4e2d\u306b\u8d77\u3053\u3063\u305f\u3059\u3079\u3066\u3092\u8a18\u9332\uff1a\u3069\u306e\u6a5f\u68b0\u3001\u3069\u306e\u30d7\u30ed\u30b0\u30e9\u30e0\u3001\u8ab0\u304c\u64cd\u4f5c\u3057\u305f\u304b\u3001\u691c\u67fb\u7d50\u679c<\/li>\n<li>\u63d0\u4f9b\u3059\u308b <strong>\u30a8\u30f3\u30c9\u30c4\u30fc\u30a8\u30f3\u30c9\u306e\u8ffd\u8de1\u6027<\/strong> \u5404\u751f\u7523\u30ed\u30c3\u30c8\u3054\u3068\u306b<\/li>\n<\/ul>\n<\/li>\n<li><strong>DMR\uff08\u30c7\u30d0\u30a4\u30b9\u30de\u30b9\u30bf\u30ec\u30b3\u30fc\u30c9\uff09<\/strong>\n<ul>\n<li>\u4ed5\u69d8\u66f8\u306e\u5b8c\u5168\u306a\u30bb\u30c3\u30c8\uff1a\u627f\u8a8d\u3055\u308c\u305f\u56f3\u9762\u3001\u6750\u6599\u4ed5\u69d8\u3001CNC\u30d7\u30ed\u30b0\u30e9\u30e0\u3001\u691c\u67fb\u8a08\u753b<\/li>\n<li>\u30c7\u30d0\u30a4\u30b9\u306e\u6b63\u78ba\u306a\u88fd\u9020\u65b9\u6cd5\u3092\u5b9a\u7fa9\u3059\u308b <strong>\u5fc5\u305a<\/strong> \u6bce\u56de\u88fd\u9020\u3055\u308c\u308b\u5fc5\u8981\u304c\u3042\u308b<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p>If an auditor asks &#8220;prove that lot XYZ was machined correctly,&#8221; the <strong>DHR\u3068DMR<\/strong> \u304c\u56de\u7b54\u3068\u306a\u308b\u3002\u3059\u3079\u3066\u304c\u8a18\u9332\u3055\u308c\u3001\u691c\u7d22\u53ef\u80fd\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u533b\u7642\u7528CNC\u90e8\u54c1\u306e\u6750\u6599\u8981\u4ef6<\/h3>\n\n\n\n<p>\u533b\u7642\u6a5f\u5668\u306e\u6750\u6599\u306f\u53b3\u683c\u306b\u7ba1\u7406\u3055\u308c\u3066\u3044\u308b\u3002\u4e00\u822c\u7684\u306b\u52a0\u5de5\u3059\u308b\u6750\u6599\u306b\u306f\u6b21\u306e\u3082\u306e\u304c\u542b\u307e\u308c\u308b\uff1a<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><thead><tr><th>\u6750\u6599<\/th><th>\u898f\u683c<\/th><th>\u4e00\u822c\u7684\u306a\u7528\u9014<\/th><\/tr><\/thead><tbody><tr><td><strong>\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc316L<\/strong><\/td><td>ASTM F138\u3001ISO 5832-1<\/td><td>\u5916\u79d1\u7528\u5668\u5177\u3001\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3001\u6574\u5f62\u5916\u79d1\u7528\u5de5\u5177<\/td><\/tr><tr><td><strong>\u30c1\u30bf\u30f3\u30b0\u30ec\u30fc\u30c95\uff08Ti-6Al-4V\uff09<\/strong><\/td><td>ASTM F136\u3001ISO 5832-3<\/td><td>\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3001\u7fa9\u80a2\u3001\u5916\u79d1\u7528\u5668\u5177<\/td><\/tr><tr><td><strong>PEEK\u6a39\u8102<\/strong><\/td><td>ASTM F2026\u3001USP\u30af\u30e9\u30b9VI<\/td><td>\u810a\u690e\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3001\u9aa8\u56fa\u5b9a\u3001\u5916\u79d1\u7528\u30cf\u30f3\u30c9\u30eb<\/td><\/tr><tr><td><strong>\u30c7\u30e5\u30ec\u30ea\u30f3 \/ \u30a2\u30bb\u30bf\u30fc\u30eb<\/strong><\/td><td>USP\u30af\u30e9\u30b9VI<\/td><td>\u5916\u79d1\u7528\u30b8\u30b0\u3001\u6cbb\u5177\u3001\u5668\u5177<\/td><\/tr><tr><td><strong>\u30a2\u30eb\u30df\u30cb\u30a6\u30e06061<\/strong><\/td><td>ASTM B211\u3001AMS 4117<\/td><td>\u5916\u79d1\u7528\u30c8\u30ec\u30a4\u3001\u5668\u5177\u30cf\u30a6\u30b8\u30f3\u30b0<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>\u3059\u3079\u3066\u306e\u6750\u6599\u306f <strong>\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u3067\u5b8c\u5168\u306a\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3092\u6709\u3059\u308b\u3053\u3068<\/strong> \u2014 \u627f\u8a8d\u3055\u308c\u305f\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u5909\u66f4\u306a\u3057\u306b\u4ee3\u66ff\u54c1\u3092\u4f7f\u7528\u3057\u306a\u3044\u3053\u3068\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u6d17\u6d44\u304a\u3088\u3073\u8868\u9762\u4ed5\u4e0a\u3052\u306e\u8981\u4ef6<\/h3>\n\n\n\n<p>\u533b\u7642\u90e8\u54c1\u306f\u53b3\u683c\u306a\u6e05\u6d44\u5ea6\u3068\u8868\u9762\u4ed5\u4e0a\u3052\u57fa\u6e96\u3092\u6e80\u305f\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u8868\u9762\u4ed5\u4e0a\u3052<\/strong>\uff1a\u5916\u79d1\u7528\u5668\u5177\u306eRa 0.2\u20130.8 \u00b5m\u304c\u4e00\u822c\u7684\uff1b\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u30d9\u30a2\u30ea\u30f3\u30b0\u9762\u306f\u93e1\u9762\u4ed5\u4e0a\u3052<\/li>\n<li><strong>\u30d0\u30ea\u53d6\u308a<\/strong>\uff1a\u3059\u3079\u3066\u306e\u30a8\u30c3\u30b8\u3068\u7a74\u306f\u6ed1\u3089\u304b\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044 \u2014 \u30d0\u30ea\u3001\u92ed\u5229\u306a\u30a8\u30c3\u30b8\u3001\u6c5a\u67d3\u30ea\u30b9\u30af\u306a\u3057<\/li>\n<li><strong>\u6d17\u6d44<\/strong>\uff1a\u90e8\u54c1\u306f\u52a0\u5de5\u6cb9\u3001\u30c1\u30c3\u30d7\u3001\u6b8b\u7559\u7269\u304c\u306a\u3044\u72b6\u614b\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u7ba1\u7406\u3055\u308c\u305f\u6d17\u6d44\u5de5\u7a0b\u306e\u8a18\u9332<\/li>\n<li><strong>\u30d1\u30c3\u30b7\u30d9\u30fc\u30b7\u30e7\u30f3<\/strong>\uff1a\u30b9\u30c6\u30f3\u30ec\u30b9\u92fc\u90e8\u54c1\u306f\u3057\u3070\u3057\u3070\u30d1\u30c3\u30b7\u30d9\u30fc\u30b7\u30e7\u30f3\uff08ASTM A967\uff09\u3092\u5fc5\u8981\u3068\u3057\u3001\u8010\u98df\u6027\u3092\u56de\u5fa9\u3055\u305b\u308b<\/li>\n<li><strong>\u68b1\u5305<\/strong>\uff1a\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u5bfe\u5fdc\u306e\u68b1\u5305\u3067\u3001\u7d44\u7acb\u3084\u6ec5\u83cc\u307e\u3067\u90e8\u54c1\u306e\u6e05\u6d44\u5ea6\u3092\u7dad\u6301<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u8cc7\u683c\u8a8d\u8a3c \u2014 \u78ba\u8a8d\u3059\u3079\u304d\u30dd\u30a4\u30f3\u30c8<\/h3>\n\n\n\n<p>\u533b\u7642\u90e8\u54c1\u306eCNC\u52a0\u5de5\u30d1\u30fc\u30c8\u30ca\u30fc\u3092\u9078\u5b9a\u3059\u308b\u969b\u306b\u3001\u3053\u308c\u3089\u306e\u80fd\u529b\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\uff1a<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>ISO 13485\u8a8d\u8a3c<\/strong> \u2014 \u5f7c\u3089\u306eQMS\u306f\u533b\u7642\u6a5f\u5668\u88fd\u9020\u306e\u305f\u3081\u306b\u8a8d\u8a3c\u3055\u308c\u3066\u3044\u307e\u3059\u304b\uff1f<\/li>\n<li><strong>\u6750\u6599\u8ffd\u8de1\u6027<\/strong> \u2014 \u71b1\u756a\u53f7\u3092\u8ffd\u8de1\u3057\u3001\u6750\u6599\u306e\u8abf\u9054\u3092\u8a8d\u8a3c\u3057\u3066\u3044\u307e\u3059\u304b\uff1f<\/li>\n<li><strong>\u691c\u67fb\u80fd\u529b<\/strong> \u2014 CMM\u3001\u5149\u5b66\u6bd4\u8f03\u8a08\u6e2c\u5668\u3001\u8868\u9762\u8f2a\u90ed\u8a08\u6e2c\u5668\u3001\u6821\u6b63\u6e08\u307f\u30b2\u30fc\u30b8<\/li>\n<li><strong>\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u307e\u305f\u306f\u7ba1\u7406\u3055\u308c\u305f\u74b0\u5883<\/strong> \u2014 \u5f7c\u3089\u306f\u30af\u30ea\u30fc\u30f3\u306a\u74b0\u5883\u3067\u90e8\u54c1\u3092\u52a0\u5de5\u30fb\u53d6\u308a\u6271\u3046\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u304b\uff1f<\/li>\n<li><strong>\u30d7\u30ed\u30bb\u30b9\u691c\u8a3c<\/strong> \u2014 \u91cd\u8981\u306a\u30d7\u30ed\u30bb\u30b9\uff08\u6d17\u6d44\u3001\u30d1\u30c3\u30b7\u30d9\u30fc\u30b7\u30e7\u30f3\u3001\u7279\u6b8a\u30d7\u30ed\u30bb\u30b9\uff09\u306e\u691c\u8a3c\u3092\u884c\u3044\u307e\u3059\u304b\uff1f<\/li>\n<li><strong>\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8<\/strong> \u2014 DHR\u3001DMR\u3001\u691c\u67fb\u5831\u544a\u66f8\u3001\u6750\u6599\u8a3c\u660e\u66f8\u3092\u63d0\u4f9b\u3067\u304d\u307e\u3059\u304b\uff1f<\/li>\n<\/ol>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">CNC\u533b\u7642\u7528\u6a5f\u68b0\u52a0\u5de5\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3068\u306e\u30d1\u30fc\u30c8\u30ca\u30fc\u30b7\u30c3\u30d7<\/h2>\n\n\n\n<p>ZSCNC\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u88fd\u9020\u306e\u53b3\u3057\u3044\u8981\u4ef6\u3092\u7406\u89e3\u3057\u3066\u3044\u307e\u3059\u3002\u5f53\u793e\u306e\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306fISO 13485\u304a\u3088\u3073FDA\u898f\u5236\u74b0\u5883\u306e\u671f\u5f85\u306b\u5fdc\u3048\u308b\u3088\u3046\u8a2d\u8a08\u3055\u308c\u3066\u304a\u308a\u3001\u5168\u3066\u306e\u533b\u7642\u90e8\u54c1\u306b\u5bfe\u3057\u3066\u5b8c\u5168\u306a\u6750\u6599\u8ffd\u8de1\u6027\u3001\u7ba1\u7406\u3055\u308c\u305f\u30d7\u30ed\u30bb\u30b9\u3001\u5305\u62ec\u7684\u306a\u691c\u67fb\u6587\u66f8\u3092\u5099\u3048\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p><strong>\u533b\u7642\u6a5f\u5668\u90e8\u54c1\u306eCNC\u52a0\u5de5\u30d1\u30fc\u30c8\u30ca\u30fc\u3092\u304a\u63a2\u3057\u3067\u3059\u304b\uff1f<\/strong> <a href=\"https:\/\/zscncparts.com\/ja\/request-quote\/\">ZSCNC\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044<\/a> \u9069\u5408\u6027\u30ec\u30d3\u30e5\u30fc\u3068\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u8a55\u4fa1\u306e\u305f\u3081\u306b\u3002CAD\u30d5\u30a1\u30a4\u30eb\u3068\u4ed5\u69d8\u66f8\u3092\u30a2\u30c3\u30d7\u30ed\u30fc\u30c9\u3057\u3066\u7121\u6599\u306eDFM\u8a55\u4fa1\u3092\u53d7\u3051\u3066\u304f\u3060\u3055\u3044\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>ISO 13485\u6e96\u62e0\u306e\u6750\u6599\u3001\u516c\u5dee\u3001\u8868\u9762\u4ed5\u4e0a\u3052\u3092\u542b\u3080\u533b\u7642\u6a5f\u5668\u90e8\u54c1\u306eCNC\u52a0\u5de5\u306b\u5fc5\u8981\u306a\u4e3b\u8981\u8981\u4ef6\u3092\u767a\u898b\u3059\u308b<\/p>","protected":false},"author":1,"featured_media":3332,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[56],"tags":[],"class_list":["post-3329","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-industry-applications"],"_links":{"self":[{"href":"https:\/\/zscncparts.com\/ja\/wp-json\/wp\/v2\/posts\/3329","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zscncparts.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zscncparts.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zscncparts.com\/ja\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/zscncparts.com\/ja\/wp-json\/wp\/v2\/comments?post=3329"}],"version-history":[{"count":0,"href":"https:\/\/zscncparts.com\/ja\/wp-json\/wp\/v2\/posts\/3329\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zscncparts.com\/ja\/wp-json\/wp\/v2\/media\/3332"}],"wp:attachment":[{"href":"https:\/\/zscncparts.com\/ja\/wp-json\/wp\/v2\/media?parent=3329"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zscncparts.com\/ja\/wp-json\/wp\/v2\/categories?post=3329"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zscncparts.com\/ja\/wp-json\/wp\/v2\/tags?post=3329"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}