{"id":51614,"date":"2026-01-19T14:42:06","date_gmt":"2026-01-19T06:42:06","guid":{"rendered":"https:\/\/zetarmold.com\/?p=51614"},"modified":"2026-05-02T02:19:33","modified_gmt":"2026-05-01T18:19:33","slug":"iso-13485-%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e7%94%a8%e5%b0%84%e5%87%ba%e6%88%90%e5%bd%a2","status":"publish","type":"post","link":"https:\/\/zetarmold.com\/ja\/iso-13485-%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e7%94%a8%e5%b0%84%e5%87%ba%e6%88%90%e5%bd%a2\/","title":{"rendered":"ISO 13485\u533b\u7642\u6a5f\u5668\u5c04\u51fa\u6210\u5f62\uff1a\u5b8c\u5168\u6e96\u62e0\u30ac\u30a4\u30c9"},"content":{"rendered":"<p>Medical device <a href=\"https:\/\/zetarmold.com\/ja\/injection-molding-complete-guide\/\">\u5c04\u51fa\u6210\u5f62<\/a> ISO 13485\u00b9\u306b\u57fa\u3065\u304f\u88fd\u9020\u306f\u3001\u5358\u306a\u308b\u901a\u5e38\u306e\u88fd\u9020\u306b\u8ffd\u52a0\u66f8\u985e\u3092\u52a0\u3048\u305f\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u54c1\u8cea\u7ba1\u7406\u306b\u5bfe\u3059\u308b\u5168\u304f\u7570\u306a\u308b\u30a2\u30d7\u30ed\u30fc\u30c1\u3067\u3059\u3002\u533b\u7642\u90e8\u54c1\u309220\u5e74\u9593\u88fd\u9020\u3057\u3066\u304d\u305f\u7d4c\u9a13\u304b\u3089\u3001ISO 9001\u304b\u3089\u533b\u7642\u6a5f\u5668\u306e\u4e16\u754c\u3078\u306e\u79fb\u884c\u306b\u82e6\u52b4\u3059\u308b\u30e1\u30fc\u30ab\u30fc\u3092\u898b\u3066\u304d\u307e\u3057\u305f\u3002\u9055\u3044\u306f\u5358\u306b\u8981\u6c42\u304c\u53b3\u3057\u304f\u306a\u3063\u305f\u3060\u3051\u3067\u306a\u304f\u3001\u30ea\u30b9\u30af\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u5de5\u7a0b\u7ba1\u7406\u306b\u5bfe\u3059\u308b\u8003\u3048\u65b9\u305d\u306e\u3082\u306e\u304c\u6839\u672c\u7684\u306b\u5909\u308f\u3063\u305f\u3053\u3068\u306b\u3042\u308a\u307e\u3059\u3002<\/p>\n<div class=\"callout-key\" style=\"background:#f0f7ff; border-left:4px solid #2563eb; padding:1em 1.2em; border-radius:6px; margin:1.5em 0;\">\n<strong>\u8981\u70b9<\/strong><\/p>\n<ul>\n<li>ISO 13485\u306f\u3001\u5c04\u51fa\u6210\u5f62\u30d7\u30ed\u30bb\u30b9\u5168\u4f53\u3092\u901a\u3058\u3066\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u601d\u8003\u3092\u8981\u6c42\u3057\u307e\u3059<\/li>\n<li>\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u74b0\u5883\u3068\u6c5a\u67d3\u7ba1\u7406\u306f\u3001\u307b\u3068\u3093\u3069\u306e\u533b\u7642\u6a5f\u5668\u88fd\u9020\u306b\u304a\u3044\u3066\u5fc5\u9808\u3067\u3059<\/li>\n<li>IQ\u3001OQ\u3001\u304a\u3088\u3073PQ\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u3088\u308b\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306f\u3001\u898f\u5236\u627f\u8a8d\u306b\u4e0d\u53ef\u6b20\u3067\u3059<\/li>\n<li>\u539f\u6750\u6599\u304b\u3089\u5b8c\u6210\u30c7\u30d0\u30a4\u30b9\u307e\u3067\u306e\u5b8c\u5168\u306a\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3092\u7dad\u6301\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044<\/li>\n<li>\u6750\u6599\u306e\u9078\u629e\u306b\u306f\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\u3068\u898f\u5236\u9075\u5b88\u6587\u66f8\u304c\u5fc5\u8981<\/li>\n<\/ul>\n<\/div>\n<h2>ISO 13485\u3068\u306f\u4f55\u304b\uff1fISO 9001\u3068\u306e\u9055\u3044\u306f\uff1f<\/h2>\n<p>ISO 13485\u3068\u305d\u308c\u304cISO 9001\u3068\u3069\u306e\u3088\u3046\u306b\u7570\u306a\u308b\u304b\u306f\u3001\u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u3067\u8aac\u660e\u3055\u308c\u3066\u3044\u308b\u6a5f\u80fd\u3001\u5236\u7d04\u3001\u30c8\u30ec\u30fc\u30c9\u30aa\u30d5\u306b\u3088\u3063\u3066\u5b9a\u7fa9\u3055\u308c\u307e\u3059\u3002\u3088\u308a\u5e83\u3044\u8996\u70b9\u306b\u3064\u3044\u3066\u306f\u3001 <a href=\"https:\/\/zetarmold.com\/ja\/injection-mold-complete-guide\/\">\u5c04\u51fa\u6210\u5f62\u91d1\u578b\u8a2d\u8a08<\/a>, our pillar guide covers tooling structure, thermal control, and manufacturability tradeoffs.<\/p>\n<p>ISO 13485\u00b9\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u5411\u3051\u306b\u7279\u5225\u306b\u8a2d\u8a08\u3055\u308c\u305f\u54c1\u8cea\u7ba1\u7406\u57fa\u6e96\u3067\u3059\u3002ISO 9001\u3068\u4e00\u90e8\u5171\u901a\u70b9\u306f\u3042\u308a\u307e\u3059\u304c\u3001\u985e\u4f3c\u70b9\u306f\u3059\u3050\u306b\u7121\u304f\u306a\u308a\u307e\u3059\u3002ISO 13485\u306f\u3001ISO 9001\u306e\u300c\u7d99\u7d9a\u7684\u6539\u5584\u300d\u8981\u4ef6\u3092\u6392\u9664\u3057\u3001\u300c\u6709\u52b9\u6027\u306e\u7dad\u6301\u300d\u3092\u91cd\u8996\u3057\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u306b\u304a\u3044\u3066\u306f\u3001\u7121\u8a31\u53ef\u306e\u5909\u66f4\u304c\u4eba\u547d\u3092\u596a\u3046\u53ef\u80fd\u6027\u304c\u3042\u308b\u305f\u3081\u3067\u3059\u3002\u3053\u306e\u57fa\u6e96\u306f\u3001\u4e00\u822c\u7684\u306a\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3092\u306f\u308b\u304b\u306b\u8d85\u3048\u308b\u30ea\u30b9\u30af\u7ba1\u7406\u306e\u7d71\u5408\u3001\u898f\u5236\u9075\u5b88\u3001\u5e02\u8ca9\u5f8c\u76e3\u8996\u3092\u8981\u6c42\u3057\u307e\u3059\u3002<\/p>\n<p>\u5c04\u51fa\u6210\u5f62\u3078\u306e\u5f71\u97ff\u306f\u91cd\u5927\u3067\u3059\u3002ISO 9001\u304c\u52b9\u7387\u5411\u4e0a\u306b\u57fa\u3065\u304f\u5de5\u7a0b\u6539\u5584\u3092\u53d7\u3051\u5165\u308c\u308b\u304b\u3082\u3057\u308c\u306a\u3044\u4e00\u65b9\u3067\u3001ISO 13485\u3067\u306f\u3001\u3042\u3089\u3086\u308b\u5de5\u7a0b\u5909\u66f4\u306b\u5bfe\u3057\u3066\u6b63\u5f0f\u306a\u5909\u66f4\u7ba1\u7406\u3001\u5f71\u97ff\u8a55\u4fa1\u3001\u305d\u3057\u3066\u591a\u304f\u306e\u5834\u5408\u898f\u5236\u5f53\u5c40\u3078\u306e\u901a\u77e5\u304c\u5fc5\u8981\u3067\u3059\u3002\u6e29\u5ea6\u3001\u5727\u529b\u3001\u30b5\u30a4\u30af\u30eb\u30bf\u30a4\u30e0\u3068\u3044\u3063\u305f\u5c04\u51fa\u6210\u5f62\u306e\u3042\u3089\u3086\u308b\u30d1\u30e9\u30e1\u30fc\u30bf\u306f\u3001\u5b89\u6613\u306b\u8abf\u6574\u3067\u304d\u306a\u3044\u59a5\u5f53\u6027\u78ba\u8a8d\u6e08\u307f\u30d7\u30ed\u30bb\u30b9\u306e\u4e00\u90e8\u3068\u306a\u308a\u307e\u3059\u3002\u6587\u66f8\u5316\u3055\u308c\u305f <a href=\"https:\/\/zetarmold.com\/ja\/%e5%b0%84%e5%87%ba%e6%88%90%e5%bd%a2%e3%81%ae%e3%82%b9%e3%83%86%e3%83%83%e3%83%97\/\">\u5c04\u51fa\u6210\u5f62\u5de5\u7a0b\u30b9\u30c6\u30c3\u30d7<\/a> \u30de\u30c3\u30d7\u306f\u3001\u5404\u30d1\u30e9\u30e1\u30fc\u30bf\u304c\u59a5\u5f53\u6027\u78ba\u8a8d\u4e2d\u306b\u4f7f\u7528\u3055\u308c\u305f\u540c\u3058\u8a3c\u62e0\u30d1\u30c3\u30b1\u30fc\u30b8\u306b\u7d10\u4ed8\u3051\u3089\u308c\u308b\u3088\u3046\u306b\u3057\u307e\u3059\u3002<\/p>\n<table style=\"width:100%;border-collapse:collapse;margin:1.5em 0;\">\n<thead>\n<tr>\n<th style=\"border:1px solid #ddd;padding:8px;background:#f5f5f5;\">\u30a2\u30b9\u30da\u30af\u30c8<\/th>\n<th style=\"border:1px solid #ddd;padding:8px;background:#f5f5f5;\">ISO 9001<\/th>\n<th style=\"border:1px solid #ddd;padding:8px;background:#f5f5f5;\">ISO 13485<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u4e3b\u306a\u7126\u70b9<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u9867\u5ba2\u6e80\u8db3\u5ea6<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027<\/td>\n<\/tr>\n<tr>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u6539\u5584\u306e\u54f2\u5b66<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u7d99\u7d9a\u7684\u6539\u5584<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u6709\u52b9\u6027\u306e\u7dad\u6301<\/td>\n<\/tr>\n<tr>\n<td style=\"border:1px solid #ddd;padding:8px;\">Risk Management<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u4efb\u610f\u306e\u8003\u616e\u4e8b\u9805<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u5fc5\u9808\u7d71\u5408<\/td>\n<\/tr>\n<tr>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u898f\u5236\u9075\u5b88<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u7279\u306b\u306a\u3057<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u660e\u793a\u7684\u306a\u8981\u6c42<\/td>\n<\/tr>\n<tr>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u30d7\u30ed\u30bb\u30b9\u5909\u66f4<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u6709\u76ca\u3067\u3042\u308c\u3070\u63a8\u5968<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u5236\u5fa1\u304a\u3088\u3073\u691c\u8a3c\u6e08\u307f<\/td>\n<\/tr>\n<tr>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u6587\u66f8\u5316\u30ec\u30d9\u30eb<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u4e2d\u7a0b\u5ea6<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u5e83\u7bc4\u304b\u3064\u8ffd\u8de1\u53ef\u80fd<\/td>\n<\/tr>\n<tr>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u51fa\u8377\u5f8c\u6d3b\u52d5<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u9867\u5ba2\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u5e02\u8ca9\u5f8c\u76e3\u8996<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<div class=\"claim claim-true\" style=\"background-color: #eff7ef; border-color: #eff7ef; color: #5a8a5a;\">\n<p><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"20\" height=\"20\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"#16a34a\" stroke-width=\"2\"><path d=\"M9 16.17L4.83 12l-1.42 1.41L9 19 21 7l-1.41-1.41z\"\/><\/svg><b>\u300cISO 13485\u8a8d\u8a3c\u3092\u53d7\u3051\u305f\u5c04\u51fa\u6210\u5f62\u65bd\u8a2d\u306f\u3001\u6b63\u5f0f\u306a\u627f\u8a8d\u306a\u3057\u306b\u5909\u66f4\u3067\u304d\u306a\u3044\u691c\u8a3c\u6e08\u307f\u306e\u5de5\u7a0b\u3092\u7dad\u6301\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u300d<\/b><span class=\"claim-true-or-false\">\u771f<\/span><\/p>\n<p class=\"claim-explanation\">\u3053\u308c\u306f\u7d76\u5bfe\u306b\u6b63\u3057\u3044\u3067\u3059\u3002ISO 13485\u3067\u306f\u3001\u5168\u3066\u306e\u88fd\u9020\u5de5\u7a0b\u304c\u691c\u8a3c\u3055\u308c\u3001\u7ba1\u7406\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u304c\u8981\u6c42\u3055\u308c\u307e\u3059\u3002\u5c04\u51fa\u6210\u5f62\u306e\u30d1\u30e9\u30e1\u30fc\u30bf\u3001\u6750\u6599\u3001\u624b\u9806\u306e\u5909\u66f4\u306f\u3001\u30ea\u30b9\u30af\u8a55\u4fa1\u3068\u691c\u8a3c\u3092\u542b\u3080\u6b63\u5f0f\u306a\u5909\u66f4\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9\u3092\u7d4c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u5909\u66f4\u304c\u30c7\u30d0\u30a4\u30b9\u306e\u5b89\u5168\u6027\u3084\u6709\u52b9\u6027\u3092\u640d\u306a\u308f\u306a\u3044\u3053\u3068\u304c\u4fdd\u8a3c\u3055\u308c\u307e\u3059\u3002<\/p>\n<\/div>\n<div class=\"claim claim-false\" style=\"background-color: #f7e8e8; border-color: #f7e8e8; color: #8a4a4a;\">\n<p><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"20\" height=\"20\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"#dc2626\" stroke-width=\"2\"><line x1=\"18\" y1=\"6\" x2=\"6\" y2=\"18\"\/><line x1=\"6\" y1=\"6\" x2=\"18\" y2=\"18\"\/><\/svg><b>\u300cISO 13485\u306f\u3001\u5358\u306bISO 9001\u306b\u533b\u7642\u6a5f\u5668\u306e\u6587\u66f8\u8981\u4ef6\u3092\u8ffd\u52a0\u3057\u305f\u3082\u306e\u306b\u904e\u304e\u307e\u305b\u3093\u3002\u300d<\/b><span class=\"claim-true-or-false\">\u507d<\/span><\/p>\n<p class=\"claim-explanation\">\u3053\u308c\u306f\u5371\u967a\u306a\u904e\u5ea6\u306e\u5358\u7d14\u5316\u3067\u3059\u3002ISO 13485\u306fISO 9001\u3092\u57fa\u76e4\u3068\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u54c1\u8cea\u7ba1\u7406\u3078\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u6839\u672c\u7684\u306b\u5909\u3048\u3066\u3044\u307e\u3059\u3002\u7d99\u7d9a\u7684\u6539\u5584\u304b\u3089\u6709\u52b9\u6027\u306e\u7dad\u6301\u3078\u306e\u79fb\u884c\u3001\u5fc5\u9808\u306e\u30ea\u30b9\u30af\u7ba1\u7406\u7d71\u5408\u3001\u898f\u5236\u9075\u5b88\u8981\u4ef6\u306f\u3001\u5358\u306a\u308b\u8ffd\u52a0\u66f8\u985e\u3067\u306f\u306a\u304f\u3001\u5168\u304f\u7570\u306a\u308b\u54c1\u8cea\u54f2\u5b66\u3092\u8868\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<\/div>\n<h2>\u533b\u7642\u7528\u5c04\u51fa\u6210\u5f62\u306b\u9069\u7528\u3055\u308c\u308b\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u8981\u4ef6\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h2>\n<p>\u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u306f\u3001\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u8981\u4ef6\u304c\u533b\u7642\u7528\u5c04\u51fa\u6210\u5f62\u306b\u3069\u306e\u3088\u3046\u306b\u9069\u7528\u3055\u308c\u3001\u30b3\u30b9\u30c8\u3001\u54c1\u8cea\u3001\u7d0d\u671f\u3001\u8abf\u9054\u30ea\u30b9\u30af\u306b\u3069\u306e\u3088\u3046\u306a\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u304b\u306b\u3064\u3044\u3066\u3067\u3059\u3002\u533b\u7642\u7528\u5c04\u51fa\u6210\u5f62\u306b\u304a\u3051\u308b\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u8981\u4ef6\u306f\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u5206\u985e\u3068\u6c5a\u67d3\u30ea\u30b9\u30af\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u3002\u30af\u30e9\u30b9I\u306e\u30c7\u30d0\u30a4\u30b9\u306f\u57fa\u672c\u7684\u306a\u6e05\u6d44\u5ea6\u7ba1\u7406\u306e\u307f\u304c\u5fc5\u8981\u306a\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u304c\u3001\u57cb\u8fbc\u578b\u30c7\u30d0\u30a4\u30b9\u306b\u306fISO 14644\u30af\u30e9\u30b97\u4ee5\u4e0a\u306e\u74b0\u5883\u304c\u5fc5\u8981\u3067\u3059\u3002\u8ab2\u984c\u306f\u5358\u306b\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u3092\u7dad\u6301\u3059\u308b\u3053\u3068\u3060\u3051\u3067\u306a\u304f\u3001\u6e05\u6d44\u5ea6\u3068\u6210\u5f62\u5de5\u7a0b\u306e\u3044\u305a\u308c\u3082\u640d\u306a\u3046\u3053\u3068\u306a\u304f\u3001\u5c04\u51fa\u6210\u5f62\u8a2d\u5099\u3092\u7ba1\u7406\u3055\u308c\u305f\u74b0\u5883\u306b\u7d71\u5408\u3059\u308b\u3053\u3068\u3067\u3059\u3002<\/p>\n<p>\u6e29\u5ea6\u7ba1\u7406\u306f\u3001\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u306eHVAC\u30b7\u30b9\u30c6\u30e0\u3068\u5c04\u51fa\u6210\u5f62\u306e\u71b1\u8981\u4ef6\u304c\u885d\u7a81\u3059\u308b\u5834\u5408\u306b\u6975\u3081\u3066\u91cd\u8981\u306b\u306a\u308a\u307e\u3059\u3002\u00b12\u00b0C\u306e\u6e29\u5ea6\u7ba1\u7406\u3092\u7dad\u6301\u3057\u306a\u304c\u3089\u3001\u5927\u91cf\u306e\u71b1\u8ca0\u8377\u3092\u767a\u751f\u3055\u305b\u308b1850\u30c8\u30f3\u306e\u6a5f\u68b0\u3092\u7a3c\u50cd\u3055\u305b\u308b\u306e\u306b\u82e6\u52b4\u3059\u308b\u65bd\u8a2d\u3092\u898b\u3066\u304d\u307e\u3057\u305f\u3002\u6c17\u6d41\u30d1\u30bf\u30fc\u30f3\u306f\u6a5f\u68b0\u914d\u7f6e\u306b\u5408\u308f\u305b\u3066\u8a2d\u8a08\u3057\u3001\u4eba\u54e1\u306e\u52d5\u7dda\u3082\u614e\u91cd\u306b\u8003\u616e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306f\u7279\u306b2-3\u6642\u9593\u304b\u304b\u308b\u91d1\u578b\u4ea4\u63db\u6642\u306b\u306f\u6ce8\u610f\u304c\u5fc5\u8981\u3067\u3059\u3002<\/p>\n<table style=\"width:100%;border-collapse:collapse;margin:1.5em 0;\">\n<thead>\n<tr>\n<th style=\"border:1px solid #ddd;padding:8px;background:#f5f5f5;\">\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u30fb\u30af\u30e9\u30b9<\/th>\n<th style=\"border:1px solid #ddd;padding:8px;background:#f5f5f5;\">\u7c92\u5b50\u6570 \u22650.5\u03bcm\/m\u00b3<\/th>\n<th style=\"border:1px solid #ddd;padding:8px;background:#f5f5f5;\">\u533b\u7642\u6a5f\u5668\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3<\/th>\n<th style=\"border:1px solid #ddd;padding:8px;background:#f5f5f5;\">\u5178\u578b\u7684\u306a\u8981\u6c42\u4e8b\u9805<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td style=\"border:1px solid #ddd;padding:8px;\">ISO 5<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">3,520<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u57cb\u3081\u8fbc\u307f\u53ef\u80fd\u30c7\u30d0\u30a4\u30b9\u3001\u7121\u83cc\u90e8\u54c1<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u5b8c\u5168\u306a\u30ac\u30a6\u30cb\u30f3\u30b0\u3001\u5c64\u6d41<\/td>\n<\/tr>\n<tr>\n<td style=\"border:1px solid #ddd;padding:8px;\">ISO 6<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">35,200<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u91cd\u8981\u306a\u5916\u79d1\u7528\u5668\u5177<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u30b9\u30fc\u30c4\u3001\u5236\u5fa1\u3055\u308c\u305f\u30a2\u30af\u30bb\u30b9<\/td>\n<\/tr>\n<tr>\n<td style=\"border:1px solid #ddd;padding:8px;\">ISO 7<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">352,000<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u975e\u6ec5\u83cc\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u3001\u8a3a\u65ad\u6a5f\u5668<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u5b9f\u9a13\u5ba4\u7528\u30b3\u30fc\u30c8\u3001\u30b7\u30e5\u30fc\u30ba\u30ab\u30d0\u30fc<\/td>\n<\/tr>\n<tr>\n<td style=\"border:1px solid #ddd;padding:8px;\">ISO 8<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">3,520,000<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u4f53\u5916\u533b\u7642\u6a5f\u5668<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u57fa\u672c\u7684\u306a\u4fdd\u8b77\u670d<\/td>\n<\/tr>\n<tr>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u6a19\u6e96\u30eb\u30fc\u30e0<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">>3,520,000<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u30af\u30e9\u30b9I\u30c7\u30d0\u30a4\u30b9\uff08\u4f4e\u30ea\u30b9\u30af\uff09<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u9069\u5207\u306a\u6574\u7406\u6574\u9813\u306e\u5b9f\u8df5<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<figure style=\"text-align:center;margin:2em 0;\">\n<img fetchpriority=\"high\" decoding=\"async\" width=\"800\" height=\"457\" src=\"https:\/\/zetarmold.com\/wp-content\/uploads\/2026\/04\/medical-injection-molding-prod-800x457-1.jpg\" alt=\"\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u74b0\u5883\u3067\u306e\u533b\u7642\u6a5f\u5668\u5c04\u51fa\u6210\u5f62\u88fd\u54c1\" class=\"wp-image-53253 size-full\" style=\"max-width:100%;height:auto;\" srcset=\"https:\/\/zetarmold.com\/wp-content\/uploads\/2026\/04\/medical-injection-molding-prod-800x457-1.jpg 800w, https:\/\/zetarmold.com\/wp-content\/uploads\/2026\/04\/medical-injection-molding-prod-800x457-1-300x171.jpg 300w, https:\/\/zetarmold.com\/wp-content\/uploads\/2026\/04\/medical-injection-molding-prod-800x457-1-768x439.jpg 768w, https:\/\/zetarmold.com\/wp-content\/uploads\/2026\/04\/medical-injection-molding-prod-800x457-1-18x10.jpg 18w, https:\/\/zetarmold.com\/wp-content\/uploads\/2026\/04\/medical-injection-molding-prod-800x457-1-600x343.jpg 600w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><figcaption style=\"font-size:0.78em; color:#888; font-style:italic; margin-top:4px; text-align:center;\">\u533b\u7642\u6210\u5f62\u751f\u7523<\/figcaption><\/figure>\n<h2>\u533b\u7642\u7528\u6210\u5f62\u306b\u304a\u3051\u308b\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08IQ\u3001OQ\u3001PQ\uff09\u306f\u3069\u306e\u3088\u3046\u306b\u5b9f\u884c\u3055\u308c\u307e\u3059\u304b\uff1f<\/h2>\n<p>\u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u306f\u4ee5\u4e0b\u306b\u3064\u3044\u3066\u3067\u3059 <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/process-validation-general-principles-and-practices\">\u30d7\u30ed\u30bb\u30b9\u30fb\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3<\/a><sup id=\"fnref1:1\"><a href=\"#fn:1\" class=\"footnote-ref\">1<\/a><\/sup> 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<a href=\"https:\/\/zetarmold.com\/ja\/%e5%b0%84%e5%87%ba%e6%88%90%e5%bd%a2%e3%81%ae%e7%94%9f%e7%94%a3%e6%99%82%e9%96%93\/\">\u5c04\u51fa\u6210\u5f62\u306e\u751f\u7523\u6642\u9593<\/a> \u7d04\u675f\u3055\u308c\u305f\u767a\u58f2\u65e5\u307e\u3067\u306b\u3002<\/p>\n<div class=\"claim claim-true\" style=\"background-color: #eff7ef; border-color: #eff7ef; color: #5a8a5a;\">\n<p><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"20\" height=\"20\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"#16a34a\" stroke-width=\"2\"><path d=\"M9 16.17L4.83 12l-1.42 1.41L9 19 21 7l-1.41-1.41z\"\/><\/svg><b>\u300c\u30d7\u30ed\u30bb\u30b9\u691c\u8a3c\u306f\u3001\u533b\u7642\u30c7\u30d0\u30a4\u30b9\u306e\u5546\u696d\u751f\u7523\u304c\u958b\u59cb\u3055\u308c\u308b\u524d\u306b\u5b8c\u4e86\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u300d<\/b><span class=\"claim-true-or-false\">\u771f<\/span><\/p>\n<p class=\"claim-explanation\">\u3053\u308c\u306f\u6b63\u3057\u304f\u3001\u4ea4\u6e09\u306e\u4f59\u5730\u306f\u3042\u308a\u307e\u305b\u3093\u3002FDA\u898f\u5236\u304a\u3088\u3073ISO 13485\u8981\u4ef6\u306f\u3001\u5546\u696d\u751f\u7523\u524d\u306b\u30d7\u30ed\u30bb\u30b9\u3092\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3059\u308b\u3053\u3068\u3092\u7fa9\u52d9\u4ed8\u3051\u3066\u3044\u307e\u3059\u3002\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3055\u308c\u3066\u3044\u306a\u3044\u30d7\u30ed\u30bb\u30b9\u3067\u751f\u7523\u3055\u308c\u305f\u533b\u7642\u6a5f\u5668\u3092\u51fa\u8377\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002\u3053\u308c\u306b\u306f\u5c04\u51fa\u6210\u5f62\u30d1\u30e9\u30e1\u30fc\u30bf\u3001\u74b0\u5883\u5236\u5fa1\u3001\u54c1\u8cea\u7ba1\u7406\u624b\u9806\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u30d7\u30ed\u30bb\u30b9\u306e\u5909\u66f4\u304c\u3042\u3063\u305f\u5834\u5408\u3001\u751f\u7523\u518d\u958b\u524d\u306b\u518d\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u304c\u5fc5\u8981\u3067\u3059\u3002<\/p>\n<\/div>\n<div class=\"claim claim-false\" style=\"background-color: #f7e8e8; border-color: #f7e8e8; color: #8a4a4a;\">\n<p><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"20\" height=\"20\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"#dc2626\" stroke-width=\"2\"><line x1=\"18\" y1=\"6\" x2=\"6\" y2=\"18\"\/><line x1=\"6\" y1=\"6\" x2=\"18\" y2=\"18\"\/><\/svg><b>\u300c\u30d7\u30ed\u30bb\u30b9\u304c\u4e00\u5ea6\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3055\u308c\u308b\u3068\u3001\u8a2d\u5099\u304c\u6545\u969c\u3057\u306a\u3044\u9650\u308a\u518d\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306f\u4e0d\u8981\u3067\u3042\u308b\u3002\u300d<\/b><span class=\"claim-true-or-false\">\u507d<\/span><\/p>\n<p class=\"claim-explanation\">\u3053\u308c\u306f\u8aa4\u308a\u3067\u3042\u308a\u3001\u5371\u967a\u3092\u4f34\u3046\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u8a2d\u5099\u306e\u6539\u9020\u3001\u30d7\u30ed\u30bb\u30b9\u30d1\u30e9\u30e1\u30fc\u30bf\u306e\u5909\u66f4\u3001\u65bd\u8a2d\u79fb\u8ee2\u3001\u30d7\u30ed\u30bb\u30b9\u5236\u5fa1\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u4eba\u54e1\u5909\u66f4\u3001\u5b9a\u671f\u7684\u306a\u518d\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff08\u901a\u5e38\u306f\u5e741\u56de\u307e\u305f\u306f\u534a\u5e74\u306b1\u56de\uff09\u306b\u306f\u518d\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u304c\u5fc5\u8981\u3067\u3059\u3002\u5c04\u51fa\u6210\u5f62\u6a5f\u30b3\u30f3\u30c8\u30ed\u30fc\u30e9\u30fc\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u66f4\u65b0\u3067\u3055\u3048\u3001\u518d\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u8981\u4ef6\u3092\u5f15\u304d\u8d77\u3053\u3059\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<\/div>\n<h2>ISO 13485\u6e96\u62e0\u306b\u304a\u3044\u3066\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306f\u3069\u306e\u3088\u3046\u306a\u5f79\u5272\u3092\u679c\u305f\u3057\u307e\u3059\u304b\uff1f<\/h2>\n<p>\u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u306f\u3001ISO 13485\u9069\u5408\u306b\u304a\u3051\u308b\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306e\u5f79\u5272\u3068\u3001\u30b3\u30b9\u30c8\u3001\u54c1\u8cea\u3001\u6642\u9593\u3001\u307e\u305f\u306f\u4f9b\u7d66\u30ea\u30b9\u30af\u3078\u306e\u5f71\u97ff\u306b\u3064\u3044\u3066\u3067\u3059\u3002ISO 13485\u533b\u7642\u5c04\u51fa\u6210\u5f62\u306b\u304a\u3051\u308b\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3068\u306f\u3001\u539f\u6750\u6599\u30ed\u30c3\u30c8\u304b\u3089\u7279\u5b9a\u306e\u60a3\u8005\u304c\u53d7\u3051\u53d6\u3063\u305f\u30c7\u30d0\u30a4\u30b9\u307e\u3067\u3001\u3059\u3079\u3066\u306e\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u3092\u8ffd\u8de1\u3067\u304d\u308b\u3053\u3068\u3092\u610f\u5473\u3057\u307e\u3059\u3002\u3053\u308c\u306f\u5358\u306a\u308b\u30d0\u30c3\u30c1\u8a18\u9332\u3067\u306f\u306a\u304f\u3001\u6750\u6599\u30ed\u30c3\u30c8\u756a\u53f7\u3001\u52a0\u5de5\u30d1\u30e9\u30e1\u30fc\u30bf\u3001\u54c1\u8cea\u30c6\u30b9\u30c8\u7d50\u679c\u3001\u304a\u3088\u3073\u95a2\u4fc2\u3059\u308b\u4eba\u54e1\u3092\u542b\u3080\u5b8c\u5168\u306a\u7cfb\u8b5c\u3067\u3059\u3002\u533b\u7642\u30c7\u30d0\u30a4\u30b9\u304c\u73fe\u5834\u3067\u6545\u969c\u3057\u305f\u5834\u5408\u3001\u898f\u5236\u5f53\u5c40\u306f\u6570\u6642\u9593\u4ee5\u5185\u306b\u3059\u3079\u3066\u306e\u6f5c\u5728\u7684\u306b\u5f71\u97ff\u3092\u53d7\u3051\u305f\u30c7\u30d0\u30a4\u30b9\u3092\u7279\u5b9a\u3059\u308b\u3053\u3068\u3092\u671f\u5f85\u3057\u307e\u3059\u3002<\/p>\n<p>\u5c04\u51fa\u6210\u5f62\u3078\u306e\u5f71\u97ff\u306f\u5e83\u7bc4\u56f2\u3067\u3059\u3002\u3059\u3079\u3066\u306e\u6750\u6599\u30ed\u30c3\u30c8\u306f\u3001\u52a0\u5de5\u3092\u901a\u3058\u3066\u5206\u96e2\u3055\u308c\u8ffd\u8de1\u3055\u308c\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u518d\u751f\u6750\u306e\u4f7f\u7528\u306b\u306f\u3001\u6c5a\u67d3\u6bd4\u7387\u3068\u627f\u8a8d\u8a18\u9332\u3092\u793a\u3059\u6587\u66f8\u304c\u5fc5\u8981\u3067\u3059\u3002\u6a5f\u68b0\u306e\u4fdd\u5b88\u8a18\u9332\u306f\u30c7\u30d0\u30a4\u30b9\u5c65\u6b74\u306e\u4e00\u90e8\u306b\u306a\u308a\u307e\u3059\u3002\u306a\u305c\u306a\u3089\u3001\u6469\u8017\u3057\u305f\u30b9\u30af\u30ea\u30e5\u30fc\u3084\u6c5a\u67d3\u3055\u308c\u305f\u30d0\u30ec\u30eb\u306f\u88fd\u54c1\u54c1\u8cea\u306b\u5f71\u97ff\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u79c1\u305f\u3061\u306f\u30c7\u30d0\u30a4\u30b9\u5c65\u6b74\u8a18\u9332\u2074\uff08<a href=\"https:\/\/www.fda.gov\/medical-devices\/quality-systems-regulation\/device-master-record-and-device-history-record\">DHR<\/a><sup id=\"fnref1:2\"><a href=\"#fn:2\" class=\"footnote-ref\">2<\/a><\/sup>\uff09\u306f\u3001\u591a\u30ad\u30e3\u30d3\u30c6\u30a3\u91d1\u578b\u306e\u7279\u5b9a\u306e\u30ad\u30e3\u30d3\u30c6\u30a3\u4f4d\u7f6e\u306b\u500b\u3005\u306e\u90e8\u54c1\u3092\u8ffd\u8de1\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>\u52b9\u679c\u7684\u306a\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306e\u305f\u3081\u306b\u306f\u3001\u30c7\u30b8\u30bf\u30eb\u30b7\u30b9\u30c6\u30e0\u304c\u4e8b\u5b9f\u4e0a\u5fc5\u9808\u3067\u3059\u3002\u624b\u52d5\u306e\u7d19\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u5c11\u306a\u3044\u751f\u7523\u91cf\u3092\u8d85\u3048\u308b\u3068\u7ba1\u7406\u4e0d\u80fd\u306b\u306a\u308a\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u8981\u4ef6\u306b\u5bfe\u5fdc\u53ef\u80fd\u306aMES\u307e\u305f\u306fERP\u30b7\u30b9\u30c6\u30e0\u306b5\u4e07\uff5e20\u4e07\u30c9\u30eb\u306e\u6295\u8cc7\u3092\u898b\u8fbc\u3093\u3067\u304f\u3060\u3055\u3044\u3002\u3053\u306e\u30b7\u30b9\u30c6\u30e0\u306f\u5c04\u51fa\u6210\u5f62\u6a5f\u306e\u5236\u5fa1\u88c5\u7f6e\u3068\u9023\u643a\u3057\u3066\u30d7\u30ed\u30bb\u30b9\u30d1\u30e9\u30e1\u30fc\u30bf\u3092\u81ea\u52d5\u7684\u306b\u53d6\u5f97\u3057\u3001\u6570\u5341\u5e74\u306b\u308f\u305f\u308b\u898f\u5236\u76e3\u67fb\u306e\u305f\u3081\u306b\u30c7\u30fc\u30bf\u5b8c\u5168\u6027\u3092\u7dad\u6301\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<h2>\u533b\u7642\u7528\u5c04\u51fa\u6210\u5f62\u3067\u4e00\u822c\u7684\u306b\u4f7f\u7528\u3055\u308c\u308b\u6750\u6599\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h2>\n<p>\u533b\u7642\u7528\u5c04\u51fa\u6210\u5f62\u6750\u6599\u306f\u3001\u751f\u4f53\u9069\u5408\u6027\u8981\u4ef6\u3068\u7528\u9014\u306b\u57fa\u3065\u3044\u3066\u3044\u304f\u3064\u304b\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002 <a href=\"https:\/\/www.usp.org\/harmonization-standards\/pdg\/general-chapters\/biological-reactivity-tests-in-vivo\">USP\u30af\u30e9\u30b9VI<\/a><sup id=\"fnref1:3\"><a href=\"#fn:3\" class=\"footnote-ref\">3<\/a><\/sup> \u6750\u6599\u306f\u307b\u3068\u3093\u3069\u306e\u533b\u7642\u7528\u9014\u306e\u57fa\u6e96\u3067\u3042\u308a\u3001\u57cb\u3081\u8fbc\u307f\u578b\u30c7\u30d0\u30a4\u30b9\u306b\u306fISO 10993\u751f\u7269\u5b66\u7684\u8a55\u4fa1\u304c\u5fc5\u8981\u3067\u3059\u3002\u6700\u3082\u4e00\u822c\u7684\u306a\u6750\u6599\u306b\u306f\u3001\u533b\u7642\u7528\u30dd\u30ea\u30d7\u30ed\u30d4\u30ec\u30f3\u3001\u30dd\u30ea\u30ab\u30fc\u30dc\u30cd\u30fc\u30c8\u3001ABS\u3001\u304a\u3088\u3073\u9ad8\u6027\u80fd\u7528\u9014\u5411\u3051\u306ePEEK\u306a\u3069\u306e\u7279\u6b8a\u30dd\u30ea\u30de\u30fc\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n<p>\u6750\u6599\u9078\u629e\u306f\u6a5f\u68b0\u7684\u7279\u6027\u4ee5\u4e0a\u306e\u3082\u306e\u3092\u542b\u307f\u307e\u3059\u3002\u3059\u3079\u3066\u306e\u6750\u6599\u306b\u306f\u3001\u751f\u4f53\u9069\u5408\u6027\u6587\u66f8\u3001\u62bd\u51fa\u7269\u304a\u3088\u3073\u6eb6\u51fa\u7269\u30c6\u30b9\u30c8\u3001\u304a\u3088\u3073\u591a\u304f\u306e\u5834\u5408\u6ec5\u83cc\u691c\u8a3c\u304c\u5fc5\u8981\u3067\u3059\u3002\u30dd\u30ea\u30d7\u30ed\u30d4\u30ec\u30f3\u306f\u3001\u30ac\u30f3\u30de\u304a\u3088\u3073\u30a8\u30c1\u30ec\u30f3\u30aa\u30ad\u30b5\u30a4\u30c9\u6ec5\u83cc\u9069\u5408\u6027\u306b\u3088\u308a\u3001\u4f7f\u3044\u6368\u3066\u30c7\u30d0\u30a4\u30b9\u306b\u9069\u3057\u3066\u3044\u307e\u3059\u3002\u30dd\u30ea\u30ab\u30fc\u30dc\u30cd\u30fc\u30c8\u306f\u8a3a\u65ad\u6a5f\u5668\u306e\u5149\u5b66\u900f\u660e\u5ea6\u3092\u63d0\u4f9b\u3057\u307e\u3059\u304c\u3001\u6ec5\u83cc\u30b5\u30a4\u30af\u30eb\u4e2d\u306b\u30b9\u30c8\u30ec\u30b9\u30af\u30e9\u30c3\u30af\u3092\u907f\u3051\u308b\u305f\u3081\u306b\u614e\u91cd\u306a\u52a0\u5de5\u304c\u5fc5\u8981\u3067\u3059\u3002<\/p>\n<p>\u7279\u6b8a\u6750\u6599\u306f\u30d7\u30ec\u30df\u30a2\u30e0\u4fa1\u683c\u3092\u8981\u6c42\u3057\u307e\u3059\u304c\u3001\u7279\u5b9a\u306e\u8ab2\u984c\u3092\u89e3\u6c7a\u3057\u307e\u3059\u3002PEEK\u306f\u5316\u5b66\u8010\u6027\u3068\u653e\u5c04\u7dda\u900f\u904e\u6027\u3092\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u306b\u63d0\u4f9b\u3057\u307e\u3059\u304c\u3001400\u00b0C\u4ee5\u4e0a\u306e\u52a0\u5de5\u6e29\u5ea6\u3092\u5fc5\u8981\u3068\u3057\u307e\u3059\u3002\u6db2\u4f53\u30b7\u30ea\u30b3\u30fc\u30f3\u30b4\u30e0\uff08LSR\uff09\u306f\u751f\u4f53\u9069\u5408\u6027\u3068\u67d4\u8edf\u6027\u3092\u63d0\u4f9b\u3057\u307e\u3059\u304c\u3001\u7279\u6b8a\u306a\u5c04\u51fa\u6210\u5f62\u8a2d\u5099\u304c\u5fc5\u8981\u3067\u3059\u3002\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u306e\u6750\u6599\u306f\u901a\u5e38\u3001\u6a19\u6e96\u30b0\u30ec\u30fc\u30c9\u306e2\uff5e5\u500d\u306e\u30b3\u30b9\u30c8\u304c\u304b\u304b\u308a\u3001\u30ed\u30c3\u30c8\u3054\u3068\u306e\u8a8d\u8a3c\u306f\u30ea\u30fc\u30c9\u30bf\u30a4\u30e0\u3068\u5728\u5eab\u30b3\u30b9\u30c8\u3092\u5897\u52a0\u3055\u305b\u307e\u3059\u3002<\/p>\n<figure style=\"text-align:center;margin:2em 0;\">\n<img decoding=\"async\" width=\"800\" height=\"457\" src=\"https:\/\/zetarmold.com\/wp-content\/uploads\/2026\/03\/prototype-plastic-parts-batch-800x457-1.jpg\" alt=\"\u5c04\u51fa\u6210\u5f62\u3055\u308c\u305f\u533b\u7642\u90e8\u54c1\u306e\u30d0\u30c3\u30c1\u691c\u67fb\" class=\"wp-image-53194 size-full\" style=\"max-width:100%;height:auto;\" srcset=\"https:\/\/zetarmold.com\/wp-content\/uploads\/2026\/03\/prototype-plastic-parts-batch-800x457-1.jpg 800w, https:\/\/zetarmold.com\/wp-content\/uploads\/2026\/03\/prototype-plastic-parts-batch-800x457-1-300x171.jpg 300w, https:\/\/zetarmold.com\/wp-content\/uploads\/2026\/03\/prototype-plastic-parts-batch-800x457-1-768x439.jpg 768w, https:\/\/zetarmold.com\/wp-content\/uploads\/2026\/03\/prototype-plastic-parts-batch-800x457-1-18x10.jpg 18w, https:\/\/zetarmold.com\/wp-content\/uploads\/2026\/03\/prototype-plastic-parts-batch-800x457-1-600x343.jpg 600w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><figcaption style=\"font-size:0.78em; color:#888; font-style:italic; margin-top:4px; text-align:center;\">\u533b\u7642\u90e8\u54c1\u691c\u67fb<\/figcaption><\/figure>\n<h2>ISO 13485\u6e96\u62e0\u306e\u9577\u6240\u3068\u77ed\u6240\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h2>\n<p>ISO 13485\u9069\u5408\u306e\u5229\u70b9\u3068\u6b20\u70b9\u306f\u3001\u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u3067\u8aac\u660e\u3055\u308c\u308b\u4e3b\u306a\u30ab\u30c6\u30b4\u30ea\u307e\u305f\u306f\u9078\u629e\u80a2\u3067\u3059\u3002ISO 13485\u9069\u5408\u306f\u3001\u53ce\u76ca\u6027\u306e\u9ad8\u3044\u533b\u7642\u30c7\u30d0\u30a4\u30b9\u5e02\u5834\u3078\u306e\u6249\u3092\u958b\u304d\u307e\u3059\u304c\u3001\u91cd\u8981\u306a\u6295\u8cc7\u3068\u904b\u7528\u4e0a\u306e\u5909\u66f4\u3092\u8981\u6c42\u3057\u307e\u3059\u3002\u5229\u70b9\u306b\u306f\u3001\u898f\u5236\u5e02\u5834\u3078\u306e\u30a2\u30af\u30bb\u30b9\u3001\u533b\u7642\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306e\u30d7\u30ec\u30df\u30a2\u30e0\u4fa1\u683c\u8a2d\u5b9a\u3001\u304a\u3088\u3073\u7af6\u4e89\u4e0a\u306e\u5dee\u5225\u5316\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u9069\u5408\u8ca0\u62c5\u306f\u3001\u6587\u66f8\u8981\u4ef6\u304b\u3089\u4eba\u54e1\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3001\u30d7\u30ed\u30bb\u30b9\u67d4\u8edf\u6027\u307e\u3067\u3001\u904b\u7528\u306e\u3059\u3079\u3066\u306e\u5074\u9762\u306b\u5f71\u97ff\u3057\u307e\u3059\u3002<\/p>\n<table style=\"width:100%;border-collapse:collapse;margin:1.5em 0;\">\n<thead>\n<tr>\n<th style=\"border:1px solid #ddd;padding:8px;background:#f5f5f5;\">\u30a2\u30b9\u30da\u30af\u30c8<\/th>\n<th style=\"border:1px solid #ddd;padding:8px;background:#f5f5f5;\">\u30e1\u30ea\u30c3\u30c8<\/th>\n<th style=\"border:1px solid #ddd;padding:8px;background:#f5f5f5;\">\u30c7\u30e1\u30ea\u30c3\u30c8<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td style=\"border:1px solid #ddd;padding:8px;\">Market Access<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u30b0\u30ed\u30fc\u30d0\u30eb\u533b\u7642\u30c7\u30d0\u30a4\u30b9\u5e02\u5834\u3001\u898f\u5236\u627f\u8a8d<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u9577\u3044\u8a8d\u8a3c\u30d7\u30ed\u30bb\u30b9\u3001\u7d99\u7d9a\u7684\u306a\u76e3\u67fb<\/td>\n<\/tr>\n<tr>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u4fa1\u683c\u8a2d\u5b9a<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u5272\u9ad8\u306a\u6599\u91d1\uff0820-40%\u9ad8\u3044\uff09\u3001\u9577\u671f\u5951\u7d04<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u9ad8\u3044\u6750\u6599\u304a\u3088\u3073\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30b3\u30b9\u30c8<\/td>\n<\/tr>\n<tr>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u5805\u7262\u306a\u30d7\u30ed\u30bb\u30b9\u3001\u6b20\u9665\u306e\u524a\u6e1b\u3001\u9867\u5ba2\u306e\u4fe1\u983c<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u5e83\u7bc4\u306a\u6587\u66f8\u5316\u3001\u30d7\u30ed\u30bb\u30b9\u5909\u66f4\u304c\u9045\u3044<\/td>\n<\/tr>\n<tr>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u7af6\u4e89<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u8a8d\u5b9a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c\u5c11\u306a\u3044\u3001\u5e02\u5834\u969c\u58c1<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u9ad8\u3044\u53c2\u5165\u969c\u58c1\u3001\u5c02\u9580\u77e5\u8b58\u304c\u5fc5\u8981<\/td>\n<\/tr>\n<tr>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u904b\u7528<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u4f53\u7cfb\u7684\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u3001\u30ea\u30b9\u30af\u7ba1\u7406\u306e\u7d71\u5408<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u67d4\u8edf\u6027\u306e\u4f4e\u4e0b\u3001\u30ea\u30fc\u30c9\u30bf\u30a4\u30e0\u306e\u9577\u671f\u5316<\/td>\n<\/tr>\n<tr>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u6295\u8cc7<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u9577\u671f\u7684\u306a\u9867\u5ba2\u95a2\u4fc2\u3001\u5b89\u5b9a\u3057\u305f\u53ce\u76ca<\/td>\n<td style=\"border:1px solid #ddd;padding:8px;\">\u521d\u671f\u8cbb\u7528\u304c\u9ad8\u984d\u3001\u7d99\u7d9a\u7684\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8cbb\u7528<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<div class=\"factory-insight\" data-fact-ids=\"location.shanghai_factory,equipment.cleanroom_m8_6,certification.iso_9001_13485_14001_45001,company.experience_20_years,equipment.injection_machines_47,equipment.tonnage_90_1850\" style=\"background:#f0f7ff;border-left:4px solid #0066cc;padding:12px 16px;margin:1.5em 0;\"><strong>\ud83c\udfed ZetarMold Factory Insight<\/strong><br \/>\u5f53\u793e\u306e\u4e0a\u6d77\u5de5\u5834\u3067\u306f\u3001\u30c1\u30fc\u30e0\u306fISO 9001\u3001ISO 13485\u3001ISO 14001\u3001\u304a\u3088\u3073ISO 45001\u30b7\u30b9\u30c6\u30e0\u306e\u4e0b\u3067\u4f5c\u696d\u3057\u3066\u3044\u307e\u3059\u3002\u533b\u7642\u7528\u6210\u5f62\u4f5c\u696d\u3067\u306f\u3001\u30af\u30e9\u30b9M8\u306e\u7121\u5875\u5ba4\u306b\u3042\u308b6\u53f0\u306e\u6a5f\u68b0\u304c\u30af\u30ea\u30fc\u30f3\u306a\u751f\u7523\u7ba1\u7406\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u3001\u4e00\u65b9\u306747\u53f0\u306e\u5c04\u51fa\u6210\u5f62\u6a5f\u306890T\u304b\u30891850T\u306e\u7bc4\u56f2\u3092\u6301\u3064\u5e83\u7bc4\u306a\u8a2d\u5099\u306b\u3088\u308a\u3001\u975e\u533b\u7642\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u5411\u3051\u306e\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u80fd\u529b\u3092\u78ba\u4fdd\u3057\u3066\u3044\u307e\u3059\u300220\u5e74\u4ee5\u4e0a\u306e\u5c04\u51fa\u6210\u5f62\u304a\u3088\u3073\u91d1\u578b\u88fd\u9020\u306e\u7d4c\u9a13\u304b\u3089\u3001\u533b\u7642\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3067\u306f\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3068\u306e\u4f1a\u8a71\u304c\u4fa1\u683c\u6bd4\u8f03\u304b\u3089\u8a8d\u5b9a\u306b\u79fb\u884c\u3059\u308b\u524d\u306b\u3001\u6587\u66f8\u5316\u3055\u308c\u305f\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3001\u6750\u6599\u306e\u8ffd\u8de1\u53ef\u80fd\u6027\u3001\u304a\u3088\u3073\u5de5\u7a0b\u5185\u30c1\u30a7\u30c3\u30af\u304c\u5fc5\u8981\u3067\u3059\u3002<\/div>\n<h2>ISO 13485\u8a8d\u8a3c\u5c04\u51fa\u6210\u5f62\u30d1\u30fc\u30c8\u30ca\u30fc\u3092\u3069\u306e\u3088\u3046\u306b\u9078\u3076\u304b\uff1f<\/h2>\n<p>ISO 13485\u8a8d\u5b9a\u5c04\u51fa\u6210\u5f62\u30d1\u30fc\u30c8\u30ca\u30fc\u3092\u9078\u629e\u3059\u308b\u3053\u3068\u306f\u3001\u5de5\u5177\u80fd\u529b\u3001\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3001\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3001\u304a\u3088\u3073\u5546\u696d\u7684\u9069\u5408\u6027\u306b\u3064\u3044\u3066\u3067\u3059\u3002ISO 13485\u5c04\u51fa\u6210\u5f62\u30d1\u30fc\u30c8\u30ca\u30fc\u3092\u9078\u629e\u3059\u308b\u306b\u306f\u3001\u57fa\u672c\u7684\u306a\u8a8d\u5b9a\u3092\u8d85\u3048\u305f\u80fd\u529b\u8a55\u4fa1\u304c\u5fc5\u8981\u3067\u3059\u3002\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u65bd\u8a2d\u3092\u76e3\u67fb\u3057\u3001\u691c\u8a3c\u6587\u66f8\u3092\u30ec\u30d3\u30e5\u30fc\u3057\u3001\u898f\u5236\u7d4c\u9a13\u3092\u8a55\u4fa1\u3057\u307e\u3059\u3002\u58c1\u306b\u8cbc\u3089\u308c\u305f\u8a3c\u660e\u66f8\u306f\u3001\u9069\u5207\u306a\u5b9f\u884c\u3092\u4fdd\u8a3c\u3057\u307e\u305b\u3093\u3002FDA\u898f\u5236\u3001EU MDR\u8981\u4ef6\u3001\u304a\u3088\u3073\u533b\u7642\u30c7\u30d0\u30a4\u30b9\u88fd\u9020\u306e\u7279\u5b9a\u306e\u8ab2\u984c\u3092\u7406\u89e3\u3059\u308b\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c\u5fc5\u8981\u3067\u3059\u3002<\/p>\n<p>\u6280\u8853\u80fd\u529b\u306f\u8a8d\u8a3c\u3068\u540c\u69d8\u306b\u91cd\u8981\u3067\u3059\u3002\u4f9b\u7d66\u5148\u306e\u3001\u304a\u5ba2\u69d8\u306e\u7279\u5b9a\u306e\u6750\u6599\u3068\u7528\u9014\u306b\u95a2\u3059\u308b\u5c04\u51fa\u6210\u5f62\u306e\u7d4c\u9a13\u3092\u8a55\u4fa1\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u533b\u7642\u7528\u30b0\u30ec\u30fc\u30c9\u306e\u6750\u6599\u306f\u3057\u3070\u3057\u3070\u5c02\u9580\u7684\u306a\u52a0\u5de5\u77e5\u8b58\u3092\u5fc5\u8981\u3068\u3057\u3001\u8907\u96d1\u306a\u5f62\u72b6\u306f\u9ad8\u5ea6\u306a\u6210\u5f62\u6280\u8853\u3092\u5fc5\u8981\u3068\u3059\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3001\u7d71\u8a08\u7684\u5de5\u7a0b\u7ba1\u7406\u80fd\u529b\u3001\u6587\u66f8\u5316\u306e\u5b9f\u8df5\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u5305\u62ec\u7684\u306a <a href=\"https:\/\/zetarmold.com\/ja\/injection-molding-supplier-sourcing-guide\/\">sourcing guide<\/a> \u306f\u3001\u8a55\u4fa1\u30d7\u30ed\u30bb\u30b9\u306e\u69cb\u7bc9\u3092\u652f\u63f4\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>\u8ca1\u52d9\u7684\u5b89\u5b9a\u6027\u3068\u62e1\u5f35\u6027\u306f\u3001\u9577\u671f\u7684\u306a\u30d1\u30fc\u30c8\u30ca\u30fc\u30b7\u30c3\u30d7\u306b\u3068\u3063\u3066\u91cd\u8981\u3067\u3059\u3002\u533b\u7642\u6a5f\u5668\u88fd\u54c1\u306f\u591a\u304f\u306e\u5834\u540810\u301c15\u5e74\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u6301\u3061\u3001\u5897\u52a0\u3059\u308b\u751f\u7523\u91cf\u3068\u898f\u5236\u306e\u5909\u5316\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c\u5fc5\u8981\u3067\u3059\u3002\u9867\u5ba2\u57fa\u76e4\u3001\u65bd\u8a2d\u3078\u306e\u6295\u8cc7\u3001\u6280\u8853\u30b9\u30bf\u30c3\u30d5\u306e\u5b9a\u7740\u7387\u3092\u8a55\u4fa1\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u6700\u4f4e\u30b3\u30b9\u30c8\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f\u3001\u6301\u7d9a\u7684\u306a\u533b\u7642\u6a5f\u5668\u88fd\u9020\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8981\u6c42\u3068\u6295\u8cc7\u8981\u4ef6\u3092\u6e80\u305f\u3059\u3053\u3068\u306f\u307b\u3068\u3093\u3069\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n<h2>\u3088\u304f\u3042\u308b\u8cea\u554f<\/h2>\n<h3>\u5c04\u51fa\u6210\u5f62\u65bd\u8a2d\u306eISO 13485\u8a8d\u8a3c\u53d6\u5f97\u306b\u306f\u3069\u306e\u304f\u3089\u3044\u306e\u6642\u9593\u304c\u304b\u304b\u308a\u307e\u3059\u304b\uff1f<\/h3>\n<p>\u78ba\u7acb\u3055\u308c\u305f\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3092\u6301\u3064\u65e2\u5b58\u306e\u5c04\u51fa\u6210\u5f62\u65bd\u8a2d\u306e\u5834\u5408\u3001ISO 13485\u306e\u521d\u671f\u8a8d\u8a3c\u53d6\u5f97\u306b\u306f\u901a\u5e3812\u301c18\u30f6\u6708\u304b\u304b\u308a\u307e\u3059\u3002\u3053\u306e\u671f\u9593\u306b\u306f\u3001\u30ae\u30e3\u30c3\u30d7\u5206\u6790\u3001\u624b\u9806\u7b56\u5b9a\u3001\u8981\u54e1\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3001\u30b7\u30b9\u30c6\u30e0\u5c0e\u5165\u3001\u5185\u90e8\u76e3\u67fb\u3001\u304a\u3088\u3073\u901a\u77e5\u6a5f\u95a2\u306b\u3088\u308b2\u6bb5\u968e\u306e\u8a8d\u8a3c\u76e3\u67fb\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u3084\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u6e08\u307f\u8a2d\u5099\u304c\u306a\u3044\u72b6\u614b\u304b\u3089\u306e\u30b9\u30bf\u30fc\u30c8\u3068\u306a\u308b\u65bd\u8a2d\u306f\u300118\u301c24\u30f6\u6708\u306e\u671f\u9593\u3092\u898b\u8fbc\u3080\u3079\u304d\u3067\u3059\u3002\u6700\u3082\u5927\u304d\u306a\u9045\u5ef6\u8981\u56e0\u306f\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3067\u3059\u3002\u5404\u91d1\u578b\u30fb\u6750\u6599\u306e\u7d44\u307f\u5408\u308f\u305b\u3054\u3068\u306b\u72ec\u81ea\u306eIQ\/OQ\/PQ\u30d1\u30c3\u30b1\u30fc\u30b8\u304c\u5fc5\u8981\u3067\u3042\u308a\u3001\u591a\u304f\u306e\u65bd\u8a2d\u306f\u3053\u306e\u4f5c\u696d\u91cf\u3092\u904e\u5c0f\u8a55\u4fa1\u3057\u3066\u3044\u307e\u3059\u3002\u76e3\u67fb\u6bb5\u968e\u3067\u306e\u4e88\u671f\u305b\u306c\u30b3\u30b9\u30c8\u3092\u907f\u3051\u308b\u305f\u3081\u3001\u4e88\u7b97\u306f\u5341\u5206\u306b\u78ba\u4fdd\u3057\u3001\u7d4c\u9a13\u8c4a\u5bcc\u306a\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3092\u30d7\u30ed\u30bb\u30b9\u306e\u65e9\u3044\u6bb5\u968e\u304b\u3089\u95a2\u4e0e\u3055\u305b\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n<h3>ISO 13485\u8a8d\u8a3c\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306e\u5e74\u9593\u30b3\u30b9\u30c8\u306f\u3044\u304f\u3089\u3067\u3059\u304b\uff1f<\/h3>\n<p>\u65e2\u5b58\u306e\u5c04\u51fa\u6210\u5f62\u8a2d\u5099\u306f\u533b\u7642\u6a5f\u5668\u751f\u7523\u306b\u9069\u5fdc\u3067\u304d\u308b\u3053\u3068\u304c\u591a\u3044\u3067\u3059\u304c\u3001\u305d\u306e\u9053\u7b4b\u306f\u5358\u7d14\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u8a2d\u5099\u306f\u3001\u4ed5\u69d8\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306e\u5b8c\u5168\u306a\u636e\u4ed8\u9069\u683c\u6027\u8a55\u4fa1\uff08IQ\uff09\u3092\u53d7\u3051\u3001\u305d\u306e\u5f8c\u3001\u52d5\u4f5c\u7bc4\u56f2\u5168\u4f53\u3067\u306e\u80fd\u529b\u3092\u5b9f\u8a3c\u3059\u308b\u904b\u8ee2\u9069\u683c\u6027\u8a55\u4fa1\uff08OQ\uff09\u3092\u884c\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u6a5f\u68b0\u306b\u306f\u3001\u5404\u30b7\u30e7\u30c3\u30c8\u306e\u30d1\u30e9\u30e1\u30fc\u30bf\u3092\u8a18\u9332\u3059\u308b\u305f\u3081\u306e\u30d7\u30ed\u30bb\u30b9\u76e3\u8996\u3068\u30c7\u30fc\u30bf\u30ed\u30ae\u30f3\u30b0\u6a5f\u80fd\u304c\u5fc5\u8981\u3067\u3059\u3002\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u9069\u5408\u6027\u3082\u8003\u616e\u3059\u3079\u304d\u70b9\u3067\u3059\u2014\u6cb9\u5727\u6a5f\u68b0\u306f\u71b1\u3068\u7c92\u5b50\u3092\u767a\u751f\u3055\u305b\u3001\u5236\u5fa1\u3055\u308c\u305f\u74b0\u5883\u3092\u640d\u306a\u3046\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u9589\u30eb\u30fc\u30d7\u5236\u5fa1\u3084\u9069\u5207\u306a\u6587\u66f8\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u3092\u6b20\u304f\u53e4\u3044\u6a5f\u68b0\u306f\u3001\u5927\u5e45\u306a\u30a2\u30c3\u30d7\u30b0\u30ec\u30fc\u30c9\uff0810,000\u301c50,000\u30c9\u30eb\uff09\u307e\u305f\u306f\u4ea4\u63db\u304c\u5fc5\u8981\u306b\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u8a2d\u5099\u306e\u7d4c\u5e74\u3060\u3051\u3067\u306f\u4e0d\u9069\u683c\u3068\u306f\u306a\u308a\u307e\u305b\u3093\u304c\u3001\u6b63\u5f0f\u306a\u9069\u683c\u6027\u8a55\u4fa1\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u901a\u3058\u3066\u5404\u6a5f\u68b0\u306e\u80fd\u529b\u3092\u8a3c\u660e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<h3>\u65e2\u5b58\u306e\u5c04\u51fa\u6210\u5f62\u8a2d\u5099\u306f\u533b\u7642\u6a5f\u5668\u306e\u751f\u7523\u306b\u4f7f\u7528\u3067\u304d\u307e\u3059\u304b\uff1f<\/h3>\n<p>\u533b\u7642\u6a5f\u5668\u5c04\u51fa\u6210\u5f62\u306b\u306f\u3001\u5305\u62ec\u7684\u306a\u6587\u66f8\u7ba1\u7406\u30a8\u30b3\u30b7\u30b9\u30c6\u30e0\u304c\u5fc5\u8981\u3067\u3059\u3002\u4e2d\u6838\u3068\u306a\u308b\u6587\u66f8\u306b\u306f\u3001\u56f3\u9762\u3001\u6750\u6599\u4ed5\u69d8\u3001\u4f5c\u696d\u6307\u793a\u3092\u542b\u3080\u30c7\u30d0\u30a4\u30b9\u30de\u30b9\u30bf\u30fc\u30ec\u30b3\u30fc\u30c9\uff08DMR\uff09\u3001\u5404\u30ed\u30c3\u30c8\u304cDMR\u306b\u5f93\u3063\u3066\u88fd\u9020\u3055\u308c\u305f\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u30c7\u30d0\u30a4\u30b9\u5c65\u6b74\u8a18\u9332\uff08DHR\uff09\u3001\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u8a08\u753b\u66f8\u3068\u5831\u544a\u66f8\uff08IQ\/OQ\/PQ\uff09\u3001\u6750\u6599\u8a3c\u660e\u66f8\u3068\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\u7d50\u679c\u3001\u8a2d\u5099\u306e\u9069\u683c\u6027\u8a55\u4fa1\u3068\u6821\u6b63\u8a18\u9332\u3001\u5404\u5de5\u7a0b\u30b9\u30c6\u30c3\u30d7\u306e\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\u3001\u304a\u3088\u3073\u5909\u66f4\u7ba1\u7406\u6587\u66f8\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u5404\u751f\u7523\u30ed\u30c3\u30c8\u306f\u3001\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u306e\u30d7\u30ed\u30bb\u30b9\u30d1\u30e9\u30e1\u30fc\u30bf\u3001\u54c1\u8cea\u691c\u67fb\u7d50\u679c\u3001\u5b8c\u5168\u306a\u6750\u6599\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3092\u542b\u3080\u5b8c\u5168\u306a\u30d0\u30c3\u30c1\u8a18\u9332\u3092\u751f\u6210\u3057\u307e\u3059\u3002\u6a19\u6e96\u7684\u306a\u5c04\u51fa\u6210\u5f62\u306b\u6bd4\u3079\u3066\u6587\u66f8\u91cf\u304c10\u301c20\u500d\u306b\u306a\u308b\u3068\u4e88\u60f3\u3055\u308c\u3001\u8ca0\u62c5\u3092\u52b9\u679c\u7684\u306b\u7ba1\u7406\u3059\u308b\u305f\u3081\u306e\u30c7\u30b8\u30bf\u30eb\u30b7\u30b9\u30c6\u30e0\u306e\u5c0e\u5165\u3092\u8a08\u753b\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n<h3>\u533b\u7642\u7528\u5c04\u51fa\u6210\u5f62\u30d7\u30ed\u30bb\u30b9\u306b\u5fc5\u8981\u306a\u6587\u66f8\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h3>\n<p>ISO 13485\u306f\u3001\u5c04\u51fa\u6210\u5f62\u91d1\u578b\u306e\u8a2d\u8a08\u3001\u4fdd\u5b88\u3001\u5909\u66f4\u306e\u65b9\u6cd5\u3092\u6839\u672c\u7684\u306b\u5909\u3048\u307e\u3059\u3002\u91d1\u578b\u8a2d\u8a08\u306f\u3001\u8a2d\u8a08\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9\u5185\u3067\u7ba1\u7406\u6587\u66f8\u3068\u306a\u308a\u3001\u6b63\u5f0f\u306a\u8a2d\u8a08\u30ec\u30d3\u30e5\u30fc\u3001\u30ea\u30b9\u30af\u5206\u6790\uff08FMEA\u306a\u3069\u306e\u30c4\u30fc\u30eb\u3092\u4f7f\u7528\uff09\u3001\u91d1\u578b\u304c\u30c7\u30d0\u30a4\u30b9\u4ed5\u69d8\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u306e\u6587\u66f8\u5316\u3055\u308c\u305f\u691c\u8a3c\u304c\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002\u91d1\u578b\u306e\u5909\u66f4\u306f\u3001\u4e00\u898b\u4e9b\u7d30\u306a\u30ad\u30e3\u30d3\u30c6\u30a3\u7814\u78e8\u3067\u3042\u3063\u3066\u3082\u3001\u5f71\u97ff\u8a55\u4fa1\u3068\u518d\u691c\u8a3c\u306e\u53ef\u80fd\u6027\u3092\u4f34\u3046\u5909\u66f4\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9\u3092\u5f15\u304d\u8d77\u3053\u3057\u307e\u3059\u3002\u91d1\u578b\u306e\u4fdd\u5b88\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u306f\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306e\u4e00\u90e8\u3068\u306a\u308a\u3001\u5404\u4fdd\u5b88\u4f5c\u696d\u306f\u30c7\u30d0\u30a4\u30b9\u306e\u5c65\u6b74\u306b\u6587\u66f8\u5316\u3055\u308c\u307e\u3059\u3002\u591a\u30ad\u30e3\u30d3\u30c6\u30a3\u91d1\u578b\u3067\u306f\u30ad\u30e3\u30d3\u30c6\u30a3\u30ec\u30d9\u30eb\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u304c\u5fc5\u8981\u3067\u3042\u308a\u3001\u5404\u30ad\u30e3\u30d3\u30c6\u30a3\u306f\u751f\u7523\u3092\u901a\u3058\u3066\u500b\u5225\u306b\u8b58\u5225\u30fb\u8ffd\u8de1\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u3053\u306e\u53b3\u683c\u3055\u306b\u3088\u308a\u3001\u91d1\u578b\u306b\u95a2\u9023\u3059\u308b\u6b20\u9665\u3092\u3001\u5f71\u97ff\u3092\u53d7\u3051\u3066\u3044\u306a\u3044\u30ad\u30e3\u30d3\u30c6\u30a3\u3084\u30c7\u30d0\u30a4\u30b9\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u3053\u3068\u306a\u304f\u3001\u9694\u96e2\u3057\u3066\u4fee\u6b63\u3059\u308b\u3053\u3068\u304c\u53ef\u80fd\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n<h3>ISO 13485\u306f\u5c04\u51fa\u91d1\u578b\u306e\u8a2d\u8a08\u3068\u88fd\u9020\u306b\u3069\u306e\u3088\u3046\u306a\u5f71\u97ff\u3092\u4e0e\u3048\u307e\u3059\u304b\uff1f<\/h3>\n<p>\u5c04\u51fa\u6210\u5f62\u3055\u308c\u305f\u533b\u7642\u6a5f\u5668\u306e\u4e00\u822c\u7684\u306a\u6ec5\u83cc\u65b9\u6cd5\u306b\u306f\u3001\u30ac\u30f3\u30de\u7dda\u7167\u5c04\uff0825\u301c40 kGy\uff09\u3001\u30a8\u30c1\u30ec\u30f3\u30aa\u30ad\u30b5\u30a4\u30c9\u30ac\u30b9\u3001\u96fb\u5b50\u30d3\u30fc\u30e0\u3001\u84b8\u6c17\u30aa\u30fc\u30c8\u30af\u30ec\u30fc\u30d6\u3001\u904e\u9178\u5316\u6c34\u7d20\u30d7\u30e9\u30ba\u30de\u304c\u3042\u308a\u307e\u3059\u3002\u6750\u6599\u306e\u9078\u629e\u306f\u3001\u8a2d\u8a08\u6bb5\u968e\u304b\u3089\u6ec5\u83cc\u9069\u5408\u6027\u3092\u8003\u616e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\uff1a\u30dd\u30ea\u30d7\u30ed\u30d4\u30ec\u30f3\u3068\u30dd\u30ea\u30a8\u30c1\u30ec\u30f3\u306f\u30ac\u30f3\u30de\u7dda\u306b\u8010\u6027\u304c\u3042\u308a\u307e\u3059\u304c\u3001\u30dd\u30ea\u30d7\u30ed\u30d4\u30ec\u30f3\u306f\u9ad8\u7dda\u91cf\u3067\u8106\u304f\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u30dd\u30ea\u30ab\u30fc\u30dc\u30cd\u30fc\u30c8\u306f\u653e\u5c04\u7dda\u3067\u9ec4\u5909\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002PEEK\u306f\u4e8b\u5b9f\u4e0a\u5168\u3066\u306e\u6ec5\u83cc\u65b9\u6cd5\u306b\u5bfe\u5fdc\u3067\u304d\u307e\u3059\u304c\u3001\u6a19\u6e96\u6750\u6599\u306e10\u301c20\u500d\u306e\u30b3\u30b9\u30c8\u304c\u304b\u304b\u308a\u307e\u3059\u3002EtO\u6ec5\u83cc\u306b\u306f\u591a\u5b54\u8cea\u306e\u5305\u88c5\u3068\u6b8b\u7559\u7269\u3092\u9664\u53bb\u3059\u308b\u305f\u3081\u306e\u5341\u5206\u306a\u901a\u6c17\u6642\u9593\u304c\u5fc5\u8981\u3067\u3059\u3002\u5404\u30c7\u30d0\u30a4\u30b9\u30fb\u6750\u6599\u30fb\u6ec5\u83cc\u65b9\u6cd5\u306e\u7d44\u307f\u5408\u308f\u305b\u306b\u306f\u3001\u7121\u83cc\u4fdd\u8a3c\u30ec\u30d9\u30eb\uff08SAL\uff0910\u207b\u2076\u3092\u5b9f\u8a3c\u3059\u308b\u72ec\u81ea\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u7814\u7a76\u304c\u5fc5\u8981\u3067\u3059\u3002\u7279\u5b9a\u306e\u7d44\u307f\u5408\u308f\u305b\u3092\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3057\u306a\u3044\u3068\u3001\u30c7\u30d0\u30a4\u30b9\u7533\u8acb\u6642\u306e\u898f\u5236\u4e0a\u306e\u62d2\u5426\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<h3>\u5c04\u51fa\u6210\u5f62\u3055\u308c\u305f\u533b\u7642\u6a5f\u5668\u3068\u4e92\u63db\u6027\u306e\u3042\u308b\u6ec5\u83cc\u65b9\u6cd5\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h3>\n<p>ISO 13485\u306f\u3001\u88fd\u54c1\u54c1\u8cea\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u4ed5\u4e8b\u3092\u884c\u3046\u3059\u3079\u3066\u306e\u4eba\u306b\u5bfe\u3057\u3066\u3001\u6587\u66f8\u5316\u3055\u308c\u305f\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u30d7\u30ed\u30b0\u30e9\u30e0\u3092\u7fa9\u52d9\u4ed8\u3051\u3066\u3044\u307e\u3059\u3002\u5c04\u51fa\u6210\u5f62\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u306f\u3001\u72ec\u7acb\u3057\u3066\u4f5c\u696d\u3092\u958b\u59cb\u3059\u308b\u524d\u306b\u3001\u533b\u7642\u6a5f\u5668\u306e\u8981\u4ef6\u3001\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u30d7\u30ed\u30c8\u30b3\u30eb\u3001\u6c5a\u67d3\u9632\u6b62\u3001\u304a\u3088\u3073\u7279\u5b9a\u306e\u30d7\u30ed\u30bb\u30b9\u624b\u9806\u306b\u95a2\u3059\u308b\u80fd\u529b\u3092\u5b9f\u8a3c\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u8a18\u9332\u306b\u306f\u3001\u521d\u671f\u8cc7\u683c\u8a8d\u5b9a\u3001\u5b9a\u671f\u7684\u306a\u518d\u6559\u80b2\u30b3\u30fc\u30b9\uff08\u901a\u5e38\u306f\u5e741\u56de\uff09\u3001\u624b\u9806\u5909\u66f4\u3084\u662f\u6b63\u51e6\u7f6e\u306e\u305f\u3081\u306e\u81e8\u6642\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3092\u542b\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u80fd\u529b\u8a55\u4fa1\u306f\u51fa\u5e2d\u3092\u8d85\u3048\u3066\u884c\u308f\u308c\u3001\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u306f\u5b9f\u8df5\u7684\u8a55\u4fa1\u3092\u901a\u3058\u3066\u7406\u89e3\u5ea6\u3092\u5b9f\u8a3c\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u7d4c\u55b6\u9663\u306f\u3001\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u306e\u6709\u52b9\u6027\u3092\u78ba\u4fdd\u3057\u3001\u898f\u5236\u76e3\u67fb\u306b\u8010\u3048\u3046\u308b\u8a18\u9332\u3092\u7dad\u6301\u3059\u308b\u8cac\u4efb\u3092\u8ca0\u3044\u307e\u3059\u3002\u591a\u304f\u306e\u65bd\u8a2d\u3067\u306f\u3001ISO 13485\u3001\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u904b\u7528\u3001GMP\u539f\u5247\u306b\u95a2\u3059\u308b\u5916\u90e8\u30b3\u30fc\u30b9\u3092\u5185\u90e8\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u306b\u88dc\u5b8c\u3057\u3066\u3044\u307e\u3059\u3002\u30aa\u30da\u30ec\u30fc\u30bf\u30fc1\u4eba\u3042\u305f\u308a\u521d\u671f\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3068\u3057\u306640\u301c80\u6642\u9593\u3001\u7d99\u7d9a\u8981\u4ef6\u3068\u3057\u3066\u5e74\u959316\u301c24\u6642\u9593\u306e\u4e88\u7b97\u3092\u78ba\u4fdd\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n<h3>ISO 13485\u5c04\u51fa\u6210\u5f62\u306b\u304a\u3051\u308b\u8981\u54e1\u306b\u7279\u5b9a\u306e\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u8981\u4ef6\u306f\u3042\u308a\u307e\u3059\u304b\uff1f<\/h3>\n<p>\u306f\u3044\u3001ISO 13485\u3067\u306f\u3001\u4f5c\u696d\u304c\u88fd\u54c1\u54c1\u8cea\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u8981\u54e1\u306b\u5bfe\u3057\u3066\u6587\u66f8\u5316\u3055\u308c\u305f\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u304c\u8981\u6c42\u3055\u308c\u307e\u3059\u3002\u5c04\u51fa\u6210\u5f62\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u3001\u30d7\u30ed\u30bb\u30b9\u6280\u8853\u8005\u3001QC\u691c\u67fb\u54e1\u3001\u5009\u5eab\u30b9\u30bf\u30c3\u30d5\u3001\u533b\u7642\u6a5f\u5668\u30d7\u30ed\u30b0\u30e9\u30e0\u3092\u7ba1\u7406\u3059\u308b\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30a8\u30f3\u30b8\u30cb\u30a2\u306f\u5168\u54e1\u3001\u4f53\u7cfb\u7684\u306a\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3092\u53d7\u3051\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u3001\u521d\u671f\u8cc7\u683c\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3001\u5e74\u9593\u30ea\u30d5\u30ec\u30c3\u30b7\u30e3\u30fc\u30b3\u30fc\u30b9\u3001\u304a\u3088\u3073\u624b\u9806\u304c\u5909\u66f4\u3055\u308c\u305f\u3068\u304d\u3084\u662f\u6b63\u51e6\u7f6e\u304c\u5b9f\u65bd\u3055\u308c\u305f\u3068\u304d\u306e\u968f\u6642\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u306e\u52b9\u679c\u306f\u3001\u5358\u306a\u308b\u51fa\u5e2d\u8a18\u9332\u3067\u306f\u306a\u304f\u3001\u5b9f\u8df5\u7684\u306a\u8a55\u4fa1\u3092\u901a\u3058\u3066\u691c\u8a3c\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u7ba1\u7406\u8077\u306f\u3001\u5168\u3066\u306e\u5f79\u5272\u306b\u304a\u3044\u3066\u80fd\u529b\u304c\u78ba\u4fdd\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u76f4\u63a5\u7684\u306b\u8cac\u4efb\u3092\u6301\u3063\u3066\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u65bd\u8a2d\u306f\u3001\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u3054\u3068\u306b40\u301c80\u6642\u9593\u306e\u521d\u671f\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u306b\u52a0\u3048\u3001\u7d99\u7d9a\u7684\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8981\u4ef6\u3068\u7d99\u7d9a\u6559\u80b2\u306e\u305f\u3081\u306b\u5e74\u959316\u301c24\u6642\u9593\u306e\u4e88\u7b97\u3092\u7d44\u3080\u3079\u304d\u3067\u3059\u3002<\/p>\n<p>\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3067ISO 13485 \u533b\u7642\u6a5f\u5668\u5c04\u51fa\u6210\u5f62\u3092\u691c\u8a0e\u3059\u308b\u6e96\u5099\u306f\u3067\u304d\u3066\u3044\u307e\u3059\u304b\uff1f\u8a8d\u5b9a\u54c1\u8cea\u30b9\u30da\u30b7\u30e3\u30ea\u30b9\u30c8\u3068\u5177\u4f53\u7684\u306a\u8981\u4ef6\u306b\u3064\u3044\u3066\u8a71\u3057\u5408\u3046\u305f\u3081\u306b\u3001ZetarMold\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u300220\u5e74\u4ee5\u4e0a\u306e\u533b\u7642\u6a5f\u5668\u88fd\u9020\u7d4c\u9a13\u3001\u5305\u62ec\u7684\u306a\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u80fd\u529b\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u6e08\u307f\u30d7\u30ed\u30bb\u30b9\u3092\u7d44\u307f\u5408\u308f\u305b\u308b\u3053\u3068\u3067\u3001\u304a\u5ba2\u69d8\u306e\u533b\u7642\u6a5f\u5668\u3092\u5b89\u5168\u304b\u3064\u52b9\u7387\u7684\u306b\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u304a\u624b\u4f1d\u3044\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<hr style=\"margin:2em 0;border:none;border-top:1px solid #e0e0e0;\" \/>\n<ol class=\"footnotes\">\n<li id=\"fn:1\">\n<p><strong>\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3:<\/strong> \u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3068\u306f\u3001\u78ba\u7acb\u3055\u308c\u305f\u30d1\u30e9\u30e1\u30fc\u30bf\u5185\u3067\u904b\u55b6\u3055\u308c\u308b\u30d7\u30ed\u30bb\u30b9\u304c\u3001\u4e8b\u524d\u306b\u6c7a\u3081\u3089\u308c\u305f\u4ed5\u69d8\u3092\u6e80\u305f\u3059\u533b\u85ac\u54c1\u3092\u751f\u7523\u3059\u308b\u305f\u3081\u306b\u3001\u52b9\u679c\u7684\u304b\u3064\u518d\u73fe\u6027\u3092\u3082\u3063\u3066\u5b9f\u884c\u3067\u304d\u308b\u3053\u3068\u3092\u793a\u3059\u6587\u66f8\u5316\u3055\u308c\u305f\u8a3c\u62e0\u3092\u6307\u3057\u307e\u3059\u3002 <a href=\"#fnref1:1\" class=\"footnote-backref\">\u21a9<\/a><\/p>\n<\/li>\n<li id=\"fn:2\">\n<p><strong>DHR:<\/strong> DHR\u3068\u306f\u3001Device History Record\uff08\u30c7\u30d0\u30a4\u30b9\u5c65\u6b74\u8a18\u9332\uff09\u306e\u7565\u3067\u3001\u5b8c\u6210\u3057\u305f\u533b\u7642\u6a5f\u5668\u306e\u751f\u7523\u5c65\u6b74\u3092\u542b\u3080\u8a18\u9332\u306e\u307e\u3068\u3081\u3092\u6307\u3057\u307e\u3059\u3002 <a href=\"#fnref1:2\" class=\"footnote-backref\">\u21a9<\/a><\/p>\n<\/li>\n<li id=\"fn:3\">\n<p><strong>USP Class VI:<\/strong> USP\u30af\u30e9\u30b9VI\u3068\u306f\u3001\u533b\u7642\u6a5f\u5668\u306b\u4f7f\u7528\u3055\u308c\u308b\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u6750\u6599\u306b\u95a2\u3059\u308b\u7c73\u56fd\u85ac\u5c40\u65b9\u306e\u751f\u7269\u5b66\u7684\u53cd\u5fdc\u6027\u8a66\u9a13\u898f\u683c\u3092\u6307\u3057\u307e\u3059\u3002 <a href=\"#fnref1:3\" class=\"footnote-backref\">\u21a9<\/a><\/p>\n<\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"<p>ISO 13485\u00b9\u306b\u6e96\u62e0\u3057\u305f\u533b\u7642\u6a5f\u5668\u7528\u5c04\u51fa\u6210\u5f62\u306f\u3001\u5358\u306a\u308b\u901a\u5e38\u306e\u88fd\u9020\u696d\u52d9\u306b\u8ffd\u52a0\u6587\u66f8\u3092\u52a0\u3048\u305f\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u305d\u308c\u306f\u54c1\u8cea\u7ba1\u7406\u306b\u5bfe\u3059\u308b\u6839\u672c\u7684\u306b\u7570\u306a\u308b\u30a2\u30d7\u30ed\u30fc\u30c1\u3067\u3059\u300220\u5e74\u9593\u533b\u7642\u6a5f\u5668\u90e8\u54c1\u3092\u88fd\u9020\u3057\u3066\u304d\u305f\u7d4c\u9a13\u304b\u3089\u3001ISO 9001\u304b\u3089\u533b\u7642\u6a5f\u5668\u5206\u91ce\u3078\u306e\u79fb\u884c\u306b\u82e6\u6226\u3059\u308b\u88fd\u9020\u696d\u8005\u3092\u76ee\u6483\u3057\u307e\u3057\u305f\u3002\u305d\u306e\u9055\u3044\u306f\u5358\u306b\u8981\u6c42\u304c\u53b3\u683c\u5316\u3055\u308c\u308b\u3060\u3051\u3067\u306f\u306a\u304f\u3001\u30ea\u30b9\u30af\u3001\u8ffd\u8de1\u53ef\u80fd\u6027\u3001\u30d7\u30ed\u30bb\u30b9\u7ba1\u7406\u306b\u5bfe\u3059\u308b\u8003\u3048\u65b9\u306e\u6839\u672c\u7684\u306a\u8ee2\u63db\u3067\u3059\u3002\u91cd\u8981\u306a\u30dd\u30a4\u30f3\u30c8 ISO 13485\u306f\u5c04\u51fa\u6210\u5f62\u30d7\u30ed\u30bb\u30b9\u5168\u4f53\u3092\u901a\u3058\u3066\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u601d\u8003\u3092\u8981\u6c42\u3059\u308b \u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u74b0\u5883\u3068\u6c5a\u67d3\u7ba1\u7406\u306f\u3001\u307b\u3068\u3093\u3069\u306e\u533b\u7642\u6a5f\u5668\u88fd\u9020\u306b\u304a\u3044\u3066\u5fc5\u9808\u3067\u3042\u308b \u898f\u5236\u627f\u8a8d\u306b\u306fIQ\u3001OQ\u3001PQ\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u306b\u3088\u308b\u30d7\u30ed\u30bb\u30b9\u59a5\u5f53\u6027\u78ba\u8a8d\u304c\u4e0d\u53ef\u6b20 \u539f\u6750\u6599\u304b\u3089\u5b8c\u6210\u30c7\u30d0\u30a4\u30b9\u307e\u3067\u306e\u5b8c\u5168\u306a\u8ffd\u8de1\u53ef\u80fd\u6027\u304c[\u2026]<\/p>","protected":false},"author":1,"featured_media":50393,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_seopress_robots_primary_cat":"none","_seopress_titles_title":"ISO 13485 Medical Device Injection Molding Guide | ZetarMold","_seopress_titles_desc":"Complete guide to ISO 13485 medical device injection molding. 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