{"id":966,"date":"2026-05-21T08:24:26","date_gmt":"2026-05-21T08:24:26","guid":{"rendered":"https:\/\/isbm-blow-molding.com\/?p=966"},"modified":"2026-05-21T08:24:26","modified_gmt":"2026-05-21T08:24:26","slug":"isbm-medical-device-bottle-production-korean-guide","status":"publish","type":"post","link":"https:\/\/isbm-blow-molding.com\/ja\/isbm-medical-device-bottle-production-korean-guide\/","title":{"rendered":"ISBM\u533b\u7642\u6a5f\u5668\u30dc\u30c8\u30eb\u88fd\u9020\uff1a\u97d3\u56fd\u898f\u5236\u30ac\u30a4\u30c92026"},"content":{"rendered":"<div style=\"margin: 0; padding: 20px; font-family: 'Helvetica Neue',Helvetica,Arial,sans-serif; color: #1f2937; line-height: 1.78; background: #fff;\">\n<p><!-- HERO: clean medical blue --><\/p>\n<header style=\"position: relative; min-height: min(580px,86vh); display: flex; align-items: center; padding: clamp(40px,6vw,80px) clamp(18px,5vw,56px); background: #020c1a; background-image: linear-gradient(150deg,rgba(2,8,22,0.98) 0%,rgba(4,22,54,0.94) 58%,rgba(3,105,161,0.34) 100%),url('https:\/\/isbm-blow-molding.com\/wp-content\/uploads\/2026\/02\/ISBM-2.webp'); background-size: cover; background-position: center;\">\n<div style=\"max-width: 680px;\"><span style=\"display: inline-block; font-size: 10px; font-weight: bold; letter-spacing: 2.5px; text-transform: uppercase; color: #7dd3fc; border: 1px solid rgba(125,211,252,0.35); padding: 4px 12px; border-radius: 3px; margin-bottom: 18px;\">ISBM\u306e\u5fdc\u7528\u30fb\u533b\u7642\u6a5f\u5668\u5305\u88c5\u30fb\u97d3\u56fdISBM 2026<\/span><\/p>\n<h1 style=\"font-size: clamp(24px,4.2vw,40px); font-weight: 900; color: #fff; line-height: 1.18; margin: 0 0 20px; letter-spacing: -0.5px;\">ISBM\u533b\u7642\u6a5f\u5668\u30dc\u30c8\u30eb<br \/>\n\u88fd\u9020\uff1a\u97d3\u56fd\u898f\u5236\u30ac\u30a4\u30c9<\/h1>\n<p style=\"font-size: clamp(14px,1.9vw,17px); color: #e0f2fe; line-height: 1.7; margin: 0 0 28px; max-width: 560px;\">\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u5305\u88c5\u306f\u3001ISBM\uff08\u7d71\u5408\u578b\u30dc\u30c8\u30eb\u88fd\u9020\uff09\u306e\u4e2d\u3067\u3082\u6700\u3082\u9ad8\u3044\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u57fa\u6e96\u304c\u6c42\u3081\u3089\u308c\u308b\u5206\u91ce\u3067\u3059\u3002\u3059\u3079\u3066\u306e\u30dc\u30c8\u30eb\u306f\u3001\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\u3001\u6ec5\u83cc\u691c\u8a3c\u3001GMP IQ\/OQ\/PQ\u57fa\u6e96\u306b\u6e96\u62e0\u3057\u305f\u5bf8\u6cd5\u691c\u67fb\u3092\u53d7\u3051\u3001\u6587\u66f8\u5316\u3055\u308c\u305f\u30af\u30ea\u30fc\u30f3\u306a\u74b0\u5883\u3067\u88fd\u9020\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u3053\u306e\u5e02\u5834\u306b\u6b63\u3057\u304f\u53c2\u5165\u3059\u308b\u97d3\u56fd\u306eISBM\u88fd\u9020\u696d\u8005\u306f\u3001\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u4f01\u696d\u304c10\uff5e15\u5e74\u3054\u3068\u306b\u66f4\u65b0\u3059\u308b\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u8cc7\u683c\u3092\u78ba\u7acb\u3057\u307e\u3059\u3002\u898f\u5236\u306e\u67a0\u7d44\u307f\u3092\u7406\u89e3\u305b\u305a\u306b\u53c2\u5165\u3059\u308b\u696d\u8005\u306f\u3001\u6700\u521d\u306eKFDA\uff08\u97d3\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5b89\u5168\u5e81\uff09\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u76e3\u67fb\u3067\u4e0d\u5408\u683c\u3068\u306a\u308b\u30dc\u30c8\u30eb\u3092\u88fd\u9020\u3059\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n<div style=\"display: flex; flex-wrap: wrap; gap: 8px;\"><span style=\"background: rgba(255,255,255,0.08); border: 1px solid rgba(255,255,255,0.18); color: #e0f2fe; font-size: 11.5px; font-weight: 600; padding: 5px 14px; border-radius: 20px;\">KFDA\u30af\u30e9\u30b9I\uff5eIV\u898f\u5236\u67a0\u7d44\u307f<\/span><br \/>\n<span style=\"background: rgba(255,255,255,0.08); border: 1px solid rgba(255,255,255,0.18); color: #e0f2fe; font-size: 11.5px; font-weight: 600; padding: 5px 14px; border-radius: 20px;\">ISO 10993 \u751f\u4f53\u9069\u5408\u6027<\/span><br \/>\n<span style=\"background: rgba(255,255,255,0.08); border: 1px solid rgba(255,255,255,0.18); color: #e0f2fe; font-size: 11.5px; font-weight: 600; padding: 5px 14px; border-radius: 20px;\">GMP IQ \/ OQ \/ PQ \u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3<\/span><\/div>\n<p style=\"font-size: 11px; color: #38bdf8; margin: 22px 0 0;\">\u97d3\u56fd\u30a8\u30d0\u30fc\u30d1\u30ef\u30fc\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u30c7\u30b9\u30af \u00b7 \u5b89\u5c71\u5e02 \u00b7 2026\u5e745\u6708<\/p>\n<\/div>\n<\/header>\n<p>&nbsp;<\/p>\n<p><!-- KFDA CLASSIFICATION REFERENCE --><\/p>\n<div style=\"background: #f0f9ff; border: 1px solid #bae6fd; border-radius: 8px; padding: 20px 24px; margin: 44px 0 0;\">\n<p style=\"font-size: 10.5px; font-weight: 800; letter-spacing: 2px; text-transform: uppercase; color: #075985; margin: 0 0 14px;\">\u97d3\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5b89\u5168\u5e81\uff08KFDA\uff09\u533b\u7642\u6a5f\u5668\u5206\u985e \u2015 \u5305\u88c5\u5f71\u97ff\u6982\u8981<\/p>\n<div style=\"overflow-x: auto;\">\n<table style=\"width: 100%; border-collapse: collapse; font-size: 13px; min-width: 520px;\">\n<thead>\n<tr style=\"background: #075985;\">\n<th style=\"color: #fff; padding: 9px 12px; text-align: left; font-weight: bold;\">KFDA\u30af\u30e9\u30b9<\/th>\n<th style=\"color: #fff; padding: 9px 12px; text-align: left; font-weight: bold;\">\u97d3\u56fd\u3067\u306e\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9<\/th>\n<th style=\"color: #fff; padding: 9px 12px; text-align: left; font-weight: bold;\">\u68b1\u5305\u8981\u4ef6<\/th>\n<th style=\"color: #fff; padding: 9px 12px; text-align: left; font-weight: bold;\">\u97d3\u56fdISBM\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">\u30af\u30e9\u30b9I<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\uc2e0\uace0 (\u901a\u77e5)<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\u57fa\u672c\u6750\u6599\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3068\u5bf8\u6cd5<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\u30b5\u30f3\u30d7\u30eb\u30ab\u30c3\u30d7\u3001\u4f4e\u30ea\u30b9\u30af\u691c\u4f53\u5bb9\u5668<\/td>\n<\/tr>\n<tr style=\"background: #f0f9ff;\">\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">\u30af\u30e9\u30b9II<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\uc778\uc99d (\u8a8d\u8a3c)<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">ISO 10993\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\u304a\u3088\u3073GMP\u95a2\u9023\u6587\u66f8<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\u4f53\u5916\u8a3a\u65ad\u7528\u8a66\u85ac\u30dc\u30c8\u30eb\u3001\u8a3a\u65ad\u30ad\u30c3\u30c8\u3001\u6d17\u6d44\u30dc\u30c8\u30eb<\/td>\n<\/tr>\n<tr>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600; color: #0369a1;\">\u30af\u30e9\u30b9III<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\ud5c8\uac00 (KFDA \u627f\u8a8d)<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600; color: #0369a1;\">\u5b8c\u5168\u306aGMP\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff0b\u62bd\u51fa\u7269\uff0f\u6eb6\u51fa\u7269<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\u85ac\u5264\u9001\u9054\u30b7\u30b9\u30c6\u30e0\u5bb9\u5668\u3001\u6ec5\u83cc\u6e08\u307f\u533b\u7642\u6a5f\u5668\u5305\u88c5<\/td>\n<\/tr>\n<tr style=\"background: #f0f9ff;\">\n<td style=\"padding: 8px 12px; font-weight: 600; color: #0369a1;\">\u30af\u30e9\u30b9IV<\/td>\n<td style=\"padding: 8px 12px;\">\ud5c8\uac00 (KFDA \u627f\u8a8d)<\/td>\n<td style=\"padding: 8px 12px; font-weight: 600; color: #0369a1;\">\u5b8c\u5168\u306aGMP\u6e96\u62e0 + \u81e8\u5e8a\u30c7\u30fc\u30bf + \u6ec5\u83cc\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3<\/td>\n<td style=\"padding: 8px 12px;\">\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u90e8\u54c1\u5bb9\u5668\u3001\u751f\u547d\u7dad\u6301\u88c5\u7f6e\u306e\u5305\u88c5<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n<p><!-- TOC --><\/p>\n<nav style=\"margin: 32px 0 0; background: #f9fafb; border: 1px solid #e5e7eb; border-radius: 8px; padding: 20px 22px;\">\n<p style=\"font-size: 10.5px; font-weight: bold; text-transform: uppercase; letter-spacing: 1.5px; color: #374151; margin: 0 0 12px;\">\u30b3\u30f3\u30c6\u30f3\u30c4<\/p>\n<div style=\"display: grid; grid-template-columns: repeat(auto-fit,minmax(min(100%,260px),1fr)); gap: 4px 20px;\"><a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s1\">1. \u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u5305\u88c5\u5e02\u5834\u3068ISBM\u306e\u5f79\u5272<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s2\">2. \u97d3\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5b89\u5168\u5e81\uff08KFDA\uff09\u306e\u533b\u7642\u6a5f\u5668\u767b\u9332\u5236\u5ea6<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s3\">3\uff0e\u6750\u6599\u9078\u5b9a\uff1a\u533b\u7642\u7528\u5bb9\u5668\u306b\u306fPET\u3001PETG\u3001PP\u3092\u4f7f\u7528\u3059\u308b<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s4\">4. ISO 10993 \u751f\u4f53\u9069\u5408\u6027\u8a55\u4fa1\u30d7\u30ed\u30c8\u30b3\u30eb<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s5\">5. \u6ec5\u83cc\u65b9\u6cd5\u306e\u9069\u5408\u6027<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s6\">6\uff0e\u62bd\u51fa\u7269\u304a\u3088\u3073\u6eb6\u51fa\u7269\uff1aKFDA\u306e\u671f\u5f85\u4e8b\u9805<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s7\">7. \u97d3\u56fdISBM\u306e\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u751f\u7523\u57fa\u6e96<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s8\">8. GMP\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff1a\u97d3\u56fdISBM\u30e9\u30a4\u30f3\u306eIQ\u3001OQ\u3001PQ<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#faq\">\u3088\u304f\u3042\u308b\u8cea\u554f<\/a><\/div>\n<\/nav>\n<p><!-- S1 --><\/p>\n<section id=\"s1\" style=\"margin: 56px 0 0; padding: 36px 0 0; border-top: 2px solid #0369a1;\">\n<h2 style=\"font-size: clamp(18px,2.6vw,24px); font-weight: 800; color: #075985; margin: 0 0 18px;\">1. \u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u5305\u88c5\u5e02\u5834\u3068ISBM\u306e\u5f79\u5272<\/h2>\n<figure style=\"margin: 0 0 22px;\"><img decoding=\"async\" style=\"width: 100%; height: auto; border-radius: 8px; display: block;\" src=\"https:\/\/isbm-blow-molding.com\/wp-content\/uploads\/2026\/02\/Injection-Stretch-Blow-Molding-HGY150-V4-EV.webp\" alt=\"\u97d3\u56fd\u306e\u30a8\u30d0\u30fc\u30d1\u30ef\u30fc\u793e\u88fdISBM\u30de\u30b7\u30f3HGY150-V4-EV\u306f\u3001\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u30dc\u30c8\u30eb\u88fd\u9020\u5411\u3051\u306b\u8a2d\u8a08\u3055\u308c\u305f\u5168\u96fb\u52d5\u30b5\u30fc\u30dc\u5f0f\u3067\u3059\u3002EV\u30b5\u30fc\u30dc\u306f\u3001\u00b10.05\u79d2\u306e\u30d6\u30ed\u30fc\u4fdd\u6301\u7cbe\u5ea6\u3001\u00b10.3\u2103\u306e\u8abf\u6574\u6e29\u5ea6\u5747\u4e00\u6027\u3001\u304a\u3088\u3073KFDA\u30af\u30e9\u30b9II\u304a\u3088\u3073III\u533b\u7642\u6a5f\u5668\u5305\u88c5\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u6587\u66f8\u4f5c\u6210\u306e\u305f\u3081\u306e\u30b5\u30a4\u30af\u30eb\u3054\u3068\u306eGMP\u30d7\u30ed\u30bb\u30b9\u30c7\u30fc\u30bf\u30ed\u30ae\u30f3\u30b0\u6a5f\u80fd\u3092\u5099\u3048\u3066\u3044\u307e\u3059\u3002\" \/><figcaption style=\"font-size: 12px; color: #6b7280; margin-top: 8px; text-align: center;\">\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u5305\u88c5\u5411\u3051Ever-Power HGY150-V4-EV\u5168\u96fb\u52d5ISBM\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u306f\u3001EV\u30b5\u30fc\u30dc\u306e\u00b10.3\u2103\u306e\u8abf\u6574\u6e29\u5ea6\u7cbe\u5ea6\u3001\u00b10.05\u79d2\u306e\u30d6\u30ed\u30fc\u4fdd\u6301\u6642\u9593\u3001\u304a\u3088\u3073\u30b5\u30a4\u30af\u30eb\u3054\u3068\u306e\u30d7\u30ed\u30bb\u30b9\u30ed\u30b0\u306b\u3088\u308a\u3001\u533b\u7642\u6a5f\u5668ISBM\u3068\u533b\u85ac\u54c1ISBM\u3092\u533a\u5225\u3059\u308bKFDA GMP\u306e3\u3064\u306e\u8981\u4ef6\uff08\u691c\u8a3c\u6e08\u307f\u306e\u30d7\u30ed\u30bb\u30b9\u30d1\u30e9\u30e1\u30fc\u30bf\u7bc4\u56f2\u3001\u76e3\u67fb\u8a3c\u8de1\u4ed8\u304d\u306e\u96fb\u5b50\u30d7\u30ed\u30bb\u30b9\u8a18\u9332\u3001\u304a\u3088\u3073\u6a5f\u5668\u767b\u9332\u671f\u9593\u5168\u4f53\uff08\u97d3\u56fdKFDA\u306e\u533b\u85ac\u54c1\u88fd\u9020\u53ca\u3073\u88fd\u54c1\u7ba1\u7406\u898f\u5247\u306b\u57fa\u3065\u304d\u88fd\u9020\u65e5\u304b\u3089\u6700\u4f4e3\u5e74\u9593\uff09\u306e\u88fd\u9020\u30c7\u30fc\u30bf\u4fdd\u6301\uff09\u306b\u5bfe\u5fdc\u3057\u3066\u3044\u307e\u3059\u3002<\/figcaption><\/figure>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u7523\u696d\u306f\u3001\u91d1\u984d\u30d9\u30fc\u30b9\u3067\u4e16\u754c\u30c8\u30c3\u30d710\u306b\u30e9\u30f3\u30af\u30a4\u30f3\u3057\u3001\u5e74\u95938.51\u5146\u30a6\u30a9\u30f3\u306e\u30da\u30fc\u30b9\u3067\u6210\u9577\u3092\u7d9a\u3051\u30012025\u5e74\u306b\u306f12.4\u5146\u30a6\u30a9\u30f3\u306b\u9054\u3059\u308b\u3068\u4e88\u6e2c\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u7523\u696d\u3067\u306f\u3001\u4f53\u5916\u8a3a\u65ad\uff08IVD\uff09\u3001\u8a66\u85ac\u306e\u4fdd\u7ba1\u3001\u691c\u4f53\u63a1\u53d6\u3001\u533b\u85ac\u54c1\u6295\u4e0e\u88c5\u7f6e\u306e\u5305\u88c5\u306a\u3069\u306b\u3001\u9ad8\u7cbe\u5ea6\u306a\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u5bb9\u5668\u304c\u5927\u91cf\u306b\u5fc5\u8981\u3068\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u97d3\u56fd\u306eISBM\u30dc\u30c8\u30eb\u306f\u3001\u3053\u306e\u5e02\u5834\u306e\u30cb\u30fc\u30ba\u306b\u5fdc\u3048\u3066\u3044\u307e\u3059\u3002ISBM\u306e\u30ef\u30f3\u30b9\u30c6\u30c3\u30d7\u30d7\u30ed\u30bb\u30b9\u306b\u3088\u308a\u3001\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u4f01\u696d\u304c\u8a66\u85ac\u3001\u6d17\u6d44\u6db2\u3001\u6821\u6b63\u6db2\u3001\u8a3a\u65ad\u30ad\u30c3\u30c8\u306e\u69cb\u6210\u8981\u7d20\u306e\u4e3b\u8981\u5bb9\u5668\u3068\u3057\u3066\u5fc5\u8981\u3068\u3059\u308b\u5bf8\u6cd5\u7cbe\u5ea6\uff08\u30cd\u30c3\u30af\u5916\u5f84\u00b10.04mm\uff09\u3001\u5149\u5b66\u7684\u306a\u900f\u660e\u5ea6\uff08\u76ee\u8996\u306b\u3088\u308b\u5145\u586b\u30ec\u30d9\u30eb\u78ba\u8a8d\u306e\u305f\u3081\u306e\u30d8\u30a4\u30ba\u22662.51\u5146\u30a6\u30a9\u30f3\uff09\u3001\u69cb\u9020\u7684\u5b8c\u5168\u6027\uff08\u58c1\u539aCV1\u226681\u5146\u30a6\u30a9\u30f3\uff09\u3092\u5099\u3048\u305f\u5bb9\u5668\u3092\u88fd\u9020\u3067\u304d\u308b\u304b\u3089\u3067\u3059\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\u97d3\u56fd\u306eISBM\u306f\u3001\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u5bb9\u5668\u306b\u304a\u3044\u3066\u30013\u3064\u306e\u7279\u5b9a\u306e\u30b5\u30a4\u30ba\u3068\u5f62\u72b6\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u3067\u30ac\u30e9\u30b9\u3084IBM\uff08\u5c04\u51fa\u30d6\u30ed\u30fc\u6210\u5f62\uff09\u3068\u512a\u4f4d\u306b\u7af6\u4e89\u3057\u3066\u3044\u307e\u3059\u30021\u3064\u76ee\u306f\u300130ml\uff5e500ml\u306e\u30dc\u30c8\u30eb\u3067\u3001\u30cd\u30c3\u30af\u5e45\u304c\u72ed\u3044\u3082\u306e\u304b\u3089\u4e2d\u7a0b\u5ea6\u306e\u3082\u306e\uff0813\uff5e38mm\uff09\u3067\u3059\u3002ISBM\u306e\u512a\u308c\u305f\u58c1\u9762\u5747\u4e00\u6027\u3068\u5149\u5b66\u7684\u306a\u900f\u660e\u5ea6\u306f\u3001\u30ac\u30e9\u30b9\u306e\u3088\u3046\u306a\u91cd\u91cf\u3084\u7834\u640d\u30ea\u30b9\u30af\u306a\u3057\u306bIBM\u306e\u80fd\u529b\u3092\u51cc\u99d5\u3057\u307e\u3059\u30022\u3064\u76ee\u306f\u3001\u30ad\u30c3\u30c8\u90e8\u54c1\u7528\u306e\u540c\u4e00\u30dc\u30c8\u30eb\u3092\u8907\u6570\u306e\u30ad\u30e3\u30d3\u30c6\u30a3\uff082\uff5e4\u30ad\u30e3\u30d3\u30c6\u30a3\uff09\u3067\u7cbe\u5bc6\u306b\u88fd\u9020\u3059\u308b\u5834\u5408\u3067\u3001\u30ad\u30e3\u30d3\u30c6\u30a3\u9593\u306e\u5bf8\u6cd5\u5909\u52d5\u306f\u30cd\u30c3\u30af\u5916\u5f84\u304c\u00b10.04mm\u4ee5\u4e0b\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002ISBM\u306f\u3053\u306e\u4ed5\u69d8\u3092\u3001\u30d7\u30ea\u30d5\u30a9\u30fc\u30e0\u304b\u3089\u30dc\u30c8\u30eb\u3078\u306e\u30ef\u30f3\u30b9\u30c6\u30c3\u30d7\u5236\u5fa1\u3067\u6e80\u305f\u3057\u3066\u3044\u307e\u3059\u30023\u3064\u76ee\u306f\u3001\u900f\u660e\u306a\u8a66\u85ac\u30dc\u30c8\u30eb\u3067\u3001\u5145\u586b\u30ec\u30d9\u30eb\u306e\u8996\u8a8d\u6027\u304c\u7f8e\u7684\u55dc\u597d\u3067\u306f\u306a\u304f\u5b89\u5168\u6a5f\u80fd\u3067\u3042\u308b\u305f\u3081\u3001\u4e0d\u900f\u660e\u306a\u9078\u629e\u80a2\u306f\u5b8c\u5168\u306b\u6392\u9664\u3055\u308c\u30010.5\u30e1\u30fc\u30c8\u30eb\u96e2\u308c\u305f\u5834\u6240\u304b\u3089\u8a66\u85ac\u30ec\u30d9\u30eb\u3092\u78ba\u8a8d\u3067\u304d\u308b\u97d3\u56fdISBM\u306e\u30d8\u30a4\u30ba\u6027\u80fd\uff08\u22642.5%\uff09\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 0;\">\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u7528\u9014\u306b\u304a\u3051\u308bISBM\u306e\u4e3b\u306a\u5229\u70b9\u306f\u3001\u97d3\u56fd\u306e\u533b\u85ac\u54c1\u7528\u9014\u3068\u540c\u69d8\u3001\u30b5\u30a4\u30af\u30eb\u3054\u3068\u306e\u30d7\u30ed\u30bb\u30b9\u8ffd\u8de1\u53ef\u80fd\u6027\u3067\u3059\u3002\u97d3\u56fd\u306eKFDA\u533b\u7642\u6a5f\u5668GMP\uff08\u533b\u85ac\u54c1\u88fd\u9020\u53ca\u3073\u88fd\u54c1\u7ba1\u7406\u57fa\u6e96\u3001ISO 13485\u306b\u76f8\u5f53\uff09\u3067\u306f\u3001\u5404\u88fd\u9020\u30ed\u30c3\u30c8\u3054\u3068\u306b\u4e00\u6b21\u5bb9\u5668\u306e\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u6761\u4ef6\u3092\u6587\u66f8\u5316\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u97d3\u56fd\u306eEV\u30b5\u30fc\u30dcISBM\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u306f\u3001 <a style=\"color: #0369a1; font-weight: 600; text-decoration: none;\" href=\"https:\/\/isbm-blow-molding.com\/ja\/product-category\/4-station-isbm-machine\/\">\u97d3\u56fd\u30a8\u30d0\u30fc\u30d1\u30ef\u30fc\u793e\u88fd 4\u30b9\u30c6\u30fc\u30b7\u30e7\u30f3ISBM\u30de\u30b7\u30f3\u30b7\u30ea\u30fc\u30ba<\/a> \u3053\u306e\u30c7\u30fc\u30bf\u3092\u81ea\u52d5\u7684\u306b\u751f\u6210\u3059\u308b\u3053\u3068\u3067\u3001\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u5305\u88c5\u306b\u304a\u3051\u308bGMP\u6587\u66f8\u4f5c\u6210\u306e\u8ca0\u62c5\u3092\u3001\u624b\u52d5\u306b\u3088\u308b\u691c\u67fb\u4f5c\u696d\u3067\u306f\u306a\u304f\u3001\u30c7\u30fc\u30bf\u7ba1\u7406\u4f5c\u696d\u3078\u3068\u79fb\u884c\u3055\u305b\u308b\u3002<\/p>\n<\/section>\n<p><!-- S2 --><\/p>\n<section id=\"s2\" style=\"margin: 56px 0 0; padding: 36px 0 0; border-top: 2px solid #e5e7eb;\">\n<h2 style=\"font-size: clamp(18px,2.6vw,24px); font-weight: 800; color: #075985; margin: 0 0 18px;\">2. KFDA\u533b\u7642\u6a5f\u5668\u767b\u9332\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\uff1a\u97d3\u56fd\u306eISBM\u5305\u88c5\u30e1\u30fc\u30ab\u30fc\u304c\u77e5\u3063\u3066\u304a\u304f\u3079\u304d\u3053\u3068<\/h2>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\u97d3\u56fd\u306eKFDA\u306f\u3001\u533b\u7642\u6a5f\u5668\u6cd5\u306b\u57fa\u3065\u304d\u3001\u533b\u7642\u6a5f\u5668\u3092\u30ea\u30b9\u30af\u30ec\u30d9\u30eb\u306b\u5fdc\u3058\u30664\u3064\u306e\u30af\u30e9\u30b9\u306b\u5206\u985e\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u5206\u985e\u306b\u3088\u3063\u3066\u627f\u8a8d\u7d4c\u8def\u304c\u6c7a\u5b9a\u3055\u308c\u3001\u5305\u88c5\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u7279\u306b\u91cd\u8981\u306a\u306e\u306f\u3001\u5fc5\u8981\u306a\u88fd\u9020\u6587\u66f8\u304a\u3088\u3073\u691c\u8a3c\u306e\u8a73\u7d30\u5ea6\u304c\u6c7a\u307e\u308b\u70b9\u3067\u3059\u3002\u97d3\u56fd\u306eISBM\u5305\u88c5\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u9867\u5ba2\u306e\u6a5f\u5668\u304c\u3069\u306e\u30af\u30e9\u30b9\u306b\u8a72\u5f53\u3059\u308b\u304b\u3092\u7406\u89e3\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u306a\u305c\u306a\u3089\u3001\u5305\u88c5\u30e1\u30fc\u30ab\u30fc\u306eGMP\u7fa9\u52d9\u306f\u3001\u5305\u88c5\u30e1\u30fc\u30ab\u30fc\u81ea\u8eab\u306e\u5206\u985e\u3067\u306f\u306a\u304f\u3001\u6a5f\u5668\u306e\u30af\u30e9\u30b9\u306b\u3088\u3063\u3066\u898f\u5b9a\u3055\u308c\u308b\u304b\u3089\u3067\u3059\u3002<\/p>\n<p style=\"font-size: 16px; 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padding: 36px 0 0; border-top: 2px solid #e5e7eb;\">\n<h2 style=\"font-size: clamp(18px,2.6vw,24px); font-weight: 800; color: #075985; margin: 0 0 18px;\">3\uff0e\u6750\u6599\u9078\u5b9a\uff1a\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u5bb9\u5668\u306b\u306fPET\u3001PETG\u3001PP\u304c\u7528\u3044\u3089\u308c\u308b<\/h2>\n<figure style=\"margin: 0 0 22px;\"><img decoding=\"async\" style=\"width: 100%; height: auto; border-radius: 8px; display: block;\" src=\"https:\/\/isbm-blow-molding.com\/wp-content\/uploads\/2026\/02\/bottle-7.webp\" alt=\"\u97d3\u56fdISBM\u533b\u7642\u6a5f\u5668PET\u30dc\u30c8\u30eb \u2015 \u97d3\u56fd\u306e\u8a3a\u65ad\u30ad\u30c3\u30c8\u4e8c\u6b21\u5305\u88c5\u7528\u3001\u30cd\u30c3\u30af\u5916\u5f84\u00b10.04mm\u516c\u5dee\u306e\u900f\u660ePET\u30af\u30e9\u30b9II IVD\u8a66\u85ac\u30dc\u30c8\u30eb\u3002\u5145\u586b\u30ec\u30d9\u30eb\u306e\u76ee\u8996\u78ba\u8a8d\u306e\u305f\u3081\u306e\u900f\u660e\u5ea6\u3068\u3001\u9589\u9396\u30c8\u30eb\u30af\u4e92\u63db\u6027\u306e\u305f\u3081\u306e\u4e00\u8cab\u3057\u305f\u30cd\u30c3\u30af\u306d\u3058\u5f62\u72b6\u3092\u5099\u3048\u3066\u3044\u307e\u3059\u3002\" \/><figcaption style=\"font-size: 12px; color: #6b7280; margin-top: 8px; text-align: center;\">\u97d3\u56fd\u306eISBM\u533b\u7642\u6a5f\u5668PET\u30dc\u30c8\u30eb - \u30af\u30e9\u30b9II IVD\u8a66\u85ac\u4fdd\u7ba1\u7528\u30af\u30ea\u30b9\u30bf\u30ebPET\uff08\u30d8\u30a4\u30ba\u22642.0%\uff09\u88fd\u3001\u30cd\u30c3\u30af\u5916\u5f84\u00b10.04mm\u306e\u8a8d\u5b9a\u6e08\u307f\u3002\u97d3\u56fd\u306e\u8a3a\u65ad\u696d\u754c\u306e\u6a19\u6e96\u30cd\u30c3\u30af\u4ed5\u4e0a\u3052\u306f\u300115\uff5e100ml\u8a66\u85ac\u30dc\u30c8\u30eb\u304cGPI 24\/415\u3001100\uff5e500ml\u304cGPI 28\/415\u3067\u3042\u308a\u3001\u5358\u4e00\u306e\u8a8d\u5b9a\u6e08\u307f\u97d3\u56fdISBM\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304b\u3089\u3001\u8907\u6570\u306e\u97d3\u56fdIVD\u30e1\u30fc\u30ab\u30fc\u306e\u30ad\u30c3\u30c8\u69cb\u6210\u30dc\u30c8\u30eb\u5168\u4f53\u306b\u308f\u305f\u3063\u3066\u3001\u6a19\u6e96\u5316\u3055\u308c\u305f\u97d3\u56fd\u88fd\u30b9\u30ca\u30c3\u30d7\u30ad\u30e3\u30c3\u30d7\u304a\u3088\u3073\u30b9\u30af\u30ea\u30e5\u30fc\u30ad\u30e3\u30c3\u30d7\u306e\u8a8d\u5b9a\u304c\u53ef\u80fd\u306b\u306a\u308a\u307e\u3059\u3002<\/figcaption><\/figure>\n<p style=\"font-size: 16px; 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margin-bottom: 14px;\"><strong>\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u5411\u3051PET\uff1a<\/strong> PET\uff08\u30dd\u30ea\u30a8\u30c1\u30ec\u30f3\u30c6\u30ec\u30d5\u30bf\u30ec\u30fc\u30c8\uff09\u306f\u3001\u30af\u30e9\u30b9I\u304a\u3088\u3073II\u306e\u533b\u7642\u6a5f\u5668\u5bb9\u5668\u306b\u6700\u3082\u5e83\u304f\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u97d3\u56fd\u306eISBM\u6750\u6599\u3067\u3059\u3002\u305d\u306e\u5229\u70b9\u306f\u3001\u5e38\u6e29\u3067\u306e\u6eb6\u51fa\u7269\u304c\u5c11\u306a\u3044\u3053\u3068\uff08\u30ea\u30b9\u30af\u8a55\u4fa1\u306e\u305f\u3081\u306bISO 10993-17\u3067\u5341\u5206\u306b\u7279\u6027\u8a55\u4fa1\u3055\u308c\u3066\u3044\u308b\uff09\u3001\u97d3\u56fd\u306eIVD\u8a66\u85ac\u30de\u30c8\u30ea\u30c3\u30af\u30b9\u306e\u5927\u90e8\u5206\u3092\u5360\u3081\u308b\u6c34\u6eb6\u6db2\u3001\u9178\u6027\u7de9\u885d\u6db2\uff08pH 3\uff5e9\uff09\u3001\u751f\u7406\u98df\u5869\u6c34\u306a\u3069\u5e45\u5e83\u3044\u5316\u5b66\u7684\u9069\u5408\u6027\u304c\u3042\u308b\u3053\u3068\u3001\u305d\u3057\u3066\u97d3\u56fd\u306eKFDA\u3078\u306e\u63d0\u51fa\u66f8\u985e\u3067\u9ad8\u3044\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u5b9f\u7e3e\u304c\u3042\u308b\u3053\u3068\u3067\u3059\u3002\u305d\u306e\u5236\u9650\u4e8b\u9805\u306f\u3001PET\u304c65\uff5e70\u2103\u4ee5\u4e0a\u3067\u5909\u5f62\u3059\u308b\u3053\u3068\uff08\u30ac\u30f3\u30de\u7dda\u6ec5\u83cc\u306e\u71b1\u8ca0\u8377\u306b\u95a2\u4fc2\u3059\u308b\u304c\u3001PET\u306f\u5ba4\u6e29\u3067\u30ac\u30f3\u30de\u7dda\u307e\u305f\u306fEO\u6ec5\u83cc\u3055\u308c\u308b\u305f\u3081\u901a\u5e38\u306f\u554f\u984c\u306b\u306a\u3089\u306a\u3044\uff09\u3001PET\u304c340nm\u4ee5\u4e0b\u306e\u7d2b\u5916\u7dda\u3092\u5438\u53ce\u3059\u308b\u3053\u3068\uff08\u7d2b\u5916\u7dda\u306b\u654f\u611f\u306a\u8a66\u85ac\u306b\u95a2\u4fc2\u3059\u308b\u3002\u5149\u611f\u53d7\u6027\u8a3a\u65ad\u88fd\u5264\u306b\u306f\u7d2b\u5916\u7dda\u5b89\u5b9a\u5316PET\u30b0\u30ec\u30fc\u30c9\u3092\u6307\u5b9a\u3059\u308b\uff09\u3001\u305d\u3057\u3066PET\u306f10%\u3092\u8d85\u3048\u308b\u6709\u6a5f\u6eb6\u5a92\u542b\u6709\u91cf\u306e\u8a66\u85ac\u306b\u306f\u4f7f\u7528\u3059\u3079\u304d\u3067\u306f\u306a\u3044\u3053\u3068\uff08\u5fdc\u529b\u4e80\u88c2\u306e\u30ea\u30b9\u30af\uff09\u3067\u3059\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\"><strong>\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u5411\u3051PETG\uff1a<\/strong> PETG\uff08\u30dd\u30ea\u30a8\u30c1\u30ec\u30f3\u30c6\u30ec\u30d5\u30bf\u30ec\u30fc\u30c8\u30b0\u30ea\u30b3\u30fc\u30eb\uff09\u306f\u3001\u6bd4\u8272\u5206\u6790\u306e\u76ee\u8996\u5224\u5b9a\u306b\u7d50\u6676\u900f\u660e\u5ea6\uff08\u30d8\u30a4\u30ba\u22661.5%\uff09\u304c\u6c42\u3081\u3089\u308c\u308b\u97d3\u56fd\u306e\u30af\u30e9\u30b9II\u8a3a\u65ad\u30ad\u30c3\u30c8\u306e\u69cb\u6210\u90e8\u54c1\u3001\u304a\u3088\u3073PET\u306e\u9ad8\u3044\u525b\u6027\u306b\u3088\u3063\u3066\u5b9f\u73fe\u304c\u56f0\u96e3\u306a\u30b9\u30ca\u30c3\u30d7\u30d6\u30ec\u30a4\u30af\u6a5f\u80fd\u3084\u30b9\u30b3\u30a2\u30e9\u30a4\u30f3\u6a5f\u80fd\u3092\u5fc5\u8981\u3068\u3059\u308b\u97d3\u56fd\u306eIVD\u5bb9\u5668\u306b\u63a8\u5968\u3055\u308c\u307e\u3059\u3002PETG\u306f\u7279\u5b9a\u306e\u6709\u6a5f\u6eb6\u5264\uff0840%\u3092\u8d85\u3048\u308b\u30a8\u30bf\u30ce\u30fc\u30eb\u3001\u30a2\u30bb\u30c8\u30f3\u3001MEK\uff09\u306b\u5bfe\u3059\u308b\u8010\u85ac\u54c1\u6027\u304c\u4f4e\u3044\u305f\u3081\u3001\u97d3\u56fd\u306e\u5b9f\u9a13\u5ba4\u6d17\u6d44\u6db2\u3084\u6eb6\u5264\u542b\u6709\u8a66\u85ac\u3078\u306e\u4f7f\u7528\u304c\u5236\u9650\u3055\u308c\u307e\u3059\u300230%\u3092\u8d85\u3048\u308b\u6709\u6a5f\u6eb6\u5264\u6fc3\u5ea6\u3092\u542b\u3080\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u8a66\u85ac\u306bPETG\u3092\u6307\u5b9a\u3059\u308b\u524d\u306b\u3001\u9069\u5408\u6027\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 0;\"><strong>\u97d3\u56fd\u88fd\u533b\u7642\u6a5f\u5668\u7528PP\uff1a<\/strong> \u30dd\u30ea\u30d7\u30ed\u30d4\u30ec\u30f3\u306f\u3001\u84b8\u6c17\u30aa\u30fc\u30c8\u30af\u30ec\u30fc\u30d6\uff08121\u2103\u306720\u5206\u9593\uff09\u306b\u8010\u3048\u308b\u5fc5\u8981\u304c\u3042\u308b\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u5bb9\u5668\u306b\u9069\u3057\u305f\u6750\u6599\u3067\u3059\u3002PET\u3068PETG\u306f\u30aa\u30fc\u30c8\u30af\u30ec\u30fc\u30d6\u6e29\u5ea6\u306b\u8010\u3048\u3089\u308c\u307e\u305b\u3093\u3002\u97d3\u56fd\u306e\u30aa\u30fc\u30c8\u30af\u30ec\u30fc\u30d6\u5bfe\u5fdc\u533b\u7642\u6a5f\u5668\u5bb9\u5668\u7528\u306ePP ISBM\u306b\u306f\u3001PP\u30db\u30c3\u30c8\u30d5\u30a3\u30ebISBM\u6a5f\u80fd\uff08120\uff5e145\u2103\u306e\u30b3\u30f3\u30c7\u30a3\u30b7\u30e7\u30cb\u30f3\u30b0\u3001\u52a0\u71b1\u3055\u308c\u305f\u91d1\u578b\u30d9\u30fc\u30b9\u30a4\u30f3\u30b5\u30fc\u30c8\uff09\u304c\u5fc5\u8981\u3067\u3059\u3002\u3053\u308c\u306fPET ISBM\u3088\u308a\u3082\u6280\u8853\u7684\u306b\u96e3\u3057\u304f\u3001\u5e83\u304f\u666e\u53ca\u3057\u3066\u3044\u306a\u3044\u30d7\u30ed\u30bb\u30b9\u3067\u3059\u3002PP\u533b\u7642\u6a5f\u5668\u5bb9\u5668\u306e\u898b\u7a4d\u3082\u308a\u3092\u884c\u3046\u97d3\u56fd\u306eISBM\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u5951\u7d04\u3092\u53d7\u8afe\u3059\u308b\u524d\u306b\u3001\u6a5f\u68b0\u306e\u30b3\u30f3\u30c7\u30a3\u30b7\u30e7\u30cb\u30f3\u30b0\u30b9\u30c6\u30fc\u30b7\u30e7\u30f3\u306e\u6700\u9ad8\u6e29\u5ea6\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002PETG\u304c\u8272\u5f69\u6e2c\u5b9a\u7528\u9014\u306b\u3082\u305f\u3089\u3059\u5149\u5b66\u7684\u900f\u660e\u5ea6\u306e\u8981\u4ef6\u306b\u3064\u3044\u3066\u306f\u3001\u5b8c\u5168\u30ac\u30a4\u30c9\u3067\u8aac\u660e\u3055\u308c\u3066\u3044\u307e\u3059\u3002 <a style=\"color: #0369a1; font-weight: 600; text-decoration: none;\" href=\"https:\/\/isbm-blow-molding.com\/ja\/how-to-improve-transparency-isbm-injection-stretch-blow-molding\/\">\u97d3\u56fdISBM\u306e\u900f\u660e\u6027\u5411\u4e0a<\/a>.<\/p>\n<\/section>\n<p><!-- S4 --><\/p>\n<section id=\"s4\" style=\"margin: 56px 0 0; padding: 36px 0 0; border-top: 2px solid #e5e7eb;\">\n<h2 style=\"font-size: clamp(18px,2.6vw,24px); font-weight: 800; color: #075985; margin: 0 0 18px;\">4. ISO 10993 \u751f\u4f53\u9069\u5408\u6027\u8a55\u4fa1\uff1a\u97d3\u56fd\u306eISBM\u88fd\u9020\u696d\u8005\u304c\u63d0\u4f9b\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3082\u306e<\/h2>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">ISO 10993-1:2018\uff08\u533b\u7642\u6a5f\u5668\u306e\u751f\u7269\u5b66\u7684\u8a55\u4fa1\uff0d\u7b2c1\u90e8\uff1a\u30ea\u30b9\u30af\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3051\u308b\u8a55\u4fa1\u53ca\u3073\u8a66\u9a13\uff09\u306f\u3001\u97d3\u56fd\u306eKFDA\u304c\u3059\u3079\u3066\u306e\u97d3\u56fd\u88fd\u533b\u7642\u6a5f\u5668\u306e\u4e00\u6b21\u5305\u88c5\u306b\u53c2\u7167\u3059\u308b\u751f\u4f53\u9069\u5408\u6027\u8a55\u4fa1\u306e\u56fd\u969b\u898f\u683c\u3067\u3059\u3002ISO 10993\u306f\u56fa\u5b9a\u306e\u8a66\u9a13\u9805\u76ee\u3092\u898f\u5b9a\u3059\u308b\u3082\u306e\u3067\u306f\u306a\u304f\u3001\u6a5f\u5668\u3068\u4eba\u4f53\u3068\u306e\u63a5\u89e6\u306e\u6027\u8cea\uff08\u8868\u9762\u63a5\u89e6\u3001\u640d\u50b7\u9762\u3001\u8840\u6db2\u63a5\u89e6\uff09\u304a\u3088\u3073\u63a5\u89e6\u671f\u9593\uff08\u9650\u5b9a\u7684\u3001\u9577\u671f\u7684\u3001\u6c38\u7d9a\u7684\uff09\u306b\u5fdc\u3058\u3066\u8a66\u9a13\u3092\u9078\u629e\u3059\u308b\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u8a55\u4fa1\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u898f\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\u97d3\u56fd\u306eISBM\u8a66\u85ac\u30dc\u30c8\u30eb\uff08\u30af\u30e9\u30b9II IVD\u3001\u60a3\u8005\u3068\u306e\u9593\u63a5\u63a5\u89e6 \u2015 \u8a66\u85ac\u306f\u60a3\u8005\u3067\u306f\u306a\u304f\u6a5f\u5668\u306b\u63a5\u89e6\u3059\u308b\uff09\u306e\u5834\u5408\u3001\u751f\u4f53\u9069\u5408\u6027\u8a55\u4fa1\u306f\u901a\u5e38\u3001ISO 10993-5\uff08\u7d30\u80de\u6bd2\u6027\uff09\u304a\u3088\u3073ISO 10993-12\uff08\u751f\u7269\u5b66\u7684\u8a55\u4fa1\u306e\u305f\u3081\u306e\u30b5\u30f3\u30d7\u30eb\u8abf\u88fd\uff09\u306b\u9650\u5b9a\u3055\u308c\u307e\u3059\u3002\u3053\u308c\u3089\u306e2\u3064\u306e\u8a66\u9a13\u306b\u3088\u308a\u3001PET\u307e\u305f\u306fPETG\u6750\u6599\u304c\u9593\u63a5\u7684\u306a\u60a3\u8005\u66dd\u9732\u306b\u95a2\u9023\u3059\u308b\u91cf\u306e\u7d30\u80de\u6bd2\u6027\u7269\u8cea\u3092\u653e\u51fa\u3057\u306a\u3044\u3053\u3068\u3001\u304a\u3088\u3073\u5f8c\u7d9a\u306e\u8a66\u9a13\u306b\u4f7f\u7528\u3055\u308c\u308b\u30b5\u30f3\u30d7\u30eb\u8abf\u88fd\u30d7\u30ed\u30c8\u30b3\u30eb\u304c\u691c\u8a3c\u6e08\u307f\u3067\u3042\u308b\u3053\u3068\u304c\u78ba\u8a8d\u3055\u308c\u307e\u3059\u3002\u97d3\u56fd\u306eISBM\u30af\u30e9\u30b9II IVD\u8a66\u85ac\u30dc\u30c8\u30eb\u306e\u8a66\u9a13\u8cbb\u7528\u7dcf\u984d\uff1a\u97d3\u56fd\u306e\u8a66\u9a13\u6a5f\u95a2\uff08\u97d3\u56fd\u8a66\u9a13\u7814\u7a76\u9662 \u2015 KTR\u3001\u307e\u305f\u306f\u97d3\u56fd\u9069\u5408\u6027\u8a66\u9a13\u6240 \u2015 KCL\uff09\u3067400\u4e07\uff5e800\u4e07\u30a6\u30a9\u30f3\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\u97d3\u56fd\u306e\u30af\u30e9\u30b9III\u533b\u7642\u6a5f\u5668\u5bb9\u5668\uff08\u60a3\u8005\u306e\u76ae\u819a\u307e\u305f\u306f\u7c98\u819c\u306b\u76f4\u63a5\u63a5\u89e6\u3059\u308b\u3082\u306e\uff09\u306e\u5834\u5408\u3001ISO 10993\u306e\u5b8c\u5168\u306a\u8a55\u4fa1\u306b\u306f\u3001\u7d30\u80de\u6bd2\u6027\uff08ISO 10993-5\uff09\u3001\u611f\u4f5c\u6027\uff08ISO 10993-10\uff09\u3001\u523a\u6fc0\u6027\uff08ISO 10993-23\uff09\u3001\u6025\u6027\u5168\u8eab\u6bd2\u6027\uff08ISO 10993-11\uff09\u3001\u304a\u3088\u3073\u4e9c\u6162\u6027\u6bd2\u6027\uff08ISO 10993-11 - 90\u65e5\u9593\u8a66\u9a13\uff09\u304c\u542b\u307e\u308c\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u7dcf\u8a66\u9a13\u8cbb\u7528\uff1a2,500\u4e07\uff5e6,500\u4e07\u30a6\u30a9\u30f3\u3001\u6240\u8981\u671f\u9593\uff1a6\uff5e9\u30f6\u6708\u3002\u30af\u30e9\u30b9III\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306b\u88fd\u54c1\u3092\u4f9b\u7d66\u3059\u308b\u97d3\u56fd\u306eISBM\u5305\u88c5\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u9867\u5ba2\u304c\u65e2\u306b\u5305\u88c5\u4ed5\u69d8\u306b\u30b3\u30df\u30c3\u30c8\u3057\u3066\u3044\u308b\u5951\u7d04\u7de0\u7d50\u6642\u3067\u306f\u306a\u304f\u3001\u91d1\u578b\u8a8d\u5b9a\u6642\u306b\u3053\u306e\u8a55\u4fa1\u3092\u8a08\u753b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 0;\">\u97d3\u56fd\u306eISBM\u751f\u4f53\u9069\u5408\u6027\u8a55\u4fa1\u6587\u66f8\u8981\u4ef6\uff1a\u5404ISO 10993\u8a66\u9a13\u5831\u544a\u66f8\u306b\u306f\u3001\u7279\u5b9a\u306e\u6a39\u8102\u30b0\u30ec\u30fc\u30c9\uff08\u88fd\u9020\u696d\u8005\u3001\u30b0\u30ec\u30fc\u30c9\u6307\u5b9a\u3001\u30ed\u30c3\u30c8\u756a\u53f7\uff09\u3001\u8a66\u9a13\u30b5\u30f3\u30d7\u30eb\u306e\u88fd\u9020\u306b\u4f7f\u7528\u3055\u308c\u305fISBM\u30d7\u30ed\u30bb\u30b9\u6761\u4ef6\uff08\u8abf\u6574\u6e29\u5ea6\u3001\u30d6\u30ed\u30fc\u5727\u529b\u3001\u30b5\u30a4\u30af\u30eb\u6642\u9593 - \u30d7\u30ed\u30bb\u30b9\u6761\u4ef6\u306f\u62bd\u51fa\u7269\u30ec\u30d9\u30eb\u306b\u5f71\u97ff\u3059\u308b\u305f\u3081\uff09\u3001\u304a\u3088\u3073\u8a66\u9a13\u6a5f\u95a2\u306eKFDA\u8a8d\u5b9a\u30b9\u30c6\u30fc\u30bf\u30b9\u3092\u660e\u8a18\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u751f\u7523\u30b5\u30f3\u30d7\u30eb\u3068\u306f\u7570\u306a\u308b\u30d7\u30ed\u30bb\u30b9\u6761\u4ef6\u3067\u88fd\u9020\u3055\u308c\u305f\u30b5\u30f3\u30d7\u30eb\u306b\u5bfe\u3057\u3066\u5b9f\u65bd\u3055\u308c\u305f\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\u306f\u3001\u97d3\u56fdKFDA\u30af\u30e9\u30b9III\u306e\u63d0\u51fa\u306b\u306f\u6709\u52b9\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3053\u308c\u306f\u3001\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\u306b\u975e\u6a19\u6e96\u6761\u4ef6\u3067\u88fd\u9020\u3055\u308c\u305f\u5b9f\u9a13\u5ba4\u30b5\u30f3\u30d7\u30eb\u3092\u4f7f\u7528\u3057\u3001\u305d\u306e\u5f8c\u5546\u696d\u751f\u7523\u8a8d\u5b9a\u4e2d\u306b\u30d7\u30ed\u30bb\u30b9\u6761\u4ef6\u3092\u5909\u66f4\u3059\u308b\u97d3\u56fd\u306eISBM\u88fd\u9020\u696d\u8005\u3092\u6355\u6349\u3059\u308b\u6280\u8853\u7684\u306a\u8a73\u7d30\u3067\u3059\u3002<\/p>\n<\/section>\n<p><!-- S5 --><\/p>\n<section id=\"s5\" style=\"margin: 56px 0 0; padding: 36px 0 0; border-top: 2px solid #e5e7eb;\">\n<h2 style=\"font-size: clamp(18px,2.6vw,24px); font-weight: 800; color: #075985; margin: 0 0 18px;\">5. \u6ec5\u83cc\u65b9\u6cd5\u306e\u4e92\u63db\u6027\uff1a\u97d3\u56fd\u306eISBM\u30dc\u30c8\u30eb\u306e\u9078\u629e\u80a2\u3068\u5236\u7d04<\/h2>\n<p style=\"font-size: 16px; margin-bottom: 20px;\">\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u5bb9\u5668\u306f\u3001\u5305\u88c5\u30e1\u30fc\u30ab\u30fc\uff08ISBM\u30dc\u30c8\u30eb\u3067\u306f\u3042\u307e\u308a\u4e00\u822c\u7684\u3067\u306f\u306a\u3044\uff09\u307e\u305f\u306f\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u4f1a\u793e\u306e\u5145\u586b\u65bd\u8a2d\uff08\u3088\u308a\u4e00\u822c\u7684\uff09\u3067\u6ec5\u83cc\u3055\u308c\u307e\u3059\u3002\u97d3\u56fd\u306eISBM\u5305\u88c5\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u9867\u5ba2\u304c\u4f7f\u7528\u3059\u308b\u6ec5\u83cc\u65b9\u6cd5\u3092\u7406\u89e3\u3057\u3066\u304a\u304f\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u306a\u305c\u306a\u3089\u3001\u6ec5\u83cc\u6761\u4ef6\u4e0b\u306b\u304a\u3051\u308b\u6750\u6599\u9069\u5408\u6027\u3001\u5bf8\u6cd5\u5b89\u5b9a\u6027\u3001\u304a\u3088\u3073\u5149\u5b66\u7279\u6027\u306e\u4fdd\u6301\u306f\u5927\u304d\u304f\u7570\u306a\u308a\u3001\u3069\u306e\u97d3\u56fd\u88fdISBM\u6750\u6599\u304c\u6280\u8853\u7684\u306b\u8a31\u5bb9\u3055\u308c\u308b\u304b\u3092\u6c7a\u5b9a\u3059\u308b\u304b\u3089\u3067\u3059\u3002<\/p>\n<div style=\"overflow-x: auto; margin: 0 0 20px;\">\n<table style=\"width: 100%; border-collapse: collapse; font-size: 13.5px; min-width: 520px;\">\n<thead>\n<tr style=\"background: #075985;\">\n<th style=\"color: #fff; padding: 9px 12px; text-align: left; font-weight: bold;\">\u6ec5\u83cc\u65b9\u6cd5<\/th>\n<th style=\"color: #fff; padding: 9px 12px; text-align: center; font-weight: bold;\">\u30da\u30c3\u30c8<\/th>\n<th style=\"color: #fff; padding: 9px 12px; text-align: center; font-weight: bold;\">PETG<\/th>\n<th style=\"color: #fff; padding: 9px 12px; text-align: center; font-weight: bold;\">PP<\/th>\n<th style=\"color: #fff; padding: 9px 12px; text-align: left; font-weight: bold;\">\u97d3\u56fdISBM\u30ce\u30fc\u30c8<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">EO\uff08\u9178\u5316\u30a8\u30c1\u30ec\u30f3\uff09<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713\u4e92\u63db\u6027\u3042\u308a<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713\u4e92\u63db\u6027\u3042\u308a<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713\u4e92\u63db\u6027\u3042\u308a<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd;\">EO\u51e6\u7406\u6e29\u5ea6\u306f55\u2103\u4ee5\u4e0b\u3067\u30013\u3064\u306e\u5de5\u7a0b\u3059\u3079\u3066\u306b\u304a\u3044\u3066\u5b89\u5168\u3067\u3059\u3002\u51fa\u8377\u524d\u306b24\uff5e48\u6642\u9593\u306eEO\u6b8b\u7559\u30ac\u30b9\u9664\u53bb\u304c\u5fc5\u8981\u3067\u3059\u3002ISO 10993-7\uff08\u30c7\u30d0\u30a4\u30b9\u4e2d\u306eEO\u6b8b\u7559\u6fc3\u5ea6\u304c10\u03bcg\/g\u4ee5\u4e0b\uff09\u306b\u5f93\u3063\u3066EO\u6b8b\u7559\u6fc3\u5ea6\u3092\u691c\u8a3c\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/td>\n<\/tr>\n<tr style=\"background: #f0f9ff;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">\u30ac\u30f3\u30de\u7dda\u7167\u5c04<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 \u2264 25 kGy<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #f59e0b; font-weight: bold;\">\u26a0 \u2264 15 kGy<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 \u2264 50 kGy<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd;\">PET\u306f25kGy\u3092\u8d85\u3048\u308b\u3068\u5f90\u3005\u306b\u9ec4\u5909\u3057\u307e\u3059\u300220kGy\u3092\u8d85\u3048\u308b\u7dda\u91cf\u306e\u5834\u5408\u306f\u3001\u653e\u5c04\u7dda\u5b89\u5b9a\u5316PET\u30b0\u30ec\u30fc\u30c9\uff08\u4f8b\uff1aEastman EB062\uff09\u3092\u6307\u5b9a\u3057\u3066\u304f\u3060\u3055\u3044\u3002PETG\u306f15kGy\u3092\u8d85\u3048\u308b\u3068\u9ec4\u5909\u3057\u3001\u4e00\u822c\u7684\u306b\u6a19\u6e96\u7684\u306a25kGy\u306e\u30ac\u30f3\u30de\u7dda\u7167\u5c04\u30b5\u30a4\u30af\u30eb\u306b\u306f\u9069\u3057\u3066\u3044\u307e\u305b\u3093\u3002<\/td>\n<\/tr>\n<tr>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">E\u30d3\u30fc\u30e0<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 \u2264 25 kGy<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #f59e0b; font-weight: bold;\">\u26a0 \u2264 15 kGy<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 \u2264 50 kGy<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd;\">\u30ac\u30f3\u30de\u7dda\u306b\u4f3c\u3066\u3044\u308b\u304c\u3001\u96fb\u5b50\u7dda\u306f\u30ac\u30f3\u30de\u7dda\u3088\u308a\u3082\u900f\u904e\u6df1\u5ea6\u304c\u6d45\u304f\u3001\u591a\u5c64\u69cb\u9020\u306e\u5305\u88c5\u306b\u9069\u3057\u3066\u3044\u308b\u3002\u30dc\u30c8\u30eb1\u672c\u306e\u5834\u5408\uff1a\u30ac\u30f3\u30de\u7dda\u3068\u540c\u7b49\u306e\u52b9\u679c\u3002<\/td>\n<\/tr>\n<tr style=\"background: #f0f9ff;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">\u84b8\u6c17\u30aa\u30fc\u30c8\u30af\u30ec\u30fc\u30d6\uff08121\u2103\uff09<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #dc2626; font-weight: bold;\">\u2717 \u4e92\u63db\u6027\u306a\u3057<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #dc2626; font-weight: bold;\">\u2717 \u4e92\u63db\u6027\u306a\u3057<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713\u4e92\u63db\u6027\u3042\u308a<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd;\">PET\u306e\u30ac\u30e9\u30b9\u8ee2\u79fb\u6e29\u5ea6\uff08Tg\uff09\u306f\u7d0475\u2103\u3001PETG\u306e\u30ac\u30e9\u30b9\u8ee2\u79fb\u6e29\u5ea6\uff08Tg\uff09\u306f\u7d0481\u2103\u3067\u3001\u3044\u305a\u308c\u3082121\u2103\u3067\u8457\u3057\u304f\u8edf\u5316\u3057\u307e\u3059\u3002PP\u306f\u30aa\u30fc\u30c8\u30af\u30ec\u30fc\u30d6\u7528\u9014\u5411\u3051\u306eISBM\u6750\u6599\u3067\u3059\u3002PP ISBM\u306b\u306f\u52a0\u71b1\u5f0f\u91d1\u578b\u30d9\u30fc\u30b9\u30a4\u30f3\u30b5\u30fc\u30c8\u304c\u5fc5\u8981\u3067\u3059\u3002\u4ed5\u69d8\u3092\u6c7a\u5b9a\u3059\u308b\u524d\u306b\u3001\u6a5f\u68b0\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306b\u3054\u78ba\u8a8d\u304f\u3060\u3055\u3044\u3002<\/td>\n<\/tr>\n<tr>\n<td style=\"padding: 9px 12px; font-weight: 600;\">UV-C\uff08254nm\uff09<\/td>\n<td style=\"padding: 9px 12px; text-align: center; color: #16a34a; font-weight: bold;\">\u2713\u8868\u9762\u306e\u307f<\/td>\n<td style=\"padding: 9px 12px; text-align: center; color: #16a34a; font-weight: bold;\">\u2713\u8868\u9762\u306e\u307f<\/td>\n<td style=\"padding: 9px 12px; text-align: center; color: #16a34a; font-weight: bold;\">\u2713\u8868\u9762\u306e\u307f<\/td>\n<td style=\"padding: 9px 12px;\">\u8868\u9762\u9664\u67d3\u306e\u307f\u306b\u4f7f\u7528\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u97d3\u56fd\u306e\u30af\u30e9\u30b9III\/IV\u5bb9\u5668\u306b\u5bfe\u3059\u308b\u6ec5\u83cc\u306f\u691c\u8a3c\u3055\u308c\u3066\u3044\u307e\u305b\u3093\u3002\u97d3\u56fd\u306e\u30af\u30e9\u30b9I\/II\u4f4e\u30ea\u30b9\u30af\u8868\u9762\u6d88\u6bd2\u306b\u4f7f\u7528\u3057\u307e\u3059\u3002PET\u306f\u7d2b\u5916\u7dda\u3092\u52b9\u7387\u7684\u306b\u5438\u53ce\u3059\u308b\u305f\u3081\u3001\u539a\u8089\u30dc\u30c8\u30eb\u306b\u3064\u3044\u3066\u306f\u5185\u8868\u9762\u3078\u306e\u7167\u5c04\u91cf\u8a08\u7b97\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p style=\"font-size: 16px; margin-bottom: 0;\">\u97d3\u56fd\u306eISBM\uff08\u72ec\u7acb\u578b\u6ec5\u83cc\u5bb9\u5668\uff09\u88fd\u9020\u696d\u8005\u306f\u3001\u6750\u6599\u4ed5\u69d8\u3092\u6c7a\u5b9a\u3059\u308b\u524d\u306b\u3001\u898b\u7a4d\u3082\u308a\u6bb5\u968e\u3067\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u9867\u5ba2\u306b\u5bfe\u3057\u3001\u6ec5\u83cc\u65b9\u6cd5\u3068\u691c\u8a3c\u7dda\u91cf\u3092\u78ba\u8a8d\u3059\u3079\u304d\u3067\u3042\u308b\u3002\u4f8b\u3048\u3070\u300125kGy\u306e\u30ac\u30f3\u30de\u7dda\u3067\u6ec5\u83cc\u3092\u884c\u3046\u9867\u5ba2\u306b\u5bfe\u3057\u3001\u900f\u660e\u306aPETG\u88fd\u3068\u3057\u3066\u898b\u7a4d\u3082\u308a\u3092\u51fa\u3057\u305f\u97d3\u56fd\u306e\u30af\u30e9\u30b9II IVD\u5bb9\u5668\u306f\u3001\u6ec5\u83cc\u691c\u8a3c\u6642\u306b\u6750\u6599\u306e\u4e0d\u9069\u5408\u6027\u306e\u554f\u984c\u3092\u5f15\u304d\u8d77\u3053\u3059\u3002\u901a\u5e38\u3001\u91d1\u578b\u88fd\u9020\u304b\u30896\uff5e8\u304b\u6708\u5f8c\u306b\u884c\u308f\u308c\u308b\u691c\u8a3c\u3067\u3001\u9ec4\u5909\u3057\u305fPETG\u30dc\u30c8\u30eb\u304c\u9867\u5ba2\u306e\u7167\u5c04\u5f8c\u900f\u660e\u5ea6\u4ed5\u69d8\u3092\u6e80\u305f\u3055\u306a\u3044\u3053\u3068\u304c\u5224\u660e\u3059\u308b\u3002<\/p>\n<\/section>\n<p><!-- S6 --><\/p>\n<section id=\"s6\" style=\"margin: 56px 0 0; padding: 36px 0 0; border-top: 2px solid #e5e7eb;\">\n<h2 style=\"font-size: clamp(18px,2.6vw,24px); font-weight: 800; color: #075985; margin: 0 0 18px;\">6\uff0e\u62bd\u51fa\u7269\u304a\u3088\u3073\u6eb6\u51fa\u7269\uff1aISBM\u533b\u7642\u5bb9\u5668\u306b\u95a2\u3059\u308b\u97d3\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5b89\u5168\u5e81\uff08KFDA\uff09\u306e\u671f\u5f85\u4e8b\u9805<\/h2>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\u62bd\u51fa\u7269\u304a\u3088\u3073\u6eb6\u51fa\u7269\uff08E&amp;L\uff09\u5206\u6790\u306f\u3001\u97d3\u56fd\u306eISBM\u30af\u30e9\u30b9III\u533b\u7642\u6a5f\u5668\u5bb9\u5668\u306b\u304a\u3044\u3066\u3001\u6700\u3082\u6280\u8853\u7684\u306b\u8981\u6c42\u306e\u53b3\u3057\u3044\u6587\u66f8\u5316\u8981\u4ef6\u3067\u3059\u3002\u62bd\u51fa\u7269\u3068\u306f\u3001\u904e\u9177\u306a\u5b9f\u9a13\u6761\u4ef6\uff08\u9ad8\u6e29\u3001\u6eb6\u5a92\u62bd\u51fa\u306a\u3069\uff09\u4e0b\u3067\u5305\u88c5\u6750\u6599\u304b\u3089\u6eb6\u51fa\u3059\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u5316\u5b66\u7269\u8cea\u3067\u3042\u308a\u3001\u5305\u88c5\u6750\u6599\u304b\u3089\u306e\u5316\u5b66\u7269\u8cea\u3078\u306e\u66dd\u9732\u306e\u6700\u5927\u5024\u3092\u8868\u3057\u307e\u3059\u3002\u6eb6\u51fa\u7269\u3068\u306f\u3001\u901a\u5e38\u307e\u305f\u306f\u904e\u9177\u306a\u4fdd\u7ba1\u6761\u4ef6\u4e0b\u3067\u5b9f\u969b\u306b\u88fd\u54c1\u306b\u79fb\u884c\u3059\u308b\u62bd\u51fa\u7269\u306e\u30b5\u30d6\u30bb\u30c3\u30c8\u3067\u3042\u308a\u3001\u5305\u88c5\u3055\u308c\u305f\u88fd\u54c1\u304b\u3089\u306e\u60a3\u8005\u307e\u305f\u306f\u4f7f\u7528\u8005\u3078\u306e\u5b9f\u969b\u306e\u66dd\u9732\u91cf\u3092\u8868\u3057\u307e\u3059\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\u97d3\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5b89\u5168\u5e81\uff08KFDA\uff09\u304c\u5b9a\u3081\u308b\u3001\u97d3\u56fd\u306e\u30af\u30e9\u30b9III\u533b\u7642\u6a5f\u5668\uff08\ud5c8\uac00\uff09\u7533\u8acb\u66f8\u985e\u306b\u304a\u3051\u308b\u4e00\u6b21\u5bb9\u5668ISBM\u5305\u88c5\u306b\u95a2\u3059\u308b\u6eb6\u51fa\u7269\u30fb\u62bd\u51fa\u7269\uff08E&amp;L\uff09\u8981\u4ef6\u306f\u3001ISO 10993-18:2020\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\uff08\u6750\u6599\u306e\u5316\u5b66\u7684\u7279\u6027\u8a55\u4fa1\uff09\u304a\u3088\u3073PQRI\uff08\u88fd\u54c1\u54c1\u8cea\u7814\u7a76\u6240\uff092006\u5e74\u7248\u6eb6\u51fa\u7269\u30fb\u62bd\u51fa\u7269\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff08\u97d3\u56fdKFDA\u304c\u533b\u7642\u6a5f\u5668\u7533\u8acb\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u5f15\u7528\u3057\u3066\u3044\u308b\u696d\u754c\u6a19\u6e96\uff09\u306b\u6e96\u62e0\u3057\u3066\u3044\u307e\u3059\u3002\u97d3\u56fd\u306eISBM\u88fd\u9020\u696d\u8005\u304c\u7406\u89e3\u3057\u3066\u304a\u304f\u3079\u304d\u91cd\u8981\u306a\u5206\u6790\u95be\u5024\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n<ul style=\"margin: 0 0 20px; padding-left: 20px; display: flex; flex-direction: column; gap: 8px;\">\n<li style=\"font-size: 15px; color: #374151; line-height: 1.65;\"><strong>\u97d3\u56fd\u306e\u30af\u30e9\u30b9III IVD\u306e\u5206\u6790\u8a55\u4fa1\u95be\u5024\uff08AET\uff09\uff1a<\/strong> \u540c\u5b9a\u3067\u304d\u306a\u3044\u5316\u5408\u7269\u306f0.1\u03bcg\/\u65e5\u4ee5\u4e0b\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u6a21\u64ec\u4f7f\u7528\u62bd\u51fa\u3067\u3053\u306e\u6fc3\u5ea6\u3092\u8d85\u3048\u308b\u62bd\u51fa\u53ef\u80fd\u306a\u5316\u5408\u7269\u306f\u3001\u6bd2\u6027\u5b66\u8005\u306b\u3088\u3063\u3066\u5206\u6790\u7684\u306b\u540c\u5b9a\u3055\u308c\u3001\u5b89\u5168\u6027\u304c\u8a55\u4fa1\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u97d3\u56fd\u306eIVD\u8a66\u85ac\u30dc\u30c8\u30eb\uff08\u60a3\u8005\u3068\u306e\u9593\u63a5\u7684\u306a\u63a5\u89e6\uff09\u306e\u5834\u5408\u3001AET\u306f\u901a\u5e38\u3001\u8a66\u85ac\u306e\u76f4\u63a5\u6442\u53d6\u3067\u306f\u306a\u304f\u3001\u60a3\u8005\u306e1\u65e5\u6700\u5927\u6295\u4e0e\u91cf\u306b\u57fa\u3065\u3044\u3066\u8a08\u7b97\u3055\u308c\u308b\u305f\u3081\u3001\u7d4c\u53e3\u85ac\u5bb9\u5668\u306eE&amp;L\u3088\u308a\u3082\u9ad8\u3044AET\u5024\u304c\u8a31\u5bb9\u3055\u308c\u307e\u3059\u3002<\/li>\n<li style=\"font-size: 15px; color: #374151; line-height: 1.65;\"><strong>PET\u7279\u6709\u306e\u97d3\u56fd\u7523\u62bd\u51fa\u7269\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\uff1a<\/strong> PET\u306e\u4e3b\u8981\u62bd\u51fa\u7269\u306f\u5341\u5206\u306b\u7279\u6027\u304c\u89e3\u660e\u3055\u308c\u3066\u304a\u308a\u3001\u30a2\u30bb\u30c8\u30a2\u30eb\u30c7\u30d2\u30c9\uff08AA\u3001\u71b1\u5206\u89e3\u751f\u6210\u7269\uff09\u3001\u30aa\u30ea\u30b4\u30de\u30fc\uff08\u74b0\u72b6PET\u4e09\u91cf\u4f53\u304a\u3088\u3073\u4e8c\u91cf\u4f53\u3001\u30d7\u30ed\u30bb\u30b9\u6e29\u5ea6\u4f9d\u5b58\u6027\uff09\u3001\u30d3\u30b9\uff082-\u30a8\u30c1\u30eb\u30d8\u30ad\u30b7\u30eb\uff09\u30d5\u30bf\u30eb\u9178\u30a8\u30b9\u30c6\u30eb\uff08DEHP \u2015 PET\u6a39\u8102\u304cDEHP\u542b\u6709\u6f64\u6ed1\u5264\u3092\u4f7f\u7528\u3057\u3066\u3044\u308b\u5834\u5408\u3002\u305f\u3060\u3057\u3001\u97d3\u56fd\u306e\u533b\u85ac\u54c1\u30b0\u30ec\u30fc\u30c9PET\u6a39\u8102\u306fDEHP\u542b\u6709\u6f64\u6ed1\u5264\u3092\u4f7f\u7528\u3057\u3066\u3044\u306a\u3044\uff09\u306a\u3069\u304c\u6319\u3052\u3089\u308c\u308b\u3002\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u7528\u9014\u3067\u306f\u3001\u97d3\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5b89\u5168\u5e81\uff08KFDA\uff09\u304c\u627f\u8a8d\u3057\u305f\u98df\u54c1\u63a5\u89e6\u30dd\u30b8\u30c6\u30a3\u30d6\u30ea\u30b9\u30c8\u306b\u63b2\u8f09\u3055\u308c\u3066\u3044\u308bPET\u6a39\u8102\u3092\u6307\u5b9a\u3057\u3001\u6a39\u8102\u4f9b\u7d66\u696d\u8005\u306b\u30d5\u30bf\u30eb\u9178\u30a8\u30b9\u30c6\u30eb\u542b\u6709\u30d7\u30ed\u30bb\u30b9\u52a9\u5264\u304c\u4f7f\u7528\u3055\u308c\u3066\u3044\u306a\u3044\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002<\/li>\n<li style=\"font-size: 15px; color: #374151; line-height: 1.65;\"><strong>\u97d3\u56fd\u7523ISBM\u62bd\u51fa\u7269\u306b\u5bfe\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u6761\u4ef6\u306e\u5f71\u97ff\uff1a<\/strong> \u30d0\u30ec\u30eb\u6e29\u5ea6\u304c\u9ad8\u3044\u3068\u3001PET\u306e\u71b1\u5206\u89e3\u3068AA\u306e\u751f\u6210\u304c\u5897\u52a0\u3057\u307e\u3059\u3002\u8abf\u6574\u4fdd\u6301\u6642\u9593\u304c\u9577\u3044\u3068\u3001\u30d7\u30ea\u30d5\u30a9\u30fc\u30e0\u5185\u90e8\u304b\u3089\u30dc\u30c8\u30eb\u58c1\u9762\u3078\u306eAA\u306e\u79fb\u884c\u304c\u5897\u52a0\u3057\u307e\u3059\u3002\u97d3\u56fd\u306eISBM\u88fd\u9020\u696d\u8005\u306f\u3001E&amp;L\u30c6\u30b9\u30c8\u30b5\u30f3\u30d7\u30eb\u306e\u88fd\u9020\u306b\u4f7f\u7528\u3055\u308c\u308b\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u6761\u4ef6\u3092\u6587\u66f8\u5316\u3057\u3001\u691c\u8a3c\u6e08\u307f\u7bc4\u56f2\u3092\u8d85\u3048\u308b\u5c06\u6765\u306e\u30d7\u30ed\u30bb\u30b9\u5909\u66f4\u3092\u9632\u6b62\u3059\u308b\u5909\u66f4\u7ba1\u7406\u3092\u5b9f\u65bd\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u30c7\u30b8\u30bf\u30eb\u30d7\u30ed\u30bb\u30b9\u30ed\u30b0\u306eKFDA\u30af\u30e9\u30b9III\u8981\u4ef6\u3067\u3059\u3002 <a style=\"color: #0369a1; font-weight: 600; text-decoration: none;\" href=\"https:\/\/isbm-blow-molding.com\/ja\/isbm-industry-4-automation-korean-production-guide\/\">\u97d3\u56fdISBM\u30a4\u30f3\u30c0\u30b9\u30c8\u30ea\u30fc4.0\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af<\/a> \u81ea\u52d5\u5316\u3055\u308c\u305f\u6a5f\u80fd\u3068\u3057\u3066\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/li>\n<\/ul>\n<\/section>\n<p><!-- S7 --><\/p>\n<section id=\"s7\" style=\"margin: 56px 0 0; padding: 36px 0 0; border-top: 2px solid #e5e7eb;\">\n<h2 style=\"font-size: clamp(18px,2.6vw,24px); font-weight: 800; color: #075985; margin: 0 0 18px;\">7. \u97d3\u56fdISBM\u533b\u7642\u6a5f\u5668\u5305\u88c5\u306e\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u751f\u7523\u57fa\u6e96<\/h2>\n<figure style=\"margin: 0 0 22px;\"><img decoding=\"async\" style=\"width: 100%; height: auto; border-radius: 8px; display: block;\" src=\"https:\/\/isbm-blow-molding.com\/wp-content\/uploads\/2026\/02\/injection-stretch-blow-moulding-application-1.webp\" alt=\"\u97d3\u56fd\u306eISBM\u533b\u7642\u6a5f\u5668\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\u74b0\u5883 \u2015 ISO\u30af\u30e9\u30b98\uff08100,000\u7c92\u5b50\/m\u00b3\uff09\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0ISBM\u88fd\u9020\uff08KFDA\u30af\u30e9\u30b9II IVD\u8a66\u85ac\u30dc\u30c8\u30eb\u7528\uff09\u3002\u308d\u904e\u5c64\u6d41HVAC\u3001\u4f5c\u696d\u54e1\u7528\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u8863\u670d\u3001\u967d\u5727\u5ba4\u3001\u304a\u3088\u3073\u97d3\u56fd\u533b\u7642\u6a5f\u5668\u5305\u88c5GMP\u6e96\u62e0\u306e\u305f\u3081\u306e\u30a4\u30f3\u30e9\u30a4\u30f3\u7c92\u5b50\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3092\u793a\u3059\u3002\" \/><figcaption style=\"font-size: 12px; color: #6b7280; margin-top: 8px; text-align: center;\">\u97d3\u56fd\u306eISBM\u533b\u7642\u6a5f\u5668\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u88fd\u9020\uff08ISO\u30af\u30e9\u30b98\uff08ISO 14644-1\u30010.5\u03bcm\u4ee5\u4e0a\u306e\u7c92\u5b50\u304c3,520,000\u500b\/m\u00b3\u4ee5\u4e0b\uff09\uff09\u306f\u3001\u97d3\u56fd\u306e\u30af\u30e9\u30b9II IVD\u8a66\u85ac\u30dc\u30c8\u30eb\u304a\u3088\u3073\u30af\u30e9\u30b9III\u533b\u7642\u6a5f\u5668\u63a5\u89e6\u5bb9\u5668\u306e\u6a19\u6e96\u7684\u306a\u88fd\u9020\u74b0\u5883\u3067\u3059\u3002ISBM\u30d7\u30ed\u30bb\u30b9\u81ea\u4f53\u306f\u3001\u5bc6\u9589\u3055\u308c\u305f\u6a5f\u68b0\u5185\u3067\u306e\u30ef\u30f3\u30b9\u30c6\u30c3\u30d7\u5c04\u51fa\u6210\u5f62\u3068\u30d6\u30ed\u30fc\u6210\u5f62\u3067\u3042\u308a\u30012\u6bb5\u968eSBM\uff08\u30d7\u30ea\u30d5\u30a9\u30fc\u30e0\u3092\u958b\u653e\u3055\u308c\u305f\u5916\u6c17\u3092\u901a\u3057\u3066\u79fb\u9001\u3059\u308b\uff09\u3088\u308a\u3082\u672c\u8cea\u7684\u306b\u30af\u30ea\u30fc\u30f3\u3067\u3059\u3002\u97d3\u56fd\u306eISBM\u306e\u5bc6\u9589\u51e6\u7406\u306f\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u4e0a\u306e\u5229\u70b9\u3068\u306a\u308a\u307e\u3059\u3002\u30dc\u30c8\u30eb\u5185\u90e8\u306f\u3001\u5c04\u51fa\u307e\u3067\u5916\u6c17\u306b\u3055\u3089\u3055\u308c\u308b\u3053\u3068\u306a\u304f\u30d6\u30ed\u30fc\u30ad\u30e3\u30d3\u30c6\u30a3\u5185\u3067\u5f62\u6210\u3055\u308c\u308b\u305f\u3081\u3001\u5236\u5fa1\u3055\u308c\u305f\u5c04\u51fa\u74b0\u5883\u306b\u3088\u3063\u3066\u6700\u7d42\u7684\u306a\u5185\u90e8\u6c5a\u67d3\u30ea\u30b9\u30af\u304c\u6c7a\u307e\u308a\u307e\u3059\u3002<\/figcaption><\/figure>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\u97d3\u56fd\u306eKFDA GMP\uff08\u533b\u7642\u6a5f\u5668\u88fd\u9020\u306e\u9069\u6b63\u88fd\u9020\u53ca\u3073\u88fd\u54c1\u7ba1\u7406\u57fa\u6e96\uff09\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306b\u5bfe\u3057\u3001\u88fd\u9020\u3059\u308b\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u30ec\u30d9\u30eb\u306b\u5fdc\u3058\u305f\u30af\u30ea\u30fc\u30f3\u306a\u88fd\u9020\u74b0\u5883\u3092\u78ba\u7acb\u3057\u3001\u7dad\u6301\u3059\u308b\u3053\u3068\u3092\u7fa9\u52d9\u4ed8\u3051\u3066\u3044\u307e\u3059\u3002\u97d3\u56fd\u306e\u4e00\u6b21\u5bb9\u5668ISBM\u306e\u88fd\u9020\u306b\u304a\u3044\u3066\u306f\u3001ISO 14644-1\uff08\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u53ca\u3073\u95a2\u9023\u3059\u308b\u7ba1\u7406\u74b0\u5883\uff09\u304c\u95a2\u9023\u898f\u683c\u3068\u306a\u308a\u307e\u3059\u3002\u6a5f\u5668\u30af\u30e9\u30b9\u5225\u306e\u97d3\u56fdISBM\u533b\u7642\u6a5f\u5668\u5305\u88c5\u88fd\u9020\u74b0\u5883\u8981\u4ef6\uff1a<\/p>\n<ul style=\"margin: 0 0 20px; padding-left: 20px; display: flex; flex-direction: column; gap: 9px;\">\n<li style=\"font-size: 15px; color: #374151; line-height: 1.65;\"><strong>\u97d3\u56fd\u8a9e\u30af\u30e9\u30b9 I (\uc2e0\uace0):<\/strong> \u6b63\u5f0f\u306a\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u57fa\u6e96\u306f\u4e0d\u8981\u3067\u3059\u3002\u6587\u66f8\u5316\u3055\u308c\u305fHVAC\u30d5\u30a3\u30eb\u30bf\u30fc\uff08MERV 8\u307e\u305f\u306f\u540c\u7b49\u54c1\u3001\u6a19\u6e96\u7684\u306a\u958b\u653e\u578b\u5de5\u5834\u7a7a\u6c17\u53d6\u308a\u5165\u308c\u53e3\u306b\u4ee3\u308f\u308b\u3082\u306e\uff09\u3068\u57fa\u672c\u7684\u306a\u6e05\u6383\u624b\u9806\u3092\u5099\u3048\u305f\u4e00\u822c\u7684\u306a\u5de5\u696d\u751f\u7523\u74b0\u5883\u3067\u3042\u308c\u3070\u554f\u984c\u3042\u308a\u307e\u305b\u3093\u3002\u7a7a\u6c17\u4e2d\u306e\u5fae\u7c92\u5b50\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3092\u56db\u534a\u671f\u3054\u3068\u306b\u5b9f\u65bd\u3059\u308b\u3053\u3068\u3092\u63a8\u5968\u3057\u307e\u3059\u304c\u3001\u5fc5\u9808\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/li>\n<li style=\"font-size: 15px; color: #374151; line-height: 1.65;\"><strong>\u97d3\u56fd\u8a9e\u30af\u30e9\u30b9II\uff08\u30a4\u30f3\u30b8\u30e5\u30f3\uff09\u2014 IVD\u8a66\u85ac\u5bb9\u5668\uff1a<\/strong> ISO 14644-1 \u30af\u30e9\u30b9 8 \u751f\u7523\u74b0\u5883\uff080.5\u03bcm \u4ee5\u4e0a\u306e\u7c92\u5b50\u6570 \u2264 3,520,000 \u500b\/m\u00b3\u3001\u65e7\u7c73\u56fd\u9023\u90a6\u898f\u683c 209E \u30af\u30e9\u30b9 100,000 \u306b\u76f8\u5f53\uff09\u3002\u5b9f\u969b\u306e\u5b9f\u65bd\u65b9\u6cd5\uff1a\u751f\u7523\u30a8\u30ea\u30a2\u3078\u306e HEPA \u30d5\u30a3\u30eb\u30bf\u30fc\u4ed8\u304d\u7a7a\u6c17\u4f9b\u7d66\u3001\u96a3\u63a5\u3059\u308b\u975e\u751f\u7523\u30a8\u30ea\u30a2\u3068\u306e\u6b63\u5727\u5dee\uff08\u2265 +15 Pa\uff09\u3001\u30ac\u30a6\u30f3\u7740\u7528\u7fa9\u52d9\uff08\u30d8\u30a2\u30ab\u30d0\u30fc\u3001\u9632\u5875\u30b3\u30fc\u30c8\u3001\u30d6\u30fc\u30c4\u30ab\u30d0\u30fc\uff09\u3001\u304a\u3088\u3073 ISO 14644-2 \u306b\u57fa\u3065\u304f\u56db\u534a\u671f\u3054\u3068\u306e\u6d6e\u904a\u7c92\u5b50\u6570\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3002<\/li>\n<li style=\"font-size: 15px; color: #374151; line-height: 1.65;\"><strong>\u97d3\u56fd\u306e\u30af\u30e9\u30b9III\uff08\ud5c8\uac00\uff09\u2014\u76f4\u63a5\u63a5\u89e6\u578b\u533b\u7642\u6a5f\u5668\u5bb9\u5668\uff1a<\/strong> ISBM\u30de\u30b7\u30f3\u3068\u30dc\u30c8\u30eb\u6392\u51fa\u30be\u30fc\u30f3\u306e\u751f\u7523\u74b0\u5883\u306f\u3001ISO 14644-1\u30af\u30e9\u30b97\uff080.5\u03bcm\u4ee5\u4e0a\u306e\u7c92\u5b50\u304c352,000\u500b\/m\u00b3\u4ee5\u4e0b\u3001\u30af\u30e9\u30b910,000\u306b\u76f8\u5f53\uff09\u3067\u3059\u3002\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u7528\u8863\u985e\u4e00\u5f0f\uff08\u5168\u8eab\u4f5c\u696d\u670d\u3001\u624b\u888b\u3001\u30d5\u30a7\u30a4\u30b9\u30de\u30b9\u30af\uff09\u3001UV\u9664\u67d3\u4ed8\u304d\u901a\u904e\u5f0f\u8cc7\u6750\u642c\u5165\u3001\u7c92\u5b50\u6fc3\u5ea6\u306e\u9023\u7d9a\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\uff08\u30af\u30e9\u30b97\u306e\u5236\u9650\u5024\u8d85\u904e\u6642\u306b\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u3067\u8b66\u5831\uff09\u3001\u304a\u3088\u3073\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u6027\u80fd\u306e\u5e74\u6b21\u8a8d\u8a3c\u304c\u5fc5\u8981\u3067\u3059\u3002ISBM\u6392\u51fa\u30be\u30fc\u30f3\u3067\u30af\u30e9\u30b97\u3092\u9054\u6210\u3059\u308b\u97d3\u56fd\u306eISBM\u30aa\u30da\u30ec\u30fc\u30b7\u30e7\u30f3\u3067\u306f\u3001\u901a\u5e38\u3001\u30dc\u30c8\u30eb\u6392\u51fa\u30b3\u30f3\u30d9\u30a2\u306e\u771f\u4e0a\u306b\u5c40\u6240\u7684\u306a\u5c64\u6d41\u30d5\u30fc\u30c9\u3092\u4f7f\u7528\u3057\u307e\u3059\u3002\u3053\u308c\u306f\u3001ISBM\u30de\u30b7\u30f3\u5168\u4f53\u3092\u56f2\u3080\u5b8c\u5168\u306a\u30af\u30e9\u30b97\u30eb\u30fc\u30e0\u3092\u69cb\u7bc9\u3059\u308b\u3088\u308a\u3082\u7d4c\u6e08\u7684\u3067\u3059\u3002<\/li>\n<\/ul>\n<\/section>\n<p><!-- S8 --><\/p>\n<section id=\"s8\" style=\"margin: 56px 0 0; padding: 36px 0 0; border-top: 2px solid #e5e7eb;\">\n<h2 style=\"font-size: clamp(18px,2.6vw,24px); font-weight: 800; color: #075985; margin: 0 0 18px;\">8. GMP\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\uff1a\u97d3\u56fdISBM\u533b\u7642\u6a5f\u5668\u30e9\u30a4\u30f3\u306eIQ\u3001OQ\u3001PQ<\/h2>\n<figure style=\"margin: 0 0 22px;\"><figcaption style=\"font-size: 12px; color: #6b7280; margin-top: 8px; text-align: center;\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-209\" src=\"https:\/\/isbm-blow-molding.com\/wp-content\/uploads\/2026\/02\/factory-4.webp\" alt=\"\u5de5\u58344\" width=\"1536\" height=\"1024\" srcset=\"https:\/\/isbm-blow-molding.com\/wp-content\/uploads\/2026\/02\/factory-4.webp 1536w, https:\/\/isbm-blow-molding.com\/wp-content\/uploads\/2026\/02\/factory-4-1280x853.webp 1280w, https:\/\/isbm-blow-molding.com\/wp-content\/uploads\/2026\/02\/factory-4-980x653.webp 980w, https:\/\/isbm-blow-molding.com\/wp-content\/uploads\/2026\/02\/factory-4-480x320.webp 480w\" sizes=\"auto, (min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) and (max-width: 1280px) 1280px, (min-width: 1281px) 1536px, 100vw\" \/><br \/>\n\u97d3\u56fd\u306eISBM GMP\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u30d7\u30ed\u30c8\u30b3\u30eb\u306f\u3001IQ\uff08\u8a2d\u7f6e\u9069\u683c\u6027\u78ba\u8a8d\uff09\u3067\u6a5f\u68b0\u304c\u4ed5\u69d8\u3069\u304a\u308a\u306b\u8a2d\u7f6e\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3001OQ\uff08\u904b\u8ee2\u9069\u683c\u6027\u78ba\u8a8d\uff09\u3067\u691c\u8a3c\u6e08\u307f\u306e\u30d7\u30ed\u30bb\u30b9\u30d1\u30e9\u30e1\u30fc\u30bf\u7bc4\u56f2\u3092\u6c7a\u5b9a\u3057\u3001PQ\uff08\u6027\u80fd\u9069\u683c\u6027\u78ba\u8a8d\uff09\u3067\u6a19\u6e96\u6761\u4ef6\u4e0b\u3067\u3059\u3079\u3066\u306e\u54c1\u8cea\u4ed5\u69d8\u3092\u6e80\u305f\u3059\u4e00\u8cab\u3057\u305f\u751f\u7523\u3092\u5b9f\u8a3c\u3057\u307e\u3059\u3002\u97d3\u56fd\u306eKFDA \ud5c8\uac00\u3078\u306e\u63d0\u51fa\u3067\u306f\u3001\u5546\u696d\u751f\u7523\u958b\u59cb\u524d\u306b\u3053\u308c\u30893\u3064\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u30d5\u30a7\u30fc\u30ba\u3059\u3079\u3066\u3092\u5b8c\u4e86\u3057\u3001\u6587\u66f8\u5316\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u97d3\u56fd\u306eISBM\u88fd\u9020\u696d\u8005\u304c\u5951\u7d04\u4ea4\u6e09\u6bb5\u968e\u3067\u8a08\u753b\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u3067\u3042\u308a\u3001\u901a\u5e38\u3001\u91d1\u578b\u88fd\u9020\u304b\u3089PQ\u5b8c\u4e86\u307e\u30674\uff5e6\u304b\u6708\u304b\u304b\u308a\u307e\u3059\u3002<\/figcaption><\/figure>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">GMP IQ\/OQ\/PQ\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306f\u3001\u97d3\u56fd\u306e\u30af\u30e9\u30b9III\u533b\u7642\u6a5f\u5668\u5bb9\u5668ISBM\u9069\u683c\u6027\u8a55\u4fa1\u306e\u4e2d\u6838\u3092\u6210\u3059\u3082\u306e\u3067\u3059\u3002\u5404\u30d5\u30a7\u30fc\u30ba\u306f\u305d\u308c\u305e\u308c\u7570\u306a\u308b\u76ee\u7684\u3092\u6301\u3061\u3001KFDA\u306e\u627f\u8a8d\u7533\u8acb\u66f8\u985e\u306b\u5fc5\u8981\u306a\u7279\u5b9a\u306e\u6587\u66f8\u3092\u4f5c\u6210\u3057\u307e\u3059\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\"><strong>IQ\uff08\u8a2d\u7f6e\u8cc7\u683c\u8a8d\u5b9a\uff09\uff1a<\/strong> \u97d3\u56fd\u88fdISBM\u30de\u30b7\u30f3\u3001\u91d1\u578b\u3001\u304a\u3088\u3073\u4ed8\u5c5e\u6a5f\u5668\uff08\u4e7e\u71e5\u6a5f\u3001\u30c1\u30e9\u30fc\u3001\u5727\u7e2e\u7a7a\u6c17\u30b7\u30b9\u30c6\u30e0\uff09\u304c\u88fd\u9020\u5143\u306e\u4ed5\u69d8\u306b\u5f93\u3063\u3066\u8a2d\u7f6e\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u97d3\u56fdKFDA\u30af\u30e9\u30b9III\u306eIQ\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306b\u306f\u3001\u30de\u30b7\u30f3\u306e\u30b7\u30ea\u30a2\u30eb\u756a\u53f7\u3068\u30e2\u30c7\u30eb\u306e\u78ba\u8a8d\u3001KRISS\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u4ed8\u304d\u306e\u3059\u3079\u3066\u306e\u6e2c\u5b9a\u6a5f\u5668\uff08\u71b1\u96fb\u5bfe\u3001\u5727\u529b\u5909\u63db\u5668\u3001\u91cd\u91cf\u8a08\uff09\u306e\u6821\u6b63\u8a3c\u660e\u66f8\u3001\u30e6\u30fc\u30c6\u30a3\u30ea\u30c6\u30a3\u691c\u8a3c\uff08\u51b7\u5374\u6c34\u6e29\u5ea6\u3001\u6d41\u91cf\u3001\u9001\u98a8\u7a7a\u6c17\u5727\u3001\u30de\u30b7\u30f3\u5165\u53e3\u306e\u9732\u70b9\uff09\u3001\u304a\u3088\u3073\u8a2d\u7f6e\u6642\u306e\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u74b0\u5883\u6e2c\u5b9a\uff08\u7c92\u5b50\u6570\u3001\u6e29\u5ea6\u3001\u6e7f\u5ea6\u3001\u5dee\u5727\uff09\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u97d3\u56fd\u306eEver-Power\u306f\u3001\u97d3\u56fdKFDA\u533b\u7642\u6a5f\u5668IQ\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u5b8c\u4e86\u306b\u5fc5\u8981\u306a\u3059\u3079\u3066\u306e\u30c7\u30fc\u30bf\u30d5\u30a3\u30fc\u30eb\u30c9\u3092\u7db2\u7f85\u3057\u305f\u30de\u30b7\u30f3\u56fa\u6709\u306eIQ\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\"><strong>OQ\uff08\u904b\u7528\u8cc7\u683c\u8a8d\u5b9a\uff09\uff1a<\/strong> \u5404\u91cd\u8981\u30d7\u30ed\u30bb\u30b9 \u30d1\u30e9\u30e1\u30fc\u30bf\u306e\u6975\u9650\u3067\u30d7\u30ed\u30bb\u30b9\u306b\u8ca0\u8377\u3092\u304b\u3051\u3001\u5404\u30ec\u30d9\u30eb\u3067\u8a31\u5bb9\u53ef\u80fd\u306a\u88fd\u54c1\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u306b\u3088\u308a\u3001\u5404\u91cd\u8981\u30d7\u30ed\u30bb\u30b9 \u30d1\u30e9\u30e1\u30fc\u30bf\u306e\u691c\u8a3c\u6e08\u307f\u52d5\u4f5c\u7bc4\u56f2\u3092\u6c7a\u5b9a\u3057\u307e\u3059\u3002\u5178\u578b\u7684\u306a\u97d3\u56fd\u306e ISBM OQ \u8abf\u67fb: \u8abf\u6574\u6e29\u5ea6\u3001\u30d6\u30ed\u30fc\u4fdd\u6301\u6642\u9593\u3001\u304a\u3088\u3073\u5c04\u51fa\u5145\u586b\u5727\u529b\u306e\u5404\u91cd\u8981\u30d1\u30e9\u30e1\u30fc\u30bf\u306e 3 \u3064\u306e\u30ec\u30d9\u30eb (\u516c\u79f0 \u2212 5%\u3001\u516c\u79f0\u3001\u516c\u79f0 + 5%)\u3002\u5404\u30d1\u30e9\u30e1\u30fc\u30bf \u30ec\u30d9\u30eb\u3067 30 \u672c\u306e\u30b5\u30f3\u30d7\u30eb\u3002\u5404\u30ec\u30d9\u30eb\u3067\u5bf8\u6cd5\u304a\u3088\u3073\u54c1\u8cea\u6e2c\u5b9a (\u91cd\u91cf\u3001\u30cd\u30c3\u30af OD\u3001\u30d8\u30a4\u30ba\u30015 \u7b87\u6240\u3067\u306e\u8089\u539a\u3001\u76ee\u8996\u691c\u67fb)\u3002OQ \u306e\u53d7\u5165\u57fa\u6e96: \u3059\u3079\u3066\u306e\u30d1\u30e9\u30e1\u30fc\u30bf \u30ec\u30d9\u30eb\u3067\u3059\u3079\u3066\u306e\u54c1\u8cea\u5c5e\u6027\u304c\u4ed5\u69d8\u5185\u3067\u3042\u308b\u3053\u3068\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u751f\u7523\u304c\u7a3c\u50cd\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u691c\u8a3c\u6e08\u307f\u30d1\u30e9\u30e1\u30fc\u30bf\u7bc4\u56f2\u304c\u78ba\u7acb\u3055\u308c\u307e\u3059\u3002\u516c\u79f0 \u00b1 5% \u3067\u4e0d\u826f\u88fd\u54c1\u3092\u751f\u6210\u3059\u308b\u30d1\u30e9\u30e1\u30fc\u30bf\u3067\u306f\u3001\u516c\u79f0\u8a2d\u5b9a\u5024\u3092\u518d\u6700\u9069\u5316\u3057\u3001OQ \u3092\u7e70\u308a\u8fd4\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u3053\u308c\u307e\u3067\u30af\u30e9\u30b9 III \u306e\u7cbe\u5bc6\u516c\u5dee\u3067\u751f\u7523\u3057\u305f\u3053\u3068\u304c\u306a\u3044\u97d3\u56fd\u306e ISBM \u30af\u30e9\u30b9 III \u751f\u7523\u8005\u306b\u3088\u304f\u898b\u3089\u308c\u308b OQ \u306e\u7d50\u679c\u3067\u3059\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 0;\"><strong>PQ\uff08\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u8cc7\u683c\uff09\uff1a<\/strong> \u97d3\u56fd\u306eISBM\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u5546\u696d\u898f\u6a21\u3067\u6700\u4f4e3\u56de\u306e\u9023\u7d9a\u751f\u7523\u5b9f\u884c\u306b\u304a\u3044\u3066\u3001\u516c\u79f0\u6761\u4ef6\u4e0b\u3067\u4ed5\u69d8\u306b\u6e96\u62e0\u3057\u305f\u4e00\u8cab\u3057\u305f\u88fd\u54c1\u3092\u751f\u6210\u3059\u308b\u3053\u3068\u3092\u5b9f\u8a3c\u3057\u3066\u3044\u307e\u3059\u3002 PQ\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u8a08\u753b\uff1a1\u56de\u306e\u5b9f\u884c\u306b\u3064\u304d\u30011\u30ad\u30e3\u30d3\u30c6\u30a3\u3042\u305f\u308a\u6700\u4f4e125\u672c\u306e\u30dc\u30c8\u30eb\uff083\u56de\u306e\u5b9f\u884c\u30671\u30ad\u30e3\u30d3\u30c6\u30a3\u3042\u305f\u308a\u5408\u8a08375\u672c\uff09\u3092\u3001\u5bf8\u6cd5\u6e2c\u5b9a\u3001\u91cd\u91cf\u3001\u6fc1\u5ea6\u3001AQL\u30ec\u30d9\u30ebII\uff08ANSI\/ASQ Z1.4 \/ ISO 2859-1\uff09\u306b\u3088\u308b\u76ee\u8996\u691c\u67fb\u3001\u751f\u4f53\u9069\u5408\u6027\u30b5\u30f3\u30d7\u30eb\u751f\u7523\u78ba\u8a8d\u3092\u542b\u30809\u3064\u306e\u54c1\u8cea\u5c5e\u6027\u3067\u6e2c\u5b9a\u3057\u307e\u3059\u3002 PQ\u7d71\u8a08\u5206\u6790\uff1a\u5404\u91cd\u8981\u54c1\u8cea\u5c5e\u6027\u306b\u3064\u3044\u3066\u30d7\u30ed\u30bb\u30b9\u80fd\u529b\uff08Cpk\uff09\u2265 1.33 - \u691c\u8a3c\u6e08\u307f\u88fd\u9020\u80fd\u529b\u306b\u95a2\u3059\u308b\u97d3\u56fdKFDA\u30af\u30e9\u30b9III\u898f\u683c\u3002 EV\u30b5\u30fc\u30dcISBM\u97d3\u56fd\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u306f\u3001\u516c\u79f0\u6761\u4ef6\u4e0b\u3067\u30dc\u30c8\u30eb\u91cd\u91cf\u3068\u30cd\u30c3\u30afOD\u306b\u3064\u3044\u3066\u4e00\u8cab\u3057\u3066Cpk \u2265 1.50\u3092\u9054\u6210\u3057\u307e\u3059\u3002\u97d3\u56fd\u306e\u6cb9\u5727\u5f0f\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u306f\u901a\u5e38\u3001Cpk\u5024\u304c1.00\uff5e1.20\u3067\u3042\u308a\u3001\u3053\u308c\u306f\u97d3\u56fd\u306e\u30af\u30e9\u30b9III\u898f\u683c\u3092\u4e0b\u56de\u3063\u3066\u3044\u308b\u305f\u3081\u3001\u30af\u30e9\u30b9III\u4f9b\u7d66\u306b\u53c2\u5165\u3059\u308b\u97d3\u56fd\u306eISBM\u751f\u7523\u8005\u306f\u3001PQ\u3092\u6210\u529f\u88cf\u306b\u5b8c\u4e86\u3059\u308b\u305f\u3081\u306e\u524d\u63d0\u6761\u4ef6\u3068\u3057\u3066\u3001\u6cb9\u5727\u5f0f\u304b\u3089EV\u30b5\u30fc\u30dc\u5f0f\u3078\u306e\u30a2\u30c3\u30d7\u30b0\u30ec\u30fc\u30c9\u3092\u5e38\u306b\u5fc5\u8981\u3068\u3057\u3066\u3044\u308b\u3002<\/p>\n<\/section>\n<p><!-- FAQ --><\/p>\n<section style=\"margin: 56px 0 0; padding: 36px 0 0; border-top: 2px solid #075985;\">\n<h2 id=\"faq\" style=\"font-size: clamp(19px,2.8vw,25px); font-weight: 800; color: #075985; margin: 0 0 24px;\">\u3088\u304f\u3042\u308b\u8cea\u554f<\/h2>\n<div style=\"display: flex; flex-direction: column; gap: 2px;\">\n<div style=\"border: 1px solid #bae6fd; border-radius: 8px 8px 0 0; overflow: hidden;\">\n<div style=\"background: #f0f9ff; padding: 14px 20px; border-bottom: 1px solid #bae6fd;\">\n<p style=\"font-size: 15px; font-weight: bold; color: #075985; margin: 0;\">Q1 \u2014 \u97d3\u56fd\u306e\u30af\u30e9\u30b9II IVD\u533b\u7642\u6a5f\u5668\u5305\u88c5\u4f9b\u7d66\u5e02\u5834\u306b\u53c2\u5165\u3059\u308b\u305f\u3081\u306e\u3001\u97d3\u56fdISBM\u306e\u6700\u4f4e\u6295\u8cc7\u984d\u306f\u3044\u304f\u3089\u3067\u3059\u304b\uff1f<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">\u97d3\u56fd\u306eISBM\u88fd\u9020\u696d\u8005\u304c\u3001\u97d3\u56fd\u306e\u8a8d\u8a3c\u6a5f\u95a2\uff08\uc778\uc99d\uae30\uad00\uff09\u8a8d\u5b9a\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306b\u5bfe\u3057\u3066\u97d3\u56fd\u30af\u30e9\u30b9II IVD\u8a66\u85ac\u5bb9\u5668\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3068\u3057\u3066\u8a8d\u5b9a\u3055\u308c\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u6700\u4f4e\u9650\u306e\u6295\u8cc7\u306f\u30014\u3064\u306e\u8981\u7d20\u304b\u3089\u69cb\u6210\u3055\u308c\u307e\u3059\u3002(1) \u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306eISO 13485:2016\u3078\u306e\u30a2\u30c3\u30d7\u30b0\u30ec\u30fc\u30c9\uff1a\u3059\u3067\u306bISO 9001:2015\u3067\u904b\u7528\u3057\u3066\u3044\u308b\u97d3\u56fd\u306eISBM\u88fd\u9020\u696d\u8005\u306f\u3001\u97d3\u56fd\u306e\u8a8d\u5b9a\u8a8d\u8a3c\u6a5f\u95a2\u30676\uff5e9\u304b\u6708\u3067800\u4e07\uff5e1500\u4e07\u30a6\u30a9\u30f3\uff08\u30ae\u30e3\u30c3\u30d7\u5206\u6790\u3001\u6587\u66f8\u6539\u8a02\u3001\u76e3\u67fb\u3001\u8a8d\u8a3c\uff09\u3067ISO 13485\u3078\u306e\u30a2\u30c3\u30d7\u30b0\u30ec\u30fc\u30c9\u3092\u9054\u6210\u3067\u304d\u307e\u3059\u3002ISO 13485\u306f\u3001KFDA\u8a8d\u8a3c\u30d7\u30ed\u30bb\u30b9\u8981\u4ef6\u3067\u53c2\u7167\u3055\u308c\u3066\u3044\u308b\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u54c1\u8cea\u7ba1\u7406\u898f\u683c\u3067\u3059\u3002(2) \u88fd\u9020\u30b5\u30f3\u30d7\u30eb\u306b\u5bfe\u3059\u308bISO 10993-5\u7d30\u80de\u6bd2\u6027\u8a66\u9a13\uff1aKTR\u307e\u305f\u306fKCL\u3067150\u4e07\uff5e300\u4e07\u30a6\u30a9\u30f3\u3002\u97d3\u56fd\u306e\u8a8d\u8a3c\u6a5f\u95a2\u304c\u5fc5\u8981\u3068\u3059\u308b\u751f\u4f53\u9069\u5408\u6027\u8a3c\u660e\u66f8\u3092\u4f5c\u6210\u3057\u307e\u3059\u3002 \uff08\uff13\uff09\u751f\u7523\u74b0\u5883\u306eISO 14644-1\u30af\u30e9\u30b98\u3078\u306e\u30a2\u30c3\u30d7\u30b0\u30ec\u30fc\u30c9\uff1a\u97d3\u56fd\u306eISBM\u751f\u7523\u30a8\u30ea\u30a2\u304c80\uff5e120m\u00b2\u306e\u5834\u5408\u3001HEPA\u30d5\u30a3\u30eb\u30bf\u30fc\u306e\u6539\u4fee\u3068\u967d\u5727\u7ba1\u7406\uff1a\u691c\u8a3c\u3092\u542b\u3081\u30661,500\u4e07\uff5e3,000\u4e07\u30a6\u30a9\u30f3\u3002 \uff08\uff14\uff09GMP\u6587\u66f8\u30b7\u30b9\u30c6\u30e0\uff1a\u30d0\u30c3\u30c1\u8a18\u9332\u3001\u6a5f\u5668\u6821\u6b63\u30d7\u30ed\u30b0\u30e9\u30e0\u3001\u6a39\u8102\u304a\u3088\u3073\u30de\u30b9\u30bf\u30fc\u30d0\u30c3\u30c1\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u8a8d\u5b9a\u3001\u5e74\u6b21\u7ba1\u7406\u30ec\u30d3\u30e5\u30fc\u3002\u30bc\u30ed\u304b\u3089\u5c0e\u5165\u3059\u308b\u5834\u5408\uff1a\u6587\u66f8\u4f5c\u6210\u3068\u30b9\u30bf\u30c3\u30d5\u7814\u4fee\u306b500\u4e07\uff5e1,000\u4e07\u30a6\u30a9\u30f3\u3002\u7dcf\u6295\u8cc7\u984d\u306e\u6700\u5c0f\u5024\uff1a12\uff5e18\u304b\u6708\u30673,000\u4e07\uff5e5,800\u4e07\u30a6\u30a9\u30f3\u3002\u5bfe\u5fdc\u3059\u308b\u5546\u696d\u7684\u30e1\u30ea\u30c3\u30c8\uff1a\u97d3\u56fd\u306e\u30af\u30e9\u30b9II IVD\u533b\u7642\u6a5f\u5668\u5bb9\u5668\u306e\u4fa1\u683c\u8a2d\u5b9a\u306f\u901a\u5e381\u672c\u3042\u305f\u308a45\uff5e120\u30a6\u30a9\u30f3\u3067\u3001\u540c\u7b49\u306e\u97d3\u56fd\u306e\u6c4e\u7528\u5305\u88c5\u306e1\u672c\u3042\u305f\u308a\u306e\u5229\u76ca\u306e2\uff5e4\u500d\u3067\u3042\u308a\u3001\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306e\u5951\u7d04\u306f\u901a\u5e383\uff5e5\u5e74\u306e\u4f9b\u7d66\u5951\u7d04\u3067\u3001\u97d3\u56fd\u306e\u6c4e\u7528\u5305\u88c5\u5e02\u5834\u3067\u306f\u5f97\u3089\u308c\u306a\u3044\u53ce\u76ca\u306e\u5b89\u5b9a\u6027\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002<\/p>\n<\/div>\n<\/div>\n<div style=\"border: 1px solid #bae6fd; border-top: none; overflow: hidden;\">\n<div style=\"background: #f0f9ff; padding: 14px 20px; border-bottom: 1px solid #bae6fd;\">\n<p style=\"font-size: 15px; font-weight: bold; color: #075985; margin: 0;\">Q2 \u2014 \u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u306e\u9069\u5408\u6027\u5be9\u67fb\u306b\u304a\u3044\u3066\u3001\u97d3\u56fd\u306eISBM\u30ef\u30f3\u30b9\u30c6\u30c3\u30d7\u51e6\u7406\u306f\u30012\u6bb5\u968eSBM\u3068\u3069\u306e\u3088\u3046\u306b\u7570\u306a\u308a\u307e\u3059\u304b\uff1f<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">\u97d3\u56fd\u306eISBM\u30ef\u30f3\u30b9\u30c6\u30c3\u30d7\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u7528\u9014\u306b\u304a\u3044\u3066\u30012\u6bb5\u968eSBM\uff08\u88fd\u9020\u6e08\u307f\u30d7\u30ea\u30d5\u30a9\u30fc\u30e0\u304b\u3089\u306e\u5ef6\u4f38\u30d6\u30ed\u30fc\u6210\u5f62\uff09\u306b\u6bd4\u3079\u30662\u3064\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u4e0a\u306e\u5229\u70b9\u304c\u3042\u308a\u307e\u3059\u30021\u3064\u76ee\u306f\u3001\u500b\u5225\u306e\u691c\u8a3c\u304c\u5fc5\u8981\u306a\u30d7\u30ed\u30bb\u30b9\u30b9\u30c6\u30c3\u30d7\u304c\u5c11\u306a\u3044\u3053\u3068\u3067\u3059\u30022\u6bb5\u968eSBM\u3067\u306f\u3001\u30d7\u30ea\u30d5\u30a9\u30fc\u30e0\u5c04\u51fa\u6210\u5f62\uff08\u5c04\u51fa\u6210\u5f62\u6a5f\u306eIQ\/OQ\/PQ\uff09\u306eGMP\u691c\u8a3c\u3068\u3001\u518d\u52a0\u71b1SBM\u30d7\u30ed\u30bb\u30b9\u306eGMP\u691c\u8a3c\u304c\u5225\u3005\u306b\u5fc5\u8981\u3067\u3001ISO 14644\u306e\u8a8d\u5b9a\u3092\u53d7\u3051\u308b\u306b\u306f\u30012\u3064\u306e\u500b\u5225\u306e\u691c\u8a3c\u4f5c\u696d\u30012\u30bb\u30c3\u30c8\u306e\u6a5f\u5668\u6821\u6b63\u30012\u3064\u306e\u751f\u7523\u74b0\u5883\u304c\u5fc5\u8981\u3067\u3059\u3002\u97d3\u56fd\u306e\u30ef\u30f3\u30b9\u30c6\u30c3\u30d7ISBM\u306f\u3001\u4e21\u65b9\u306e\u30b9\u30c6\u30c3\u30d7\u30921\u3064\u306e\u691c\u8a3c\u6e08\u307f\u30d7\u30ed\u30bb\u30b9\u306b\u7d71\u5408\u3057\u30011\u3064\u306eIQ\/OQ\/PQ\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u4f7f\u7528\u3059\u308b\u3053\u3068\u3067\u3001\u691c\u8a3c\u4f5c\u696d\u3092\u307b\u307c\u534a\u5206\u306b\u524a\u6e1b\u3057\u307e\u3059\u30022\u3064\u76ee\u306f\u3001\u30d7\u30ea\u30d5\u30a9\u30fc\u30e0\u306e\u5728\u5eab\u3068\u53d6\u308a\u6271\u3044\u306b\u95a2\u3059\u308b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8981\u4ef6\u304c\u306a\u3044\u3053\u3068\u3067\u3059\u30022\u6bb5\u968eSBM\u3067\u306f\u3001\u4e2d\u9593\u30d7\u30ea\u30d5\u30a9\u30fc\u30e0\u306e\u5728\u5eab\u304c\u4f5c\u6210\u3055\u308c\u3001\u3053\u308c\u3092\u8a8d\u5b9a\u3055\u308c\u305f\u74b0\u5883\u306b\u4fdd\u7ba1\u3057\u3001\u30ed\u30c3\u30c8\u756a\u53f7\u3067\u8ffd\u8de1\u3057\u3001\u4fdd\u7ba1\u6642\u9593\u5236\u9650\u3092\u7ba1\u7406\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\uff08PET\u30d7\u30ea\u30d5\u30a9\u30fc\u30e0\u306f\u3001\u30d6\u30ed\u30fc\u6210\u5f62\u524d\u306b\u9577\u671f\u9593\u4fdd\u7ba1\u3059\u308b\u3068\u7d50\u6676\u6027\u304c\u4f4e\u4e0b\u3057\u307e\u3059\uff09\u3002\u97d3\u56fd\u306e\u30ef\u30f3\u30b9\u30c6\u30c3\u30d7ISBM\u306f\u3001\u30d7\u30ea\u30d5\u30a9\u30fc\u30e0\u306e\u4fdd\u7ba1\u306b\u95a2\u3059\u308b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8981\u4ef6\u3092\u5b8c\u5168\u306b\u6392\u9664\u3057\u307e\u3059\u3002\u30d7\u30ea\u30d5\u30a9\u30fc\u30e0\u306f\u540c\u3058\u30b5\u30a4\u30af\u30eb\u3067\u88fd\u9020\u3055\u308c\u3001\u3059\u3050\u306b\u30d6\u30ed\u30fc\u6210\u5f62\u3055\u308c\u308b\u305f\u3081\u3001\u74b0\u5883\u7ba1\u7406\u3001\u30ed\u30c3\u30c8\u8ffd\u8de1\u3001\u307e\u305f\u306f\u6709\u52b9\u671f\u9650\u7ba1\u7406\u3092\u5fc5\u8981\u3068\u3059\u308b\u4e2d\u9593\u88fd\u54c1\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u97d3\u56fd\u306e\u533b\u85ac\u54c1ISBM\u3067\u306f\u3001\u3053\u306e\u5229\u70b9\u306f\u5e83\u304f\u8a8d\u8b58\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668ISBM\u306b\u3068\u3063\u3066\u3082\u540c\u69d8\u306b\u91cd\u8981\u3067\u3059\u3002\u30ef\u30f3\u30b9\u30c6\u30c3\u30d7\u51e6\u7406\u306b\u3088\u308a\u3001\u500b\u5225\u306e\u691c\u8a3c\u304c\u5fc5\u8981\u306a\u91cd\u8981\u306a\u30d7\u30ed\u30bb\u30b9\u30b9\u30c6\u30c3\u30d7\u306e\u6570\u304c\u524a\u6e1b\u3055\u308c\u308b\u305f\u3081\u3001\u97d3\u56fd\u306e\u30af\u30e9\u30b9III\u5305\u88c5\u306e\u63d0\u51fa\u66f8\u985e\u304c\u7c21\u7d20\u5316\u3055\u308c\u30012\u6bb5\u968e\u306e\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u9069\u683c\u6027\u8a55\u4fa1\u3068\u6bd4\u8f03\u3057\u3066\u3001IQ\/OQ\/PQ\u306e\u671f\u9593\u304c2\uff5e4\u304b\u6708\u77ed\u7e2e\u3055\u308c\u307e\u3059\u3002<\/p>\n<\/div>\n<\/div>\n<div style=\"border: 1px solid #bae6fd; border-top: none; overflow: hidden;\">\n<div style=\"background: #f0f9ff; padding: 14px 20px; border-bottom: 1px solid #bae6fd;\">\n<p style=\"font-size: 15px; font-weight: bold; color: #075985; margin: 0;\">Q3 \u2014 \u30ac\u30f3\u30de\u7dda\u7167\u5c04\u306f\u3001\u97d3\u56fd\u306eISBM PET\u533b\u7642\u6a5f\u5668\u30dc\u30c8\u30eb\u304b\u3089\u306e\u6eb6\u51fa\u7269\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u3092\u5909\u5316\u3055\u305b\u307e\u3059\u304b\uff1f<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">\u306f\u3044\u3001\u30ac\u30f3\u30de\u7dda\u7167\u5c04\u306b\u3088\u308aPET\u306b\u30d5\u30ea\u30fc\u30e9\u30b8\u30ab\u30eb\u304c\u751f\u6210\u3055\u308c\u3001\u7167\u5c04\u524d\u306b\u5b58\u5728\u3057\u3066\u3044\u305f\u71b1\u5206\u89e3\u751f\u6210\u7269\u306b\u52a0\u3048\u3066\u3001\u653e\u5c04\u7dda\u8a98\u767a\u5206\u89e3\u751f\u6210\u7269\u306e\u660e\u78ba\u306a\u30bb\u30c3\u30c8\u304c\u751f\u6210\u3055\u308c\u307e\u3059\u300225 kGy\u306e\u7167\u5c04\u3092\u53d7\u3051\u305f\u97d3\u56fd\u88fdISBM PET\u304b\u3089\u306e\u4e3b\u306a\u653e\u5c04\u7dda\u8a98\u767a\u62bd\u51fa\u7269\u306f\u6b21\u306e\u3068\u304a\u308a\u3067\u3059\u3002(1) \u30a2\u30bb\u30c8\u30a2\u30eb\u30c7\u30d2\u30c9\u306e\u5897\u52a0\uff08\u30ac\u30f3\u30de\u7dda\u7167\u5c04\u306b\u3088\u308aPET\u9396\u306e\u30a8\u30b9\u30c6\u30eb\u7d50\u5408\u304c\u3055\u3089\u306b\u5207\u65ad\u3055\u308c\u3001ISBM\u30d7\u30ed\u30bb\u30b9\u304b\u3089\u306e\u71b1\u5206\u89e3\u751f\u6210\u7269\u306b\u52a0\u3048\u3066\u30a2\u30bb\u30c8\u30a2\u30eb\u30c7\u30d2\u30c9\u304c\u653e\u51fa\u3055\u308c\u307e\u3059\uff09\u3002(2) \u30d3\u30cb\u30eb\u30a2\u30eb\u30b3\u30fc\u30eb\u30aa\u30ea\u30b4\u30de\u30fc\uff08\u672b\u7aef\u30d3\u30cb\u30eb\u57fa\u306e\u30ac\u30f3\u30de\u7dda\u5207\u65ad\uff09\u3002(3) PET\u74b0\u72b6\u30aa\u30ea\u30b4\u30de\u30fc\u306e\u5897\u52a0\uff08\u653e\u5c04\u7dda\u306b\u3088\u308a\u9396\u5207\u65ad\u304b\u3089\u30aa\u30ea\u30b4\u30de\u30fc\u5f62\u6210\u304c\u4fc3\u9032\u3055\u308c\u307e\u3059\uff09\u3002\u30ac\u30f3\u30de\u7dda\u6ec5\u83cc\u3055\u308c\u305f\u97d3\u56fdKFDA\u30af\u30e9\u30b9III\u533b\u7642\u6a5f\u5668\u5bb9\u5668\u306e\u5834\u5408\u3001\u653e\u5c04\u7dda\u8a98\u767a\u62bd\u51fa\u7269\u306f\u60a3\u8005\u304c\u66dd\u9732\u3055\u308c\u308b\u5bb9\u5668\u306e\u5b9f\u969b\u306e\u5316\u5b66\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306e\u4e00\u90e8\u3067\u3042\u308b\u305f\u3081\u3001E&amp;L\u8a66\u9a13\u306f\u7167\u5c04\u6e08\u307f\u30b5\u30f3\u30d7\u30eb\u3067\u5b9f\u65bd\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u3001\u672a\u7167\u5c04\u306e\u88fd\u9020\u30b5\u30f3\u30d7\u30eb\u3067\u306f\u5b9f\u65bd\u3067\u304d\u307e\u305b\u3093\u3002\u975e\u7167\u5c04\u30dc\u30c8\u30eb\u3067\u62bd\u51fa\u30fb\u6eb6\u89e3\u8a66\u9a13\uff08E&amp;L\u8a66\u9a13\uff09\u3092\u5b9f\u65bd\u3057\u3001\u305d\u306e\u5f8c\u30ac\u30f3\u30de\u7dda\u3067\u6ec5\u83cc\u3059\u308b\u97d3\u56fd\u306eISBM\u88fd\u9020\u696d\u8005\u306f\u3001\u97d3\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5b89\u5168\u5e81\uff08KFDA\uff09\u306e\u8a8d\u8a3c\u7533\u8acb\u66f8\u985e\u306b\u4e0d\u5099\u304c\u3042\u308a\u3001KFDA\u306e\u5be9\u67fb\u6642\u306b\u521d\u3081\u3066\u660e\u3089\u304b\u306b\u306a\u308b\u305f\u3081\u3001\u7167\u5c04\u6e08\u307f\u30b5\u30f3\u30d7\u30eb\u3092\u7528\u3044\u305fE&amp;L\u8a66\u9a13\u306e\u518d\u5b9f\u65bd\u304c\u5fc5\u8981\u3068\u306a\u308a\u3001\u8a8d\u8a3c\u627f\u8a8d\u304c3\uff5e6\u30f6\u6708\u9045\u308c\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002\u62bd\u51fa\u524d\u306b\u30b5\u30f3\u30d7\u30eb\u3092\u6700\u5927\u7167\u5c04\u91cf\u3067\u7167\u5c04\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3053\u3068\u3092E&amp;L\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u6700\u521d\u304b\u3089\u660e\u8a18\u3059\u308b\u3053\u3068\u3067\u3001\u518d\u8a66\u9a13\u306e\u8cbb\u7528\u3068\u627f\u8a8d\u306e\u9045\u5ef6\u3092\u56de\u907f\u3067\u304d\u307e\u3059\u3002<\/p>\n<\/div>\n<\/div>\n<div style=\"border: 1px solid #bae6fd; border-top: none; overflow: hidden;\">\n<div style=\"background: #f0f9ff; padding: 14px 20px; border-bottom: 1px solid #bae6fd;\">\n<p style=\"font-size: 15px; font-weight: bold; color: #075985; margin: 0;\">Q4 \u2014 \u97d3\u56fd\u306eISBM PET\u306b\u542b\u307e\u308c\u308b\u30a2\u30bb\u30c8\u30a2\u30eb\u30c7\u30d2\u30c9\u306f\u3001\u533b\u7642\u6a5f\u5668\u7528\u8a66\u85ac\u306e\u54c1\u8cea\u306b\u3069\u306e\u3088\u3046\u306a\u5f71\u97ff\u3092\u4e0e\u3048\u307e\u3059\u304b\uff1f<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">\u97d3\u56fd\u88fdISBM PET\u30dc\u30c8\u30eb\u304b\u3089\u533b\u7642\u6a5f\u5668\u8a66\u85ac\u3078\u306e\u30a2\u30bb\u30c8\u30a2\u30eb\u30c7\u30d2\u30c9\uff08AA\uff09\u306e\u79fb\u884c\u306f\u3001\u7279\u5b9a\u306e\u97d3\u56fd\u88fdIVD\u8a66\u85ac\u30ab\u30c6\u30b4\u30ea\u30fc\u3001\u7279\u306bAA\u304c\u9175\u7d20\u6d3b\u6027\u90e8\u4f4d\u3068\u53cd\u5fdc\u3059\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u9175\u7d20\u30d9\u30fc\u30b9\u306e\u8a3a\u65ad\u8a66\u85ac\u3084\u3001AA\u304c\u30e1\u30a4\u30e9\u30fc\u30c9\u53cd\u5fdc\u3092\u4ecb\u3057\u3066\u6297\u4f53\u30bf\u30f3\u30d1\u30af\u8cea\u3068\u53cd\u5fdc\u3057\u3001\u30a2\u30c3\u30bb\u30a4\u611f\u5ea6\u3092\u4f4e\u4e0b\u3055\u305b\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u514d\u75ab\u6e2c\u5b9a\u8a66\u85ac\u306b\u3068\u3063\u3066\u91cd\u8981\u306a\u54c1\u8cea\u4e0a\u306e\u61f8\u5ff5\u4e8b\u9805\u3067\u3059\u3002\u6e2c\u5b9a\u53ef\u80fd\u306a\u97d3\u56fd\u88fdIVD\u8a66\u85ac\u306e\u6027\u80fd\u52a3\u5316\u3092\u5f15\u304d\u8d77\u3053\u3059AA\u79fb\u884c\u306e\u95be\u5024\u306f\u3001\u7279\u5b9a\u306e\u8a66\u85ac\u30de\u30c8\u30ea\u30c3\u30af\u30b9\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u3002\u9175\u7d20\u30d9\u30fc\u30b9\u306eIVD\u8a66\u85ac\u306f\u3001\u4fdd\u5b58\u4e2d\u306e\u8a66\u85ac\u4e2d\u306eAA\u6fc3\u5ea6\u304c15 ppb\u3092\u8d85\u3048\u308b\u3068\u6027\u80fd\u52a3\u5316\u3092\u793a\u3057\u307e\u3059\u3002\u514d\u75ab\u6e2c\u5b9a\u8a66\u85ac\u306f\u901a\u5e38\u3001\u97d3\u56fd\u88fdISBM PET AA\u30ec\u30d9\u30eb\uff08\u5ba4\u6e29\u30673\u304b\u6708\u9593\u4fdd\u5b58\u3057\u305f100ml PET\u30dc\u30c8\u30eb\u4e2d\u306e\u30d8\u30c3\u30c9\u30b9\u30da\u30fc\u30b9AA\u6fc3\u5ea61\uff5e8 ppb\uff09\u3067\u306f\u5f71\u97ff\u3092\u53d7\u3051\u307e\u305b\u3093\u3002\u97d3\u56fd\u306eISBM\u88fd\u9020\u696d\u8005\u306f\u3001\u97d3\u56fd\u306eIVD\u8a3a\u65ad\u4f1a\u793e\u306b\u88fd\u54c1\u3092\u4f9b\u7d66\u3059\u308b\u969b\u3001\u5546\u696d\u6761\u4ef6\uff08\u8abf\u6574\u6e29\u5ea6\u3001\u30d0\u30ec\u30eb\u6e29\u5ea6\u3001\u30b5\u30a4\u30af\u30eb\u6642\u9593\uff09\u3067\u88fd\u9020\u3055\u308c\u305f\u30dc\u30c8\u30eb\u5185\u306e\u30d8\u30c3\u30c9\u30b9\u30da\u30fc\u30b9AA\u306e\u6e2c\u5b9a\u5024\u3092\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u9867\u5ba2\u306e\u88fd\u5264\u30c1\u30fc\u30e0\u306b\u958b\u793a\u3057\u3001\u30d7\u30ed\u30bb\u30b9\u30d1\u30e9\u30e1\u30fc\u30bf\u7ba1\u7406\u3068\u5e74\u6b21\u691c\u8a3c\u8a66\u9a13\u3092\u901a\u3058\u3066\u3001\u3059\u3079\u3066\u306e\u5546\u696d\u751f\u7523\u306b\u304a\u3044\u3066AA\u3092\u5408\u610f\u3055\u308c\u305f\u5236\u9650\u5024\u4ee5\u4e0b\u306b\u7dad\u6301\u3059\u308b\u3053\u3068\u3092\u7d04\u675f\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668PET\u30dc\u30c8\u30eb\u5185\u306eAA\u3092\u4f4e\u6e1b\u3059\u308b\u305f\u3081\u306e\u4e3b\u306aISBM\u30d1\u30e9\u30e1\u30fc\u30bf\u30ec\u30d0\u30fc\u306f\u3001\u30d0\u30ec\u30eb\u6e29\u5ea6\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u3053\u3068\uff08\u76ee\u6a19\u306f265\u2103\u30be\u30fc\u30f31\u3001280\u2103\u4ee5\u4e0a\u3067\u306f\u306a\u3044\uff09\u3001\u30d0\u30ec\u30eb\u6ede\u7559\u6642\u9593\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u3053\u3068\uff0810\u5206\u3092\u8d85\u3048\u308b\u505c\u6b62\u4e2d\u306bPET\u3092\u30d0\u30ec\u30eb\u5185\u306e\u6e29\u5ea6\u306b\u653e\u7f6e\u3057\u306a\u3044\uff09\u3001\u304a\u3088\u3073\u8abf\u6574\u6ede\u7559\u6642\u9593\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u3053\u3068\uff08\u54c1\u8cea\u306b\u5341\u5206\u306a\u6700\u5c0f\u9650\u306e\u6642\u9593\u3001\u6700\u5927\u6642\u9593\u3067\u306f\u306a\u3044\uff09\u3067\u3059\u3002<\/p>\n<\/div>\n<\/div>\n<div style=\"border: 1px solid #bae6fd; border-top: none; overflow: hidden;\">\n<div style=\"background: #f0f9ff; padding: 14px 20px; border-bottom: 1px solid #bae6fd;\">\n<p style=\"font-size: 15px; font-weight: bold; color: #075985; margin: 0;\">Q5 \u2014 \u97d3\u56fd\u306e\u30af\u30e9\u30b9III KFDA\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u305f\u5f8c\u3001\u3069\u306e\u3088\u3046\u306a\u97d3\u56fdISBM\u5909\u66f4\u7ba1\u7406\u8981\u4ef6\u304c\u9069\u7528\u3055\u308c\u307e\u3059\u304b\uff1f<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">\u97d3\u56fd\u306eKFDA \ud5c8\uac00\u627f\u8a8d\u533b\u7642\u6a5f\u5668\u5305\u88c5\u306f\u3001\u5bb9\u5668\u4ed5\u69d8\u304c\u97d3\u56fd\u306e\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306e\ud5c8\uac00\u30c9\u30b7\u30a8\u306b\u542b\u307e\u308c\u308b\u3068\u3001\u97d3\u56fd\u306eISBM\u5305\u88c5\u30e1\u30fc\u30ab\u30fc\u3092\u62d8\u675f\u3059\u308b\u5909\u66f4\u7ba1\u7406\u8981\u4ef6\u306e\u5bfe\u8c61\u3068\u306a\u308a\u307e\u3059\u3002\u97d3\u56fd\u306eKFDA\u5909\u66f4\u901a\u77e5\uff08\u91cd\u8981\u5ea6\u306b\u5fdc\u3058\u3066\u5909\u66f4\ud5c8\uac00\u307e\u305f\u306f\u5909\u66f4\u5c4a\u51fa\uff09\u304a\u3088\u3073\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u97d3\u56fd\u306eKFDA\u306e\u5be9\u67fb\u3068\u518d\u627f\u8a8d\u304c\u5fc5\u8981\u3068\u306a\u308bISBM\u5bb9\u5668\u306e\u5909\u66f4\u306b\u306f\u3001\u6a39\u8102\u30b0\u30ec\u30fc\u30c9\u307e\u305f\u306f\u30e1\u30fc\u30ab\u30fc\u306e\u5909\u66f4\u3001\u7740\u8272\u5264\u307e\u305f\u306f\u30de\u30b9\u30bf\u30fc\u30d0\u30c3\u30c1\u4ed5\u69d8\u306e\u5909\u66f4\u3001ISBM\u30de\u30b7\u30f3\uff08\u30e2\u30c7\u30eb\u3001\u30b7\u30ea\u30a2\u30eb\u756a\u53f7\u3001\u5834\u6240\uff09\u306e\u5909\u66f4\u3001OQ\u3067\u8a2d\u5b9a\u3055\u308c\u305f\u691c\u8a3c\u6e08\u307f\u7bc4\u56f2\u5916\u306e\u91cd\u8981\u306a\u30d7\u30ed\u30bb\u30b9\u30d1\u30e9\u30e1\u30fc\u30bf\u306e\u5909\u66f4\u3001\ud5c8\uac00\u30c9\u30b7\u30a8\u3067\u627f\u8a8d\u3055\u308c\u305f\u8a31\u5bb9\u7bc4\u56f2\u3092\u8d85\u3048\u308b\u5bf8\u6cd5\u4ed5\u69d8\u306e\u5909\u66f4\u306a\u3069\u304c\u3042\u308a\u307e\u3059\u3002\u901a\u5e38\u3001KFDA\u5909\u66f4\u901a\u77e5\u3092\u5fc5\u8981\u3068\u3057\u306a\u3044\uff08\u305f\u3060\u3057\u3001\u5185\u90e8\u5909\u66f4\u7ba1\u7406\u6587\u66f8\u5316\u306f\u5fc5\u8981\uff09\u5909\u66f4\u306b\u306f\u3001\u7bc4\u56f2\u5185\u306e\u30d7\u30ed\u30bb\u30b9\u30d1\u30e9\u30e1\u30fc\u30bf\u8abf\u6574\u3001ISBM\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u8a8d\u8a3c\u306e\u5909\u66f4\u3001\u691c\u8a3c\u6e08\u307f\u306e\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u30af\u30e9\u30b9\u3092\u7dad\u6301\u307e\u305f\u306f\u8d85\u3048\u308b\u751f\u7523\u74b0\u5883\u306e\u6539\u5584\u306a\u3069\u304c\u3042\u308a\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u5bb9\u5668\u306e\u88fd\u9020\u5de5\u7a0b\u306b\u304a\u3044\u3066\u3001\u627f\u8a8d\u6e08\u307f\u306eISBM\u5305\u88c5\u6750\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u3092\u53ef\u5909\u7684\u306a\u3082\u306e\u3068\u3057\u3066\u6271\u3046\u97d3\u56fd\u306eISBM\u5305\u88c5\u6750\u88fd\u9020\u696d\u8005\uff08\u5909\u66f4\u7ba1\u7406\u3092\u884c\u308f\u305a\u306b\u30d0\u30ec\u30eb\u6e29\u5ea6\u3092\u8abf\u6574\u3057\u305f\u308a\u3001\u4f9b\u7d66\u696d\u8005\u306e\u8cc7\u683c\u8a8d\u5b9a\u306a\u3057\u306b\u6a39\u8102\u30b0\u30ec\u30fc\u30c9\u3092\u5909\u66f4\u3057\u305f\u308a\u3001KFDA\u3078\u306e\u901a\u77e5\u306a\u3057\u306bISBM\u88fd\u9020\u88c5\u7f6e\u3092\u65bd\u8a2d\u9593\u3067\u79fb\u52d5\u3057\u305f\u308a\u3059\u308b\u696d\u8005\uff09\u306f\u3001KFDA\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u4e0a\u306e\u4e0d\u5099\u3092\u62db\u304d\u3001\u305d\u308c\u304c\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306e\u6b21\u56de\u306eKFDA\u691c\u67fb\u3067\u660e\u3089\u304b\u306b\u306a\u308a\u3001\u5305\u88c5\u6750\u4f9b\u7d66\u696d\u8005\u306b\u5bfe\u3059\u308b\u662f\u6b63\u63aa\u7f6e\u8981\u6c42\u306b\u3064\u306a\u304c\u308a\u307e\u3059\u3002\u5b9f\u969b\u7684\u306a\u610f\u5473\u5408\u3044\u3068\u3057\u3066\u306f\u3001\u97d3\u56fd\u306e\u30af\u30e9\u30b9III\u533b\u7642\u6a5f\u5668\u4f9b\u7d66\u306b\u53c2\u5165\u3059\u308bISBM\u5305\u88c5\u6750\u88fd\u9020\u696d\u8005\u306f\u3001\u533b\u7642\u6a5f\u5668\u5951\u7d04\u5c02\u7528\u306e\u6a5f\u68b0\u3001\u91d1\u578b\u3001\u6a39\u8102\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u3092\u7528\u610f\u3057\u3001\u6b63\u5f0f\u306a\u5be9\u67fb\u306a\u3057\u306b\u3044\u304b\u306a\u308b\u5909\u66f4\u3082\u884c\u308f\u306a\u3044\u5909\u66f4\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u5c0e\u5165\u3057\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066KFDA\u3078\u306e\u901a\u77e5\u3092\u884c\u3046\u3079\u304d\u3067\u3059\u3002<\/p>\n<\/div>\n<\/div>\n<div style=\"border: 1px solid #bae6fd; border-radius: 0 0 8px 8px; overflow: hidden;\">\n<div style=\"background: #f0f9ff; padding: 14px 20px; border-bottom: 1px solid #bae6fd;\">\n<p style=\"font-size: 15px; font-weight: bold; color: #075985; margin: 0;\">Q6 \u2014 \u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u5bb9\u5668\u306e\u30cd\u30c3\u30af\u5916\u5f84\u306e\u9069\u5408\u6027\u306b\u95a2\u3057\u3066\u3001\u97d3\u56fd\u306eISBM\u306e\u5bf8\u6cd5\u7cbe\u5ea6\u306f\u30ac\u30e9\u30b9\u3068\u6bd4\u8f03\u3057\u3066\u3069\u3046\u3067\u3059\u304b\uff1f<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">\u97d3\u56fd\u306eISBM PET\u304a\u3088\u3073PETG\u30dc\u30c8\u30eb\u306f\u30014\u30ad\u30e3\u30d3\u30c6\u30a3\u751f\u7523\u306b\u304a\u3044\u3066\u3001\u30cd\u30c3\u30af\u5916\u5f84\u306e\u5bf8\u6cd5\u7cbe\u5ea6\u304c\u00b10.04mm\uff084\u30b7\u30b0\u30de\u3001EV\u30b5\u30fc\u30dc\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\uff09\u3092\u9054\u6210\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u533b\u85ac\u54c1\u30b0\u30ec\u30fc\u30c9\u306e\u30ac\u30e9\u30b9\u30dc\u30c8\u30eb\u306e\u30cd\u30c3\u30af\u5916\u5f84\u7cbe\u5ea6\uff08\u30ac\u30e9\u30b9\u6210\u5f62\u30d7\u30ed\u30bb\u30b9\u3068\u30cd\u30c3\u30af\u30b5\u30a4\u30ba\u306b\u3088\u3063\u3066\u901a\u5e38\u00b10.05\uff5e0.10mm\uff09\u3068\u540c\u7b49\u304b\u305d\u308c\u4ee5\u4e0a\u3067\u3059\u3002\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u7528\u9014\u3067\u306f\u3001\u6f0f\u308c\u306e\u306a\u3044\u5bc6\u5c01\u306e\u305f\u3081\u306b\u30af\u30ed\u30fc\u30b8\u30e3\u30fc\uff08\u30b9\u30ca\u30c3\u30d7\u30ad\u30e3\u30c3\u30d7\u3001\u30eb\u30a2\u30fc\u30b3\u30cd\u30af\u30bf\u3001\u30bb\u30d7\u30bf\u30e0\uff09\u304c\u30cd\u30c3\u30af\u5916\u5f84\u306e\u516c\u5dee\u306b\u4f9d\u5b58\u3059\u308b\u305f\u3081\u3001\u97d3\u56fdISBM\u306e\u00b10.04mm\u306e\u7cbe\u5ea6\u306f\u3001\u30ac\u30e9\u30b9\u306e\u00b10.05\uff5e0.10mm\u3088\u308a\u3082\u4e00\u8cab\u3057\u305f\u5bc6\u5c01\u6027\u80fd\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u751f\u7523\u6642\u306b\u30ad\u30e3\u30d3\u30c6\u30a3\u3054\u3068\u306b\u5b9a\u91cf\u7684\u306b\u691c\u8a3c\u3067\u304d\u308b\u3068\u3044\u3046\u5229\u70b9\u3082\u3042\u308a\u307e\u3059\uff08\u30ac\u30e9\u30b9\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u30ad\u30e3\u30d3\u30c6\u30a3\u3054\u3068\u3067\u306f\u306a\u304f\u3001\u7d71\u8a08\u7684\u30b5\u30f3\u30d7\u30eb\u30ec\u30d9\u30eb\u3067\u5bf8\u6cd5\u8a8d\u8a3c\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\uff09\u3002\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u5bb9\u5668\u306e\u8981\u4ef6\u306e\u3046\u3061\u3001\u30ac\u30e9\u30b9\u304c\u97d3\u56fd\u306eISBM PET\/PETG\u3088\u308a\u3082\u512a\u4f4d\u6027\u3092\u6301\u3064\u70b9\u304c2\u3064\u3042\u308a\u307e\u3059\u3002(1) \u5149\u611f\u53d7\u6027\u306e\u9ad8\u3044\u8a66\u85ac\u306b\u5bfe\u3059\u308bUV\u30d0\u30ea\u30a2 - \u30a2\u30f3\u30d0\u30fc\u30ac\u30e9\u30b9\u306f450nm\u4ee5\u4e0b\u306eUV\u309299.9%\u4ee5\u4e0a\u906e\u65ad\u3057\u307e\u3059\u3002\u30a2\u30f3\u30d0\u30fcPET\u307e\u305f\u306f\u30a2\u30f3\u30d0\u30fcPETG\u306f95\uff5e99%\u3092\u906e\u65ad\u3057\u307e\u3059\u304c\u3001\u691c\u8a3c\u6e08\u307f\u306e\u30de\u30b9\u30bf\u30fc\u30d0\u30c3\u30c1\u3068\u79fb\u884c\u8a66\u9a13\u304c\u5fc5\u8981\u3067\u3059\u3002(2) \u6c34\u84b8\u6c17\u900f\u904e\u7387(WVTR) - \u30ac\u30e9\u30b9\u306eWVTR\u306f\u30bc\u30ed\u3067\u3059\u3002PET\u306eWVTR\u306f38\u00b0C\/90% RH\u3067\u7d041.5\uff5e3.0 g\u00b7mm\/m\u00b2\u00b7day\u3067\u3059\u3002\u3053\u308c\u306f\u3001\u97d3\u56fd\u306e\u6a19\u6e96\u7684\u306a\u5b9f\u9a13\u5ba4\u4fdd\u7ba1(15\uff5e30\u00b0C)\u306b\u304a\u3051\u308b\u307b\u3068\u3093\u3069\u306e\u6c34\u6027IVD\u8a66\u85ac\u306b\u306f\u8a31\u5bb9\u7bc4\u56f2\u5185\u3067\u3059\u304c\u300118\u304b\u6708\u4ee5\u4e0a\u306e\u4fdd\u5b58\u671f\u9593\u306b\u308f\u305f\u3063\u3066\u5927\u6c17\u4e2d\u306e\u6c34\u5206\u5438\u53ce\u306b\u3088\u308b\u5e0c\u91c8\u306b\u654f\u611f\u306a\u8a66\u85ac\u306b\u306f\u6e7f\u5ea6\u30d0\u30ea\u30a2\u306b\u3088\u308b\u5bc6\u9589\u304c\u5fc5\u8981\u3067\u3059\u3002<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<p><!-- CTA --><\/p>\n<div style=\"background: linear-gradient(135deg,#020c1a 0%,#0369a1 100%); border-radius: 10px; padding: clamp(30px,5vw,50px) clamp(20px,4vw,40px); text-align: center; margin: 56px 0 48px;\">\n<p style=\"font-size: 10px; font-weight: bold; letter-spacing: 2px; text-transform: uppercase; color: #7dd3fc; margin: 0 0 12px;\">\u533b\u7642\u6a5f\u5668\u8a8d\u8a3c\u30b5\u30dd\u30fc\u30c8<\/p>\n<h2 style=\"font-size: clamp(18px,3vw,26px); font-weight: 800; color: #fff; margin: 0 0 14px;\">\u97d3\u56fd\u306eKFDA\u30af\u30e9\u30b9II\u307e\u305f\u306f\u30af\u30e9\u30b9III\u533b\u7642\u6a5f\u5668\u5305\u88c5\u5e02\u5834\u3078\u306e\u53c2\u5165\u3092\u304a\u8003\u3048\u3067\u3059\u304b\uff1fGMP\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3001ISO 10993\u3001\u307e\u305f\u306fIQ\/OQ\/PQ\u306e\u30b5\u30dd\u30fc\u30c8\u304c\u5fc5\u8981\u3067\u3059\u304b\uff1f<\/h2>\n<p style=\"font-size: 15px; color: #e0f2fe; max-width: 480px; margin: 0 auto 26px; line-height: 1.65;\">Korean Ever-Power\u306f\u3001KFDA\u30af\u30e9\u30b9II\/III\u6587\u66f8\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3001GMP IQ\/OQ\/PQ\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u958b\u767a\u3001\u751f\u4f53\u9069\u5408\u6027\u30b5\u30f3\u30d7\u30eb\u306e\u88fd\u9020\u3001KFDA Annex 11\u6e96\u62e0\u306e\u305f\u3081\u306eEV\u30b5\u30fc\u30dc\u30d7\u30ed\u30bb\u30b9\u30ed\u30ae\u30f3\u30b0\u3001\u304a\u3088\u3073\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u5305\u88c5\u306e\u9069\u683c\u6027\u8a55\u4fa1\u306e\u305f\u3081\u306e\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0ISBM\u30b3\u30df\u30c3\u30b7\u30e7\u30cb\u30f3\u30b0\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p><a style=\"display: inline-block; background: #f97316; color: #fff; padding: 14px 36px; border-radius: 6px; text-decoration: none; font-weight: bold; font-size: 15px;\" href=\"https:\/\/isbm-blow-molding.com\/ja\/contact-us\/\">\u533b\u7642\u6a5f\u5668\u8a8d\u8a3c\u30b5\u30dd\u30fc\u30c8\u3092\u4f9d\u983c\u3059\u308b<\/a><\/p>\n<\/div>\n<p><!-- RELATED RESOURCES --><\/p>\n<section style=\"margin-bottom: 56px;\">\n<p style=\"font-size: 10.5px; font-weight: bold; letter-spacing: 2px; text-transform: uppercase; color: #075985; margin-bottom: 16px;\">\u95a2\u9023\u30ea\u30bd\u30fc\u30b9<\/p>\n<div style=\"display: flex; flex-wrap: wrap; gap: 16px;\">\n<div style=\"background: #fff; border: 1.5px solid #bae6fd; border-top: 4px solid #075985; border-radius: 8px; padding: 18px 20px;\"><span style=\"display: block; font-size: 9px; font-weight: bold; color: #f97316; letter-spacing: 1.5px; text-transform: uppercase; margin-bottom: 8px;\">\u6700\u9ad8\u7d1a\u533b\u7642\u30b0\u30ec\u30fc\u30c9<\/span><br \/>\n<span style=\"display: block; font-size: 15px; font-weight: bold; color: #1e3a8a; margin-bottom: 8px; line-height: 1.3;\">\u5c04\u51fa\u5ef6\u4f38\u30d6\u30ed\u30fc\u6210\u5f62\u6a5f HGY150-V4-EV<\/span><br \/>\n<span style=\"display: block; font-size: 13px; color: #6b7280; line-height: 1.55;\">\u5168\u96fb\u52d5EV\u30b5\u30fc\u30dc\u3001KFDA Annex 11 GMP\u30c7\u30fc\u30bf\u30ed\u30ae\u30f3\u30b0\u3001\u30af\u30e9\u30b9III PQ\u8981\u4ef6\u306eCpk \u2265 1.50\u3001\u97d3\u56fd\u533b\u7642\u6a5f\u5668IQ\/OQ\/PQ\u6587\u66f8\u30d1\u30c3\u30b1\u30fc\u30b8\u304c\u5229\u7528\u53ef\u80fd\u3002<\/span><\/div>\n<p>&nbsp;<\/p>\n<div style=\"background: #fff; border: 1.5px solid #bae6fd; border-top: 4px solid #075985; border-radius: 8px; padding: 18px 20px;\"><span style=\"display: block; font-size: 9px; font-weight: bold; color: #f97316; letter-spacing: 1.5px; text-transform: uppercase; margin-bottom: 8px;\">\u30af\u30e9\u30b9II IVD\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0<\/span><br \/>\n<span style=\"display: block; font-size: 15px; font-weight: bold; color: #1e3a8a; margin-bottom: 8px; line-height: 1.3;\">\u5c04\u51fa\u5ef6\u4f38\u30d6\u30ed\u30fc\u6210\u5f62\u6a5f HGY200-V4<\/span><br \/>\n<span style=\"display: block; font-size: 13px; color: #6b7280; line-height: 1.55;\">\u30de\u30eb\u30c1\u30ec\u30b8\u30f3PET \/ PETG \/ PP \u00b7 \u00b10.04mm\u30cd\u30c3\u30af\u5916\u5f84\u7cbe\u5ea6 \u00b7 \u97d3\u56fd\u30af\u30e9\u30b9II ISO 13485\u6e96\u62e0 \u00b7 \u653e\u5c04\u7dda\u5b89\u5b9a\u5316PET\u30b0\u30ec\u30fc\u30c9\u691c\u8a3c\u6e08\u307f \u00b7 IVD\u8a66\u85ac\u30dc\u30c8\u30eb15\uff5e500ml\u3002<\/span><\/div>\n<p>&nbsp;<\/p>\n<div style=\"background: #fff; border: 1.5px solid #bae6fd; border-top: 4px solid #075985; border-radius: 8px; padding: 18px 20px;\"><span style=\"display: block; font-size: 9px; font-weight: bold; color: #f97316; letter-spacing: 1.5px; text-transform: uppercase; margin-bottom: 8px;\">\u5927\u91cf\u533b\u7642<\/span><br \/>\n<span style=\"display: block; font-size: 15px; font-weight: bold; color: #1e3a8a; margin-bottom: 8px; line-height: 1.3;\">\u5c04\u51fa\u5ef6\u4f38\u30d6\u30ed\u30fc\u6210\u5f62\u6a5f HGY250-V4<\/span><br \/>\n<span style=\"display: block; font-size: 13px; color: #6b7280; line-height: 1.55;\">\u5927\u578bIVD\u8a66\u85ac\u30ad\u30c3\u30c8\u30dc\u30c8\u30eb\u306e\u88fd\u9020\u30fb6\u30ad\u30e3\u30d3\u30c6\u30a3\u97d3\u56fd\u30af\u30e9\u30b9II\u51fa\u529b\u30fb\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u5bfe\u5fdc\u6392\u51fa\u30b7\u30b9\u30c6\u30e0\u30fb\u5927\u578b\u8a3a\u65ad\u8a66\u85ac\u5bb9\u5668\u7528\u306e\u5e83\u53e386mm\u30cd\u30c3\u30af\u3002<\/span><\/div>\n<p>&nbsp;<\/p>\n<\/div>\n<\/section>\n<p>&nbsp;<\/p>\n<footer style=\"text-align: center; padding: 32px 0 24px; border-top: 1px solid #e5e7eb;\">\n<p style=\"font-size: 12px; color: #9ca3af; margin: 0;\">\u7de8\u96c6\u8005: Cxm<\/p>\n<\/footer>\n<\/div>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>ISBM\u306e\u9069\u7528 \u00b7 \u533b\u7642\u6a5f\u5668\u5305\u88c5 \u00b7 \u97d3\u56fdISBM 2026 ISBM\u533b\u7642\u6a5f\u5668\u30dc\u30c8\u30eb\u88fd\u9020\uff1a\u97d3\u56fd\u898f\u5236\u30ac\u30a4\u30c9 \u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u5305\u88c5\u306f\u3001\u6700\u3082\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u304c\u53b3\u3057\u3044ISBM\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u3067\u3059\u3002\u3059\u3079\u3066\u306e\u30dc\u30c8\u30eb\u306f\u3001\u751f\u4f53\u9069\u5408\u6027\u8a66\u9a13\u3001\u6ec5\u83cc\u691c\u8a3c\u3001GMP IQ\/OQ\/PQ\u57fa\u6e96\u306b\u6e96\u62e0\u3057\u305f\u5bf8\u6cd5\u9069\u683c\u6027\u8a66\u9a13\u3092\u53d7\u3051\u3001\u6587\u66f8\u5316\u3055\u308c\u305f\u30af\u30ea\u30fc\u30f3\u74b0\u5883\u3067\u88fd\u9020\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u3053\u306e\u5e02\u5834\u306b\u6b63\u3057\u304f\u53c2\u5165\u3059\u308b\u97d3\u56fdISBM\u88fd\u9020\u696d\u8005\u306f\u3001\u97d3\u56fd\u306e\u533b\u7642\u6a5f\u5668\u4f1a\u793e\u304c10\uff5e15\u5e74\u3054\u3068\u306b\u66f4\u65b0\u3059\u308b\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u8cc7\u683c\u3092\u69cb\u7bc9\u3057\u307e\u3059\u3002\u898f\u5236\u67a0\u7d44\u307f\u3092\u7406\u89e3\u305b\u305a\u306b\u53c2\u5165\u3059\u308b\u696d\u8005\u306f\u3001\u6700\u521d\u306eKFDA\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u76e3\u67fb\u306b\u4e0d\u5408\u683c\u3068\u306a\u308b\u30dc\u30c8\u30eb\u3092\u88fd\u9020\u3057\u307e\u3059\u3002 KFDA\u30af\u30e9\u30b9I\uff5eIV\u898f\u5236\u67a0\u7d44\u307f ISO 10993 \u751f\u4f53\u9069\u5408\u6027 GMP IQ \/ OQ \/ PQ\u691c\u8a3c Korean Ever-Power Engineering Desk \u00b7 Ansan-si \u00b7 May [\u2026]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[24],"tags":[],"class_list":["post-966","post","type-post","status-publish","format-standard","hentry","category-technical-deep-dive"],"_links":{"self":[{"href":"https:\/\/isbm-blow-molding.com\/ja\/wp-json\/wp\/v2\/posts\/966","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/isbm-blow-molding.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/isbm-blow-molding.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/ja\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/ja\/wp-json\/wp\/v2\/comments?post=966"}],"version-history":[{"count":1,"href":"https:\/\/isbm-blow-molding.com\/ja\/wp-json\/wp\/v2\/posts\/966\/revisions"}],"predecessor-version":[{"id":967,"href":"https:\/\/isbm-blow-molding.com\/ja\/wp-json\/wp\/v2\/posts\/966\/revisions\/967"}],"wp:attachment":[{"href":"https:\/\/isbm-blow-molding.com\/ja\/wp-json\/wp\/v2\/media?parent=966"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/ja\/wp-json\/wp\/v2\/categories?post=966"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/ja\/wp-json\/wp\/v2\/tags?post=966"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}