{"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\/zh\/isbm-medical-device-bottle-production-korean-guide\/","title":{"rendered":"ISBM\u533b\u7597\u5668\u68b0\u74f6\u751f\u4ea7\uff1a\u97e9\u56fd\u76d1\u7ba1\u6307\u53572026"},"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\u7684\u5e94\u7528\u00b7\u533b\u7597\u5668\u68b0\u5305\u88c5\u00b7\u97e9\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\u7597\u5668\u68b0\u74f6<br \/>\n\u751f\u4ea7\uff1a\u97e9\u56fd\u76d1\u7ba1\u6307\u5357<\/h1>\n<p style=\"font-size: clamp(14px,1.9vw,17px); color: #e0f2fe; line-height: 1.7; margin: 0 0 28px; max-width: 560px;\">\u97e9\u56fd\u533b\u7597\u5668\u68b0\u5305\u88c5\u662fISBM\uff08\u56fd\u9645\u6807\u51c6\u5305\u88c5\u6750\u6599\uff09\u5408\u89c4\u6027\u6700\u9ad8\u7684\u5e94\u7528\u9886\u57df\u2014\u2014\u6bcf\u4e2a\u74f6\u5b50\u90fd\u5fc5\u987b\u7ecf\u8fc7\u751f\u7269\u76f8\u5bb9\u6027\u6d4b\u8bd5\u3001\u706d\u83cc\u9a8c\u8bc1\u3001\u5c3a\u5bf8\u7b26\u5408GMP IQ\/OQ\/PQ\u6807\u51c6\uff0c\u5e76\u5728\u6709\u8bb0\u5f55\u7684\u6d01\u51c0\u73af\u5883\u4e2d\u751f\u4ea7\u3002\u6b63\u786e\u8fdb\u5165\u8be5\u5e02\u573a\u7684\u97e9\u56fdISBM\u751f\u4ea7\u5546\u4f1a\u5efa\u7acb\u4f9b\u5e94\u5546\u8d44\u8d28\uff0c\u97e9\u56fd\u533b\u7597\u5668\u68b0\u516c\u53f8\u4f1a\u5b9a\u671f\u7eed\u7b7e\u8be5\u8d44\u8d28\uff0c\u6709\u6548\u671f\u4e3a10-15\u5e74\u3002\u800c\u90a3\u4e9b\u4e0d\u4e86\u89e3\u76d1\u7ba1\u6846\u67b6\u5c31\u8fdb\u5165\u5e02\u573a\u7684\u751f\u4ea7\u5546\uff0c\u5176\u751f\u4ea7\u7684\u74f6\u5b50\u5f80\u5f80\u65e0\u6cd5\u901a\u8fc7\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08KFDA\uff09\u7684\u9996\u6b21\u4f9b\u5e94\u5546\u5ba1\u6838\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;\">\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u5b89\u5168\u90e8\uff08KFDA\uff09I-IV\u7c7b\u76d1\u7ba1\u6846\u67b6<\/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\u7269\u76f8\u5bb9\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 \u9a8c\u8bc1<\/span><\/div>\n<p style=\"font-size: 11px; color: #38bdf8; margin: 22px 0 0;\">\u97e9\u56fd\u6c38\u80fd\u5de5\u7a0b\u90e8 \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;\">\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u5b89\u5168\u90e8\uff08KFDA\uff09\u533b\u7597\u5668\u68b0\u5206\u7c7b\u2014\u2014\u5305\u88c5\u5f71\u54cd\u6982\u8ff0<\/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\u5206\u7c7b<\/th>\n<th style=\"color: #fff; padding: 9px 12px; text-align: left; font-weight: bold;\">\u97e9\u56fd\u5ba1\u6279\u9014\u5f84<\/th>\n<th style=\"color: #fff; padding: 9px 12px; text-align: left; font-weight: bold;\">\u5305\u88c5\u8981\u6c42<\/th>\n<th style=\"color: #fff; padding: 9px 12px; text-align: left; font-weight: bold;\">\u97e9\u56fdISBM\u5e94\u7528<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">\u4e00\u7ea7<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\uc2e0\uace0\uff08\u901a\u77e5\uff09<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\u57fa\u672c\u6750\u6599\u53ef\u8ffd\u6eaf\u6027 + \u5c3a\u5bf8<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\u6837\u54c1\u676f\uff0c\u4f4e\u98ce\u9669\u6807\u672c\u5bb9\u5668<\/td>\n<\/tr>\n<tr style=\"background: #f0f9ff;\">\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">\u4e8c\u7c7b<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\uc778\uc99d\uff08\u8ba4\u8bc1\uff09<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">ISO 10993 \u751f\u7269\u76f8\u5bb9\u6027 + GMP \u6587\u4ef6<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u74f6\u3001\u8bca\u65ad\u8bd5\u5242\u76d2\u3001\u6d17\u74f6<\/td>\n<\/tr>\n<tr>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600; color: #0369a1;\">\u4e09\u7ea7<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\ud5c8\u0456 (KFDA \u6279\u51c6)<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600; color: #0369a1;\">\u5b8c\u6574\u7684GMP\u9a8c\u8bc1 + \u53ef\u8403\u53d6\u7269\/\u53ef\u6d78\u51fa\u7269<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\u836f\u7269\u8f93\u9001\u7cfb\u7edf\u5bb9\u5668\uff0c\u65e0\u83cc\u5668\u68b0\u5305\u88c5<\/td>\n<\/tr>\n<tr style=\"background: #f0f9ff;\">\n<td style=\"padding: 8px 12px; font-weight: 600; color: #0369a1;\">\u56db\u7ea7<\/td>\n<td style=\"padding: 8px 12px;\">\ud5c8\u0456 (KFDA \u6279\u51c6)<\/td>\n<td style=\"padding: 8px 12px; font-weight: 600; color: #0369a1;\">\u5b8c\u6574\u7684GMP\u8981\u6c42 + \u4e34\u5e8a\u6570\u636e + \u706d\u83cc\u9a8c\u8bc1<\/td>\n<td style=\"padding: 8px 12px;\">\u690d\u5165\u7269\u7ec4\u4ef6\u5bb9\u5668\uff0c\u751f\u547d\u7ef4\u6301\u8bbe\u5907\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;\">\u5185\u5bb9<\/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. \u97e9\u56fd\u533b\u7597\u5668\u68b0\u5305\u88c5\u5e02\u573a\u53caISBM\u7684\u4f5c\u7528<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s2\">2. \u97e9\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u533b\u7597\u5668\u68b0\u6ce8\u518c\u6846\u67b6<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s3\">3. \u6750\u6599\u9009\u62e9\uff1a\u533b\u7528\u5bb9\u5668\u5e38\u7528PET\u3001PETG\u548cPP\u6750\u6599<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s4\">4. ISO 10993 \u751f\u7269\u76f8\u5bb9\u6027\u8bc4\u4ef7\u89c4\u7a0b<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s5\">5. \u706d\u83cc\u65b9\u6cd5\u517c\u5bb9\u6027<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s6\">6. \u53ef\u8403\u53d6\u7269\u548c\u53ef\u6d78\u51fa\u7269\uff1a\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (KFDA) \u7684\u671f\u671b<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s7\">7. \u97e9\u56fdISBM\u6d01\u51c0\u5ba4\u751f\u4ea7\u6807\u51c6<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s8\">8. GMP\u9a8c\u8bc1\uff1a\u97e9\u56fdISBM\u751f\u4ea7\u7ebf\u7684IQ\u3001OQ\u548cPQ<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#faq\">\u5e38\u95ee\u95ee\u9898<\/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. \u97e9\u56fd\u533b\u7597\u5668\u68b0\u5305\u88c5\u5e02\u573a\u53caISBM\u7684\u4f5c\u7528<\/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=\"\u97e9\u56fdEver-Power ISBM HGY150-V4-EV\u5168\u7535\u52a8\u4f3a\u670d\u673a\u5668\uff0c\u7528\u4e8e\u97e9\u56fd\u533b\u7597\u5668\u68b0\u74f6\u7684\u751f\u4ea7\u2014\u2014\u7535\u52a8\u4f3a\u670d\u5439\u6c14\u505c\u7559\u7cbe\u5ea6\u00b10.05\u79d2\uff0c\u8c03\u6e29\u6e29\u5ea6\u5747\u5300\u6027\u00b10.3\u00b0C\uff0c\u5e76\u53ef\u9010\u5468\u671f\u8bb0\u5f55GMP\u5de5\u827a\u6570\u636e\uff0c\u7528\u4e8e\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08KFDA\uff09II\u7c7b\u548cIII\u7c7b\u533b\u7597\u5668\u68b0\u5305\u88c5\u9a8c\u8bc1\u6587\u4ef6\u3002\" \/><figcaption style=\"font-size: 12px; color: #6b7280; margin-top: 8px; text-align: center;\">\u97e9\u56fd Ever-Power HGY150-V4-EV \u5168\u7535\u52a8 ISBM \u5e73\u53f0\uff0c\u9002\u7528\u4e8e\u97e9\u56fd\u533b\u7597\u5668\u68b0\u5305\u88c5\u2014\u2014EV \u4f3a\u670d\u7535\u673a\u7684 \u00b10.3\u00b0C \u8c03\u8282\u6e29\u5ea6\u7cbe\u5ea6\u3001\u00b10.05s \u5439\u6c14\u505c\u7559\u65f6\u95f4\u4ee5\u53ca\u9010\u5468\u671f\u8fc7\u7a0b\u8bb0\u5f55\uff0c\u6ee1\u8db3\u4e86\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (KFDA) GMP \u7684\u4e09\u9879\u8981\u6c42\uff0c\u8fd9\u4e9b\u8981\u6c42\u5c06\u533b\u7597\u5668\u68b0 ISBM \u4e0e\u836f\u54c1 ISBM \u533a\u5206\u5f00\u6765\uff1a\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u5de5\u827a\u53c2\u6570\u8303\u56f4\u3001\u5e26\u6709\u5ba1\u8ba1\u8ffd\u8e2a\u7684\u7535\u5b50\u5de5\u827a\u8bb0\u5f55\u4ee5\u53ca\u5728\u6574\u4e2a\u5668\u68b0\u6ce8\u518c\u671f\u5185\uff08\u6839\u636e\u97e9\u56fd KFDA \u7684\u300a\u533b\u7597\u5668\u68b0\u548c\u5305\u88c5\u7ba1\u7406\u6761\u4f8b\u300b\uff0c\u81ea\u751f\u4ea7\u65e5\u671f\u8d77\u81f3\u5c11 3 \u5e74\uff09\u4fdd\u7559\u751f\u4ea7\u6570\u636e\u3002<\/figcaption><\/figure>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\u97e9\u56fd\u533b\u7597\u5668\u68b0\u4ea7\u4e1a\u5728\u5168\u7403\u4ef7\u503c\u6392\u540d\u524d\u5341\uff0c\u5e76\u4ee5\u6bcf\u5e748.5%\u7684\u89c4\u6a21\u6301\u7eed\u589e\u957f\uff0c\u9884\u8ba1\u52302025\u5e74\u5c06\u8fbe\u523012.4\u4e07\u4ebf\u97e9\u5143\u3002\u8be5\u4ea7\u4e1a\u5bf9\u7528\u4e8e\u4f53\u5916\u8bca\u65ad\uff08IVD\uff09\u3001\u8bd5\u5242\u50a8\u5b58\u3001\u6837\u672c\u91c7\u96c6\u548c\u836f\u7269\u8f93\u9001\u88c5\u7f6e\u5305\u88c5\u7684\u7cbe\u5bc6\u5851\u6599\u5bb9\u5668\u6709\u7740\u5de8\u5927\u7684\u9700\u6c42\u3002\u97e9\u56fdISBM\u751f\u4ea7\u7684\u74f6\u5b50\u80fd\u591f\u6ee1\u8db3\u8fd9\u4e00\u5e02\u573a\u9700\u6c42\uff0c\u56e0\u4e3aISBM\u7684\u4e00\u6b65\u5f0f\u751f\u4ea7\u5de5\u827a\u80fd\u591f\u5236\u9020\u51fa\u5c3a\u5bf8\u7cbe\u5ea6\u9ad8\uff08\u9888\u90e8\u5916\u5f84\u00b10.04mm\uff09\u3001\u5149\u5b66\u900f\u660e\u5ea6\u597d\uff08\u96fe\u5ea6\u22642.5%\uff0c\u4fbf\u4e8e\u76ee\u6d4b\u786e\u8ba4\u704c\u88c5\u6db2\u4f4d\uff09\u4e14\u7ed3\u6784\u5b8c\u6574\u6027\u5f3a\uff08\u58c1\u539aCV%\u22648%\uff09\u7684\u5bb9\u5668\uff0c\u8fd9\u4e9b\u5bb9\u5668\u5747\u7b26\u5408\u97e9\u56fd\u533b\u7597\u5668\u68b0\u516c\u53f8\u5bf9\u8bd5\u5242\u3001\u6e05\u6d17\u6db2\u3001\u6821\u51c6\u6db2\u548c\u8bca\u65ad\u8bd5\u5242\u76d2\u7ec4\u4ef6\u7b49\u4e3b\u8981\u5bb9\u5668\u7684\u8981\u6c42\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\u5728\u97e9\u56fd\u533b\u7597\u5668\u68b0\u5bb9\u5668\u9886\u57df\uff0c\u97e9\u56fdISBM\u5728\u4e09\u4e2a\u7279\u5b9a\u5c3a\u5bf8\u548c\u51e0\u4f55\u5f62\u72b6\u7c7b\u522b\u4e2d\uff0c\u4e0e\u73bb\u7483\u548cIBM\uff08\u6ce8\u5851\u5439\u5851\uff09\u76f8\u6bd4\u5177\u6709\u663e\u8457\u4f18\u52bf\u3002\u9996\u5148\uff0c\u572830\u6beb\u5347\u81f3500\u6beb\u5347\u3001\u7a84\u9888\u81f3\u4e2d\u9888\uff0813-38\u6beb\u7c73\uff09\u7684\u74f6\u5b50\u4e2d\uff0cISBM\u5353\u8d8a\u7684\u58c1\u539a\u5747\u5300\u6027\u548c\u5149\u5b66\u900f\u660e\u5ea6\u8d85\u8d8a\u4e86IBM\uff0c\u4e14\u907f\u514d\u4e86\u73bb\u7483\u7684\u91cd\u91cf\u548c\u7834\u635f\u98ce\u9669\u3002\u5176\u6b21\uff0c\u5728\u8bd5\u5242\u76d2\u7ec4\u4ef6\u7684\u591a\u8154\u7cbe\u5bc6\u751f\u4ea7\uff082-4\u8154\uff09\u4e2d\uff0c\u5bf9\u4e8e\u8154\u95f4\u5c3a\u5bf8\u5dee\u5f02\u2264\u00b10.04\u6beb\u7c73\u7684\u74f6\u9888\u5916\u5f84\uff0cISBM\u901a\u8fc7\u4e00\u6b65\u5f0f\u9884\u6210\u578b\u74f6\u5230\u74f6\u8eab\u63a7\u5236\u6ee1\u8db3\u4e86\u8fd9\u4e00\u8981\u6c42\u3002\u7b2c\u4e09\uff0c\u5728\u900f\u660e\u8bd5\u5242\u74f6\u4e2d\uff0c\u6db2\u4f4d\u53ef\u89c1\u6027\u662f\u5b89\u5168\u529f\u80fd\u800c\u975e\u7f8e\u89c2\u8003\u91cf\u2014\u2014\u8fd9\u4e00\u8981\u6c42\u5b8c\u5168\u6392\u9664\u4e86\u4e0d\u900f\u660e\u9009\u9879\uff0c\u5e76\u8981\u6c42\u97e9\u56fdISBM\u7684\u96fe\u5ea6\u6027\u80fd\uff08\u22642.5%\uff09\u80fd\u591f\u4ece0.5\u7c73\u5916\u786e\u8ba4\u8bd5\u5242\u6db2\u4f4d\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 0;\">ISBM \u5728\u97e9\u56fd\u533b\u7597\u5668\u68b0\u5e94\u7528\u9886\u57df\u7684\u5173\u952e\u4f18\u52bf\u4e0e\u97e9\u56fd\u5236\u836f\u9886\u57df\u76f8\u540c\uff1a\u9010\u5468\u671f\u8fc7\u7a0b\u53ef\u8ffd\u6eaf\u6027\u3002\u97e9\u56fd KFDA \u533b\u7597\u5668\u68b0 GMP\uff08\uc758\ub8cc\uae30\uae30\uc758 \uc81c\uc870 \ubc0f \ud488\uc9c8\uad00\ub9ac \uae30\uc900\uff0c\u76f8\u5f53\u4e8e ISO 13485\uff09\u8981\u6c42\u5bf9\u6bcf\u4e2a\u751f\u4ea7\u6279\u6b21\u7684\u521d\u7ea7\u5bb9\u5668\u5236\u9020\u8fc7\u7a0b\u6761\u4ef6\u8fdb\u884c\u8bb0\u5f55\u3002\u97e9\u56fd\u7535\u52a8\u6c7d\u8f66\u4f3a\u670d ISBM \u5e73\u53f0 <a style=\"color: #0369a1; font-weight: 600; text-decoration: none;\" href=\"https:\/\/isbm-blow-molding.com\/zh\/product-category\/4-station-isbm-machine\/\">\u97e9\u56fd\u6c38\u529b4\u7ad9ISBM\u673a\u7cfb\u5217<\/a> \u81ea\u52a8\u751f\u6210\u8fd9\u4e9b\u6570\u636e\u2014\u2014\u4f7f\u97e9\u56fd\u533b\u7597\u5668\u68b0\u5305\u88c5\u7684 GMP \u6587\u4ef6\u7f16\u5236\u5de5\u4f5c\u6210\u4e3a\u4e00\u9879\u6570\u636e\u7ba1\u7406\u4efb\u52a1\uff0c\u800c\u4e0d\u662f\u4e00\u9879\u4eba\u5de5\u68c0\u67e5\u4efb\u52a1\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. \u97e9\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08KFDA\uff09\u533b\u7597\u5668\u68b0\u6ce8\u518c\u6846\u67b6\uff1a\u97e9\u56fdISBM\u5305\u88c5\u751f\u4ea7\u5546\u987b\u77e5<\/h2>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u5b89\u5168\u90e8 (KFDA) \u6839\u636e\u300a\u533b\u7597\u5668\u68b0\u6cd5\u300b\u5c06\u533b\u7597\u5668\u68b0\u6309\u98ce\u9669\u7b49\u7ea7\u5206\u4e3a\u56db\u7c7b\u3002\u8be5\u5206\u7c7b\u51b3\u5b9a\u4e86\u5ba1\u6279\u6d41\u7a0b\uff0c\u5e76\u4e14\u5bf9\u4e8e\u5305\u88c5\u751f\u4ea7\u5546\u800c\u8a00\u81f3\u5173\u91cd\u8981\u7684\u662f\uff0c\u5b83\u51b3\u5b9a\u4e86\u6240\u9700\u751f\u4ea7\u6587\u6863\u548c\u9a8c\u8bc1\u7684\u8be6\u7ec6\u7a0b\u5ea6\u3002\u97e9\u56fd\u7684ISBM\u5305\u88c5\u751f\u4ea7\u5546\u5fc5\u987b\u4e86\u89e3\u5176\u5ba2\u6237\u7684\u5668\u68b0\u5c5e\u4e8e\u54ea\u4e00\u7c7b\u2014\u2014\u56e0\u4e3a\u5305\u88c5\u751f\u4ea7\u5546\u7684GMP\u4e49\u52a1\u53d6\u51b3\u4e8e\u5668\u68b0\u7684\u7c7b\u522b\uff0c\u800c\u4e0d\u662f\u5305\u88c5\u751f\u4ea7\u5546\u81ea\u8eab\u7684\u5206\u7c7b\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\u97e9\u56fdI\u7c7b\u533b\u7597\u5668\u68b0\uff08\uc2e0\uace0\ud488\ubaa9\uff09\u6db5\u76d6\u4f4e\u98ce\u9669\u5668\u68b0\u53ca\u914d\u4ef6\uff0c\u5305\u62ec\u901a\u7528\u6837\u672c\u91c7\u96c6\u5bb9\u5668\u3001I\u7c7b\u6807\u672c\u676f\u4ee5\u53ca\u975e\u65e0\u83cc\u975e\u63a5\u89e6\u5f0f\u914d\u4ef6\u7684\u5305\u88c5\u3002\u97e9\u56fdI\u7c7b\u533b\u7597\u5668\u68b0\u5305\u88c5\u5bb9\u5668\uff08ISBM\uff09\u4ec5\u9700\u63d0\u4f9b\u57fa\u672c\u7684\u6750\u6599\u6807\u8bc6\uff08\u6811\u8102\u7b49\u7ea7\u3001\u8272\u6bcd\u7c92\u6279\u53f7\uff09\u3001\u5c3a\u5bf8\u8bb0\u5f55\uff08\u74f6\u9888\u5916\u5f84\u3001\u74f6\u8eab\u9ad8\u5ea6\u3001\u91cd\u91cf\uff09\u4ee5\u53ca\u98df\u54c1\u63a5\u89e6\u9633\u6027\u6e05\u5355\u786e\u8ba4\u3002\u5df2\u7b26\u5408\u97e9\u56fd\u98df\u54c1\u63a5\u89e6\u5305\u88c5\u6807\u51c6\u7684\u97e9\u56fdISBM\u751f\u4ea7\u5546\u53ea\u9700\u6295\u5165\u6781\u5c11\u7684\u989d\u5916\u6587\u4ef6\u6210\u672c\u5373\u53ef\u4f9b\u5e94I\u7c7b\u533b\u7597\u5668\u68b0\u5305\u88c5\u5bb9\u5668\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\u97e9\u56fdII\u7c7b\u533b\u7597\u5668\u68b0\uff08\uc778\uc99d\ud488\ubaa9\uff09\u6db5\u76d6\u4e2d\u7b49\u98ce\u9669\u7684\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u5bb9\u5668\u3001\u8bca\u65ad\u8bd5\u5242\u76d2\u7ec4\u4ef6\u3001\u6e05\u6d17\u6db2\u74f6\u548c\u4e34\u5e8a\u6807\u672c\u50a8\u5b58\u5bb9\u5668\u3002\u97e9\u56fdII\u7c7b\u533b\u7597\u5668\u68b0\u5305\u88c5\u7684ISBM\u8ba4\u8bc1\u8981\u6c42\u7b26\u5408ISO 10993\u751f\u7269\u76f8\u5bb9\u6027\u8bc4\u4f30\u6807\u51c6\uff08\u6700\u4f4e\u7ec6\u80de\u6bd2\u6027\u8981\u6c42\uff09\u3001\u6750\u6599\u53ef\u8ffd\u6eaf\u81f3\u7279\u5b9a\u6279\u6b21\u548c\u7b49\u7ea7\u3001\u6bcf\u4e2a\u8154\u4f53\u7684\u5c3a\u5bf8\u5408\u683c\u8bc1\u4e66\u4ee5\u53caGMP\u6279\u6b21\u8bb0\u5f55\u4fdd\u5b58\u8981\u6c42\u3002\u8d1f\u8d23\u8ba4\u8bc1\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u7684\u97e9\u56fd\u516c\u544a\u673a\u6784\uff08\uc778\uc99d\uae30\uad00\uff09\u4f1a\u5728\u533b\u7597\u5668\u68b0\u8ba4\u8bc1\u5ba1\u6838\u8fc7\u7a0b\u4e2d\u5ba1\u67e5\u5305\u88c5\u5236\u9020\u5546\u7684\u8d28\u91cf\u6587\u4ef6\u2014\u2014\u56e0\u6b64\uff0c\u5305\u88c5GMP\u6587\u4ef6\u662f\u533b\u7597\u5668\u68b0\u5ba2\u6237\u83b7\u5f97\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08KFDA\uff09\u8ba4\u8bc1\u7684\u76f4\u63a5\u524d\u63d0\u6761\u4ef6\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 0;\">\u97e9\u56fdIII\u7c7b\u548cIV\u7c7b\u533b\u7597\u5668\u68b0\uff08\u5305\u62ec\u836f\u7269\u8f93\u9001\u7cfb\u7edf\u3001\u65e0\u83cc\u5668\u68b0\u63a5\u89e6\u9762\u548c\u751f\u547d\u7ef4\u6301\u5668\u68b0\u5305\u88c5\uff09\u9700\u8981\u6700\u5168\u9762\u7684\u97e9\u56fdISBM\u751f\u4ea7\u9a8c\u8bc1\uff1a\u5b8c\u6574\u7684ISO 10993\u751f\u7269\u76f8\u5bb9\u6027\u7cfb\u5217\u6d4b\u8bd5\uff08\u901a\u5e38\u5305\u62ecISO 10993-5\u7ec6\u80de\u6bd2\u6027\u3001ISO 10993-10\u81f4\u654f\u6027\u548cISO 10993-12\u6837\u54c1\u5236\u5907\uff09\u3001\u53ef\u8403\u53d6\u7269\u548c\u53ef\u6d78\u51fa\u7269\uff08E&amp;L\uff09\u7814\u7a76\u3001GMP IQ\/OQ\/PQ\u9a8c\u8bc1\u3001\u706d\u83cc\u9a8c\u8bc1\uff08\u5982\u679c\u5bb9\u5668\u5728\u704c\u88c5\u540e\u8fdb\u884c\u706d\u83cc\uff09\u4ee5\u53ca\u5728\u5668\u68b0\u7684\u6279\u51c6\uff08\ud5c8\uac00\uff09\u6587\u4ef6\u4e2d\u8fdb\u884cKFDA\u4e3b\u5bb9\u5668\u6ce8\u518c\u3002\u8fdb\u5165III\u7c7b\/IV\u7c7b\u533b\u7597\u5668\u68b0\u4f9b\u5e94\u5e02\u573a\u7684\u97e9\u56fdISBM\u751f\u4ea7\u5546\u5fc5\u987b\u8ba1\u52126-12\u4e2a\u6708\u7684\u8d44\u8d28\u8ba4\u8bc1\u5468\u671f\uff0c\u5e76\u5728\u9996\u6b21\u5546\u4e1a\u4ea4\u4ed8\u524d\u6295\u5165250\u200b\u200b0\u4e07\u81f35500\u4e07\u97e9\u5143\u7684\u9a8c\u8bc1\u8d44\u91d1\u3002<\/p>\n<\/section>\n<p><!-- S3 --><\/p>\n<section id=\"s3\" 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;\">3. \u6750\u6599\u9009\u62e9\uff1a\u97e9\u56fd\u533b\u7597\u5668\u68b0\u5bb9\u5668\u5e38\u7528\u7684PET\u3001PETG\u548cPP\u6750\u6599<\/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=\"\u97e9\u56fdISBM\u533b\u7597\u5668\u68b0PET\u74f6\u2014\u2014\u900f\u660ePET II\u7c7b\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u74f6\uff0c\u74f6\u9888\u5916\u5f84\u516c\u5dee\u4e3a\u00b10.04mm\uff0c\u9002\u7528\u4e8e\u97e9\u56fd\u8bca\u65ad\u8bd5\u5242\u76d2\u7684\u4e8c\u6b21\u5305\u88c5\uff0c\u74f6\u8eab\u6676\u83b9\u5254\u900f\uff0c\u4fbf\u4e8e\u76ee\u6d4b\u786e\u8ba4\u704c\u88c5\u6db2\u4f4d\uff0c\u74f6\u9888\u87ba\u7eb9\u8f6e\u5ed3\u4e00\u81f4\uff0c\u786e\u4fdd\u74f6\u76d6\u62e7\u7d27\u626d\u77e9\u517c\u5bb9\u3002\" \/><figcaption style=\"font-size: 12px; color: #6b7280; margin-top: 8px; text-align: center;\">\u97e9\u56fdISBM\u533b\u7597\u5668\u68b0PET\u74f6\u2014\u2014\u7528\u4e8eII\u7c7b\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u50a8\u5b58\uff0c\u91c7\u7528\u900f\u660ePET\u6750\u8d28\uff08\u96fe\u5ea6\u22642.0%\uff09\uff0c\u74f6\u9888\u5916\u5f84\u7b26\u5408\u00b10.04mm\u6807\u51c6\u3002\u97e9\u56fd\u8bca\u65ad\u884c\u4e1a\u7684\u6807\u51c6\u74f6\u9888\u89c4\u683c\u4e3a\uff1a15-100ml\u8bd5\u5242\u74f6\u91c7\u7528GPI 24\/415\uff0c100-500ml\u8bd5\u5242\u74f6\u91c7\u7528GPI 28\/415\u2014\u2014\u8fd9\u4f7f\u5f97\u6765\u81ea\u540c\u4e00\u5bb6\u5408\u683c\u97e9\u56fdISBM\u4f9b\u5e94\u5546\u7684\u8bd5\u5242\u74f6\uff0c\u80fd\u591f\u6ee1\u8db3\u591a\u5bb6\u97e9\u56fd\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u751f\u4ea7\u5546\u8bd5\u5242\u76d2\u7ec4\u4ef6\u74f6\u7684\u6807\u51c6\u5316\u97e9\u56fd\u5361\u6263\u76d6\u548c\u87ba\u65cb\u76d6\u8ba4\u8bc1\u8981\u6c42\u3002<\/figcaption><\/figure>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\u97e9\u56fdISBM\u533b\u7597\u5668\u68b0\u5bb9\u5668\u7684\u6750\u6599\u9009\u62e9\u4e3b\u8981\u53d7\u4e09\u4e2a\u56e0\u7d20\u9a71\u52a8\uff1a\u4e0e\u7279\u5b9a\u8bd5\u5242\u6216\u5668\u68b0\u5185\u5bb9\u7269\u7684\u5316\u5b66\u76f8\u5bb9\u6027\u3001\u706d\u83cc\u65b9\u6cd5\u7684\u517c\u5bb9\u6027\u4ee5\u53ca\u6cd5\u89c4\u9075\u4ece\u6027\u3002\u4e0e\u97e9\u56fdK-Beauty\u4ea7\u54c1\u4e2dPETG\u4f5c\u4e3a\u7f8e\u5bb9\u4ea7\u54c1\u7684\u9996\u9009\u6750\u6599\u4e0d\u540c\uff0c\u97e9\u56fd\u533b\u7597\u5668\u68b0\u5e94\u7528\u5728\u9009\u62e9\u6750\u6599\u524d\u9700\u8981\u8fdb\u884c\u7ec6\u81f4\u7684\u6750\u6599\u5206\u6790\u2014\u2014PETG\u3001PET\u548cPP\u5404\u6709\u5176\u4f18\u52bf\u548c\u5c40\u9650\u6027\uff0c\u51b3\u5b9a\u4e86\u5b83\u4eec\u5bf9\u4e0d\u540c\u5668\u68b0\u7c7b\u522b\u7684\u9002\u7528\u6027\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\"><strong>\u7528\u4e8e\u97e9\u56fd\u533b\u7597\u5668\u68b0\u7684PET\uff1a<\/strong> PET\uff08\u805a\u5bf9\u82ef\u4e8c\u7532\u9178\u4e59\u4e8c\u9187\u916f\uff09\u662f\u97e9\u56fd\u6700\u5e7f\u6cdb\u4f7f\u7528\u7684ISBM\u6750\u6599\uff0c\u7528\u4e8eI\u7c7b\u548cII\u7c7b\u533b\u7597\u5668\u68b0\u5bb9\u5668\u3002\u5176\u4f18\u70b9\u5305\u62ec\uff1a\u5728\u73af\u5883\u50a8\u5b58\u6e29\u5ea6\u4e0b\u8403\u53d6\u7269\u542b\u91cf\u4f4e\uff08\u5df2\u901a\u8fc7ISO 10993-17\u98ce\u9669\u8bc4\u4f30\u6807\u51c6\u8fdb\u884c\u5145\u5206\u8868\u5f81\uff09\u3001\u5316\u5b66\u76f8\u5bb9\u6027\u5e7f\uff08\u6db5\u76d6\u6c34\u6eb6\u6db2\u3001\u9178\u6027\u7f13\u51b2\u6db2\uff08pH 3-9\uff09\u548c\u76d0\u6eb6\u6db2\uff0c\u8fd9\u4e9b\u6eb6\u6db2\u6784\u6210\u4e86\u97e9\u56fd\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u57fa\u8d28\u7684\u5927\u591a\u6570\uff09\uff0c\u4ee5\u53ca\u5728\u97e9\u56fdKFDA\u7533\u62a5\u4e2d\u826f\u597d\u7684\u5408\u89c4\u8bb0\u5f55\u3002\u5176\u7f3a\u70b9\u5305\u62ec\uff1aPET\u572865-70\u00b0C\u4ee5\u4e0a\u4f1a\u53d1\u751f\u5f62\u53d8\uff08\u4e0e\u4f3d\u9a6c\u5c04\u7ebf\u706d\u83cc\u7684\u70ed\u8d1f\u8377\u76f8\u5173\u2014\u2014\u901a\u5e38\u60c5\u51b5\u4e0b\uff0c\u7531\u4e8ePET\u5728\u5ba4\u6e29\u4e0b\u5373\u53ef\u901a\u8fc7\u4f3d\u9a6c\u5c04\u7ebf\u6216\u73af\u6c27\u4e59\u70f7\u706d\u83cc\uff0c\u56e0\u6b64\u65e0\u9700\u62c5\u5fc3\uff09\uff1bPET\u4f1a\u5438\u6536\u6ce2\u957f\u4f4e\u4e8e340nm\u7684\u7d2b\u5916\u7ebf\uff08\u4e0e\u7d2b\u5916\u7ebf\u654f\u611f\u8bd5\u5242\u76f8\u5173\u2014\u2014\u5bf9\u4e8e\u5149\u654f\u8bca\u65ad\u5236\u5242\uff0c\u5e94\u6307\u5b9a\u7d2b\u5916\u7ebf\u7a33\u5b9a\u7684PET\u7b49\u7ea7\uff09\uff1bPET\u4e0d\u5e94\u7528\u4e8e\u6709\u673a\u6eb6\u5242\u542b\u91cf\u8d85\u8fc710%\u7684\u8bd5\u5242\uff08\u5b58\u5728\u5e94\u529b\u5f00\u88c2\u98ce\u9669\uff09\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\"><strong>\u7528\u4e8e\u97e9\u56fd\u533b\u7597\u5668\u68b0\u7684PETG\uff1a<\/strong> \u5bf9\u4e8e\u9700\u8981\u6676\u83b9\u5254\u900f\uff08\u96fe\u5ea6\u22641.5%\uff09\u4ee5\u8fdb\u884c\u6bd4\u8272\u5206\u6790\u76ee\u6d4b\u5224\u8bfb\u7684\u97e9\u56fdII\u7c7b\u8bca\u65ad\u8bd5\u5242\u76d2\u7ec4\u4ef6\uff0c\u4ee5\u53ca\u9700\u8981\u6613\u6298\u65ad\u6216\u523b\u75d5\u7684\u97e9\u56fd\u4f53\u5916\u8bca\u65ad\uff08IVD\uff09\u5bb9\u5668\uff08PET\u521a\u6027\u8f83\u9ad8\uff0c\u96be\u4ee5\u5b9e\u73b0\uff09\uff0cPETG\uff08\u805a\u5bf9\u82ef\u4e8c\u7532\u9178\u4e59\u4e8c\u9187\u916f\uff09\u662f\u9996\u9009\u6750\u6599\u3002PETG\u5bf9\u67d0\u4e9b\u6709\u673a\u6eb6\u5242\uff08\u4e59\u9187\u6d53\u5ea6\u9ad8\u4e8e40%\u3001\u4e19\u916e\u3001\u7532\u57fa\u4e59\u57fa\u916e\uff09\u7684\u8010\u5316\u5b66\u6027\u8f83\u5dee\uff0c\u9650\u5236\u4e86\u5176\u5728\u97e9\u56fd\u5b9e\u9a8c\u5ba4\u6e05\u6d17\u6db2\u548c\u542b\u6eb6\u5242\u8bd5\u5242\u4e2d\u7684\u5e94\u7528\u2014\u2014\u5bf9\u4e8e\u4efb\u4f55\u6709\u673a\u6eb6\u5242\u6d53\u5ea6\u9ad8\u4e8e30%\u7684\u97e9\u56fd\u533b\u7597\u5668\u68b0\u8bd5\u5242\uff0c\u5728\u6307\u5b9a\u4f7f\u7528PETG\u4e4b\u524d\uff0c\u52a1\u5fc5\u9a8c\u8bc1\u5176\u517c\u5bb9\u6027\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 0;\"><strong>\u97e9\u56fd\u533b\u7597\u5668\u68b0\u7684PP\uff1a<\/strong> \u5bf9\u4e8e\u5fc5\u987b\u627f\u53d7\u84b8\u6c7d\u9ad8\u538b\u706d\u83cc\uff08121\u00b0C\uff0c20\u5206\u949f\uff09\u7684\u97e9\u56fd\u533b\u7597\u5668\u68b0\u5bb9\u5668\u800c\u8a00\uff0c\u805a\u4e19\u70ef\u662f\u5408\u9002\u7684\u6750\u6599\u9009\u62e9\u2014\u2014PET\u548cPETG\u65e0\u6cd5\u627f\u53d7\u9ad8\u538b\u706d\u83cc\u6e29\u5ea6\u3002\u7528\u4e8e\u97e9\u56fd\u9ad8\u538b\u706d\u83cc\u533b\u7597\u5668\u68b0\u5bb9\u5668\u7684PP ISBM\u9700\u8981\u5177\u5907PP\u70ed\u704c\u88c5ISBM\u80fd\u529b\uff08120-145\u00b0C\u7684\u9884\u5904\u7406\u6e29\u5ea6\uff0c\u52a0\u70ed\u6a21\u5ea7\u5d4c\u4ef6\uff09\u2014\u2014\u4e0ePET ISBM\u76f8\u6bd4\uff0c\u8be5\u5de5\u827a\u6280\u672f\u8981\u6c42\u66f4\u9ad8\uff0c\u5e94\u7528\u8303\u56f4\u4e5f\u66f4\u7a84\u3002\u62a5\u4ef7PP\u533b\u7597\u5668\u68b0\u5bb9\u5668\u7684\u97e9\u56fdISBM\u751f\u4ea7\u5546\u5728\u63a5\u53d7\u5408\u540c\u524d\uff0c\u5e94\u786e\u8ba4\u5176\u673a\u5668\u9884\u5904\u7406\u5de5\u4f4d\u7684\u6700\u9ad8\u6e29\u5ea6\u3002PETG\u5728\u6bd4\u8272\u5e94\u7528\u4e2d\u6240\u9700\u7684\u5149\u5b66\u900f\u660e\u5ea6\u8981\u6c42\uff0c\u8be6\u89c1\u5b8c\u6574\u6307\u5357\u3002 <a style=\"color: #0369a1; font-weight: 600; text-decoration: none;\" href=\"https:\/\/isbm-blow-molding.com\/zh\/how-to-improve-transparency-isbm-injection-stretch-blow-molding\/\">\u97e9\u56fdISBM\u900f\u660e\u5ea6\u63d0\u5347<\/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\u7269\u76f8\u5bb9\u6027\u8bc4\u4ef7\uff1a\u97e9\u56fdISBM\u751f\u4ea7\u5546\u5fc5\u987b\u63d0\u4f9b\u7684\u5185\u5bb9<\/h2>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">ISO 10993-1:2018\uff08\u533b\u7597\u5668\u68b0\u751f\u7269\u5b66\u8bc4\u4ef7\u2014\u2014\u7b2c1\u90e8\u5206\uff1a\u98ce\u9669\u7ba1\u7406\u8fc7\u7a0b\u4e2d\u7684\u8bc4\u4ef7\u548c\u6d4b\u8bd5\uff09\u662f\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08KFDA\uff09\u7528\u4e8e\u6240\u6709\u97e9\u56fd\u533b\u7597\u5668\u68b0\u521d\u7ea7\u5305\u88c5\u7684\u751f\u7269\u76f8\u5bb9\u6027\u8bc4\u4f30\u56fd\u9645\u6807\u51c6\u3002ISO 10993\u5e76\u672a\u89c4\u5b9a\u56fa\u5b9a\u7684\u6d4b\u8bd5\u9879\u76ee\uff0c\u800c\u662f\u91c7\u7528\u4e86\u4e00\u79cd\u57fa\u4e8e\u98ce\u9669\u7684\u8bc4\u4f30\u65b9\u6cd5\uff0c\u6839\u636e\u5668\u68b0\u4e0e\u4eba\u4f53\u63a5\u89e6\u7684\u6027\u8d28\uff08\u8868\u9762\u63a5\u89e6\u3001\u7834\u635f\u8868\u9762\u3001\u8840\u6db2\u63a5\u89e6\uff09\u548c\u6301\u7eed\u65f6\u95f4\uff08\u6709\u9650\u3001\u957f\u671f\u3001\u6c38\u4e45\u6027\uff09\u6765\u9009\u62e9\u6d4b\u8bd5\u9879\u76ee\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\u5bf9\u4e8e\u97e9\u56fdISBM\u8bd5\u5242\u74f6\uff08II\u7c7b\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\uff0c\u4e0e\u60a3\u8005\u95f4\u63a5\u63a5\u89e6\u2014\u2014\u8bd5\u5242\u4e0e\u4eea\u5668\u63a5\u89e6\uff0c\u800c\u975e\u4e0e\u60a3\u8005\u63a5\u89e6\uff09\uff1a\u751f\u7269\u76f8\u5bb9\u6027\u8bc4\u4f30\u901a\u5e38\u4ec5\u9650\u4e8eISO 10993-5\uff08\u7ec6\u80de\u6bd2\u6027\uff09\u548cISO 10993-12\uff08\u751f\u7269\u5b66\u8bc4\u4f30\u7684\u6837\u54c1\u5236\u5907\uff09\u3002\u8fd9\u4e24\u9879\u6d4b\u8bd5\u786e\u8ba4PET\u6216PETG\u6750\u6599\u4e0d\u4f1a\u91ca\u653e\u4e0e\u60a3\u8005\u95f4\u63a5\u63a5\u89e6\u76f8\u5173\u7684\u7ec6\u80de\u6bd2\u6027\u7269\u8d28\uff0c\u5e76\u4e14\u7528\u4e8e\u4efb\u4f55\u540e\u7eed\u6d4b\u8bd5\u7684\u6837\u54c1\u5236\u5907\u65b9\u6848\u5747\u5df2\u9a8c\u8bc1\u3002\u97e9\u56fdISBM II\u7c7b\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u74f6\u7684\u603b\u6d4b\u8bd5\u8d39\u7528\uff1a\u5728\u97e9\u56fd\u68c0\u6d4b\u5b9e\u9a8c\u5ba4\uff08\u97e9\u56fd\u68c0\u6d4b\u7814\u7a76\u9662\u2014KTR\u6216\u97e9\u56fd\u5408\u683c\u8bc4\u5b9a\u5b9e\u9a8c\u5ba4\u2014KCL\uff09\u4e3a400\u4e07\u81f3800\u4e07\u97e9\u5143\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\u5bf9\u4e8e\u97e9\u56fdIII\u7c7b\u533b\u7597\u5668\u68b0\u5305\u88c5\u5bb9\u5668\uff08\u76f4\u63a5\u63a5\u89e6\u60a3\u8005\u76ae\u80a4\u6216\u9ecf\u819c\uff09\uff1a\u5b8c\u6574\u7684ISO 10993\u8bc4\u4f30\u53ef\u80fd\u5305\u62ec\u7ec6\u80de\u6bd2\u6027\uff08ISO 10993-5\uff09\u3001\u81f4\u654f\u6027\uff08ISO 10993-10\uff09\u3001\u523a\u6fc0\u6027\uff08ISO 10993-23\uff09\u3001\u6025\u6027\u5168\u8eab\u6bd2\u6027\uff08ISO 10993-11\uff09\u548c\u4e9a\u6162\u6027\u6bd2\u6027\uff08ISO 10993-11\u2014\u201490\u5929\u7814\u7a76\uff09\u3002\u603b\u6d4b\u8bd5\u8d39\u7528\uff1a2500\u4e07\u81f36500\u4e07\u97e9\u5143\uff0c\u8017\u65f66\u81f39\u4e2a\u6708\u3002\u4e3aIII\u7c7b\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u4f9b\u8d27\u7684\u97e9\u56fdISBM\u5305\u88c5\u751f\u4ea7\u5546\u5e94\u5728\u6a21\u5177\u8ba4\u8bc1\u9636\u6bb5\u5c31\u5b89\u6392\u6b64\u9879\u8bc4\u4f30\uff0c\u800c\u4e0d\u662f\u5728\u5408\u540c\u7b7e\u8ba2\u65f6\uff0c\u56e0\u4e3a\u6b64\u65f6\u5ba2\u6237\u5df2\u7ecf\u786e\u5b9a\u4e86\u5305\u88c5\u89c4\u683c\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 0;\">\u97e9\u56fdISBM\u751f\u7269\u76f8\u5bb9\u6027\u8bc4\u4f30\u6587\u4ef6\u8981\u6c42\uff1a\u6bcf\u4efdISO 10993\u6d4b\u8bd5\u62a5\u544a\u5fc5\u987b\u660e\u786e\u6807\u660e\u5177\u4f53\u7684\u6811\u8102\u7b49\u7ea7\uff08\u5236\u9020\u5546\u3001\u7b49\u7ea7\u540d\u79f0\u3001\u6279\u53f7\uff09\u3001\u7528\u4e8e\u751f\u4ea7\u6d4b\u8bd5\u6837\u54c1\u7684ISBM\u5de5\u827a\u6761\u4ef6\uff08\u8c03\u8282\u6e29\u5ea6\u3001\u5439\u538b\u3001\u5faa\u73af\u65f6\u95f4\u2014\u2014\u56e0\u4e3a\u5de5\u827a\u6761\u4ef6\u4f1a\u5f71\u54cd\u8403\u53d6\u7269\u542b\u91cf\uff09\u4ee5\u53ca\u6d4b\u8bd5\u5b9e\u9a8c\u5ba4\u7684KFDA\u8ba4\u53ef\u72b6\u6001\u3002\u5982\u679c\u751f\u7269\u76f8\u5bb9\u6027\u6d4b\u8bd5\u6240\u7528\u7684\u6837\u54c1\u4e0e\u751f\u4ea7\u6837\u54c1\u7684\u5de5\u827a\u6761\u4ef6\u4e0d\u540c\uff0c\u5219\u8be5\u6d4b\u8bd5\u7ed3\u679c\u4e0d\u9002\u7528\u4e8e\u97e9\u56fdKFDA III\u7c7b\u8ba4\u8bc1\u7533\u8bf7\u2014\u2014\u8fd9\u4e00\u6280\u672f\u7ec6\u8282\u65e8\u5728\u8bc6\u522b\u90a3\u4e9b\u4f7f\u7528\u5728\u975e\u6807\u51c6\u6761\u4ef6\u4e0b\u751f\u4ea7\u7684\u5b9e\u9a8c\u5ba4\u6837\u54c1\u8fdb\u884c\u751f\u7269\u76f8\u5bb9\u6027\u6d4b\u8bd5\uff0c\u7136\u540e\u5728\u5546\u4e1a\u5316\u751f\u4ea7\u9a8c\u8bc1\u8fc7\u7a0b\u4e2d\u66f4\u6539\u5de5\u827a\u6761\u4ef6\u7684\u97e9\u56fdISBM\u751f\u4ea7\u5546\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. \u706d\u83cc\u65b9\u6cd5\u517c\u5bb9\u6027\uff1a\u97e9\u56fdISBM\u74f6\u7684\u9009\u62e9\u548c\u9650\u5236<\/h2>\n<p style=\"font-size: 16px; margin-bottom: 20px;\">\u97e9\u56fd\u533b\u7597\u5668\u68b0\u5bb9\u5668\u7684\u706d\u83cc\u65b9\u5f0f\u6709\u4e24\u79cd\uff1a\u4e00\u79cd\u662f\u5728\u5305\u88c5\u751f\u4ea7\u5546\u5904\u8fdb\u884c\uff08ISBM\u74f6\u8f83\u5c11\u89c1\uff09\uff0c\u53e6\u4e00\u79cd\u662f\u5728\u97e9\u56fd\u533b\u7597\u5668\u68b0\u516c\u53f8\u7684\u704c\u88c5\u5382\u8fdb\u884c\uff08\u8f83\u5e38\u89c1\uff09\u3002\u97e9\u56fdISBM\u5305\u88c5\u751f\u4ea7\u5546\u5fc5\u987b\u4e86\u89e3\u97e9\u56fd\u533b\u7597\u5668\u68b0\u5ba2\u6237\u5c06\u91c7\u7528\u7684\u706d\u83cc\u65b9\u6cd5\uff0c\u56e0\u4e3a\u4e0d\u540c\u706d\u83cc\u6761\u4ef6\u4e0b\u6750\u6599\u7684\u76f8\u5bb9\u6027\u3001\u5c3a\u5bf8\u7a33\u5b9a\u6027\u548c\u5149\u5b66\u6027\u80fd\u4fdd\u6301\u60c5\u51b5\u5dee\u5f02\u5f88\u5927\uff0c\u8fd9\u4e9b\u56e0\u7d20\u51b3\u5b9a\u4e86\u54ea\u4e9b\u97e9\u56fdISBM\u6750\u6599\u5728\u6280\u672f\u4e0a\u662f\u53ef\u63a5\u53d7\u7684\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;\">\u706d\u83cc\u65b9\u6cd5<\/th>\n<th style=\"color: #fff; padding: 9px 12px; text-align: center; font-weight: bold;\">\u5ba0\u7269<\/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;\">\u97e9\u56fdISBM\u7b14\u8bb0<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">\u73af\u6c27\u4e59\u70f7\uff08EO\uff09<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 \u517c\u5bb9<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 \u517c\u5bb9<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 \u517c\u5bb9<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd;\">\u73af\u6c27\u4e59\u70f7\uff08EO\uff09\u5de5\u827a\u6e29\u5ea6\u226455\u00b0C\u2014\u2014\u5bf9\u4e09\u79cd\u6750\u6599\u5747\u5b89\u5168\u3002\u53d1\u8d27\u524d\u9700\u8fdb\u884c24-48\u5c0f\u65f6\u7684EO\u6b8b\u7559\u8131\u6c14\u5904\u7406\u3002\u6839\u636eISO 10993-7\u6807\u51c6\u9a8c\u8bc1EO\u6b8b\u7559\u91cf\uff08\u8bbe\u5907\u4e2dEO\u542b\u91cf\u226410 \u03bcg\/g\uff09\u3002<\/td>\n<\/tr>\n<tr style=\"background: #f0f9ff;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">\u4f3d\u9a6c\u5c04\u7ebf\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\u6750\u6599\u5728\u5242\u91cf\u8d85\u8fc725 kGy\u65f6\u4f1a\u9010\u6e10\u6cdb\u9ec4\u2014\u2014\u5982\u679c\u5242\u91cf\u8d85\u8fc720 kGy\uff0c\u5219\u5e94\u6307\u5b9a\u4f7f\u7528\u8f90\u5c04\u7a33\u5b9a\u578bPET\u6750\u6599\uff08\u4f8b\u5982Eastman EB062\uff09\u3002PETG\u6750\u6599\u5728\u5242\u91cf\u8d85\u8fc715 kGy\u65f6\u5c31\u4f1a\u6cdb\u9ec4\uff0c\u901a\u5e38\u4e0d\u9002\u7528\u4e8e\u6807\u51c6\u768425 kGy\u4f3d\u9a6c\u5c04\u7ebf\u7167\u5c04\u3002<\/td>\n<\/tr>\n<tr>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">\u7535\u5b50\u675f<\/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;\">\u4e0e\u4f3d\u9a6c\u5c04\u7ebf\u7c7b\u4f3c\u2014\u2014\u7535\u5b50\u675f\u7684\u7a7f\u900f\u6df1\u5ea6\u6bd4\u4f3d\u9a6c\u5c04\u7ebf\u6d45\uff0c\u8fd9\u9002\u7528\u4e8e\u591a\u5c42\u5806\u53e0\u5305\u88c5\u3002\u5355\u74f6\u5305\u88c5\uff1a\u6548\u679c\u4e0e\u4f3d\u9a6c\u5c04\u7ebf\u76f8\u5f53\u3002<\/td>\n<\/tr>\n<tr style=\"background: #f0f9ff;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">\u84b8\u6c7d\u9ad8\u538b\u91dc\uff08121\u00b0C\uff09<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #dc2626; font-weight: bold;\">\u2717 \u4e0d\u517c\u5bb9<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #dc2626; font-weight: bold;\">\u2717 \u4e0d\u517c\u5bb9<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 \u517c\u5bb9<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd;\">PET \u7684\u73bb\u7483\u5316\u8f6c\u53d8\u6e29\u5ea6 (Tg) \u7ea6\u4e3a 75\u00b0C\uff0cPETG \u7684 Tg \u7ea6\u4e3a 81\u00b0C\u2014\u2014\u4e24\u8005\u5728 121\u00b0C \u65f6\u5747\u4f1a\u6025\u5267\u8f6f\u5316\u3002PP \u4ec5\u9002\u7528\u4e8e\u9ad8\u538b\u91dc\u6210\u578b\u5de5\u827a\u7684 ISBM \u6750\u6599\u3002PP ISBM \u9700\u8981\u52a0\u70ed\u6a21\u5ea7\u5d4c\u4ef6\u2014\u2014\u8bf7\u5728\u5236\u5b9a\u89c4\u683c\u524d\u4e0e\u673a\u5668\u4f9b\u5e94\u5546\u786e\u8ba4\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 \u4ec5\u9650\u8868\u9762<\/td>\n<td style=\"padding: 9px 12px; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 \u4ec5\u9650\u8868\u9762<\/td>\n<td style=\"padding: 9px 12px; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 \u4ec5\u9650\u8868\u9762<\/td>\n<td style=\"padding: 9px 12px;\">\u4ec5\u7528\u4e8e\u8868\u9762\u6d88\u6bd2\u2014\u2014\u672a\u7ecf\u97e9\u56fdIII\/IV\u7c7b\u5bb9\u5668\u9a8c\u8bc1\u7684\u706d\u83cc\u3002\u9002\u7528\u4e8e\u97e9\u56fdI\/II\u7c7b\u4f4e\u98ce\u9669\u8868\u9762\u6d88\u6bd2\u3002PET\u6750\u8d28\u80fd\u6709\u6548\u5438\u6536\u7d2b\u5916\u7ebf\u2014\u2014\u8bf7\u786e\u8ba4\u539a\u58c1\u74f6\u7684\u5185\u8868\u9762\u5242\u91cf\u8ba1\u7b97\u3002<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p style=\"font-size: 16px; margin-bottom: 0;\">\u97e9\u56fdISBM\u751f\u4ea7\u5546\u5e94\u5728\u62a5\u4ef7\u9636\u6bb5\uff0c\u5373\u5728\u786e\u5b9a\u6750\u6599\u89c4\u683c\u4e4b\u524d\uff0c\u5411\u97e9\u56fd\u533b\u7597\u5668\u68b0\u5ba2\u6237\u8be2\u95ee\u706d\u83cc\u65b9\u6cd5\u548c\u9a8c\u8bc1\u5242\u91cf\u3002\u4f8b\u5982\uff0c\u5982\u679c\u62a5\u4ef7\u4e2d\u5217\u51fa\u7684\u97e9\u56fdII\u7c7b\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u5bb9\u5668\u4e3a\u900f\u660ePETG\u6750\u8d28\uff0c\u800c\u5ba2\u6237\u91c7\u752825 kGy\u4f3d\u9a6c\u5c04\u7ebf\u706d\u83cc\uff0c\u5219\u5728\u706d\u83cc\u9a8c\u8bc1\u9636\u6bb5\uff08\u901a\u5e38\u5728\u6a21\u5177\u5236\u9020\u540e6-8\u4e2a\u6708\uff09\u4f1a\u51fa\u73b0\u6750\u6599\u4e0d\u76f8\u5bb9\u95ee\u9898\uff0c\u5c4a\u65f6\u6cdb\u9ec4\u7684PETG\u74f6\u5c06\u65e0\u6cd5\u6ee1\u8db3\u5ba2\u6237\u8f90\u7167\u540e\u7684\u900f\u660e\u5ea6\u8981\u6c42\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. \u53ef\u8403\u53d6\u7269\u548c\u53ef\u6d78\u51fa\u7269\uff1a\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (KFDA) \u5bf9 ISBM \u533b\u7528\u5bb9\u5668\u7684\u8981\u6c42<\/h2>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\u5bf9\u4e8e\u97e9\u56fdISBM III\u7c7b\u533b\u7597\u5668\u68b0\u5305\u88c5\u5bb9\u5668\u800c\u8a00\uff0c\u8403\u53d6\u7269\u548c\u6d78\u51fa\u7269\uff08E&amp;L\uff09\u5206\u6790\u662f\u6280\u672f\u8981\u6c42\u6700\u9ad8\u7684\u6587\u6863\u8981\u6c42\u3002\u8403\u53d6\u7269\u662f\u6307\u5728\u4e25\u82db\u7684\u5b9e\u9a8c\u6761\u4ef6\u4e0b\uff08\u4f8b\u5982\u9ad8\u6e29\u3001\u6eb6\u5242\u8403\u53d6\uff09\u53ef\u4ece\u5305\u88c5\u6750\u6599\u4e2d\u91ca\u653e\u51fa\u6765\u7684\u5316\u5b66\u7269\u8d28\u2014\u2014\u5b83\u4eec\u4ee3\u8868\u4e86\u5305\u88c5\u6750\u6599\u4e2d\u53ef\u80fd\u91ca\u653e\u51fa\u7684\u6700\u5927\u5316\u5b66\u7269\u8d28\u3002\u6d78\u51fa\u7269\u662f\u6307\u5728\u6b63\u5e38\u6216\u6781\u7aef\u50a8\u5b58\u6761\u4ef6\u4e0b\u5b9e\u9645\u8fc1\u79fb\u5230\u4ea7\u54c1\u4e2d\u7684\u8403\u53d6\u7269\u5b50\u96c6\u2014\u2014\u5b83\u4eec\u4ee3\u8868\u4e86\u60a3\u8005\u6216\u4f7f\u7528\u8005\u5b9e\u9645\u63a5\u89e6\u5230\u7684\u5305\u88c5\u4ea7\u54c1\u4e2d\u7684\u5316\u5b66\u7269\u8d28\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (KFDA) \u5bf9\u97e9\u56fd III \u7c7b\u533b\u7597\u5668\u68b0\u7533\u62a5\u6587\u4ef6\u4e2d\u521d\u7ea7\u5bb9\u5668 ISBM \u5305\u88c5\u7684 E&amp;L \u8981\u6c42\u7b26\u5408 ISO 10993-18:2020 \u6846\u67b6\uff08\u6750\u6599\u5316\u5b66\u8868\u5f81\uff09\u548c PQRI\uff08\u4ea7\u54c1\u8d28\u91cf\u7814\u7a76\u9662\uff092006 \u5e74\u5173\u4e8e\u53ef\u6d78\u51fa\u7269\u548c\u53ef\u8403\u53d6\u7269\u7684\u6307\u5357\uff08\u97e9\u56fd KFDA \u5728\u5176\u533b\u7597\u5668\u68b0\u7533\u62a5\u6307\u5357\u4e2d\u5f15\u7528\u7684\u884c\u4e1a\u53c2\u8003\u6807\u51c6\uff09\u3002\u97e9\u56fd ISBM \u751f\u4ea7\u5546\u5fc5\u987b\u4e86\u89e3\u7684\u5173\u952e\u5206\u6790\u9608\u503c\uff1a<\/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>\u97e9\u56fd III \u7c7b IVD \u7684\u5206\u6790\u8bc4\u4f30\u9608\u503c (AET)\uff1a<\/strong> \u6bcf\u65e5\u6444\u5165\u91cf\u8d85\u8fc7 0.1 \u03bcg \u7684\u4efb\u4f55\u65e0\u6cd5\u8bc6\u522b\u7684\u5316\u5408\u7269\u2014\u2014\u5728\u6a21\u62df\u4f7f\u7528\u63d0\u53d6\u8fc7\u7a0b\u4e2d\uff0c\u4efb\u4f55\u6d53\u5ea6\u9ad8\u4e8e\u6b64\u503c\u7684\u53ef\u63d0\u53d6\u5316\u5408\u7269\u90fd\u5fc5\u987b\u7ecf\u8fc7\u5206\u6790\u9274\u5b9a\uff0c\u5e76\u7531\u6bd2\u7406\u5b66\u5bb6\u8fdb\u884c\u5b89\u5168\u6027\u8bc4\u4f30\u3002\u5bf9\u4e8e\u97e9\u56fd\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u74f6\uff08\u95f4\u63a5\u63a5\u89e6\u60a3\u8005\uff09\uff0c\u5176\u5206\u6790\u66b4\u9732\u65f6\u95f4 (AET) \u901a\u5e38\u57fa\u4e8e\u8bd5\u5242\u7684\u6bcf\u65e5\u6700\u5927\u60a3\u8005\u5242\u91cf\u8ba1\u7b97\uff0c\u800c\u975e\u76f4\u63a5\u6444\u5165\u91cf\u2014\u2014\u56e0\u6b64\u5176 AET \u503c\u9ad8\u4e8e\u53e3\u670d\u836f\u7269\u5bb9\u5668 E&amp;L\u3002<\/li>\n<li style=\"font-size: 15px; color: #374151; line-height: 1.65;\"><strong>\u97e9\u56fdPET\u4e13\u7528\u53ef\u8403\u53d6\u7269\u6982\u51b5\uff1a<\/strong> PET \u7684\u4e3b\u8981\u8403\u53d6\u7269\u5df2\u5f97\u5230\u5145\u5206\u8868\u5f81\uff1a\u4e59\u919b\uff08AA\uff0c\u70ed\u964d\u89e3\u4ea7\u7269\uff09\u3001\u4f4e\u805a\u7269\uff08\u73af\u72b6 PET \u4e09\u805a\u4f53\u548c\u4e8c\u805a\u4f53\uff0c\u4e0e\u52a0\u5de5\u6e29\u5ea6\u76f8\u5173\uff09\u4ee5\u53ca\u90bb\u82ef\u4e8c\u7532\u9178\u4e8c(2-\u4e59\u57fa\u5df1\u57fa)\u916f\uff08DEHP\u2014\u2014\u5982\u679c PET \u6811\u8102\u4f7f\u7528\u4e86\u542b DEHP \u7684\u6da6\u6ed1\u5242\uff0c\u800c\u97e9\u56fd\u836f\u7528\u7ea7 PET \u6811\u8102\u4e0d\u4f7f\u7528\u6b64\u7c7b\u6da6\u6ed1\u5242\uff09\u3002\u97e9\u56fd\u533b\u7597\u5668\u68b0\u5e94\u7528\u5fc5\u987b\u6307\u5b9a\u4f7f\u7528\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (KFDA) \u6279\u51c6\u7684\u98df\u54c1\u63a5\u89e6\u7528 PET \u6811\u8102\uff0c\u5e76\u4e0e\u6811\u8102\u4f9b\u5e94\u5546\u786e\u8ba4\u672a\u4f7f\u7528\u4efb\u4f55\u542b\u90bb\u82ef\u4e8c\u7532\u9178\u916f\u7684\u52a0\u5de5\u52a9\u5242\u3002<\/li>\n<li style=\"font-size: 15px; color: #374151; line-height: 1.65;\"><strong>\u5de5\u827a\u6761\u4ef6\u5bf9\u97e9\u56fdISBM\u8403\u53d6\u7269\u7684\u5f71\u54cd\uff1a<\/strong> \u8f83\u9ad8\u7684\u6599\u7b52\u6e29\u5ea6\u4f1a\u52a0\u5267PET\u7684\u70ed\u964d\u89e3\u548cAA\u7684\u751f\u6210\uff1b\u8f83\u957f\u7684\u8c03\u8d28\u505c\u7559\u65f6\u95f4\u4f1a\u589e\u52a0AA\u4ece\u74f6\u576f\u5185\u90e8\u8fc1\u79fb\u5230\u74f6\u58c1\u8868\u9762\u3002\u97e9\u56fdISBM\u751f\u4ea7\u5546\u5fc5\u987b\u8bb0\u5f55\u7528\u4e8eE&amp;L\u6d4b\u8bd5\u6837\u54c1\u751f\u4ea7\u7684\u5de5\u827a\u6761\u4ef6\uff0c\u5e76\u5b9e\u65bd\u53d8\u66f4\u63a7\u5236\uff0c\u4ee5\u9632\u6b62\u672a\u6765\u5de5\u827a\u53d8\u66f4\u8d85\u51fa\u5df2\u9a8c\u8bc1\u7684\u8303\u56f4\u2014\u2014\u8fd9\u662f\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08KFDA\uff09III\u7c7b\u8981\u6c42\uff0c\u5373\u6570\u5b57\u5316\u8fc7\u7a0b\u65e5\u5fd7\u8bb0\u5f55\u3002 <a style=\"color: #0369a1; font-weight: 600; text-decoration: none;\" href=\"https:\/\/isbm-blow-molding.com\/zh\/isbm-industry-4-automation-korean-production-guide\/\">\u97e9\u56fdISBM\u5de5\u4e1a4.0\u6846\u67b6<\/a> \u63d0\u4f9b\u81ea\u52a8\u5316\u529f\u80fd\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. \u97e9\u56fdISBM\u533b\u7597\u5668\u68b0\u5305\u88c5\u6d01\u51c0\u5ba4\u751f\u4ea7\u6807\u51c6<\/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=\"\u97e9\u56fdISBM\u533b\u7597\u5668\u68b0\u6d01\u51c0\u5ba4\u751f\u4ea7\u73af\u5883\u2014\u2014\u7b26\u5408ISO 8\u7ea7\uff08100,000\u4e2a\u9897\u7c92\/\u7acb\u65b9\u7c73\uff09\u6807\u51c6\u7684ISBM\u6d01\u51c0\u5ba4\uff0c\u7528\u4e8e\u751f\u4ea7\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08KFDA\uff09II\u7ea7\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u74f6\u3002\u8be5\u6d01\u51c0\u5ba4\u914d\u5907\u4e86\u8fc7\u6ee4\u5c42\u6d41\u5f0f\u7a7a\u8c03\u7cfb\u7edf\u3001\u64cd\u4f5c\u4eba\u5458\u6d01\u51c0\u670d\u3001\u6b63\u538b\u6d01\u51c0\u5ba4\u4ee5\u53ca\u7528\u4e8e\u97e9\u56fd\u533b\u7597\u5668\u68b0\u5305\u88c5GMP\u5408\u89c4\u6027\u7684\u5728\u7ebf\u9897\u7c92\u76d1\u6d4b\u7cfb\u7edf\u3002\" \/><figcaption style=\"font-size: 12px; color: #6b7280; margin-top: 8px; text-align: center;\">\u97e9\u56fdISBM\u533b\u7597\u5668\u68b0\u6d01\u51c0\u5ba4\u751f\u4ea7\u2014\u2014\u7b26\u5408ISO 8\u7ea7\uff08ISO 14644-1\uff0c\u2264 3,520,000\u4e2a\u9897\u7c92\/\u7acb\u65b9\u7c73\uff0c\u2265 0.5\u03bcm\uff09\u6807\u51c6\uff0c\u662f\u97e9\u56fdII\u7c7b\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u74f6\u548cIII\u7c7b\u533b\u7597\u5668\u68b0\u63a5\u89e6\u5bb9\u5668\u7684\u6807\u51c6\u751f\u4ea7\u73af\u5883\u3002ISBM\u5de5\u827a\u672c\u8eab\u2014\u2014\u5728\u5c01\u95ed\u5f0f\u673a\u5668\u4e2d\u4e00\u6b65\u5b8c\u6210\u6ce8\u5851\u548c\u5439\u5851\u2014\u2014\u6bd4\u4e24\u6b65SBM\u5de5\u827a\uff08\u9884\u6210\u578b\u4ef6\u5728\u5f00\u653e\u7684\u7a7a\u6c14\u73af\u5883\u4e2d\u8f6c\u79fb\uff09\u66f4\u6d01\u51c0\u3002\u97e9\u56fdISBM\u7684\u5c01\u95ed\u5f0f\u5de5\u827a\u662f\u4e00\u9879\u5408\u89c4\u4f18\u52bf\uff1a\u74f6\u4f53\u5185\u90e8\u5728\u5439\u5851\u8154\u5185\u6210\u578b\uff0c\u76f4\u81f3\u5f39\u51fa\uff0c\u5168\u7a0b\u4e0d\u66b4\u9732\u4e8e\u7a7a\u6c14\u4e2d\uff0c\u8fd9\u610f\u5473\u7740\u53d7\u63a7\u7684\u5f39\u51fa\u73af\u5883\u51b3\u5b9a\u4e86\u6700\u7ec8\u7684\u5185\u90e8\u6c61\u67d3\u98ce\u9669\u3002<\/figcaption><\/figure>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\u97e9\u56fdKFDA GMP\uff08\uc758\ub8cc\uae30\uae30\uc758 \uc81c\uc870 \ubc0f \ud488\uc9c8\uad00\ub9ac \uae30\uc900\uff09\u8981\u6c42\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u5efa\u7acb\u5e76\u7ef4\u62a4\u4e0e\u5176\u6240\u751f\u4ea7\u5668\u68b0\u98ce\u9669\u7b49\u7ea7\u76f8\u9002\u5e94\u7684\u6d01\u51c0\u751f\u4ea7\u73af\u5883\u3002\u5bf9\u4e8e\u97e9\u56fdISBM\u521d\u7ea7\u5305\u88c5\u7684\u751f\u4ea7\uff0c\u76f8\u5173\u6807\u51c6\u4e3aISO 14644-1\uff08\u6d01\u51c0\u5ba4\u53ca\u76f8\u5173\u53d7\u63a7\u73af\u5883\uff09\u3002\u97e9\u56fdISBM\u533b\u7597\u5668\u68b0\u5305\u88c5\u751f\u4ea7\u73af\u5883\u8981\u6c42\uff08\u6309\u5668\u68b0\u7c7b\u522b\u5212\u5206\uff09\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>\u97e9\u8bed\u4e00\u7ea7\uff08\uc2e0\uace0\uff09\uff1a<\/strong> \u65e0\u9700\u6b63\u5f0f\u7684\u6d01\u51c0\u5ba4\u6807\u51c6\u2014\u2014\u4e00\u822c\u5de5\u4e1a\u751f\u4ea7\u73af\u5883\uff0c\u914d\u5907\u6709\u8bb0\u5f55\u7684\u6696\u901a\u7a7a\u8c03\u8fc7\u6ee4\u7cfb\u7edf\uff08MERV 8 \u6216\u540c\u7b49\u7b49\u7ea7\uff0c\u53d6\u4ee3\u6807\u51c6\u7684\u5f00\u653e\u5f0f\u5de5\u5382\u8fdb\u6c14\u53e3\uff09\u548c\u57fa\u672c\u7684\u6e05\u6d01\u7a0b\u5e8f\u5373\u53ef\u3002\u5efa\u8bae\u6bcf\u5b63\u5ea6\u8fdb\u884c\u4e00\u6b21\u7a7a\u6c14\u9897\u7c92\u7269\u76d1\u6d4b\uff0c\u4f46\u5e76\u975e\u5f3a\u5236\u8981\u6c42\u3002<\/li>\n<li style=\"font-size: 15px; color: #374151; line-height: 1.65;\"><strong>\u97e9\u56fd\u4e8c\u7ea7\uff08\uc778\uc99d\uff09\u2014\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u5bb9\u5668\uff1a<\/strong> ISO 14644-1 8\u7ea7\u751f\u4ea7\u73af\u5883\uff08\u7c92\u5f84\u22650.5\u03bcm\u7684\u9897\u7c92\u7269\u6d53\u5ea6\u22643,520,000\u4e2a\/m\u00b3\uff0c\u76f8\u5f53\u4e8e\u65e7\u7248\u7f8e\u56fd\u8054\u90a6\u6807\u51c6209E 100,000\u7ea7\uff09\u3002\u5b9e\u9645\u6267\u884c\uff1a\u751f\u4ea7\u533a\u57df\u91c7\u7528HEPA\u8fc7\u6ee4\u7a7a\u6c14\u4f9b\u5e94\uff0c\u4e0e\u76f8\u90bb\u975e\u751f\u4ea7\u533a\u57df\u4fdd\u6301\u6b63\u538b\u5dee\uff08\u2265+15 Pa\uff09\uff0c\u8981\u6c42\u7a7f\u6234\u9632\u62a4\u670d\uff08\u53d1\u5957\u3001\u9632\u5c18\u670d\u3001\u978b\u5957\uff09\uff0c\u5e76\u6309\u7167ISO 14644-2\u6807\u51c6\u6bcf\u5b63\u5ea6\u8fdb\u884c\u7a7a\u6c14\u4e2d\u9897\u7c92\u7269\u8ba1\u6570\u76d1\u6d4b\u3002<\/li>\n<li style=\"font-size: 15px; color: #374151; line-height: 1.65;\"><strong>\u97e9\u56fd\u7b2c\u4e09\u7c7b\uff08\ud5c8\uac00\uff09\u2014\u2014\u76f4\u63a5\u63a5\u89e6\u5f0f\u533b\u7597\u5668\u68b0\u5bb9\u5668\uff1a<\/strong> ISBM \u673a\u5668\u548c\u51fa\u74f6\u533a\u7684\u751f\u4ea7\u73af\u5883\u9700\u8fbe\u5230 ISO 14644-1 7 \u7ea7\u6807\u51c6\uff08\u7c92\u5f84 \u2265 0.5\u03bcm \u7684\u9897\u7c92\u7269\u6d53\u5ea6 \u2264 352,000 \u4e2a\/m\u00b3\uff0c\u76f8\u5f53\u4e8e 10,000 \u7ea7\uff09\u3002\u6d01\u51c0\u5ba4\u8981\u6c42\u7a7f\u7740\u5168\u5957\u6d01\u51c0\u670d\uff08\u5305\u62ec\u8fde\u4f53\u5de5\u4f5c\u670d\u3001\u624b\u5957\u548c\u53e3\u7f69\uff09\uff0c\u7269\u6599\u901a\u8fc7\u7d2b\u5916\u7ebf\u6d88\u6bd2\u901a\u9053\u8fdb\u5165\uff0c\u5e76\u8fdb\u884c\u8fde\u7eed\u9897\u7c92\u7269\u76d1\u6d4b\uff08\u5f53\u9897\u7c92\u7269\u6d53\u5ea6\u8d85\u8fc7 7 \u7ea7\u6807\u51c6\u65f6\u5b9e\u65f6\u62a5\u8b66\uff09\uff0c\u4e14\u6bcf\u5e74\u8fdb\u884c\u6d01\u51c0\u5ba4\u6027\u80fd\u8ba4\u8bc1\u3002\u97e9\u56fd\u7684 ISBM \u5de5\u5382\u901a\u5e38\u5728\u51fa\u74f6\u533a\u4e0a\u65b9\u5b89\u88c5\u4e00\u4e2a\u5c40\u90e8\u5c42\u6d41\u7f69\uff0c\u4ee5\u8fbe\u5230 7 \u7ea7\u6d01\u51c0\u6807\u51c6\uff0c\u8fd9\u79cd\u505a\u6cd5\u6bd4\u5728\u6574\u53f0 ISBM \u673a\u5668\u5468\u56f4\u5efa\u9020\u4e00\u4e2a\u5b8c\u6574\u7684 7 \u7ea7\u6d01\u51c0\u5ba4\u66f4\u4e3a\u7ecf\u6d4e\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\u9a8c\u8bc1\uff1a\u97e9\u56fdISBM\u533b\u7597\u5668\u68b0\u751f\u4ea7\u7ebf\u7684IQ\u3001OQ\u548cPQ<\/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\u5382-4\" 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\u97e9\u56fdISBM GMP\u9a8c\u8bc1\u65b9\u6848\u2014\u2014IQ\uff08\u5b89\u88c5\u786e\u8ba4\uff09\u786e\u8ba4\u673a\u5668\u5df2\u6309\u89c4\u8303\u5b89\u88c5\uff1bOQ\uff08\u8fd0\u884c\u786e\u8ba4\uff09\u786e\u5b9a\u5df2\u9a8c\u8bc1\u7684\u5de5\u827a\u53c2\u6570\u8303\u56f4\uff1bPQ\uff08\u6027\u80fd\u786e\u8ba4\uff09\u8bc1\u660e\u5728\u6807\u79f0\u6761\u4ef6\u4e0b\u80fd\u591f\u7a33\u5b9a\u751f\u4ea7\u5e76\u6ee1\u8db3\u6240\u6709\u8d28\u91cf\u89c4\u8303\u3002\u97e9\u56fdKFDA\u7684\u8ba4\u8bc1\u7533\u8bf7\u8981\u6c42\u6240\u6709\u4e09\u4e2a\u9a8c\u8bc1\u9636\u6bb5\u5fc5\u987b\u5728\u5546\u4e1a\u5316\u751f\u4ea7\u5f00\u59cb\u524d\u5b8c\u6210\u5e76\u8bb0\u5f55\u5728\u6848\u2014\u2014\u97e9\u56fdISBM\u751f\u4ea7\u5546\u5fc5\u987b\u5728\u5408\u540c\u8c08\u5224\u9636\u6bb5\u5c31\u89c4\u5212\u597d\u8fd9\u4e00\u65f6\u95f4\u8282\u70b9\uff0c\u901a\u5e38\u4ece\u6a21\u5177\u5236\u9020\u5230PQ\u5b8c\u6210\u9700\u89814-6\u4e2a\u6708\u3002<\/figcaption><\/figure>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">GMP IQ\/OQ\/PQ\u9a8c\u8bc1\u662f\u97e9\u56fdIII\u7c7b\u533b\u7597\u5668\u68b0\u5bb9\u5668ISBM\u8ba4\u8bc1\u7684\u6838\u5fc3\u3002\u6bcf\u4e2a\u9636\u6bb5\u90fd\u6709\u5176\u72ec\u7279\u7684\u76ee\u7684\uff0c\u5e76\u751f\u6210\u63d0\u4ea4\u7ed9\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08KFDA\uff09\u8ba4\u8bc1\u6587\u4ef6\u6240\u9700\u7684\u7279\u5b9a\u6587\u4ef6\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\"><strong>\u5b89\u88c5\u8d44\u683c\u8ba4\u8bc1 (IQ)\uff1a<\/strong> \u786e\u8ba4\u97e9\u56fdISBM\u673a\u5668\u3001\u6a21\u5177\u53ca\u8f85\u52a9\u8bbe\u5907\uff08\u5e72\u71e5\u673a\u3001\u51b7\u5374\u5668\u3001\u538b\u7f29\u7a7a\u6c14\u7cfb\u7edf\uff09\u5747\u6309\u7167\u5236\u9020\u5546\u89c4\u8303\u5b89\u88c5\u3002\u97e9\u56fdKFDA III\u7ea7\u6d01\u51c0\u5ba4\u7684\u5b89\u88c5\u786e\u8ba4\uff08IQ\uff09\u6587\u4ef6\u5305\u62ec\uff1a\u673a\u5668\u5e8f\u5217\u53f7\u548c\u578b\u53f7\u786e\u8ba4\u3001\u6240\u6709\u6d4b\u91cf\u4eea\u5668\uff08\u70ed\u7535\u5076\u3001\u538b\u529b\u4f20\u611f\u5668\u3001\u7535\u5b50\u79e4\uff09\u7684\u6821\u51c6\u8bc1\u4e66\uff08\u9700\u5177\u5907KRISS\u53ef\u8ffd\u6eaf\u6027\uff09\u3001\u516c\u7528\u8bbe\u65bd\u9a8c\u8bc1\uff08\u51b7\u5374\u6c34\u6e29\u5ea6\u3001\u6d41\u91cf\u3001\u5439\u98ce\u538b\u529b\u3001\u673a\u5668\u5165\u53e3\u9732\u70b9\uff09\u4ee5\u53ca\u5b89\u88c5\u65f6\u7684\u6d01\u51c0\u5ba4\u73af\u5883\u6d4b\u91cf\uff08\u9897\u7c92\u8ba1\u6570\u3001\u6e29\u5ea6\u3001\u6e7f\u5ea6\u3001\u538b\u5dee\uff09\u3002\u97e9\u56fdEver-Power\u516c\u53f8\u63d0\u4f9b\u673a\u5668\u4e13\u7528\u7684IQ\u6587\u4ef6\u6a21\u677f\uff0c\u6db5\u76d6\u97e9\u56fdKFDA\u533b\u7597\u5668\u68b0IQ\u6d41\u7a0b\u6240\u9700\u7684\u6240\u6709\u6570\u636e\u5b57\u6bb5\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\"><strong>\u8fd0\u884c\u8d44\u683c (OQ)\uff1a<\/strong> \u901a\u8fc7\u5728\u53c2\u6570\u6781\u7aef\u503c\u4e0b\u6d4b\u8bd5\u5de5\u827a\u6d41\u7a0b\u5e76\u786e\u8ba4\u6bcf\u4e2a\u6c34\u5e73\u4e0b\u7684\u4ea7\u54c1\u5747\u5408\u683c\uff0c\u6765\u786e\u5b9a\u6bcf\u4e2a\u5173\u952e\u5de5\u827a\u53c2\u6570\u7684\u6709\u6548\u64cd\u4f5c\u8303\u56f4\u3002\u5178\u578b\u7684\u97e9\u56fdISBM OQ\u7814\u7a76\uff1a\u6bcf\u4e2a\u5173\u952e\u53c2\u6570\u8bbe\u7f6e3\u4e2a\u6c34\u5e73\uff08\u6807\u79f0\u503c-5%\u3001\u6807\u79f0\u503c\u3001\u6807\u79f0\u503c+5%\uff09\uff0c\u5305\u62ec\u8c03\u8d28\u6e29\u5ea6\u3001\u5439\u6c14\u505c\u7559\u65f6\u95f4\u548c\u6ce8\u5c04\u704c\u88c5\u538b\u529b\uff1b\u6bcf\u4e2a\u53c2\u6570\u6c34\u5e73\u4e0b\u62bd\u53d630\u74f6\u6837\u54c1\uff1b\u5728\u6bcf\u4e2a\u6c34\u5e73\u4e0b\u8fdb\u884c\u5c3a\u5bf8\u548c\u8d28\u91cf\u6d4b\u91cf\uff08\u91cd\u91cf\u3001\u74f6\u9888\u5916\u5f84\u3001\u96fe\u5ea6\u30015\u4e2a\u4f4d\u7f6e\u7684\u58c1\u539a\u3001\u76ee\u89c6\u68c0\u67e5\uff09\u3002OQ\u9a8c\u6536\u6807\u51c6\uff1a\u6240\u6709\u53c2\u6570\u6c34\u5e73\u4e0b\u7684\u6240\u6709\u8d28\u91cf\u5c5e\u6027\u5747\u7b26\u5408\u89c4\u683c\u2014\u2014\u786e\u5b9a\u751f\u4ea7\u5fc5\u987b\u5728\u5176\u8303\u56f4\u5185\u8fd0\u884c\u7684\u6709\u6548\u53c2\u6570\u8303\u56f4\u3002\u5982\u679c\u53c2\u6570\u5728\u6807\u79f0\u503c\u00b15%\u8303\u56f4\u5185\u5bfc\u81f4\u4ea7\u54c1\u4e0d\u5408\u683c\uff0c\u5219\u9700\u8981\u91cd\u65b0\u4f18\u5316\u6807\u79f0\u8bbe\u5b9a\u503c\u5e76\u91cd\u590dOQ\u2014\u2014\u8fd9\u662f\u97e9\u56fdISBM III\u7ea7\u751f\u4ea7\u5546\u5e38\u89c1\u7684OQ\u53d1\u73b0\uff0c\u56e0\u4e3a\u4ed6\u4eec\u4e4b\u524d\u6ca1\u6709\u8fbe\u5230\u8fc7III\u7ea7\u7cbe\u5ea6\u516c\u5dee\u3002<\/p>\n<p style=\"font-size: 16px; margin-bottom: 0;\"><strong>PQ\uff08\u7ee9\u6548\u8d44\u683c\uff09\uff1a<\/strong> \u8bc1\u660e\u97e9\u56fdISBM\u5de5\u827a\u5728\u6807\u79f0\u6761\u4ef6\u4e0b\uff0c\u81f3\u5c11\u8fde\u7eed3\u6b21\u5546\u4e1a\u89c4\u6a21\u751f\u4ea7\u8fd0\u884c\uff0c\u5747\u80fd\u6301\u7eed\u751f\u4ea7\u51fa\u7b26\u5408\u89c4\u683c\u7684\u4ea7\u54c1\u3002PQ\u62bd\u6837\u8ba1\u5212\uff1a\u6bcf\u6b21\u8fd0\u884c\u6bcf\u4e2a\u6a21\u8154\u81f3\u5c11\u62bd\u53d6125\u74f6\uff083\u6b21\u8fd0\u884c\u6bcf\u4e2a\u6a21\u8154\u5171375\u74f6\uff09\uff0c\u6d4b\u91cf9\u9879\u8d28\u91cf\u5c5e\u6027\uff0c\u5305\u62ec\u5c3a\u5bf8\u6d4b\u91cf\u3001\u91cd\u91cf\u3001\u96fe\u5ea6\u3001\u7b26\u5408AQL II\u7ea7\uff08ANSI\/ASQ Z1.4 \/ ISO 2859-1\uff09\u7684\u76ee\u89c6\u68c0\u67e5\uff0c\u4ee5\u53ca\u751f\u7269\u76f8\u5bb9\u6027\u6837\u54c1\u751f\u4ea7\u786e\u8ba4\u3002PQ\u7edf\u8ba1\u5206\u6790\uff1a\u6bcf\u4e2a\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u7684\u8fc7\u7a0b\u80fd\u529b(Cpk)\u22651.33\u2014\u2014\u7b26\u5408\u97e9\u56fdKFDA III\u7ea7\u9a8c\u8bc1\u751f\u4ea7\u80fd\u529b\u6807\u51c6\u3002EV\u4f3a\u670dISBM\u97e9\u56fd\u5e73\u53f0\u5728\u6807\u79f0\u6761\u4ef6\u4e0b\uff0c\u74f6\u91cd\u548c\u74f6\u9888\u5916\u5f84\u7684Cpk\u59cb\u7ec8\u22651.50\uff1b\u97e9\u56fd\u6db2\u538b\u5e73\u53f0\u901a\u5e38\u80fd\u8fbe\u5230 Cpk 1.00\u20131.20\uff0c\u4f4e\u4e8e\u97e9\u56fd III \u7ea7\u6807\u51c6\uff0c\u56e0\u6b64\u9700\u8981\u8fdb\u884c\u6db2\u538b\u5230\u7535\u52a8\u4f3a\u670d\u7684\u5347\u7ea7\uff0c\u8fd9\u662f\u97e9\u56fd ISBM \u751f\u4ea7\u5546\u8fdb\u5165 III \u7ea7\u4f9b\u5e94\u65f6\u7ecf\u5e38\u9047\u5230\u7684\uff0c\u4e5f\u662f\u6210\u529f\u5b8c\u6210 PQ \u7684\u5148\u51b3\u6761\u4ef6\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;\">\u5e38\u89c1\u95ee\u9898\u89e3\u7b54<\/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 \u8fdb\u5165\u97e9\u56fd II \u7c7b IVD \u533b\u7597\u5668\u68b0\u5305\u88c5\u4f9b\u5e94\u9886\u57df\uff0c\u97e9\u56fd ISBM \u7684\u6700\u4f4e\u6295\u8d44\u989d\u662f\u591a\u5c11\uff1f<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">\u97e9\u56fdISBM\u751f\u4ea7\u5546\u82e5\u8981\u6210\u4e3a\u97e9\u56fdII\u7c7b\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u5bb9\u5668\u4f9b\u5e94\u5546\uff0c\u5e76\u5411\u97e9\u56fd\u516c\u544a\u673a\u6784\uff08\uc778\uc99d\uae30\uad00\uff09\u8ba4\u8bc1\u7684\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u4f9b\u8d27\uff0c\u6700\u4f4e\u6295\u8d44\u989d\u5305\u542b\u56db\u4e2a\u90e8\u5206\u3002(1) \u8d28\u91cf\u4f53\u7cfb\u5347\u7ea7\u81f3ISO 13485:2016\uff1a\u5df2\u6309\u7167ISO 9001:2015\u6807\u51c6\u8fd0\u8425\u7684\u97e9\u56fdISBM\u751f\u4ea7\u5546\uff0c\u53ef\u901a\u8fc7\u97e9\u56fd\u8ba4\u53ef\u7684\u8ba4\u8bc1\u673a\u6784\uff0c\u57286-9\u4e2a\u6708\u5185\u5b8c\u6210ISO 13485\u5347\u7ea7\uff0c\u8d39\u7528\u4e3a800\u4e07\u81f31500\u4e07\u97e9\u5143\uff08\u5305\u62ec\u5dee\u8ddd\u5206\u6790\u3001\u6587\u4ef6\u4fee\u8ba2\u3001\u5ba1\u6838\u548c\u8ba4\u8bc1\uff09\u3002ISO 13485\u662f\u97e9\u56fd\u533b\u7597\u5668\u68b0\u8d28\u91cf\u7ba1\u7406\u6807\u51c6\uff0c\u4e5f\u662f\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08KFDA\uff09\u516c\u544a\u6d41\u7a0b\u8981\u6c42\u4e2d\u5f15\u7528\u7684\u6807\u51c6\u3002(2) \u5bf9\u751f\u4ea7\u6837\u54c1\u8fdb\u884cISO 10993-5\u7ec6\u80de\u6bd2\u6027\u6d4b\u8bd5\uff1a\u5728KTR\u6216KCL\u8fdb\u884c\u6d4b\u8bd5\uff0c\u8d39\u7528\u4e3a150\u4e07\u81f3300\u4e07\u97e9\u5143\uff1b\u6d4b\u8bd5\u7ed3\u679c\u5c06\u751f\u6210\u97e9\u56fd\u516c\u544a\u673a\u6784\u8981\u6c42\u7684\u751f\u7269\u76f8\u5bb9\u6027\u8bc1\u4e66\u3002 \uff083\uff09\u751f\u4ea7\u73af\u5883\u5347\u7ea7\u81f3 ISO 14644-1 8 \u7ea7\uff1a\u9488\u5bf9\u97e9\u56fd 80-120 \u5e73\u65b9\u7c73\u7684 ISBM \u751f\u4ea7\u533a\u57df\uff0c\u5305\u62ec HEPA \u8fc7\u6ee4\u6539\u9020\u548c\u6b63\u538b\u7ba1\u7406\uff1a\u8d39\u7528\u4e3a 1500 \u4e07\u81f3 3000 \u4e07\u97e9\u5143\uff0c\u5305\u542b\u9a8c\u8bc1\u8d39\u7528\u3002\uff084\uff09GMP \u6587\u4ef6\u4f53\u7cfb\uff1a\u6279\u6b21\u8bb0\u5f55\u3001\u8bbe\u5907\u6821\u51c6\u7a0b\u5e8f\u3001\u6811\u8102\u548c\u6bcd\u6599\u4f9b\u5e94\u5546\u8d44\u8d28\u8ba4\u8bc1\u3001\u5e74\u5ea6\u7ba1\u7406\u8bc4\u5ba1\u3002\u5982\u4ece\u96f6\u5f00\u59cb\u5efa\u7acb\uff1a\u6587\u4ef6\u7f16\u5236\u548c\u5458\u5de5\u57f9\u8bad\u8d39\u7528\u4e3a 500 \u4e07\u81f3 1000 \u4e07\u97e9\u5143\u3002\u6700\u4f4e\u603b\u6295\u8d44\uff1a3000 \u4e07\u81f3 5800 \u4e07\u97e9\u5143\uff0c\u5206 12-18 \u4e2a\u6708\u5b8c\u6210\u3002\u76f8\u5e94\u7684\u5546\u4e1a\u6548\u76ca\uff1a\u97e9\u56fd II \u7c7b\u4f53\u5916\u8bca\u65ad\u533b\u7597\u5668\u68b0\u5305\u88c5\u5bb9\u5668\u7684\u4ef7\u683c\u901a\u5e38\u4e3a\u6bcf\u74f6 45-120 \u97e9\u5143\uff0c\u662f\u540c\u7b49\u97e9\u56fd\u5546\u54c1\u5305\u88c5\u6bcf\u74f6\u5229\u6da6\u7684 2-4 \u500d\uff1b\u97e9\u56fd\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u7684\u5408\u540c\u901a\u5e38\u4e3a 3-5 \u5e74\u7684\u4f9b\u8d27\u534f\u8bae\uff0c\u8fd9\u63d0\u4f9b\u4e86\u97e9\u56fd\u5546\u54c1\u5305\u88c5\u5e02\u573a\u65e0\u6cd5\u5b9e\u73b0\u7684\u6536\u5165\u7a33\u5b9a\u6027\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 \u5c31\u97e9\u56fd\u533b\u7597\u5668\u68b0\u5408\u89c4\u6027\u800c\u8a00\uff0c\u97e9\u56fdISBM\u4e00\u6b65\u5f0f\u5904\u7406\u4e0e\u4e24\u9636\u6bb5SBM\u6709\u4f55\u4e0d\u540c\uff1f<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">\u5bf9\u4e8e\u97e9\u56fd\u533b\u7597\u5668\u68b0\u5e94\u7528\u800c\u8a00\uff0c\u97e9\u56fd\u7684ISBM\u4e00\u6b65\u6210\u578b\u5de5\u827a\u76f8\u6bd4\u4e24\u9636\u6bb5SBM\uff08\u9884\u5236\u576f\u62c9\u4f38\u5439\u5851\u6210\u578b\uff09\u5177\u6709\u4e24\u9879\u5408\u89c4\u4f18\u52bf\u3002\u9996\u5148\uff0c\u6240\u9700\u9a8c\u8bc1\u7684\u5de5\u827a\u6b65\u9aa4\u66f4\u5c11\uff1a\u4e24\u9636\u6bb5SBM\u9700\u8981\u5bf9\u9884\u5236\u576f\u6ce8\u5851\u6210\u578b\u8fdb\u884c\u5355\u72ec\u7684GMP\u9a8c\u8bc1\uff08\u6ce8\u5851\u673a\u7684IQ\/OQ\/PQ\uff09\uff0c\u5e76\u5bf9\u518d\u52a0\u70edSBM\u5de5\u827a\u8fdb\u884c\u5355\u72ec\u7684GMP\u9a8c\u8bc1\u2014\u2014\u8fd9\u610f\u5473\u7740\u9700\u8981\u8fdb\u884c\u4e24\u6b21\u72ec\u7acb\u7684\u9a8c\u8bc1\uff0c\u4e24\u5957\u8bbe\u5907\u6821\u51c6\uff0c\u4ee5\u53ca\u5728\u4e24\u4e2a\u751f\u4ea7\u73af\u5883\u4e2d\u8fdb\u884c\u9a8c\u8bc1\uff0c\u624d\u80fd\u7b26\u5408ISO 14644\u6807\u51c6\u3002\u800c\u97e9\u56fd\u7684ISBM\u4e00\u6b65\u6210\u578b\u5de5\u827a\u5c06\u8fd9\u4e24\u4e2a\u6b65\u9aa4\u5408\u5e76\u4e3a\u4e00\u4e2a\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u5de5\u827a\u6d41\u7a0b\uff0c\u53ea\u9700\u4e00\u5957IQ\/OQ\/PQ\u65b9\u6848\uff0c\u9a8c\u8bc1\u5de5\u4f5c\u91cf\u5927\u7ea6\u51cf\u5c11\u4e86\u4e00\u534a\u3002\u5176\u6b21\uff0c\u65e0\u9700\u9884\u5236\u576f\u5e93\u5b58\u548c\u5904\u7406\u65b9\u9762\u7684\u5408\u89c4\u8981\u6c42\uff1a\u4e24\u9636\u6bb5SBM\u4f1a\u4ea7\u751f\u4e00\u4e2a\u4e2d\u95f4\u9884\u5236\u576f\u5e93\u5b58\uff0c\u8fd9\u4e9b\u9884\u5236\u576f\u5fc5\u987b\u50a8\u5b58\u5728\u7b26\u5408\u6807\u51c6\u7684\u73af\u5883\u4e2d\uff0c\u6309\u6279\u53f7\u8fdb\u884c\u8ddf\u8e2a\uff0c\u5e76\u63a7\u5236\u50a8\u5b58\u65f6\u95f4\uff08PET\u9884\u5236\u576f\u5728\u5439\u5851\u524d\u50a8\u5b58\u65f6\u95f4\u8fc7\u957f\u4f1a\u5bfc\u81f4\u7ed3\u6676\u5ea6\u4e0b\u964d\uff09\u3002\u97e9\u56fd\u7684\u4e00\u6b65\u5f0fISBM\u5b8c\u5168\u514d\u9664\u4e86\u74f6\u576f\u50a8\u5b58\u5408\u89c4\u6027\u8981\u6c42\u2014\u2014\u74f6\u576f\u5728\u540c\u4e00\u751f\u4ea7\u5468\u671f\u5185\u5b8c\u6210\u5236\u9020\u5e76\u7acb\u5373\u5439\u5236\uff0c\u65e0\u9700\u4e2d\u95f4\u4ea7\u54c1\u8fdb\u884c\u73af\u5883\u63a7\u5236\u3001\u6279\u6b21\u8ffd\u6eaf\u6216\u4fdd\u8d28\u671f\u7ba1\u7406\u3002\u5bf9\u4e8e\u97e9\u56fd\u7684\u836f\u54c1ISBM\u800c\u8a00\uff0c\u8fd9\u4e00\u4f18\u52bf\u5df2\u5f97\u5230\u5e7f\u6cdb\u8ba4\u53ef\u3002\u5bf9\u4e8e\u97e9\u56fd\u7684\u533b\u7597\u5668\u68b0ISBM\u800c\u8a00\uff0c\u8fd9\u4e00\u4f18\u52bf\u540c\u6837\u91cd\u8981\u2014\u2014\u4e00\u6b65\u5f0f\u5de5\u827a\u7b80\u5316\u4e86\u97e9\u56fdIII\u7c7b\u533b\u7597\u5668\u68b0\u7533\u62a5\u6587\u4ef6\uff0c\u56e0\u4e3a\u9700\u8981\u5355\u72ec\u9a8c\u8bc1\u7684\u5173\u952e\u5de5\u827a\u6b65\u9aa4\u6570\u91cf\u51cf\u5c11\uff0c\u4e0e\u4e24\u9636\u6bb5\u751f\u4ea7\u5de5\u827a\u9a8c\u8bc1\u76f8\u6bd4\uff0cIQ\/OQ\/PQ\u5468\u671f\u7f29\u77ed\u4e862-4\u4e2a\u6708\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 \u4f3d\u9a6c\u5c04\u7ebf\u8f90\u7167\u662f\u5426\u4f1a\u6539\u53d8\u97e9\u56fdISBM PET\u533b\u7597\u5668\u68b0\u74f6\u7684\u8403\u53d6\u7269\u6210\u5206\uff1f<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">\u662f\u7684\u2014\u2014\u03b3\u5c04\u7ebf\u8f90\u7167\u4f1a\u5728PET\u4e2d\u4ea7\u751f\u81ea\u7531\u57fa\uff0c\u9664\u4e86\u8f90\u7167\u524d\u5df2\u5b58\u5728\u7684\u70ed\u964d\u89e3\u4ea7\u7269\u5916\uff0c\u8fd8\u4f1a\u4ea7\u751f\u4e00\u7cfb\u5217\u72ec\u7279\u7684\u8f90\u5c04\u8bf1\u5bfc\u964d\u89e3\u4ea7\u7269\u3002\u97e9\u56fdISBM PET\u572825 kGy\u8f90\u7167\u5242\u91cf\u4e0b\u7684\u4e3b\u8981\u8f90\u5c04\u8bf1\u5bfc\u8403\u53d6\u7269\u5305\u62ec\uff1a(1) \u4e59\u919b\u542b\u91cf\u589e\u52a0\uff08\u03b3\u5c04\u7ebf\u8f90\u7167\u4f1a\u65ad\u88c2PET\u94fe\u4e2d\u66f4\u591a\u7684\u916f\u952e\uff0c\u91ca\u653e\u51fa\u6bd4ISBM\u5de5\u827a\u70ed\u964d\u89e3\u4ea7\u751f\u7684\u4e59\u919b\u66f4\u591a\u7684\u4e59\u919b\uff09\uff1b(2) \u4e59\u70ef\u9187\u4f4e\u805a\u7269\uff08\u672b\u7aef\u4e59\u70ef\u57fa\u7684\u03b3\u5c04\u7ebf\u65ad\u88c2\uff09\uff1b(3) PET\u73af\u72b6\u4f4e\u805a\u7269\u542b\u91cf\u5347\u9ad8\uff08\u8f90\u5c04\u4fc3\u8fdb\u94fe\u65ad\u88c2\u5f62\u6210\u66f4\u591a\u4f4e\u805a\u7269\uff09\u3002\u5bf9\u4e8e\u7ecf\u03b3\u5c04\u7ebf\u706d\u83cc\u7684\u97e9\u56fdKFDA III\u7c7b\u533b\u7597\u5668\u68b0\u5bb9\u5668\uff0c\u5fc5\u987b\u5bf9\u8f90\u7167\u540e\u7684\u6837\u54c1\u8fdb\u884c\u8403\u53d6\u7269\u7814\u7a76\uff0c\u800c\u4e0d\u662f\u5bf9\u672a\u8f90\u7167\u7684\u751f\u4ea7\u6837\u54c1\u8fdb\u884c\u7814\u7a76\uff0c\u56e0\u4e3a\u8f90\u5c04\u8bf1\u5bfc\u8403\u53d6\u7269\u662f\u5bb9\u5668\u5b9e\u9645\u5316\u5b66\u6210\u5206\u7684\u4e00\u90e8\u5206\uff0c\u60a3\u8005\u4f1a\u63a5\u89e6\u5230\u8fd9\u4e9b\u6210\u5206\u3002\u97e9\u56fdISBM\u751f\u4ea7\u5546\u82e5\u4f7f\u7528\u672a\u7ecf\u8f90\u7167\u7684\u74f6\u5b50\u8fdb\u884c\u63d0\u53d6\u548c\u91ca\u653e\uff08E&amp;L\uff09\u7814\u7a76\uff0c\u7136\u540e\u91c7\u7528\u4f3d\u9a6c\u5c04\u7ebf\u706d\u83cc\uff0c\u5176\u97e9\u56fdKFDA\u8ba4\u8bc1\u6587\u4ef6\u4e2d\u5b58\u5728\u7f3a\u9677\uff0c\u8be5\u7f3a\u9677\u4ec5\u5728KFDA\u5ba1\u6838\u65f6\u624d\u4f1a\u663e\u73b0\uff0c\u5bfc\u81f4\u9700\u8981\u5bf9\u8f90\u7167\u6837\u54c1\u91cd\u590d\u8fdb\u884cE&amp;L\u7814\u7a76\uff0c\u4ece\u800c\u4f7f\u8ba4\u8bc1\u5ba1\u6279\u5ef6\u8fdf3-6\u4e2a\u6708\u3002\u56e0\u6b64\uff0c\u5e94\u4ece\u4e00\u5f00\u59cb\u5c31\u5728E&amp;L\u6d4b\u8bd5\u65b9\u6848\u4e2d\u660e\u786e\u89c4\u5b9a\uff0c\u6837\u54c1\u5728\u63d0\u53d6\u524d\u5fc5\u987b\u6309\u7167\u6700\u5927\u9884\u671f\u5242\u91cf\u8fdb\u884c\u8f90\u7167\uff0c\u4ece\u800c\u907f\u514d\u91cd\u590d\u7814\u7a76\u7684\u6210\u672c\u548c\u5ba1\u6279\u5ef6\u8fdf\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 \u97e9\u56fdISBM PET\u4e2d\u7684\u4e59\u919b\u5982\u4f55\u5f71\u54cd\u533b\u7597\u5668\u68b0\u8bd5\u5242\u7684\u8d28\u91cf\uff1f<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">\u4e59\u919b (AA) \u4ece\u97e9\u56fd ISBM PET \u74f6\u8fc1\u79fb\u5230\u533b\u7597\u5668\u68b0\u8bd5\u5242\u4e2d\uff0c\u662f\u97e9\u56fd\u7279\u5b9a\u4f53\u5916\u8bca\u65ad (IVD) \u8bd5\u5242\u7c7b\u522b\u7684\u91cd\u8981\u8d28\u91cf\u95ee\u9898\u2014\u2014\u5c24\u5176\u662f\u9176\u6cd5\u8bca\u65ad\u8bd5\u5242\uff0c\u56e0\u4e3a\u4e59\u919b\u4f1a\u4e0e\u9176\u7684\u6d3b\u6027\u4f4d\u70b9\u53d1\u751f\u53cd\u5e94\uff1b\u4ee5\u53ca\u514d\u75ab\u6d4b\u5b9a\u8bd5\u5242\uff0c\u56e0\u4e3a\u4e59\u919b\u4f1a\u901a\u8fc7\u7f8e\u62c9\u5fb7\u53cd\u5e94\u4e0e\u6297\u4f53\u86cb\u767d\u53d1\u751f\u53cd\u5e94\uff0c\u4ece\u800c\u964d\u4f4e\u68c0\u6d4b\u7075\u654f\u5ea6\u3002\u5bfc\u81f4\u97e9\u56fd IVD \u8bd5\u5242\u6027\u80fd\u663e\u8457\u4e0b\u964d\u7684\u4e59\u919b\u8fc1\u79fb\u9608\u503c\u53d6\u51b3\u4e8e\u5177\u4f53\u7684\u8bd5\u5242\u57fa\u8d28\u2014\u2014\u9176\u6cd5 IVD \u8bd5\u5242\u5728\u50a8\u5b58\u7684\u8bd5\u5242\u4e2d\u4e59\u919b\u6d53\u5ea6\u8d85\u8fc7 15 ppb \u65f6\u5c31\u4f1a\u51fa\u73b0\u6027\u80fd\u4e0b\u964d\uff1b\u800c\u514d\u75ab\u6d4b\u5b9a\u8bd5\u5242\u901a\u5e38\u5728\u97e9\u56fd ISBM PET \u74f6\u7684\u4e59\u919b\u6d53\u5ea6\u6c34\u5e73\u4e0b\uff08100ml PET \u74f6\u5728\u5ba4\u6e29\u4e0b\u50a8\u5b58 3 \u4e2a\u6708\uff0c\u74f6\u5185\u9876\u7a7a\u4e59\u919b\u6d53\u5ea6\u4e3a 1-8 ppb\uff09\u4e0d\u53d7\u5f71\u54cd\u3002\u5411\u97e9\u56fd IVD \u8bca\u65ad\u516c\u53f8\u4f9b\u8d27\u7684\u97e9\u56fd ISBM \u751f\u4ea7\u5546\u5fc5\u987b\u5411\u97e9\u56fd\u533b\u7597\u5668\u68b0\u5ba2\u6237\u7684\u914d\u65b9\u56e2\u961f\u62ab\u9732\u5728\u5546\u4e1a\u6761\u4ef6\u4e0b\uff08\u8c03\u8282\u6e29\u5ea6\u3001\u6876\u6e29\u3001\u5faa\u73af\u65f6\u95f4\uff09\u751f\u4ea7\u7684\u74f6\u4e2d\u6d4b\u5f97\u7684\u74f6\u5185\u9876\u7a7a\u4e59\u919b\u6d53\u5ea6\uff0c\u5e76\u627f\u8bfa\u901a\u8fc7\u5de5\u827a\u53c2\u6570\u63a7\u5236\u548c\u5e74\u5ea6\u9a8c\u8bc1\u6d4b\u8bd5\uff0c\u5728\u6240\u6709\u5546\u4e1a\u751f\u4ea7\u4e2d\u5c06\u4e59\u919b\u6d53\u5ea6\u7ef4\u6301\u5728\u7ea6\u5b9a\u7684\u9650\u503c\u4ee5\u4e0b\u3002 ISBM \u964d\u4f4e\u97e9\u56fd\u533b\u7597\u5668\u68b0 PET \u74f6\u4e2d AA \u7684\u4e3b\u8981\u53c2\u6570\u6760\u6746\u662f\uff1a\u5c3d\u91cf\u964d\u4f4e\u6876\u6e29\uff08\u76ee\u6807\u6e29\u5ea6\u4e3a 265\u00b0C \u533a 1\uff0c\u800c\u4e0d\u662f 280\u00b0C \u4ee5\u4e0a\uff09\uff0c\u5c3d\u91cf\u7f29\u77ed\u6876\u505c\u7559\u65f6\u95f4\uff08\u505c\u673a\u8d85\u8fc7 10 \u5206\u949f\u65f6\uff0cPET \u4e0d\u5f97\u5728\u6876\u4e2d\u4fdd\u6301\u8be5\u6e29\u5ea6\uff09\uff0c\u4ee5\u53ca\u5c3d\u91cf\u7f29\u77ed\u8c03\u8282\u505c\u7559\u65f6\u95f4\uff08\u4ee5\u8d28\u91cf\u4e3a\u9650\uff0c\u800c\u975e\u6700\u957f\uff09\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 \u83b7\u5f97\u97e9\u56fdKFDA III\u7c7b\u8ba4\u8bc1\u540e\uff0c\u97e9\u56fdISBM\u53d8\u66f4\u63a7\u5236\u8981\u6c42\u6709\u54ea\u4e9b\uff1f<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">\u7ecf\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (KFDA) \u6279\u51c6\u7684\u533b\u7597\u5668\u68b0\u5305\u88c5\uff0c\u4e00\u65e6\u5176\u5bb9\u5668\u89c4\u683c\u88ab\u7eb3\u5165\u97e9\u56fd\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u7684\u6279\u51c6\u6587\u4ef6\uff0c\u5373\u987b\u9075\u5b88\u53d8\u66f4\u63a7\u5236\u8981\u6c42\u3002\u8fd9\u4e9b\u8981\u6c42\u5bf9\u97e9\u56fd\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u5177\u6709\u7ea6\u675f\u529b\u3002\u9700\u8981\u5411\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (KFDA) \u63d0\u4ea4\u53d8\u66f4\u901a\u77e5\uff08\u6839\u636e\u53d8\u66f4\u7684\u4e25\u91cd\u7a0b\u5ea6\uff0c\u53ef\u80fd\u79f0\u4e3a\u201c\u53d8\u66f4\u901a\u77e5\u201d\u6216\u201c\u53d8\u66f4\u901a\u77e5\u201d\uff09\u5e76\u53ef\u80fd\u9700\u8981\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (KFDA) \u5ba1\u6838\u548c\u91cd\u65b0\u6279\u51c6\u7684\u533b\u7597\u5668\u68b0\u5305\u88c5\u53d8\u66f4\u5305\u62ec\uff1a\u6811\u8102\u7b49\u7ea7\u6216\u5236\u9020\u5546\u53d8\u66f4\uff1b\u7740\u8272\u5242\u6216\u6bcd\u6599\u89c4\u683c\u53d8\u66f4\uff1b\u533b\u7597\u5668\u68b0\u8bbe\u5907\uff08\u578b\u53f7\u3001\u5e8f\u5217\u53f7\u3001\u4f4d\u7f6e\uff09\u53d8\u66f4\uff1b\u5de5\u827a\u53c2\u6570\u53d1\u751f\u8d85\u51fa\u8fd0\u884c\u786e\u8ba4 (OQ) \u4e2d\u5df2\u9a8c\u8bc1\u8303\u56f4\u7684\u91cd\u5927\u53d8\u66f4\uff1b\u4ee5\u53ca\u5c3a\u5bf8\u89c4\u683c\u53d8\u66f4\u8d85\u51fa\u6279\u51c6\u6587\u4ef6\u4e2d\u5df2\u6279\u51c6\u7684\u516c\u5dee\u3002\u901a\u5e38\u65e0\u9700\u5411\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (KFDA) \u63d0\u4ea4\u53d8\u66f4\u901a\u77e5\uff08\u4f46\u9700\u8981\u5185\u90e8\u53d8\u66f4\u63a7\u5236\u6587\u4ef6\uff09\u7684\u53d8\u66f4\u5305\u62ec\uff1a\u5728\u9a8c\u8bc1\u8303\u56f4\u5185\u7684\u5de5\u827a\u53c2\u6570\u8c03\u6574\uff1b\u533b\u7597\u5668\u68b0\u8bbe\u5907\u64cd\u4f5c\u5458\u8ba4\u8bc1\u53d8\u66f4\uff1b\u4ee5\u53ca\u751f\u4ea7\u73af\u5883\u6539\u8fdb\uff0c\u53ea\u8981\u8be5\u6539\u8fdb\u80fd\u591f\u7ef4\u6301\u6216\u8d85\u8fc7\u5df2\u9a8c\u8bc1\u7684\u6d01\u51c0\u5ba4\u7b49\u7ea7\u3002\u97e9\u56fdISBM\u5305\u88c5\u751f\u4ea7\u5546\u82e5\u5c06\u5df2\u9a8c\u8bc1\u7684\u533b\u7597\u5668\u68b0\u5bb9\u5668\u751f\u4ea7\u6d41\u7a0b\u89c6\u4e3a\u53ef\u968f\u610f\u66f4\u6539\u7684\uff0c\u4f8b\u5982\u672a\u7ecf\u53d8\u66f4\u63a7\u5236\u64c5\u81ea\u8c03\u6574\u6599\u7b52\u6e29\u5ea6\u3001\u672a\u7ecf\u4f9b\u5e94\u5546\u8d44\u8d28\u8ba4\u8bc1\u64c5\u81ea\u66f4\u6362\u6811\u8102\u7b49\u7ea7\uff0c\u6216\u5728\u672a\u901a\u77e5\u97e9\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08KFDA\uff09\u7684\u60c5\u51b5\u4e0b\u5c06ISBM\u8bbe\u5907\u5728\u4e0d\u540c\u5de5\u5382\u95f4\u8f6c\u79fb\uff0c\u5219\u4f1a\u5bfc\u81f4KFDA\u5408\u89c4\u6027\u7f3a\u9677\uff0c\u8fd9\u4e9b\u7f3a\u9677\u4f1a\u5728\u533b\u7597\u5668\u68b0\u5236\u9020\u5546\u7684\u4e0b\u4e00\u6b21KFDA\u68c0\u67e5\u4e2d\u66b4\u9732\u51fa\u6765\uff0c\u4ece\u800c\u89e6\u53d1\u5bf9\u5305\u88c5\u4f9b\u5e94\u5546\u7684\u6574\u6539\u8981\u6c42\u3002\u5b9e\u9645\u610f\u4e49\u5728\u4e8e\uff1a\u8fdb\u5165\u97e9\u56fdIII\u7c7b\u533b\u7597\u5668\u68b0\u4f9b\u5e94\u5e02\u573a\u7684ISBM\u751f\u4ea7\u5546\u5e94\u4e3a\u8be5\u533b\u7597\u5668\u68b0\u5408\u540c\u4e13\u95e8\u914d\u5907\u4e00\u5957\u8bbe\u5907\u3001\u6a21\u5177\u548c\u6811\u8102\u4f9b\u5e94\u94fe\uff0c\u5e76\u5efa\u7acb\u53d8\u66f4\u63a7\u5236\u7cfb\u7edf\uff0c\u4ee5\u9632\u6b62\u4efb\u4f55\u672a\u7ecf\u6b63\u5f0f\u5ba1\u67e5\u4e14\u5728\u5fc5\u8981\u65f6\u672a\u901a\u77e5KFDA\u7684\u53d8\u66f4\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 \u97e9\u56fdISBM\u7684\u5c3a\u5bf8\u7cbe\u5ea6\u4e0e\u97e9\u56fd\u533b\u7597\u5668\u68b0\u5bb9\u5668\u9888\u90e8\u5916\u5f84\u5408\u89c4\u6027\u65b9\u9762\u7684\u73bb\u7483\u76f8\u6bd4\u5982\u4f55\uff1f<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">\u97e9\u56fdISBM\u751f\u4ea7\u7684PET\u548cPETG\u74f6\u5728\u56db\u8154\u751f\u4ea7\u4e2d\uff0c\u74f6\u9888\u5916\u5f84\u5c3a\u5bf8\u7cbe\u5ea6\u53ef\u8fbe\u00b10.04mm\uff084\u03c3\uff0cEV\u4f3a\u670d\u5e73\u53f0\uff09\uff0c\u4e0e\u836f\u7528\u7ea7\u73bb\u7483\u74f6\u7684\u74f6\u9888\u5916\u5f84\u7cbe\u5ea6\u76f8\u5f53\u6216\u66f4\u4f18\uff08\u901a\u5e38\u4e3a\u00b10.05-0.10mm\uff0c\u5177\u4f53\u53d6\u51b3\u4e8e\u73bb\u7483\u6210\u578b\u5de5\u827a\u548c\u74f6\u9888\u5c3a\u5bf8\uff09\u3002\u5bf9\u4e8e\u97e9\u56fd\u533b\u7597\u5668\u68b0\u5e94\u7528\u800c\u8a00\uff0c\u74f6\u76d6\uff08\u5361\u6263\u76d6\u3001\u9c81\u5c14\u63a5\u5934\u3001\u9694\u819c\uff09\u7684\u5bc6\u5c01\u6027\u80fd\u4f9d\u8d56\u4e8e\u74f6\u9888\u5916\u5f84\u7684\u516c\u5dee\uff0c\u800c\u97e9\u56fdISBM\u7684\u00b10.04mm\u7cbe\u5ea6\u6bd4\u73bb\u7483\u7684\u00b10.05-0.10mm\u7cbe\u5ea6\u63d0\u4f9b\u4e86\u66f4\u7a33\u5b9a\u7684\u5bc6\u5c01\u6027\u80fd\uff0c\u5e76\u4e14\u5177\u6709\u5728\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u5bf9\u6bcf\u4e2a\u8154\u4f53\u8fdb\u884c\u91cf\u5316\u9a8c\u8bc1\u7684\u4f18\u52bf\uff08\u73bb\u7483\u5236\u9020\u5546\u63d0\u4f9b\u7684\u5c3a\u5bf8\u8ba4\u8bc1\u662f\u57fa\u4e8e\u7edf\u8ba1\u6837\u672c\u6c34\u5e73\uff0c\u800c\u975e\u6bcf\u4e2a\u8154\u4f53\uff09\u3002\u5728\u4ee5\u4e0b\u4e24\u4e2a\u97e9\u56fd\u533b\u7597\u5668\u68b0\u5bb9\u5668\u8981\u6c42\u4e2d\uff0c\u73bb\u7483\u4ecd\u4f18\u4e8e\u97e9\u56fdISBM PET\/PETG\uff1a\uff081\uff09\u7528\u4e8e\u9ad8\u5149\u654f\u8bd5\u5242\u7684\u7d2b\u5916\u7ebf\u963b\u9694\u2014\u2014\u7425\u73c0\u8272\u73bb\u7483\u53ef\u963b\u6321\u226599.9%\u7684450nm\u4ee5\u4e0b\u7d2b\u5916\u7ebf\uff1b\u7425\u73c0\u8272PET\u6216\u7425\u73c0\u8272PETG\u53ef\u963b\u969495\u201399%\uff0c\u4f46\u9700\u8981\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u6bcd\u6599\u548c\u8fc1\u79fb\u6d4b\u8bd5\uff1b\uff082\uff09\u6c34\u84b8\u6c14\u900f\u8fc7\u7387\uff08WVTR\uff09\u2014\u73bb\u7483\u7684WVTR\u4e3a\u96f6\uff1bPET\u7684WVTR\u572838\u00b0C\/90% RH\u4e0b\u7ea6\u4e3a1.5\u20133.0 g\u00b7mm\/m\u00b2\u00b7day \u2014\u5bf9\u4e8e\u5927\u591a\u6570\u6c34\u6027\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u5728\u97e9\u56fd\u6807\u51c6\u5b9e\u9a8c\u5ba4\u50a8\u5b58\uff0815\u201330\u00b0C\uff09\u4e0b\u662f\u53ef\u4ee5\u63a5\u53d7\u7684\uff0c\u4f46\u5bf9\u4e8e\u572818\u4e2a\u6708\u4ee5\u4e0a\u7684\u4fdd\u8d28\u671f\u5185\u5bb9\u6613\u56e0\u5438\u6536\u5927\u6c14\u6c34\u5206\u800c\u88ab\u7a00\u91ca\u7684\u8bd5\u5242\uff0c\u9700\u8981\u4f7f\u7528\u9632\u6f6e\u5bc6\u5c01\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\u7597\u5668\u68b0\u8ba4\u8bc1\u652f\u6301<\/p>\n<h2 style=\"font-size: clamp(18px,3vw,26px); font-weight: 800; color: #fff; margin: 0 0 14px;\">\u8ba1\u5212\u5c06\u533b\u7597\u5668\u68b0\u5305\u88c5\u5f15\u5165\u97e9\u56fdKFDA II\u7c7b\u6216III\u7c7b\u5e02\u573a\uff1f\u9700\u8981GMP\u9a8c\u8bc1\u3001ISO 10993\u6216IQ\/OQ\/PQ\u652f\u6301\uff1f<\/h2>\n<p style=\"font-size: 15px; color: #e0f2fe; max-width: 480px; margin: 0 auto 26px; line-height: 1.65;\">\u97e9\u56fd Ever-Power \u63d0\u4f9b KFDA II\/III \u7c7b\u6587\u4ef6\u6a21\u677f\u3001GMP IQ\/OQ\/PQ \u65b9\u6848\u5f00\u53d1\u3001\u751f\u7269\u76f8\u5bb9\u6027\u6837\u54c1\u751f\u4ea7\u3001\u7b26\u5408 KFDA Annex 11 \u8981\u6c42\u7684 EV \u4f3a\u670d\u8fc7\u7a0b\u8bb0\u5f55\u4ee5\u53ca\u97e9\u56fd\u533b\u7597\u5668\u68b0\u5305\u88c5\u8ba4\u8bc1\u7684\u6d01\u51c0\u5ba4 ISBM \u8c03\u8bd5\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\/zh\/contact-us\/\">\u7533\u8bf7\u533b\u7597\u5668\u68b0\u8ba4\u8bc1\u652f\u6301<\/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;\">\u76f8\u5173\u8d44\u6e90<\/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;\">\u4f18\u8d28\u533b\u7528\u7ea7<\/span><br \/>\n<span style=\"display: block; font-size: 15px; font-weight: bold; color: #1e3a8a; margin-bottom: 8px; line-height: 1.3;\">\u6ce8\u5851\u62c9\u4f38\u5439\u5851\u673a HGY150-V4-EV<\/span><br \/>\n<span style=\"display: block; font-size: 13px; color: #6b7280; line-height: 1.55;\">\u5168\u7535\u52a8 EV \u4f3a\u670d \u00b7 KFDA \u9644\u4ef6 11 GMP \u6570\u636e\u8bb0\u5f55 \u00b7 Cpk \u2265 1.50 \u6ee1\u8db3 III \u7c7b PQ \u8981\u6c42 \u00b7 \u63d0\u4f9b\u97e9\u56fd\u533b\u7597\u5668\u68b0 IQ\/OQ\/PQ \u6587\u4ef6\u5305\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;\">II\u7c7b\u4f53\u5916\u8bca\u65ad\u5e73\u53f0<\/span><br \/>\n<span style=\"display: block; font-size: 15px; font-weight: bold; color: #1e3a8a; margin-bottom: 8px; line-height: 1.3;\">HGY200-V4\u578b\u6ce8\u5851\u62c9\u4f38\u5439\u5851\u673a<\/span><br \/>\n<span style=\"display: block; font-size: 13px; color: #6b7280; line-height: 1.55;\">\u591a\u6811\u8102 PET \/ PETG \/ PP \u00b7 \u00b10.04mm \u74f6\u9888\u5916\u5f84\u7cbe\u5ea6 \u00b7 \u7b26\u5408\u97e9\u56fd II \u7ea7 ISO 13485 \u6807\u51c6 \u00b7 \u7ecf\u9a8c\u8bc1\u7684\u8f90\u5c04\u7a33\u5b9a PET \u7b49\u7ea7 \u00b7 IVD \u8bd5\u5242\u74f6 15\u2013500ml\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;\">\u9ad8\u5bb9\u91cf\u533b\u7597<\/span><br \/>\n<span style=\"display: block; font-size: 15px; font-weight: bold; color: #1e3a8a; margin-bottom: 8px; line-height: 1.3;\">\u6ce8\u5851\u62c9\u4f38\u5439\u5851\u673a HGY250-V4<\/span><br \/>\n<span style=\"display: block; font-size: 13px; color: #6b7280; line-height: 1.55;\">\u5927\u578b\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u76d2\u74f6\u751f\u4ea7\u00b7 6\u8154\u97e9\u56fdII\u7ea7\u751f\u4ea7\u7ebf\u00b7 \u6d01\u51c0\u5ba4\u517c\u5bb9\u7684\u5f39\u51fa\u7cfb\u7edf\u00b7 86\u6beb\u7c73\u5bbd\u53e3\u74f6\u9888\uff0c\u9002\u7528\u4e8e\u5927\u578b\u8bca\u65ad\u8bd5\u5242\u5bb9\u5668\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;\">\u7f16\u8f91\uff1aCxm<\/p>\n<\/footer>\n<\/div>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>ISBM \u5e94\u7528 \u00b7 \u533b\u7597\u5668\u68b0\u5305\u88c5 \u00b7 \u97e9\u56fd ISBM 2026 ISBM \u533b\u7597\u5668\u68b0\u74f6\u751f\u4ea7\uff1a\u97e9\u56fd\u76d1\u7ba1\u6307\u5357 \u97e9\u56fd\u533b\u7597\u5668\u68b0\u5305\u88c5\u662f\u7b26\u5408 ISBM \u6807\u51c6\u7684\u6700\u9ad8\u7ea7\u522b\u5e94\u7528\u2014\u2014\u6bcf\u4e2a\u74f6\u5b50\u90fd\u5fc5\u987b\u7ecf\u8fc7\u751f\u7269\u76f8\u5bb9\u6027\u6d4b\u8bd5\u3001\u706d\u83cc\u9a8c\u8bc1\u3001\u5c3a\u5bf8\u7b26\u5408 GMP IQ\/OQ\/PQ \u6807\u51c6\uff0c\u5e76\u5728\u6709\u8bb0\u5f55\u7684\u6d01\u51c0\u73af\u5883\u4e2d\u751f\u4ea7\u3002\u8fdb\u5165\u6b64\u9886\u57df\u7684\u97e9\u56fd ISBM \u751f\u4ea7\u5546 [\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\/zh\/wp-json\/wp\/v2\/posts\/966","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/isbm-blow-molding.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/isbm-blow-molding.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/zh\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/zh\/wp-json\/wp\/v2\/comments?post=966"}],"version-history":[{"count":1,"href":"https:\/\/isbm-blow-molding.com\/zh\/wp-json\/wp\/v2\/posts\/966\/revisions"}],"predecessor-version":[{"id":967,"href":"https:\/\/isbm-blow-molding.com\/zh\/wp-json\/wp\/v2\/posts\/966\/revisions\/967"}],"wp:attachment":[{"href":"https:\/\/isbm-blow-molding.com\/zh\/wp-json\/wp\/v2\/media?parent=966"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/zh\/wp-json\/wp\/v2\/categories?post=966"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/zh\/wp-json\/wp\/v2\/tags?post=966"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}