{"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\/ko\/isbm-medical-device-bottle-production-korean-guide\/","title":{"rendered":"ISBM \uc758\ub8cc\uae30\uae30 \uc6a9\uae30 \uc0dd\uc0b0: \ud55c\uad6d \uaddc\uc81c \uc9c0\uce68 2026"},"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\uc758 \uc751\uc6a9 \ubd84\uc57c \u00b7 \uc758\ub8cc\uae30\uae30 \ud3ec\uc7a5 \u00b7 \ud55c\uad6d ISBM 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 \uc758\ub8cc\uae30\uae30 \ubcd1<br \/>\n\uc0dd\uc0b0: \ud55c\uad6d \uaddc\uc81c \uc9c0\uce68<\/h1>\n<p style=\"font-size: clamp(14px,1.9vw,17px); color: #e0f2fe; line-height: 1.7; margin: 0 0 28px; max-width: 560px;\">\ud55c\uad6d\uc758 \uc758\ub8cc\uae30\uae30 \ud3ec\uc7a5\uc740 ISBM(\ud1b5\ud569 \uc758\uc57d\ud488 \ud3ec\uc7a5) \uaddc\uc815 \uc911 \uac00\uc7a5 \uc5c4\uaca9\ud55c \uae30\uc900\uc744 \uc801\uc6a9\ubc1b\ub294 \ubd84\uc57c\uc785\ub2c8\ub2e4. \ubaa8\ub4e0 \uc6a9\uae30\ub294 \uc0dd\uccb4 \uc801\ud569\uc131 \uc2dc\ud5d8, \uba78\uade0 \uac80\uc99d, GMP IQ\/OQ\/PQ \uae30\uc900\uc5d0 \ub530\ub978 \uce58\uc218 \uc801\uaca9\uc131 \uac80\uc0ac\ub97c \uac70\uccd0\uc57c \ud558\uba70, \ubb38\uc11c\ud654\ub41c \uccad\uc815 \ud658\uacbd\uc5d0\uc11c \uc81c\uc870\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. \ud55c\uad6d\uc758 ISBM \uc81c\uc870\uc5c5\uccb4\ub4e4\uc740 \uc774\ub7ec\ud55c \uaddc\uc81c \uccb4\uacc4\ub97c \uc81c\ub300\ub85c \uc774\ud574\ud558\uace0 \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \ud68c\uc0ac\ub4e4\uc774 10~15\ub144 \ub3d9\uc548 \uac31\uc2e0\ud560 \uc218 \uc788\ub294 \uacf5\uae09\uc5c5\uccb4 \uc790\uaca9 \uc778\uc99d\uc744 \ud68d\ub4dd\ud574\uc57c\ub9cc \uc774 \uc2dc\uc7a5\uc5d0 \uc9c4\ucd9c\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ubc18\uba74, \uaddc\uc81c \uccb4\uacc4\ub97c \uc81c\ub300\ub85c \uc774\ud574\ud558\uc9c0 \ubabb\ud55c \ucc44 \uc9c4\ucd9c\ud558\ub294 \uc5c5\uccb4\ub4e4\uc740 \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA)\uc758 \uccab \ubc88\uc9f8 \uacf5\uae09\uc5c5\uccb4 \uc2ec\uc0ac\uc5d0\uc11c \ubd88\ud569\uaca9\ud558\ub294 \uacbd\uc6b0\uac00 \ub9ce\uc2b5\ub2c8\ub2e4.<\/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;\">\uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA) 1~4\ub4f1\uae09 \uaddc\uc81c \uccb4\uacc4<\/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 \uc0dd\uccb4 \uc801\ud569\uc131<\/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 \uac80\uc99d<\/span><\/div>\n<p style=\"font-size: 11px; color: #38bdf8; margin: 22px 0 0;\">\uc5d0\ubc84\ud30c\uc6cc \ud55c\uad6d \uc5d4\uc9c0\ub2c8\uc5b4\ub9c1 \ub370\uc2a4\ud06c \u00b7 \uc548\uc0b0\uc2dc \u00b7 2026\ub144 5\uc6d4<\/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;\">\ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA) \uc758\ub8cc\uae30\uae30 \ubd84\ub958 - \ud3ec\uc7a5 \uc601\ud5a5 \uc694\uc57d<\/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 \ud074\ub798\uc2a4<\/th>\n<th style=\"color: #fff; padding: 9px 12px; text-align: left; font-weight: bold;\">\ud55c\uad6d \uc2b9\uc778 \uacbd\ub85c<\/th>\n<th style=\"color: #fff; padding: 9px 12px; text-align: left; font-weight: bold;\">\ud3ec\uc7a5 \uc694\uad6c\uc0ac\ud56d<\/th>\n<th style=\"color: #fff; padding: 9px 12px; text-align: left; font-weight: bold;\">\ud55c\uad6d\uc5b4 ISBM \uc560\ud50c\ub9ac\ucf00\uc774\uc158<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">1\ub4f1\uae09<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\uc9d5\uc9d5(\uc54c\ub9bc)<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\uae30\ubcf8 \uc7ac\ub8cc \ucd94\uc801\uc131 + \uce58\uc218<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\uac80\uccb4 \ucef5, \uc800\uc704\ud5d8 \uac80\uccb4 \uc6a9\uae30<\/td>\n<\/tr>\n<tr style=\"background: #f0f9ff;\">\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">2\ub4f1\uae09<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\uc778\uc99d(\uc778\uc99d)<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">ISO 10993 \uc0dd\uccb4 \uc801\ud569\uc131 + GMP \ubb38\uc11c<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\uccb4\uc678\uc9c4\ub2e8 \uc2dc\uc57d\ubcd1, \uc9c4\ub2e8 \ud0a4\ud2b8, \uc138\ucc99\ubcd1<\/td>\n<\/tr>\n<tr>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600; color: #0369a1;\">3\ub4f1\uae09<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\uadf8\ub798\uc11c (KFDA \uc2b9\uc778)<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600; color: #0369a1;\">GMP \uc778\uc99d \uc644\ub8cc + \ucd94\ucd9c\ubb3c\/\uc6a9\ucd9c\ubb3c \ubd84\uc11d<\/td>\n<td style=\"padding: 8px 12px; border-bottom: 1px solid #bae6fd;\">\uc57d\ubb3c \uc804\ub2ec \uc2dc\uc2a4\ud15c \uc6a9\uae30, \uba78\uade0 \uc758\ub8cc\uae30\uae30 \ud3ec\uc7a5<\/td>\n<\/tr>\n<tr style=\"background: #f0f9ff;\">\n<td style=\"padding: 8px 12px; font-weight: 600; color: #0369a1;\">\ud074\ub798\uc2a4 IV<\/td>\n<td style=\"padding: 8px 12px;\">\uadf8\ub798\uc11c (KFDA \uc2b9\uc778)<\/td>\n<td style=\"padding: 8px 12px; font-weight: 600; color: #0369a1;\">GMP \uc778\uc99d \uc644\ub8cc + \uc784\uc0c1 \ub370\uc774\ud130 + \uba78\uade0 \uac80\uc99d<\/td>\n<td style=\"padding: 8px 12px;\">\uc784\ud50c\ub780\ud2b8 \uad6c\uc131 \uc694\uc18c \uc6a9\uae30, \uc0dd\uba85 \uc720\uc9c0 \uc7a5\uce58 \ud3ec\uc7a5<\/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;\">\ub0b4\uc6a9\ubb3c<\/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. \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \ud3ec\uc7a5 \uc2dc\uc7a5 \ubc0f ISBM\uc758 \uc5ed\ud560<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s2\">2. \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA) \uc758\ub8cc\uae30\uae30 \ub4f1\ub85d \uccb4\uacc4<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s3\">3. \uc7ac\uc9c8 \uc120\uc815: \uc758\ub8cc\uc6a9 \uc6a9\uae30\uc6a9 PET, PETG \ubc0f PP<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s4\">4. ISO 10993 \uc0dd\uccb4\uc801\ud569\uc131 \ud3c9\uac00 \ud504\ub85c\ud1a0\ucf5c<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s5\">5. \uba78\uade0 \ubc29\ubc95 \ud638\ud658\uc131<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s6\">6. \ucd94\ucd9c\ubb3c \ubc0f \uc6a9\ucd9c\ubb3c: \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA)\uc758 \uae30\ub300\uc0ac\ud56d<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s7\">7. \ud55c\uad6d ISBM\uc744 \uc704\ud55c \ud074\ub9b0\ub8f8 \uc0dd\uc0b0 \ud45c\uc900<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#s8\">8. GMP \uac80\uc99d: \ud55c\uad6d ISBM \ub77c\uc778\uc5d0 \ub300\ud55c IQ, OQ \ubc0f PQ<\/a><br \/>\n<a style=\"color: #0369a1; text-decoration: none; font-size: 14px; padding: 3px 0; display: block;\" href=\"#faq\">\uc790\uc8fc \ubb3b\ub294 \uc9c8\ubb38<\/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. \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \ud3ec\uc7a5 \uc2dc\uc7a5 \ubc0f ISBM\uc758 \uc5ed\ud560<\/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=\"\ud55c\uad6d\uc0b0 Ever-Power HGY150-V4-EV \uc804\uc790\ub3d9 \uc11c\ubcf4 \ubaa8\ud130\ub294 \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc6a9\uae30 \uc0dd\uc0b0\uc5d0 \uc801\ud569\ud569\ub2c8\ub2e4. \uc774 \uc804\uc790\ub3d9 \uc11c\ubcf4 \ubaa8\ud130\ub294 \u00b10.05\ucd08\uc758 \ube14\ub85c\uc6b0 \uc720\uc9c0 \uc2dc\uac04 \uc815\ubc00\ub3c4, \u00b10.3\u00b0C\uc758 \uade0\uc77c\ud55c \uc628\ub3c4 \uc870\uc808 \uc131\ub2a5\uc744 \uc81c\uacf5\ud558\uba70, KFDA 2\uae09 \ubc0f 3\uae09 \uc758\ub8cc\uae30\uae30 \ud3ec\uc7a5 \uac80\uc99d \ubb38\uc11c\ud654\ub97c \uc704\ud55c \uc8fc\uae30\ubcc4 GMP \uacf5\uc815 \ub370\uc774\ud130 \ub85c\uae45 \uae30\ub2a5\uc744 \uac16\ucd94\uace0 \uc788\uc2b5\ub2c8\ub2e4.\" \/><figcaption style=\"font-size: 12px; color: #6b7280; margin-top: 8px; text-align: center;\">\ud55c\uad6d Ever-Power\uc758 HGY150-V4-EV \uc644\uc804 \uc804\uae30 ISBM \ud50c\ub7ab\ud3fc\uc740 \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \ud3ec\uc7a5\uc5d0 \ucd5c\uc801\ud654\ub418\uc5b4 \uc788\uc73c\uba70, EV \uc11c\ubcf4\uc758 \u00b10.3\u00b0C \uc815\ubc00\ud55c \uc628\ub3c4 \uc870\uc808, \u00b10.05\ucd08\uc758 \ube14\ub85c\uc6b0 \ub4dc\ub808\ube59 \uc2dc\uac04, \uadf8\ub9ac\uace0 \uc0ac\uc774\ud074\ubcc4 \uacf5\uc815 \ub85c\uae45 \uae30\ub2a5\uc740 \uc758\ub8cc\uae30\uae30 ISBM\uc744 \uc81c\uc57d ISBM\uacfc \uad6c\ubd84\ud558\ub294 \uc138 \uac00\uc9c0 KFDA GMP \uc694\uad6c\uc0ac\ud56d(\uac80\uc99d\ub41c \uacf5\uc815 \ub9e4\uac1c\ubcc0\uc218 \ubc94\uc704, \uac10\uc0ac \ucd94\uc801 \uae30\ub2a5\uc774 \uc788\ub294 \uc804\uc790 \uacf5\uc815 \uae30\ub85d, \uadf8\ub9ac\uace0 \uc758\ub8cc\uae30\uae30 \ub4f1\ub85d \uae30\uac04 \uc804\uccb4(\ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc81c\uc870 \ubc0f \ud488\uc9c8 \uad00\ub9ac \uae30\uc900\uc5d0 \ub530\ub77c \uc81c\uc870\uc77c\ub85c\ubd80\ud130 \ucd5c\uc18c 3\ub144) \ub3d9\uc548\uc758 \uc0dd\uc0b0 \ub370\uc774\ud130 \ubcf4\uc874)\uc744 \ucda9\uc871\ud569\ub2c8\ub2e4.<\/figcaption><\/figure>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\ud55c\uad6d\uc758 \uc758\ub8cc\uae30\uae30 \uc0b0\uc5c5\uc740 \uc138\uacc4 10\ub300 \uc0b0\uc5c5\uc5d0 \uc18d\ud558\uba70, \uc5f0\uac04 8\uc870 5\ucc9c1\ubc31\ub9cc \uc6d0(TP3T)\uc758 \uc131\uc7a5\ub960\uc744 \uae30\ub85d\ud558\uba70 2025\ub144\uc5d0\ub294 12\uc870 4\ucc9c\uc5b5 \uc6d0(TP3T) \uaddc\ubaa8\uc5d0 \uc774\ub97c \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc0b0\uc5c5\uc5d0\uc11c\ub294 \uccb4\uc678 \uc9c4\ub2e8(IVD) \uae30\uae30, \uc2dc\uc57d \ubcf4\uad00, \uac80\uccb4 \ucc44\ucde8, \uc758\uc57d\ud488 \uc804\ub2ec \uc7a5\uce58 \ud3ec\uc7a5 \ub4f1\uc5d0 \ud544\uc694\ud55c \uc815\ubc00 \ud50c\ub77c\uc2a4\ud2f1 \uc6a9\uae30\uac00 \ub300\ub7c9\uc73c\ub85c \ud544\uc694\ud569\ub2c8\ub2e4. ISBM\uc0ac\uc758 \uc6d0\uc2a4\ud15d \uacf5\uc815\uc740 \uce58\uc218 \uc815\ubc00\ub3c4(\ubaa9 \ubd80\ubd84 \uc678\uacbd \u00b10.04mm), \ud22c\uba85\ub3c4(\uc721\uc548\uc73c\ub85c \ub0b4\uc6a9\ubb3c \ub192\uc774 \ud655\uc778 \uac00\ub2a5\ud55c \ud5e4\uc774\uc988 \u22642.5%), \uad6c\uc870\uc801 \uc548\uc815\uc131(\ubcbd \ub450\uaed8 CV% \u22648%)\uc744 \uac16\ucd98 \uc6a9\uae30\ub97c \uc0dd\uc0b0\ud558\uc5ec \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc5c5\uccb4\ub4e4\uc774 \uc2dc\uc57d, \uc138\ucc99\uc561, \uad50\uc815\uc561, \uc9c4\ub2e8 \ud0a4\ud2b8 \uad6c\uc131\ud488 \ub4f1\uc758 \uc8fc\uc694 \uc6a9\uae30\ub85c \uc0ac\uc6a9\ud558\ub294 \ub370 \ud544\uc694\ud55c \uc870\uac74\uc744 \ucda9\uc871\ud569\ub2c8\ub2e4.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\ud55c\uad6d\uc0b0 ISBM\uc740 \uc138 \uac00\uc9c0 \ud2b9\uc815 \ud06c\uae30 \ubc0f \ud615\uc0c1 \ubc94\uc8fc\uc5d0\uc11c \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc6a9\uae30 \uc2dc\uc7a5\uc5d0\uc11c \uc720\ub9ac \ubc0f IBM(\uc0ac\ucd9c \ube14\ub85c\uc6b0 \uc131\ud615)\uacfc \uacbd\uc7c1\ub825\uc744 \uac16\ucd94\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uccab\uc9f8, 30ml~500ml \uc6a9\ub7c9\uc758 \uc881\uac70\ub098 \uc911\uac04 \ud06c\uae30\uc758 \ubaa9(13~38mm)\uc744 \uac00\uc9c4 \ubcd1\uc758 \uacbd\uc6b0, ISBM\uc758 \uc6b0\uc218\ud55c \ubcbd\uba74 \uade0\uc77c\uc131\uacfc \ud22c\uba85\ub3c4\ub294 \uc720\ub9ac\ubcf4\ub2e4 \ub6f0\uc5b4\ub098\uba74\uc11c\ub3c4 \ubb34\uac8c\uac00 \uac00\ubccd\uace0 \ud30c\uc190 \uc704\ud5d8\uc774 \uc801\uc2b5\ub2c8\ub2e4. \ub458\uc9f8, \ud0a4\ud2b8 \uad6c\uc131\ud488\uc6a9 \ub3d9\uc77c \ubcd1\uc758 \ub2e4\uc911 \uce90\ube44\ud2f0 \uc815\ubc00 \uc0dd\uc0b0(2~4\uac1c \uce90\ube44\ud2f0)\uc774 \uc694\uad6c\ub418\ub294 \uacbd\uc6b0, \uce90\ube44\ud2f0 \uac04 \uce58\uc218 \ud3b8\ucc28\uac00 \ubaa9 \uc678\uacbd \u00b10.04mm \uc774\ud558\uc774\uc5b4\uc57c \ud558\ub294\ub370, ISBM\uc740 \ud504\ub9ac\ud3fc\uc5d0\uc11c \ubcd1\uae4c\uc9c0 \uc6d0\uc2a4\ud15d \uacf5\uc815\uc73c\ub85c \uc774 \uaddc\uaca9\uc744 \ucda9\uc871\ud569\ub2c8\ub2e4. \uc14b\uc9f8, \uc2dc\uc57d \uc794\ub7c9 \ud655\uc778\uc774 \ubbf8\uc801 \uc120\ud638\uac00 \uc544\ub2cc \uc548\uc804 \uae30\ub2a5\uc778 \ud22c\uba85 \uc2dc\uc57d\ubcd1\uc758 \uacbd\uc6b0, \ubd88\ud22c\uba85 \uc6a9\uae30\ub294 \uc0ac\uc6a9\ud560 \uc218 \uc5c6\uc73c\uba70 0.5m \uac70\ub9ac\uc5d0\uc11c\ub3c4 \uc2dc\uc57d \uc794\ub7c9\uc744 \ud655\uc778\ud560 \uc218 \uc788\ub294 \ud55c\uad6d\uc0b0 ISBM\uc758 \ud5e4\uc774\uc988 \uc131\ub2a5(\u22642.5%)\uc774 \ud544\uc218\uc801\uc785\ub2c8\ub2e4.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 0;\">\ud55c\uad6d \uc758\ub8cc\uae30\uae30 \ubd84\uc57c\uc5d0\uc11c ISBM\uc758 \ud575\uc2ec\uc801\uc778 \uc7a5\uc810\uc740 \ud55c\uad6d \uc81c\uc57d \ubd84\uc57c\uc640 \ub9c8\ucc2c\uac00\uc9c0\ub85c \uacf5\uc815 \ub2e8\uacc4\ubcc4 \ucd94\uc801\uc131\uc785\ub2c8\ub2e4. \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA)\uc758 \uc758\ub8cc\uae30\uae30 GMP(\uc758\ub8cc\uae30\uae30\uc758 \uc81c\uc870 \ubc0f \ud488\uc9c8\uad00\ub9ac \uae30\uc900, ISO 13485\uc5d0 \ud574\ub2f9)\ub294 \uac01 \uc0dd\uc0b0 \ub85c\ud2b8\ubcc4\ub85c 1\ucc28 \uc6a9\uae30 \uc81c\uc870 \uacf5\uc815 \uc870\uac74\uc744 \ubb38\uc11c\ud654\ud558\ub3c4\ub85d \uc694\uad6c\ud569\ub2c8\ub2e4. \ud55c\uad6d\uc758 EV \uc11c\ubcf4 ISBM \ud50c\ub7ab\ud3fc\uc740 \uc774\ub7ec\ud55c \uc694\uad6c \uc0ac\ud56d\uc744 \ucda9\uc871\ud569\ub2c8\ub2e4. <a style=\"color: #0369a1; font-weight: 600; text-decoration: none;\" href=\"https:\/\/isbm-blow-molding.com\/ko\/%ec%a0%9c%ed%92%88+%ec%b9%b4%ed%85%8c%ea%b3%a0%eb%a6%ac\/4-station-isbm-machine\/\">\ud55c\uad6d Ever-Power\uc0ac\uc758 4\uc2a4\ud14c\uc774\uc158 ISBM \uc7a5\ube44 \uc81c\ud488\uad70<\/a> \uc774 \ub370\uc774\ud130\ub97c \uc790\ub3d9\uc73c\ub85c \uc0dd\uc131\ud568\uc73c\ub85c\uc368 \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \ud3ec\uc7a5\uc758 GMP \ubb38\uc11c\ud654 \ubd80\ub2f4\uc744 \uc218\ub3d9 \uac80\uc0ac \uc791\uc5c5\uc774 \uc544\ub2cc \ub370\uc774\ud130 \uad00\ub9ac \uc791\uc5c5\uc73c\ub85c \uc804\ud658\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/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. \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA) \uc758\ub8cc\uae30\uae30 \ub4f1\ub85d \uccb4\uacc4: \ud55c\uad6d ISBM \ud3ec\uc7a5\uc7ac \uc81c\uc870\uc5c5\uccb4\uac00 \uc54c\uc544\uc57c \ud560 \uc0ac\ud56d<\/h2>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA)\ub294 \uc758\ub8cc\uae30\uae30\ubc95\uc5d0 \ub530\ub77c \uc758\ub8cc\uae30\uae30\ub97c \uc704\ud5d8\ub3c4\uc5d0 \ub530\ub77c 4\ub2e8\uacc4 \ub4f1\uae09\uc73c\ub85c \ubd84\ub958\ud569\ub2c8\ub2e4. \uc774 \ubd84\ub958\ub294 \uc2b9\uc778 \uacbd\ub85c\ub97c \uacb0\uc815\ud558\uba70, \ud3ec\uc7a5 \uc81c\uc870\uc5c5\uccb4\uc5d0\uac8c \uc911\uc694\ud55c \uac83\uc740 \uc694\uad6c\ub418\ub294 \uc81c\uc870 \ubb38\uc11c \ubc0f \uac80\uc99d\uc758 \ubc94\uc704\uc785\ub2c8\ub2e4. \ud55c\uad6d\uc758 ISBM \ud3ec\uc7a5 \uc81c\uc870\uc5c5\uccb4\ub294 \uace0\uac1d\uc758 \uc758\ub8cc\uae30\uae30\uac00 \uc5b4\ub5a4 \ub4f1\uae09\uc5d0 \uc18d\ud558\ub294\uc9c0 \uc815\ud655\ud788 \ud30c\uc545\ud574\uc57c \ud569\ub2c8\ub2e4. \ud3ec\uc7a5 \uc81c\uc870\uc5c5\uccb4\uc758 GMP \uc758\ubb34\ub294 \ud3ec\uc7a5 \uc81c\uc870\uc5c5\uccb4 \uc790\uccb4\uc758 \ubd84\ub958\uac00 \uc544\ub2cc \uc758\ub8cc\uae30\uae30\uc758 \ub4f1\uae09\uc5d0 \ub530\ub77c \uacb0\uc815\ub418\uae30 \ub54c\ubb38\uc785\ub2c8\ub2e4.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\ud55c\uad6d 1\uae09 \uc758\ub8cc\uae30\uae30(\uc2e0\uace0\ud488\ubaa9)\ub294 \uc77c\ubc18 \uac80\uccb4 \ucc44\ucde8 \uc6a9\uae30, 1\uae09 \uac80\uccb4 \ucef5, \ube44\uba78\uade0 \ube44\uc811\ucd09 \uc561\uc138\uc11c\ub9ac \ud3ec\uc7a5\uc7ac \ub4f1 \uc800\uc704\ud5d8 \uae30\uae30 \ubc0f \uc561\uc138\uc11c\ub9ac\ub97c \ud3ec\ud568\ud569\ub2c8\ub2e4. 1\uae09 \uc758\ub8cc\uae30\uae30\uc5d0 \uc0ac\uc6a9\ub418\ub294 \ud55c\uad6d ISBM \uc6a9\uae30\ub294 \uae30\ubcf8\uc801\uc778 \uc7ac\uc9c8 \uc2dd\ubcc4(\uc218\uc9c0 \ub4f1\uae09, \uc0c9\uc0c1 \ub9c8\uc2a4\ud130\ubc30\uce58 \ub85c\ud2b8), \uce58\uc218 \uae30\ub85d(\ubaa9 \uc678\uacbd, \ubcd1 \ub192\uc774, \ubb34\uac8c), \uc2dd\ud488 \uc811\ucd09 \uac00\ub2a5 \ubb3c\uc9c8 \ubaa9\ub85d \ud655\uc778\ub9cc \ud544\uc694\ud569\ub2c8\ub2e4. \uc774\ubbf8 \ud55c\uad6d \uc2dd\ud488 \uc811\ucd09 \ud3ec\uc7a5 \uae30\uc900\uc744 \ucda9\uc871\ud558\ub294 \ud55c\uad6d ISBM \uc81c\uc870\uc5c5\uccb4\ub294 \ucd5c\uc18c\ud55c\uc758 \ucd94\uac00 \uc11c\ub958 \uc791\uc5c5\ub9cc\uc73c\ub85c 1\uae09 \uc758\ub8cc\uae30\uae30 \uc6a9\uae30\ub97c \uacf5\uae09\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\ud55c\uad6d\uc758 2\uae09 \uc758\ub8cc\uae30\uae30(\uc778\uc99d\ud488\ubaa9)\ub294 \uc911\uc704\ud5d8 \uccb4\uc678\uc9c4\ub2e8 \uc2dc\uc57d \uc6a9\uae30, \uc9c4\ub2e8 \ud0a4\ud2b8 \uad6c\uc131\ud488, \uc138\ucc99\uc561 \ubcd1, \uc784\uc0c1 \uac80\uccb4 \ubcf4\uad00 \uc6a9\uae30 \ub4f1\uc744 \ud3ec\ud568\ud569\ub2c8\ub2e4. 2\uae09 \uc758\ub8cc\uae30\uae30\uc758 \ud55c\uad6d ISBM \ud3ec\uc7a5\uc740 ISO 10993 \uc0dd\uccb4\uc801\ud569\uc131 \ud3c9\uac00(\ucd5c\uc18c \uc138\ud3ec\ub3c5\uc131 \uae30\uc900), \ud2b9\uc815 \ub85c\ud2b8 \ubc0f \ub4f1\uae09\uc5d0 \ub300\ud55c \uc7ac\ub8cc \ucd94\uc801\uc131, \uac01 \uc6a9\uae30\ubcc4 \uce58\uc218 \uc801\ud569\uc131 \uc778\uc99d\uc11c, GMP \ubc30\uce58 \uae30\ub85d \ubcf4\uad00\uc744 \uc694\uad6c\ud569\ub2c8\ub2e4. \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc5c5\uccb4\ub97c \uc778\uc99d\ud558\ub294 \ud55c\uad6d \uc778\uc99d\uae30\uad00\uc740 \uc758\ub8cc\uae30\uae30 \uc778\uc99d \uc2ec\uc0ac\uc758 \uc77c\ud658\uc73c\ub85c \ud3ec\uc7a5 \uc81c\uc870\uc5c5\uccb4\uc758 \ud488\uc9c8 \uad00\ub828 \ubb38\uc11c\ub97c \uac80\ud1a0\ud558\ubbc0\ub85c, \ud3ec\uc7a5 GMP \ubb38\uc11c\ub294 \uc758\ub8cc\uae30\uae30 \uad6c\ub9e4\uc5c5\uccb4\uc758 \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA) \uc778\uc99d\uc744 \uc704\ud55c \ud544\uc218 \uc694\uac74\uc785\ub2c8\ub2e4.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 0;\">\uc57d\ubb3c \uc804\ub2ec \uc2dc\uc2a4\ud15c, \ubb34\uade0 \uae30\uae30 \uc811\ucd09\uba74 \ubc0f \uc0dd\uba85 \uc720\uc9c0 \uae30\uae30 \ud3ec\uc7a5\uc744 \ud3ec\ud568\ud558\ub294 \ud55c\uad6d\uc758 3\uae09 \ubc0f 4\uae09 \uc758\ub8cc\uae30\uae30(\ud5c8\uac00\ud488\ubaa9)\ub294 \uac00\uc7a5 \uc644\ubcbd\ud55c \ud55c\uad6d ISBM \uc81c\uc870 \uac80\uc99d\uc744 \uc694\uad6c\ud569\ub2c8\ub2e4. \uc5ec\uae30\uc5d0\ub294 ISO 10993 \uc0dd\uccb4 \uc801\ud569\uc131 \uc2dc\ub9ac\uc988 \uc804\uccb4(\uc77c\ubc18\uc801\uc73c\ub85c ISO 10993-5 \uc138\ud3ec \ub3c5\uc131, ISO 10993-10 \uac10\uc791, ISO 10993-12 \uc2dc\ub8cc \uc900\ube44), \ucd94\ucd9c\ubb3c \ubc0f \uc6a9\ucd9c\ubb3c(E&amp;L) \uc5f0\uad6c, GMP IQ\/OQ\/PQ \uac80\uc99d, \uba78\uade0 \uac80\uc99d(\ucda9\uc804 \ud6c4 \uc6a9\uae30 \uba78\uade0 \uc2dc), \uadf8\ub9ac\uace0 \uae30\uae30 \ud5c8\uac00 \uc11c\ub958\uc5d0 \ud3ec\ud568\ub41c \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA) 1\ucc28 \uc6a9\uae30 \ub4f1\ub85d\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4. 3\uae09\/4\uae09 \uc758\ub8cc\uae30\uae30 \uacf5\uae09\uc5d0 \uc9c4\uc785\ud558\ub294 \ud55c\uad6d ISBM \uc81c\uc870\uc5c5\uccb4\ub294 \ucd5c\ucd08 \uc0c1\uc6a9 \ub0a9\ud488 \uc804\uc5d0 6~12\uac1c\uc6d4\uc758 \uac80\uc99d \uae30\uac04\uacfc 2,500\ub9cc~5,500\ub9cc \uc6d0\uc758 \uac80\uc99d \ud22c\uc790 \uacc4\ud68d\uc744 \uc218\ub9bd\ud574\uc57c \ud569\ub2c8\ub2e4.<\/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. \uc7ac\ub8cc \uc120\uc815: \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc6a9\uae30\uc6a9 PET, PETG \ubc0f PP<\/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=\"\ud55c\uad6d ISBM \uc758\ub8cc\uae30\uae30\uc6a9 PET \uc6a9\uae30 - \ud55c\uad6d \uc9c4\ub2e8 \ud0a4\ud2b8 2\ucc28 \ud3ec\uc7a5\uc5d0 \uc0ac\uc6a9\ub418\ub294 \ud22c\uba85 PET \uc7ac\uc9c8\uc758 2\uae09 \uccb4\uc678\uc9c4\ub2e8 \uc2dc\uc57d \uc6a9\uae30\ub85c, \ubaa9 \ubd80\ubd84 \uc678\uacbd \uacf5\ucc28 \u00b10.04mm\uc774\uba70, \ub0b4\uc6a9\ubb3c \uc591\uc744 \uc721\uc548\uc73c\ub85c \uc27d\uac8c \ud655\uc778\ud560 \uc218 \uc788\ub3c4\ub85d \ud22c\uba85\ub3c4\uac00 \ub6f0\uc5b4\ub098\uace0, \ub69c\uaed1\uc744 \ub2eb\uc744 \ub54c \ud1a0\ud06c \ud638\ud658\uc131\uc774 \uc6b0\uc218\ud558\ub3c4\ub85d \ubaa9 \ubd80\ubd84 \ub098\uc0ac\uc0b0 \ud615\uc0c1\uc774 \uade0\uc77c\ud569\ub2c8\ub2e4.\" \/><figcaption style=\"font-size: 12px; color: #6b7280; margin-top: 8px; text-align: center;\">\ud55c\uad6d ISBM \uc758\ub8cc\uae30\uae30 PET \uc6a9\uae30 - Class II IVD \uc2dc\uc57d \ubcf4\uad00\uc6a9 \ud06c\ub9ac\uc2a4\ud0c8 PET(\ud5e4\uc774\uc988 \u22642.0%) \uc6a9\uae30\ub85c, \ub125 \uc678\uacbd \u00b10.04mm\uc758 \ud488\uc9c8 \uc778\uc99d\uc744 \ubc1b\uc558\uc2b5\ub2c8\ub2e4. \ud55c\uad6d \uc9c4\ub2e8 \uc0b0\uc5c5\uc758 \ud45c\uc900 \ub125 \ub9c8\uac10 \uaddc\uaca9\uc740 15~100ml \uc2dc\uc57d \uc6a9\uae30\uc758 \uacbd\uc6b0 GPI 24\/415, 100~500ml\uc758 \uacbd\uc6b0 GPI 28\/415\uc785\ub2c8\ub2e4. \ub530\ub77c\uc11c \ub2e8\uc77c \uc778\uc99d\ub41c \ud55c\uad6d ISBM \uacf5\uae09\uc5c5\uccb4\ub85c\ubd80\ud130 \uc5ec\ub7ec \ud55c\uad6d IVD \uc81c\uc870\uc5c5\uccb4\uc758 \ud0a4\ud2b8 \uad6c\uc131\ud488 \uc6a9\uae30\uc5d0 \ub300\ud574 \ud45c\uc900\ud654\ub41c \ud55c\uad6d\uc0b0 \uc2a4\ub0c5\ucea1 \ubc0f \uc2a4\ud06c\ub958\ucea1 \ub9c8\uac1c \uaddc\uaca9\uc744 \uc801\uc6a9\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/figcaption><\/figure>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\ud55c\uad6d\uc758 ISBM \uc758\ub8cc\uae30\uae30 \uc6a9\uae30 \uc18c\uc7ac \uc120\uc815\uc740 \uc138 \uac00\uc9c0 \uc694\uc18c\uc5d0 \uc758\ud574 \uacb0\uc815\ub429\ub2c8\ub2e4. \ud2b9\uc815 \uc2dc\uc57d \ub610\ub294 \uae30\uae30 \ub0b4\uc6a9\ubb3c\uacfc\uc758 \ud654\ud559\uc801 \ud638\ud658\uc131, \uba78\uade0 \ubc29\ubc95\uacfc\uc758 \ud638\ud658\uc131, \uadf8\ub9ac\uace0 \uaddc\uc81c \uc900\uc218\uc785\ub2c8\ub2e4. \ubbf8\uc6a9\uc801\uc778 \uce21\uba74\uc5d0\uc11c PETG\uac00 \uc120\ud638\ub418\ub294 \ud55c\uad6d\uc758 K-\ubdf0\ud2f0 \ubd84\uc57c\uc640\ub294 \ub2ec\ub9ac, \uc758\ub8cc\uae30\uae30 \ubd84\uc57c\uc5d0\uc11c\ub294 \uc18c\uc7ac \uc120\uc815 \uc804\uc5d0 \uc2e0\uc911\ud55c \ubd84\uc11d\uc774 \ud544\uc694\ud569\ub2c8\ub2e4. PETG, PET, PP\ub294 \uac01\uac01 \uace0\uc720\ud55c \uc7a5\uc810\uacfc \ud55c\uacc4\ub97c \uac00\uc9c0\uace0 \uc788\uc73c\uba70, \uc774\ub7ec\ud55c \uc694\uc18c\ub4e4\uc774 \uac01\uae30 \ub2e4\ub978 \uae30\uae30 \uc885\ub958\uc5d0 \uc801\ud569\ud55c \uc18c\uc7ac\ub97c \uacb0\uc815\ud569\ub2c8\ub2e4.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\"><strong>\ud55c\uad6d \uc758\ub8cc\uae30\uae30\uc6a9 PET:<\/strong> PET(\ud3f4\ub9ac\uc5d0\ud2f8\ub80c \ud14c\ub808\ud504\ud0c8\ub808\uc774\ud2b8)\ub294 1\uae09 \ubc0f 2\uae09 \uc758\ub8cc\uae30\uae30 \uc6a9\uae30\uc5d0 \uac00\uc7a5 \ub110\ub9ac \uc0ac\uc6a9\ub418\ub294 \ud55c\uad6d\uc0b0 ISBM \uc18c\uc7ac\uc785\ub2c8\ub2e4. PET\uc758 \uc7a5\uc810\uc740 \uc0c1\uc628 \ubcf4\uad00 \uc2dc \ucd94\ucd9c\ubb3c \ud568\ub7c9\uc774 \ub0ae\ub2e4\ub294 \uc810(ISO 10993-17 \uc704\ud5d8 \ud3c9\uac00 \uae30\uc900\uc5d0 \ub530\ub77c \uc798 \ud2b9\uc131\ud654\ub428), \uc218\uc6a9\uc561, \uc0b0\uc131 \uc644\ucda9\uc561(pH 3~9), \uc0dd\ub9ac\uc2dd\uc5fc\uc218 \ub4f1 \ud55c\uad6d \uccb4\uc678\uc9c4\ub2e8 \uc2dc\uc57d\uc758 \ub300\ubd80\ubd84\uc744 \ucc28\uc9c0\ud558\ub294 \ub2e4\uc591\ud55c \uc6a9\uc561\uacfc\uc758 \ud654\ud559\uc801 \ud638\ud658\uc131, \uadf8\ub9ac\uace0 \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA) \uc2b9\uc778 \uc774\ub825\uc785\ub2c8\ub2e4. \ub2e8\uc810\uc73c\ub85c\ub294 PET\uac00 65~70\u00b0C \uc774\uc0c1\uc5d0\uc11c \ubcc0\ud615\ub41c\ub2e4\ub294 \uc810(\uac10\ub9c8\uc120 \uba78\uade0 \uc2dc \uc5f4 \ubd80\ud558\uc640 \uad00\ub828\ub418\uc9c0\ub9cc, PET\ub294 \uac10\ub9c8\uc120 \ub610\ub294 \uc804\uae30\uc0b0\ud654(EO) \uba78\uade0 \uc2dc \uc0c1\uc628\uc5d0\uc11c \uba78\uade0\ub418\ubbc0\ub85c \uc77c\ubc18\uc801\uc73c\ub85c \ubb38\uc81c\uac00 \ub418\uc9c0 \uc54a\uc74c), PET\uac00 340nm \uc774\ud558\uc758 \uc790\uc678\uc120\uc744 \ud761\uc218\ud55c\ub2e4\ub294 \uc810(\uc790\uc678\uc120\uc5d0 \ubbfc\uac10\ud55c \uc2dc\uc57d\uc5d0 \uad00\ub828\ub428 - \uad11\ubbfc\uac10\uc131 \uc9c4\ub2e8 \uc81c\uc81c\uc5d0\ub294 \uc790\uc678\uc120 \uc548\uc815\ud654 PET \ub4f1\uae09\uc744 \uc9c0\uc815\ud574\uc57c \ud568), \uadf8\ub9ac\uace0 \uc720\uae30 \uc6a9\ub9e4 \ud568\ub7c9\uc774 10%\ub97c \ucd08\uacfc\ud558\ub294 \uc2dc\uc57d\uc5d0\ub294 PET\ub97c \uc0ac\uc6a9\ud574\uc11c\ub294 \uc548 \ub41c\ub2e4\ub294 \uc810(\uc751\ub825 \uade0\uc5f4 \uc704\ud5d8) \ub4f1\uc774 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\"><strong>\ud55c\uad6d \uc758\ub8cc\uae30\uae30\uc6a9 PETG:<\/strong> PETG(\ud3f4\ub9ac\uc5d0\ud2f8\ub80c \ud14c\ub808\ud504\ud0c8\ub808\uc774\ud2b8 \uae00\ub9ac\ucf5c)\ub294 \uc0c9\ub3c4 \uce21\uc815 \uac80\uc0ac\uc758 \uc721\uc548 \ud310\ub3c5\uc5d0 \ud544\uc694\ud55c \ud22c\uba85\ub3c4(\ud5e4\uc774\uc988 \u22641.5%)\uac00 \uc694\uad6c\ub418\ub294 \ud55c\uad6d 2\uae09 \uc9c4\ub2e8 \ud0a4\ud2b8 \uad6c\uc131\ud488\uacfc, PET\uc758 \ub192\uc740 \uac15\uc131\uc73c\ub85c \uc778\ud574 \ud30c\uc190 \ubc29\uc9c0 \ub610\ub294 \uc808\ucde8\uc120 \ud45c\uc2dc\uac00 \ud544\uc694\ud55c \ud55c\uad6d \uccb4\uc678 \uc9c4\ub2e8 \uae30\uae30 \uc6a9\uae30\uc5d0 \uc120\ud638\ub429\ub2c8\ub2e4. \uadf8\ub7ec\ub098 PETG\ub294 \ud2b9\uc815 \uc720\uae30 \uc6a9\ub9e4(\uc5d0\ud0c4\uc62c 40% \uc774\uc0c1, \uc544\uc138\ud1a4, MEK)\uc5d0 \ub300\ud55c \ub0b4\ud654\ud559\uc131\uc774 \ub0ae\uc544 \ud55c\uad6d \uc2e4\ud5d8\uc2e4 \uc138\ucc99\uc561 \ubc0f \uc6a9\ub9e4 \ud568\uc720 \uc2dc\uc57d\uc5d0\ub294 \uc0ac\uc6a9\uc774 \uc81c\ud55c\uc801\uc785\ub2c8\ub2e4. \ub530\ub77c\uc11c \uc720\uae30 \uc6a9\ub9e4 \ub18d\ub3c4\uac00 30%\ub97c \ucd08\uacfc\ud558\ub294 \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc2dc\uc57d\uc5d0 PETG\ub97c \uc0ac\uc6a9\ud558\uae30 \uc804\uc5d0 \ud638\ud658\uc131\uc744 \ud655\uc778\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 0;\"><strong>\ud55c\uad6d \uc758\ub8cc\uae30\uae30\uc6a9 PP:<\/strong> \ud3f4\ub9ac\ud504\ub85c\ud544\ub80c(PP)\uc740 \uace0\uc628 \uace0\uc555\uba78\uade0(121\u00b0C\uc5d0\uc11c 20\ubd84)\uc744 \uacac\ub38c\uc57c \ud558\ub294 \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc6a9\uae30\uc5d0 \uc801\ud569\ud55c \uc18c\uc7ac\uc785\ub2c8\ub2e4. PET\uc640 PETG\ub294 \uace0\uc555\uba78\uade0 \uc628\ub3c4\ub97c \uacac\ub51c \uc218 \uc5c6\uc2b5\ub2c8\ub2e4. \ud55c\uad6d\uc758 \uace0\uc555\uba78\uade0 \uac00\ub2a5 \uc758\ub8cc\uae30\uae30 \uc6a9\uae30\uc6a9 PP ISBM(\ub2e8\uc77c \uae08\ud615 \uc81c\uc870) \uacf5\uc815\uc5d0\ub294 PP \uace0\uc628 \ucda9\uc804 ISBM(120~145\u00b0C \uc628\ub3c4 \uc870\uc808, \uac00\uc5f4\uc2dd \uae08\ud615 \ubca0\uc774\uc2a4 \uc778\uc11c\ud2b8 \uc0ac\uc6a9) \uae30\uc220\uc774 \ud544\uc694\ud569\ub2c8\ub2e4. \uc774\ub294 PET ISBM\ubcf4\ub2e4 \uae30\uc220\uc801\uc73c\ub85c \ub354 \uae4c\ub2e4\ub86d\uace0 \ub110\ub9ac \ubcf4\uae09\ub418\uc9c0 \uc54a\uc740 \uacf5\uc815\uc785\ub2c8\ub2e4. PP \uc758\ub8cc\uae30\uae30 \uc6a9\uae30 \uacac\uc801\uc744 \uc81c\ucd9c\ud558\ub294 \ud55c\uad6d ISBM \uc5c5\uccb4\ub294 \uacc4\uc57d \uccb4\uacb0 \uc804\uc5d0 \uc790\uc0ac \uc7a5\ube44\uc758 \uc628\ub3c4 \uc870\uc808 \uc2a4\ud14c\uc774\uc158 \ucd5c\ub300 \uc628\ub3c4\ub97c \ud655\uc778\ud574\uc57c \ud569\ub2c8\ub2e4. PETG\uac00 \uc0c9\ub3c4 \uce21\uc815 \uc751\uc6a9 \ubd84\uc57c\uc5d0 \uc81c\uacf5\ud558\ub294 \uad11\ud559\uc801 \ud22c\uba85\ub3c4 \uc694\uad6c \uc0ac\ud56d\uc5d0 \ub300\ud55c \uc790\uc138\ud55c \ub0b4\uc6a9\uc740 \uc804\uccb4 \uac00\uc774\ub4dc\uc5d0\uc11c \ud655\uc778\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. <a style=\"color: #0369a1; font-weight: 600; text-decoration: none;\" href=\"https:\/\/isbm-blow-molding.com\/ko\/how-to-improve-transparency-isbm-injection-stretch-blow-molding\/\">\ud55c\uad6d ISBM \ud22c\uba85\uc131 \uac1c\uc120<\/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 \uc0dd\uccb4 \uc801\ud569\uc131 \ud3c9\uac00: \ud55c\uad6d ISBM \uc0dd\uc0b0\uc790\uac00 \uc81c\uacf5\ud574\uc57c \ud558\ub294 \uc0ac\ud56d<\/h2>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">ISO 10993-1:2018(\uc758\ub8cc\uae30\uae30\uc758 \uc0dd\ubb3c\ud559\uc801 \ud3c9\uac00 - \uc81c1\ubd80: \uc704\ud5d8 \uad00\ub9ac \ud504\ub85c\uc138\uc2a4 \ub0b4\uc5d0\uc11c\uc758 \ud3c9\uac00 \ubc0f \uc2dc\ud5d8)\uc740 \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA)\uac00 \ubaa8\ub4e0 \ud55c\uad6d \uc758\ub8cc\uae30\uae30 1\ucc28 \ud3ec\uc7a5\uc7ac\uc5d0 \ub300\ud574 \ucc38\uc870\ud558\ub294 \uc0dd\uccb4\uc801\ud569\uc131 \ud3c9\uac00\uc5d0 \uad00\ud55c \uad6d\uc81c \ud45c\uc900\uc785\ub2c8\ub2e4. ISO 10993\uc740 \uace0\uc815\ub41c \uc2dc\ud5d8 \ud56d\ubaa9\uc744 \uaddc\uc815\ud558\ub294 \uac83\uc774 \uc544\ub2c8\ub77c, \uae30\uae30\uac00 \uc778\uccb4\uc640 \uc811\ucd09\ud558\ub294 \ubc29\uc2dd(\ud45c\uba74 \uc811\ucd09, \ud45c\uba74 \uc190\uc0c1, \ud608\uc561 \uc811\ucd09) \ubc0f \uc811\ucd09 \uc2dc\uac04(\ub2e8\uae30\uc801, \uc7a5\uae30\uc801, \uc601\uad6c\uc801)\uc5d0 \ub530\ub77c \uc2dc\ud5d8\uc744 \uc120\ud0dd\ud558\ub294 \uc704\ud5d8 \uae30\ubc18 \ud3c9\uac00 \uc811\uadfc\ubc95\uc744 \uba85\uc2dc\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\ud55c\uad6d\uc0b0 ISBM \uc2dc\uc57d\ubcd1(Class II IVD, \ud658\uc790\uc640 \uac04\uc811 \uc811\ucd09 - \uc2dc\uc57d\uc774 \uae30\uae30\uc5d0 \uc811\ucd09\ud558\uace0 \ud658\uc790\uc5d0\uac8c\ub294 \uc811\ucd09\ud558\uc9c0 \uc54a\uc74c)\uc758 \uc0dd\uccb4 \uc801\ud569\uc131 \ud3c9\uac00\ub294 \uc77c\ubc18\uc801\uc73c\ub85c ISO 10993-5(\uc138\ud3ec\ub3c5\uc131) \ubc0f ISO 10993-12(\uc0dd\ubb3c\ud559\uc801 \ud3c9\uac00\ub97c \uc704\ud55c \uc2dc\ub8cc \uc900\ube44)\uc5d0 \ub530\ub77c \uc81c\ud55c\ub429\ub2c8\ub2e4. \uc774 \ub450 \uac00\uc9c0 \uc2dc\ud5d8\uc740 PET \ub610\ub294 PETG \uc7ac\uc9c8\uc774 \ud658\uc790\uc5d0\uac8c \uac04\uc811\uc801\uc73c\ub85c \ub178\ucd9c\ub420 \uc218 \uc788\ub294 \uc591\uc758 \uc138\ud3ec\ub3c5\uc131 \ubb3c\uc9c8\uc744 \ubc29\ucd9c\ud558\uc9c0 \uc54a\uc73c\uba70, \ud6c4\uc18d \uc2dc\ud5d8\uc5d0 \uc0ac\uc6a9\ub418\ub294 \uc2dc\ub8cc \uc900\ube44 \ud504\ub85c\ud1a0\ucf5c\uc774 \uac80\uc99d\ub418\uc5c8\uc74c\uc744 \ud655\uc778\ud569\ub2c8\ub2e4. \ud55c\uad6d\uc0b0 ISBM Class II IVD \uc2dc\uc57d\ubcd1\uc758 \ucd1d \uc2dc\ud5d8 \ube44\uc6a9\uc740 \ud55c\uad6d\uc2dc\ud5d8\uc5f0\uad6c\uc6d0(KTR) \ub610\ub294 \ud55c\uad6d\uc801\ud569\uc131\ud3c9\uac00\uc6d0(KCL)\uc5d0\uc11c 400\ub9cc~800\ub9cc \uc6d0\uc785\ub2c8\ub2e4.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\ud55c\uad6d\uc758 3\uae09 \uc758\ub8cc\uae30\uae30 \uc6a9\uae30(\ud658\uc790\uc758 \ud53c\ubd80 \ub610\ub294 \uc810\ub9c9\uc5d0 \uc9c1\uc811 \uc811\ucd09\ud558\ub294 \uc6a9\uae30)\uc758 \uacbd\uc6b0, ISO 10993 \uc804\uccb4 \ud3c9\uac00\uc5d0\ub294 \uc138\ud3ec\ub3c5\uc131(ISO 10993-5), \uac10\uc791\uc131(ISO 10993-10), \uc790\uadf9\uc131(ISO 10993-23), \uae09\uc131 \uc804\uc2e0 \ub3c5\uc131(ISO 10993-11) \ubc0f \uc544\ub9cc\uc131 \ub3c5\uc131(ISO 10993-11 - 90\uc77c \uc5f0\uad6c)\uc774 \ud3ec\ud568\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ucd1d \uc2dc\ud5d8 \ube44\uc6a9\uc740 2,500\ub9cc~6,500\ub9cc \uc6d0\uc774\uba70, \uc18c\uc694 \uae30\uac04\uc740 6~9\uac1c\uc6d4\uc785\ub2c8\ub2e4. 3\uae09 \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc5c5\uccb4\uc5d0 \ud3ec\uc7a5\uc7ac\ub97c \uacf5\uae09\ud558\ub294 \ud55c\uad6d ISBM \ud3ec\uc7a5\uc7ac \uc81c\uc870\uc5c5\uccb4\ub294 \uace0\uac1d\uc774 \uc774\ubbf8 \ud3ec\uc7a5 \uc0ac\uc591\uc744 \ud655\uc815\ud55c \uacc4\uc57d \uccb4\uacb0 \uc2dc\uc810\uc774 \uc544\ub2cc, \uae08\ud615 \uc801\uaca9\uc131 \ud3c9\uac00 \uc2dc\uc810\uc5d0 \uc774\ub7ec\ud55c \ud3c9\uac00\ub97c \uacc4\ud68d\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 0;\">\ud55c\uad6d ISBM \uc0dd\uccb4 \uc801\ud569\uc131 \ud3c9\uac00 \ubb38\uc11c \uc694\uad6c \uc0ac\ud56d: \uac01 ISO 10993 \uc2dc\ud5d8 \ubcf4\uace0\uc11c\uc5d0\ub294 \ud2b9\uc815 \uc218\uc9c0 \ub4f1\uae09(\uc81c\uc870\uc5c5\uccb4, \ub4f1\uae09 \uba85\uce6d, \ub85c\ud2b8 \ubc88\ud638), \uc2dc\ud5d8 \uc0d8\ud50c \uc0dd\uc0b0\uc5d0 \uc0ac\uc6a9\ub41c ISBM \uacf5\uc815 \uc870\uac74(\ucee8\ub514\uc154\ub2dd \uc628\ub3c4, \ube14\ub85c\uc6b0 \uc555\ub825, \uc0ac\uc774\ud074 \uc2dc\uac04 - \uacf5\uc815 \uc870\uac74\uc774 \ucd94\ucd9c\ubb3c \ud568\ub7c9\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce58\uae30 \ub54c\ubb38), \uadf8\ub9ac\uace0 \uc2dc\ud5d8 \uae30\uad00\uc758 \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA) \uc778\uc99d \uc5ec\ubd80\ub97c \uba85\uc2dc\ud574\uc57c \ud569\ub2c8\ub2e4. \uc591\uc0b0 \uc0d8\ud50c\uacfc \ub2e4\ub978 \uacf5\uc815 \uc870\uac74\uc5d0\uc11c \uc0dd\uc0b0\ub41c \uc0d8\ud50c\ub85c \uc218\ud589\ub41c \uc0dd\uccb4 \uc801\ud569\uc131 \uc2dc\ud5d8\uc740 \ud55c\uad6d KFDA 3\uae09 \ud5c8\uac00 \uc81c\ucd9c\uc5d0 \uc720\ud6a8\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \uc774\ub294 \uc0dd\uccb4 \uc801\ud569\uc131 \uc2dc\ud5d8\uc5d0 \ube44\ud45c\uc900 \uc870\uac74\uc73c\ub85c \uc0dd\uc0b0\ub41c \uc2e4\ud5d8\uc2e4 \uc0d8\ud50c\uc744 \uc0ac\uc6a9\ud55c \ud6c4 \uc591\uc0b0 \uc801\uaca9\uc131 \ud3c9\uac00 \uacfc\uc815\uc5d0\uc11c \uacf5\uc815 \uc870\uac74\uc744 \ubcc0\uacbd\ud558\ub294 \ud55c\uad6d ISBM \uc81c\uc870\uc5c5\uccb4\ub97c \uc801\ubc1c\ud558\uae30 \uc704\ud55c \uae30\uc220\uc801 \uc138\ubd80 \uc0ac\ud56d\uc785\ub2c8\ub2e4.<\/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. \uba78\uade0 \ubc29\ubc95 \ud638\ud658\uc131: \ud55c\uad6d\uc0b0 ISBM \uc816\ubcd1 \uc885\ub958 \ubc0f \uc81c\uc57d \uc0ac\ud56d<\/h2>\n<p style=\"font-size: 16px; margin-bottom: 20px;\">\ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc6a9\uae30\ub294 \ud3ec\uc7a5 \uc81c\uc870\uc5c5\uccb4(ISBM \ubcd1\uc758 \uacbd\uc6b0 \ub4dc\ubb3c\uc9c0\ub9cc) \ub610\ub294 \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \ud68c\uc0ac\uc758 \ucda9\uc804 \uc2dc\uc124(\ub354 \uc77c\ubc18\uc801)\uc5d0\uc11c \uba78\uade0 \ucc98\ub9ac\ub429\ub2c8\ub2e4. \ud55c\uad6d ISBM \ud3ec\uc7a5\uc7ac \uc81c\uc870\uc5c5\uccb4\ub294 \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uace0\uac1d\uc774 \uc0ac\uc6a9\ud560 \uba78\uade0 \ubc29\ubc95\uc744 \uc815\ud655\ud788 \ud30c\uc545\ud574\uc57c \ud569\ub2c8\ub2e4. \uba78\uade0 \uc870\uac74\uc5d0 \ub530\ub978 \uc7ac\uc9c8 \ud638\ud658\uc131, \uce58\uc218 \uc548\uc815\uc131, \uad11\ud559\uc801 \ud2b9\uc131 \uc720\uc9c0\uc728\uc774 \ud06c\uac8c \ub2e4\ub974\uae30 \ub54c\ubb38\uc5d0 \uc5b4\ub5a4 \ud55c\uad6d\uc0b0 ISBM \uc7ac\uc9c8\uc774 \uae30\uc220\uc801\uc73c\ub85c \uc801\ud569\ud55c\uc9c0\uac00 \uacb0\uc815\ub418\uae30 \ub54c\ubb38\uc785\ub2c8\ub2e4.<\/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;\">\uc0b4\uade0 \ubc29\ubc95<\/th>\n<th style=\"color: #fff; padding: 9px 12px; text-align: center; font-weight: bold;\">\uc560\uc644 \ub3d9\ubb3c<\/th>\n<th style=\"color: #fff; padding: 9px 12px; text-align: center; font-weight: bold;\">\ud3ab\ud2f0\uadf8<\/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;\">\ud55c\uad6d\uc5b4 ISBM \ub178\ud2b8<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">EO(\uc5d0\ud2f8\ub80c\uc625\uc0ac\uc774\ub4dc)<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 \ud638\ud658 \uac00\ub2a5<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 \ud638\ud658 \uac00\ub2a5<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 \ud638\ud658 \uac00\ub2a5<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd;\">EO \uacf5\uc815\uc740 55\u00b0C \uc774\ud558\uc5d0\uc11c \uc9c4\ud589\ub418\uba70, \uc138 \uac00\uc9c0 \uc870\uac74 \ubaa8\ub450\uc5d0 \uc548\uc804\ud569\ub2c8\ub2e4. \ucd9c\ud558 \uc804 24~48\uc2dc\uac04 \ub3d9\uc548 EO \uc794\ub958\ubb3c \uc81c\uac70 \uacfc\uc815\uc744 \uac70\uccd0\uc57c \ud569\ub2c8\ub2e4. ISO 10993-7\uc5d0 \ub530\ub77c EO \uc794\ub958\ubb3c\uc744 \uac80\uc99d\ud558\uc2ed\uc2dc\uc624(\uae30\uae30 \ub0b4 EO \ub18d\ub3c4 10\u03bcg\/g \uc774\ud558).<\/td>\n<\/tr>\n<tr style=\"background: #f0f9ff;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">\uac10\ub9c8\uc120 \uc870\uc0ac<\/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 15kGy \uc774\ud558<\/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\ub294 25kGy \uc774\uc0c1\uc5d0\uc11c \uc810\uc9c4\uc801\uc73c\ub85c \ud669\ubcc0 \ud604\uc0c1\uc774 \ub098\ud0c0\ub098\ubbc0\ub85c, 20kGy \uc774\uc0c1 \uc870\uc0ac \uc2dc\uc5d0\ub294 \ubc29\uc0ac\uc120 \uc548\uc815\ud654 PET \ub4f1\uae09(\uc608: Eastman EB062)\uc744 \uc0ac\uc6a9\ud574\uc57c \ud569\ub2c8\ub2e4. PETG\ub294 15kGy \uc774\uc0c1\uc5d0\uc11c \ud669\ubcc0 \ud604\uc0c1\uc744 \ubcf4\uc774\uba70, \uc77c\ubc18\uc801\uc73c\ub85c \ud45c\uc900 25kGy \uac10\ub9c8\uc120 \uc870\uc0ac\uc5d0\ub294 \uc801\ud569\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/td>\n<\/tr>\n<tr>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">\uc804\uc790\ube54<\/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 15kGy \uc774\ud558<\/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;\">\uac10\ub9c8\uc120\uacfc \uc720\uc0ac\ud558\uac8c, \uc804\uc790\ube54\uc740 \uac10\ub9c8\uc120\ubcf4\ub2e4 \uce68\ud22c \uae4a\uc774\uac00 \uc595\uae30 \ub54c\ubb38\uc5d0 \ub2e4\uce35 \ud3ec\uc7a5\uc5d0 \uc720\ub9ac\ud569\ub2c8\ub2e4. \ub2e8\uc77c \ubcd1\uc758 \uacbd\uc6b0 \uac10\ub9c8\uc120 \uc870\uc0ac\uc640 \ub3d9\uc77c\ud55c \ud6a8\uacfc\ub97c \ub098\ud0c0\ub0c5\ub2c8\ub2e4.<\/td>\n<\/tr>\n<tr style=\"background: #f0f9ff;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; font-weight: 600;\">\uc99d\uae30 \uc624\ud1a0\ud074\ub808\uc774\ube0c(121\u00b0C)<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #dc2626; font-weight: bold;\">\u2717 \ud638\ud658\ub418\uc9c0 \uc54a\uc74c<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #dc2626; font-weight: bold;\">\u2717 \ud638\ud658\ub418\uc9c0 \uc54a\uc74c<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 \ud638\ud658 \uac00\ub2a5<\/td>\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #bae6fd;\">PET\uc758 \uc720\ub9ac\uc804\uc774\uc628\ub3c4(Tg)\ub294 \uc57d 75\u00b0C\uc774\uace0 PETG\uc758 \uc720\ub9ac\uc804\uc774\uc628\ub3c4\ub294 \uc57d 81\u00b0C\uc785\ub2c8\ub2e4. \ub450 \uc18c\uc7ac \ubaa8\ub450 121\u00b0C\uc5d0\uc11c \uc2ec\ud558\uac8c \uc5f0\ud654\ub429\ub2c8\ub2e4. PP\ub294 \uc624\ud1a0\ud074\ub808\uc774\ube0c \uacf5\uc815\uc5d0 \uc801\ud569\ud55c ISBM \uc18c\uc7ac\uc785\ub2c8\ub2e4. PP ISBM\uc5d0\ub294 \uac00\uc5f4\uc2dd \uae08\ud615 \ubca0\uc774\uc2a4 \uc778\uc11c\ud2b8\uac00 \ud544\uc694\ud558\ubbc0\ub85c \uc0ac\uc591\uc744 \uc815\ud558\uae30 \uc804\uc5d0 \uae30\uacc4 \uacf5\uae09\uc5c5\uccb4\uc640 \ud655\uc778\ud558\uc2ed\uc2dc\uc624.<\/td>\n<\/tr>\n<tr>\n<td style=\"padding: 9px 12px; font-weight: 600;\">UV-C(254nm)<\/td>\n<td style=\"padding: 9px 12px; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 \ud45c\uba74\ub9cc<\/td>\n<td style=\"padding: 9px 12px; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 \ud45c\uba74\ub9cc<\/td>\n<td style=\"padding: 9px 12px; text-align: center; color: #16a34a; font-weight: bold;\">\u2713 \ud45c\uba74\ub9cc<\/td>\n<td style=\"padding: 9px 12px;\">\ud45c\uba74 \uc624\uc5fc \uc81c\uac70\uc6a9\uc774\uba70, \ud55c\uad6d Class III\/IV \uc6a9\uae30\uc5d0 \ub300\ud55c \uc0b4\uade0 \uac80\uc99d\uc744 \ubc1b\uc9c0 \uc54a\uc558\uc2b5\ub2c8\ub2e4. \ud55c\uad6d Class I\/II \uc800\uc704\ud5d8 \ud45c\uba74 \uc18c\ub3c5\uc5d0 \uc0ac\uc6a9\ub429\ub2c8\ub2e4. PET\ub294 \uc790\uc678\uc120\uc744 \ud6a8\uc728\uc801\uc73c\ub85c \ud761\uc218\ud558\ubbc0\ub85c \ub450\uaebc\uc6b4 \ubcbd \uc6a9\uae30\uc758 \uacbd\uc6b0 \ub0b4\ubd80 \ud45c\uba74 \uc18c\ub3c5\ub7c9 \uacc4\uc0b0\uc744 \ud655\uc778\ud558\uc2ed\uc2dc\uc624.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p style=\"font-size: 16px; margin-bottom: 0;\">\ud55c\uad6d\uc758 ISBM(\uade0\uc77c \uc81c\uc870 \uae08\ud615) \uc81c\uc870\uc5c5\uccb4\ub294 \uacac\uc801 \ub2e8\uacc4\uc5d0\uc11c \uc7ac\ub8cc \uc0ac\uc591\uc744 \ud655\uc815\ud558\uae30 \uc804\uc5d0 \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uace0\uac1d\uc5d0\uac8c \uba78\uade0 \ubc29\ubc95\uacfc \uac80\uc99d \uc120\ub7c9\uc744 \uc694\uccad\ud574\uc57c \ud569\ub2c8\ub2e4. \uc608\ub97c \ub4e4\uc5b4, 25kGy \uac10\ub9c8\uc120 \uba78\uade0\uc744 \uc0ac\uc6a9\ud558\ub294 \uace0\uac1d\uc5d0\uac8c \ud22c\uba85\ud55c PETG \uc7ac\uc9c8\uc758 \ud55c\uad6d\uc0b0 2\ub4f1\uae09 \uccb4\uc678\uc9c4\ub2e8\uc6a9\uae30(IVD)\ub97c \uacac\uc801\ud560 \uacbd\uc6b0, \uae08\ud615 \uc81c\uc791 \ud6c4 6~8\uac1c\uc6d4 \ud6c4\uc5d0 \uc2e4\uc2dc\ub418\ub294 \uba78\uade0 \uac80\uc99d \uacfc\uc815\uc5d0\uc11c PETG \uc6a9\uae30\uac00 \ub204\ub807\uac8c \ubcc0\uc0c9\ub418\uc5b4 \uace0\uac1d\uc758 \uba78\uade0 \ud6c4 \ud22c\uba85\ub3c4 \uae30\uc900\uc744 \ucda9\uc871\ud558\uc9c0 \ubabb\ud558\ub294 \uc7ac\ub8cc \ubd80\uc801\ud569 \ubb38\uc81c\uac00 \ubc1c\uc0dd\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/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. \ucd94\ucd9c\ubb3c \ubc0f \uc6a9\ucd9c\ubb3c: ISBM \uc758\ub8cc\uc6a9 \uc6a9\uae30\uc5d0 \ub300\ud55c \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA)\uc758 \uae30\ub300\uc0ac\ud56d<\/h2>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\ucd94\ucd9c\ubb3c \ubc0f \uc6a9\ucd9c\ubb3c(E&amp;L) \ubd84\uc11d\uc740 \ud55c\uad6d ISBM 3\uae09 \uc758\ub8cc\uae30\uae30 \uc6a9\uae30\uc5d0 \ub300\ud55c \uac00\uc7a5 \uae30\uc220\uc801\uc73c\ub85c \uae4c\ub2e4\ub85c\uc6b4 \ubb38\uc11c \uc694\uad6c \uc0ac\ud56d\uc785\ub2c8\ub2e4. \ucd94\ucd9c\ubb3c\uc740 \uace0\uc628, \uc6a9\ub9e4 \ucd94\ucd9c\uacfc \uac19\uc740 \uac00\ud639\ud55c \uc2e4\ud5d8 \uc870\uac74\uc5d0\uc11c \ud3ec\uc7a5\uc7ac\uc5d0\uc11c \uc6a9\ucd9c\ub420 \uc218 \uc788\ub294 \ud654\ud559 \ubb3c\uc9c8\ub85c, \ud3ec\uc7a5\uc7ac\ub85c\ubd80\ud130 \ubc1c\uc0dd\ud560 \uc218 \uc788\ub294 \ucd5c\ub300 \ud654\ud559 \ubb3c\uc9c8 \ub178\ucd9c\ub7c9\uc744 \ub098\ud0c0\ub0c5\ub2c8\ub2e4. \uc6a9\ucd9c\ubb3c\uc740 \uc815\uc0c1 \ub610\ub294 \uac00\ud639\ud55c \ubcf4\uad00 \uc870\uac74\uc5d0\uc11c \uc2e4\uc81c\ub85c \uc81c\ud488\uc73c\ub85c \uc774\ub3d9\ud558\ub294 \ucd94\ucd9c\ubb3c\uc758 \ud558\uc704 \uc9d1\ud569\uc73c\ub85c, \ud3ec\uc7a5\ub41c \uc81c\ud488\uc73c\ub85c\ubd80\ud130 \ud658\uc790 \ub610\ub294 \uc0ac\uc6a9\uc790\uac00 \uc2e4\uc81c\ub85c \ub178\ucd9c\ub418\ub294 \uc591\uc744 \ub098\ud0c0\ub0c5\ub2c8\ub2e4.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA)\uc758 3\uae09 \uc758\ub8cc\uae30\uae30 \ud5c8\uac00 \uc11c\ub958\uc5d0 \ud3ec\ud568\ub418\ub294 ISBM(\ub2e8\uc77c \ubb3c\uc9c8 \ud3ec\uc7a5\uc7ac) 1\ucc28 \uc6a9\uae30\uc5d0 \ub300\ud55c \uc6a9\ucd9c\ubb3c \ubc0f \ucd94\ucd9c\ubb3c(E&amp;L) \uad00\ub828 \uae30\ub300\uce58\ub294 ISO 10993-18:2020 \ud504\ub808\uc784\uc6cc\ud06c(\uc7ac\ub8cc\uc758 \ud654\ud559\uc801 \ud2b9\uc131 \ubd84\uc11d) \ubc0f PQRI(\uc81c\ud488\ud488\uc9c8\uc5f0\uad6c\uc18c) 2006 \uac00\uc774\ub4dc\ub77c\uc778(\ud55c\uad6d KFDA\uac00 \uc758\ub8cc\uae30\uae30 \uc81c\ucd9c \uc9c0\uce68\uc5d0\uc11c \uc778\uc6a9\ud558\ub294 \uc5c5\uacc4 \ud45c\uc900)\uc744 \uc900\uc218\ud574\uc57c \ud569\ub2c8\ub2e4. \ud55c\uad6d ISBM \uc81c\uc870\uc5c5\uccb4\uac00 \ubc18\ub4dc\uc2dc \uc774\ud574\ud574\uc57c \ud560 \uc8fc\uc694 \ubd84\uc11d \uae30\uc900\uce58\ub294 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4.<\/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>\ud55c\uad6d\ud615 3\uae09 \uccb4\uc678 \uc9c4\ub2e8\uae30\uae30\uc5d0 \ub300\ud55c \ubd84\uc11d\uc801 \ud3c9\uac00 \uc784\uacc4\uac12(AET):<\/strong> \uc2dd\ubcc4\ud560 \uc218 \uc5c6\ub294 \ud654\ud569\ubb3c\uc758 \uacbd\uc6b0 0.1 \u03bcg\/\uc77c\uc744 \ucd08\uacfc\ud558\ub294 \ub18d\ub3c4\ub85c \ucd94\ucd9c\ub418\ub294 \ubaa8\ub4e0 \ud654\ud569\ubb3c\uc740 \ubaa8\uc758 \uc0ac\uc6a9 \ucd94\ucd9c\uc5d0\uc11c \ubd84\uc11d\uc801\uc73c\ub85c \uc2dd\ubcc4\ud558\uace0 \ub3c5\uc131\ud559\uc790\uac00 \uc548\uc804\uc131 \ud3c9\uac00\ub97c \uc218\ud589\ud574\uc57c \ud569\ub2c8\ub2e4. \ud55c\uad6d\uc758 \uccb4\uc678\uc9c4\ub2e8\uc6a9 \uc2dc\uc57d\ubcd1(\uac04\uc811 \ud658\uc790 \uc811\ucd09)\uc758 \uacbd\uc6b0, AET\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \uc2dc\uc57d\uc758 \uc9c1\uc811 \uc18c\ube44\ub7c9\uc774 \uc544\ub2cc \ud658\uc790\uc758 \ucd5c\ub300 \uc77c\uc77c \ubcf5\uc6a9\ub7c9\uc744 \uae30\uc900\uc73c\ub85c \uacc4\uc0b0\ub418\ubbc0\ub85c \uacbd\uad6c\uc6a9 \uc57d\ubb3c \uc6a9\uae30\uc758 E&amp;L\ubcf4\ub2e4 \ub354 \ub192\uc740 AET \uac12\uc774 \ud5c8\uc6a9\ub429\ub2c8\ub2e4.<\/li>\n<li style=\"font-size: 15px; color: #374151; line-height: 1.65;\"><strong>PET \ud2b9\uc774\uc801 \ud55c\uad6d \ucd94\ucd9c\ubb3c \ud504\ub85c\ud544:<\/strong> PET\uc758 \uc8fc\uc694 \ucd94\ucd9c\ubb3c\uc740 \uc544\uc138\ud2b8\uc54c\ub370\ud788\ub4dc(AA, \uc5f4\ubd84\ud574 \uc0dd\uc131\ubb3c), \uc62c\ub9ac\uace0\uba38(\uc21c\ud658\ud615 PET \uc0bc\ub7c9\uccb4 \ubc0f \uc774\ub7c9\uccb4, \uacf5\uc815 \uc628\ub3c4\uc5d0 \ub530\ub77c \ub2ec\ub77c\uc9d0), \uadf8\ub9ac\uace0 \ube44\uc2a4(2-\uc5d0\ud2f8\ud5e5\uc2e4)\ud504\ud0c8\ub808\uc774\ud2b8(DEHP - PET \uc218\uc9c0\uc5d0 DEHP \ud568\uc720 \uc724\ud65c\uc81c\uac00 \uc0ac\uc6a9\ub41c \uacbd\uc6b0, \ud55c\uad6d\uc758 \uc758\uc57d\ud488 \ub4f1\uae09 PET \uc218\uc9c0\uc5d0\ub294 \uc0ac\uc6a9\ub418\uc9c0 \uc54a\uc74c) \ub4f1\uc73c\ub85c \uc798 \uc54c\ub824\uc838 \uc788\uc2b5\ub2c8\ub2e4. \ud55c\uad6d\uc758 \uc758\ub8cc\uae30\uae30 \uc751\uc6a9 \ubd84\uc57c\uc5d0\uc11c\ub294 \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA)\uc5d0\uc11c \uc2b9\uc778\ud55c \uc2dd\ud488 \uc811\ucd09 \uac00\ub2a5 \ubaa9\ub85d\uc5d0 \uc788\ub294 PET \uc218\uc9c0\ub97c \uc0ac\uc6a9\ud574\uc57c \ud558\uba70, \uc218\uc9c0 \uacf5\uae09\uc5c5\uccb4\uc5d0 \ud504\ud0c8\ub808\uc774\ud2b8 \ud568\uc720 \uac00\uacf5 \ubcf4\uc870\uc81c\uac00 \uc0ac\uc6a9\ub418\uc9c0 \uc54a\uc558\ub294\uc9c0 \ud655\uc778\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n<li style=\"font-size: 15px; color: #374151; line-height: 1.65;\"><strong>\ud55c\uad6d\uc0b0 ISBM \ucd94\ucd9c\ubb3c\uc5d0 \ub300\ud55c \uacf5\uc815 \uc870\uac74\uc758 \uc601\ud5a5:<\/strong> \ubc30\ub7f4 \uc628\ub3c4\uac00 \ub192\uc744\uc218\ub85d PET\uc758 \uc5f4\ubd84\ud574 \ubc0f \uc544\uc2a4\ucf54\ub974\ube0c\uc0b0(AA) \uc0dd\uc131\uc774 \uc99d\uac00\ud558\uace0, \ucee8\ub514\uc154\ub2dd \uc720\uc9c0 \uc2dc\uac04\uc774 \uae38\uc5b4\uc9c8\uc218\ub85d \ud504\ub9ac\ud3fc \ub0b4\ubd80\uc5d0\uc11c \ubcd1 \ubcbd\uba74\uc73c\ub85c\uc758 AA \uc774\ub3d9\uc774 \uc99d\uac00\ud569\ub2c8\ub2e4. \ud55c\uad6d\uc758 ISBM(\ub2e8\uc77c \uc561\uccb4 \ud50c\ub77c\uc2a4\ud2f1) \uc81c\uc870\uc5c5\uccb4\ub294 E&amp;L(Electronic Liquid) \ud14c\uc2a4\ud2b8 \uc0d8\ud50c \uc0dd\uc0b0\uc5d0 \uc0ac\uc6a9\ub41c \uc0dd\uc0b0 \uacf5\uc815 \uc870\uac74\uc744 \ubb38\uc11c\ud654\ud558\uace0, \uac80\uc99d\ub41c \ubc94\uc704\ub97c \ubc97\uc5b4\ub098\ub294 \uacf5\uc815 \ubcc0\uacbd\uc744 \ubc29\uc9c0\ud558\uae30 \uc704\ud55c \ubcc0\uacbd \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc744 \uad6c\ucd95\ud574\uc57c \ud569\ub2c8\ub2e4. \uc774\ub294 \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA)\uc758 3\uae09 \uc694\uad6c\uc0ac\ud56d\uc73c\ub85c, \ub514\uc9c0\ud138 \uacf5\uc815 \ub85c\uae45\uc744 \ud1b5\ud574 \uc0dd\uc0b0 \uacf5\uc815\uc744 \uae30\ub85d\ud574\uc57c \ud569\ub2c8\ub2e4. <a style=\"color: #0369a1; font-weight: 600; text-decoration: none;\" href=\"https:\/\/isbm-blow-molding.com\/ko\/isbm-industry-4-automation-korean-production-guide\/\">\ud55c\uad6d ISBM \uc0b0\uc5c5 4.0 \ud504\ub808\uc784\uc6cc\ud06c<\/a> \uc790\ub3d9\ud654\ub41c \uae30\ub2a5\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/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. \ud55c\uad6d ISBM \uc758\ub8cc\uae30\uae30 \ud3ec\uc7a5 \ud074\ub9b0\ub8f8 \uc0dd\uc0b0 \ud45c\uc900<\/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=\"\ud55c\uad6d ISBM \uc758\ub8cc\uae30\uae30 \ud074\ub9b0\ub8f8 \uc0dd\uc0b0 \ud658\uacbd \u2014 ISO 8\uae09(100,000\uac1c \uc785\uc790\/m\u00b3) \ud074\ub9b0\ub8f8\uc5d0\uc11c KFDA 2\uae09 \uccb4\uc678\uc9c4\ub2e8 \uc2dc\uc57d\ubcd1 \uc0dd\uc0b0\uc744 \uc704\ud55c ISBM \uc124\ube44\ub97c \uac16\ucd94\uace0 \uc788\uc73c\uba70, \ud544\ud130\ub9c1\ub41c \uce35\ub958 HVAC \uc2dc\uc2a4\ud15c, \uc791\uc5c5\uc790 \ud074\ub9b0\ub8f8 \ubcf5\uc7a5, \uc591\uc555\uc2e4, \uadf8\ub9ac\uace0 \uc778\ub77c\uc778 \uc785\uc790 \ubaa8\ub2c8\ud130\ub9c1 \uc2dc\uc2a4\ud15c\uc744 \ud1b5\ud574 \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \ud3ec\uc7a5 GMP \uaddc\uc815\uc744 \uc900\uc218\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.\" \/><figcaption style=\"font-size: 12px; color: #6b7280; margin-top: 8px; text-align: center;\">\ud55c\uad6d\uc758 ISBM \uc758\ub8cc\uae30\uae30 \ud074\ub9b0\ub8f8 \uc0dd\uc0b0\uc740 ISO 8\ub4f1\uae09(ISO 14644-1, \u2264 3,520,000 \uc785\uc790\/m\u00b3 \u2265 0.5\u03bcm)\uc744 \ucda9\uc871\ud558\uba70, \uc774\ub294 \ud55c\uad6d\uc758 2\ub4f1\uae09 \uccb4\uc678\uc9c4\ub2e8\uc6a9 \uc2dc\uc57d\ubcd1 \ubc0f 3\ub4f1\uae09 \uc758\ub8cc\uae30\uae30 \uc811\ucd09\uc6a9\uae30 \uc0dd\uc0b0\uc5d0 \uc801\uc6a9\ub418\ub294 \ud45c\uc900 \uc0dd\uc0b0 \ud658\uacbd\uc785\ub2c8\ub2e4. ISBM \uacf5\uc815 \uc790\uccb4\ub294 \ubc00\ud3d0\ub41c \uae30\uacc4 \ub0b4\uc5d0\uc11c \uc0ac\ucd9c\uacfc \ube14\ub85c\uc6b0 \uc131\ud615\uc744 \ud55c \ubc88\uc5d0 \uc218\ud589\ud558\ub294 \ubc29\uc2dd\uc73c\ub85c, \ud504\ub9ac\ud3fc\uc744 \uac1c\ubc29\ub41c \uacf5\uae30\ub97c \ud1b5\ud574 \uc774\uc1a1\ud558\ub294 2\ub2e8\uacc4 SBM \uacf5\uc815\ubcf4\ub2e4 \ubcf8\uc9c8\uc801\uc73c\ub85c \ub354 \uccad\uacb0\ud569\ub2c8\ub2e4. \ud55c\uad6d ISBM\uc758 \ubc00\ud3d0 \uacf5\uc815\uc740 \uaddc\uc81c \uc900\uc218 \uce21\uba74\uc5d0\uc11c \uc720\ub9ac\ud569\ub2c8\ub2e4. \ubcd1 \ub0b4\ubd80\uac00 \ube14\ub85c\uc6b0 \uc131\ud615 \uacfc\uc815\uc5d0\uc11c \uc678\ubd80 \ud658\uacbd\uc5d0 \ub178\ucd9c\ub418\uc9c0 \uc54a\uace0 \uc0ac\ucd9c\ub418\uae30 \ub54c\ubb38\uc5d0, \uc81c\uc5b4\ub41c \uc0ac\ucd9c \ud658\uacbd\uc5d0\uc11c \ucd5c\uc885 \ub0b4\ubd80 \uc624\uc5fc \uc704\ud5d8\uc774 \uacb0\uc815\ub429\ub2c8\ub2e4.<\/figcaption><\/figure>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">\ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA)\uc758 GMP(\uc758\ub8cc\uae30\uae30\uc758 \uc81c\uc870 \ubc0f \ud488\uc9c8\uad00\ub9ac \uae30\uc900)\ub294 \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc5c5\uccb4\uac00 \uc81c\uc870\ub418\ub294 \uae30\uae30\uc758 \uc704\ud5d8 \uc218\uc900\uc5d0 \uc801\ud569\ud55c \uccad\uc815 \uc0dd\uc0b0 \ud658\uacbd\uc744 \uad6c\ucd95\ud558\uace0 \uc720\uc9c0\ud558\ub3c4\ub85d \uc694\uad6c\ud569\ub2c8\ub2e4. \ud55c\uad6d\uc758 ISBM(Integrated Software Manufacturing) \uc758\ub8cc\uae30\uae30 \ud3ec\uc7a5\uc7ac \uc0dd\uc0b0\uc5d0 \uc801\uc6a9\ub418\ub294 \uad00\ub828 \ud45c\uc900\uc740 ISO 14644-1(\ud074\ub9b0\ub8f8 \ubc0f \uad00\ub828 \uc81c\uc5b4 \ud658\uacbd)\uc785\ub2c8\ub2e4. \uae30\uae30 \ub4f1\uae09\ubcc4 \ud55c\uad6d\uc758 ISBM \uc758\ub8cc\uae30\uae30 \ud3ec\uc7a5 \uc0dd\uc0b0 \ud658\uacbd \uc694\uad6c \uc0ac\ud56d\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4.<\/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>\ud55c\uad6d\uc5b4 1\uae09 (\uc2e0\uace0):<\/strong> \uc815\uc2dd \ud074\ub9b0\ub8f8 \uae30\uc900\uc740 \uc694\uad6c\ub418\uc9c0 \uc54a\uc73c\uba70, HVAC \ud544\ud130(MERV 8 \ub610\ub294 \ub3d9\uae09, \uc77c\ubc18\uc801\uc778 \uacf5\uc7a5 \uacf5\uae30 \ud761\uc785\uad6c \ub300\uccb4)\uac00 \uc124\uce58\ub41c \ubb38\uc11c\ud654\ub41c \uc77c\ubc18 \uc0b0\uc5c5 \uc0dd\uc0b0 \ud658\uacbd\uacfc \uae30\ubcf8\uc801\uc778 \uc815\ub9ac\uc815\ub3c8 \uc808\ucc28\ub97c \uc900\uc218\ud558\uba74 \ub429\ub2c8\ub2e4. \uacf5\uae30 \uc911 \ubbf8\ub9bd\uc790 \ubaa8\ub2c8\ud130\ub9c1\uc740 \ubd84\uae30\ubcc4\ub85c \uad8c\uc7a5\ub418\uc9c0\ub9cc \ud544\uc218 \uc0ac\ud56d\uc740 \uc544\ub2d9\ub2c8\ub2e4.<\/li>\n<li style=\"font-size: 15px; color: #374151; line-height: 1.65;\"><strong>\ud55c\uad6d 2\uae09 \uc778\uc99d \u2014 \uccb4\uc678\uc9c4\ub2e8 \uc2dc\uc57d \uc6a9\uae30:<\/strong> ISO 14644-1 8\ub4f1\uae09 \uc0dd\uc0b0 \ud658\uacbd(0.5\u03bcm \uc774\uc0c1 \uc785\uc790 3,520,000\uac1c\/m\u00b3 \uc774\ud558, \uad6c \ubbf8\uad6d \uc5f0\ubc29 \ud45c\uc900 209E 100,000\ub4f1\uae09\uc5d0 \ud574\ub2f9). \uc2e4\uc81c \uc801\uc6a9: \uc0dd\uc0b0 \uad6c\uc5ed\uc5d0 HEPA \ud544\ud130 \uacf5\uae30 \uacf5\uae09, \uc778\uc811\ud55c \ube44\uc0dd\uc0b0 \uad6c\uc5ed \ub300\ube44 \uc591\uc555 \ucc28\uc774(\u2265 +15 Pa), \uc791\uc5c5\ubcf5 \ucc29\uc6a9 \uc694\uac74(\uba38\ub9ac \ub36e\uac1c, \ubc29\uc9c4 \ucf54\ud2b8, \ub367\uc2e0), ISO 14644-2\uc5d0 \ub530\ub978 \ubd84\uae30\ubcc4 \uacf5\uae30 \uc911 \uc785\uc790 \uc218 \ubaa8\ub2c8\ud130\ub9c1.<\/li>\n<li style=\"font-size: 15px; color: #374151; line-height: 1.65;\"><strong>\ud55c\uad6d\ud615 3\uae09(\ud5c8\uac00) - \uc9c1\uc811 \uc811\ucd09 \uae30\uae30 \uc6a9\uae30:<\/strong> ISBM \uc7a5\ube44 \ubc0f \ubcd1 \ubc30\ucd9c \uad6c\uc5ed\uc740 ISO 14644-1 Class 7 \uc0dd\uc0b0 \ud658\uacbd(0.5\u03bcm \uc774\uc0c1 \uc785\uc790 \u2264 352,000\uac1c\/m\u00b3, Class 10,000\uc5d0 \ud574\ub2f9)\uc744 \uc900\uc218\ud569\ub2c8\ub2e4. \uc644\uc804 \ud074\ub9b0\ub8f8 \ubcf5\uc7a5(\uc791\uc5c5\ubcf5, \uc7a5\uac11, \ub9c8\uc2a4\ud06c), UV \uc0b4\uade0 \ucc98\ub9ac\ub41c \ud1b5\uacfc\ud615 \uc790\uc7ac \ubc18\uc785 \uc2dc\uc2a4\ud15c, \uc9c0\uc18d\uc801\uc778 \uc785\uc790 \ubaa8\ub2c8\ud130\ub9c1(Class 7 \ud55c\uacc4 \ucd08\uacfc \uc2dc \uc2e4\uc2dc\uac04 \uacbd\ubcf4), \uadf8\ub9ac\uace0 \uc5f0\uac04 \ud074\ub9b0\ub8f8 \uc131\ub2a5 \uc778\uc99d\uc744 \uc2dc\ud589\ud569\ub2c8\ub2e4. \ud55c\uad6d\uc758 ISBM \uc124\ube44\uc5d0\uc11c\ub294 \ubcd1 \ubc30\ucd9c \uad6c\uc5ed\uc5d0\uc11c Class 7\uc744 \ub2ec\uc131\ud558\uae30 \uc704\ud574 \uc77c\ubc18\uc801\uc73c\ub85c \ubcd1 \ubc30\ucd9c \ucee8\ubca0\uc774\uc5b4 \ubc14\ub85c \uc704\uc5d0 \uad6d\uc18c\uc801\uc778 \uce35\ub958 \ud6c4\ub4dc\ub97c \uc124\uce58\ud569\ub2c8\ub2e4. \uc774\ub294 ISBM \uc7a5\ube44 \uc804\uccb4\ub97c \ub458\ub7ec\uc2f8\ub294 \uc644\uc804\ud55c Class 7 \ud074\ub9b0\ub8f8\uc744 \uad6c\ucd95\ud558\ub294 \uac83\ubcf4\ub2e4 \uacbd\uc81c\uc801\uc785\ub2c8\ub2e4.<\/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 \uac80\uc99d: \ud55c\uad6d ISBM \uc758\ub8cc\uae30\uae30 \uc0dd\uc0b0 \ub77c\uc778\uc5d0 \ub300\ud55c IQ, OQ \ubc0f PQ<\/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=\"\uacf5\uc7a5-4\" 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\ud55c\uad6d\uc758 ISBM GMP \uac80\uc99d \ud504\ub85c\ud1a0\ucf5c\uc740 IQ(\uc124\uce58 \uc801\uaca9\uc131 \ud3c9\uac00)\ub97c \ud1b5\ud574 \uc7a5\ube44\uac00 \uc0ac\uc591\uc5d0 \ub9de\uac8c \uc124\uce58\ub418\uc5c8\ub294\uc9c0 \ud655\uc778\ud558\uace0, OQ(\uc6b4\uc601 \uc801\uaca9\uc131 \ud3c9\uac00)\ub97c \ud1b5\ud574 \uac80\uc99d\ub41c \uacf5\uc815 \ub9e4\uac1c\ubcc0\uc218 \ubc94\uc704\ub97c \uacb0\uc815\ud558\uba70, PQ(\uc131\ub2a5 \uc801\uaca9\uc131 \ud3c9\uac00)\ub97c \ud1b5\ud574 \ubaa8\ub4e0 \ud488\uc9c8 \uc0ac\uc591\uc744 \ucda9\uc871\ud558\ub294 \uc815\uc0c1 \uc870\uac74\uc5d0\uc11c\uc758 \uc77c\uad00\ub41c \uc0dd\uc0b0\uc744 \uc785\uc99d\ud558\ub294 \uac83\uc73c\ub85c \uad6c\uc131\ub429\ub2c8\ub2e4. \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA) \ud5c8\uac00 \uc2e0\uccad\uc744 \uc704\ud574\uc11c\ub294 \uc0c1\uc5c5 \uc0dd\uc0b0 \uc2dc\uc791 \uc804\uc5d0 \uc774 \uc138 \uac00\uc9c0 \uac80\uc99d \ub2e8\uacc4\ub97c \ubaa8\ub450 \uc644\ub8cc\ud558\uace0 \uad00\ub828 \uc11c\ub958\ub97c \uc81c\ucd9c\ud574\uc57c \ud569\ub2c8\ub2e4. \ub530\ub77c\uc11c \ud55c\uad6d\uc758 ISBM \uc0dd\uc0b0 \uc5c5\uccb4\ub294 \uacc4\uc57d \ud611\uc0c1 \ub2e8\uacc4\uc5d0\uc11c \uae08\ud615 \uc81c\uc791\ubd80\ud130 PQ \uc644\ub8cc\uae4c\uc9c0 \uc77c\ubc18\uc801\uc73c\ub85c 4~6\uac1c\uc6d4\uc758 \uae30\uac04\uc744 \uace0\ub824\ud558\uc5ec \uacc4\ud68d\uc744 \uc218\ub9bd\ud574\uc57c \ud569\ub2c8\ub2e4.<\/figcaption><\/figure>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">GMP IQ\/OQ\/PQ \uac80\uc99d\uc740 \ud55c\uad6d 3\uae09 \uc758\ub8cc\uae30\uae30 \uc6a9\uae30 ISBM \uc778\uc99d\uc758 \ud575\uc2ec\uc785\ub2c8\ub2e4. \uac01 \ub2e8\uacc4\ub294 \uba85\ud655\ud55c \ubaa9\uc801\uc744 \uac00\uc9c0\uace0 \uc788\uc73c\uba70, \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA) \uc2b9\uc778 \uc11c\ub958\uc5d0 \ud544\uc694\ud55c \ud2b9\uc815 \ubb38\uc11c\ub97c \uc0dd\uc131\ud569\ub2c8\ub2e4.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\"><strong>IQ(\uc124\uce58 \uc801\uaca9\uc131 \ud3c9\uac00):<\/strong> \ud55c\uad6d\uc0b0 ISBM \uc7a5\ube44, \uae08\ud615 \ubc0f \ubd80\uc18d \uc7a5\ube44(\uac74\uc870\uae30, \ub0c9\uac01\uae30, \uc555\ucd95 \uacf5\uae30 \uc2dc\uc2a4\ud15c)\uac00 \uc81c\uc870\uc0ac \uc0ac\uc591\uc5d0 \ub530\ub77c \uc124\uce58\ub418\uc5c8\uc74c\uc744 \ud655\uc778\ud569\ub2c8\ub2e4. \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA) Class III \uc758\ub8cc\uae30\uae30 IQ \ubb38\uc11c\uc5d0\ub294 \uc7a5\ube44 \uc77c\ub828\ubc88\ud638 \ubc0f \ubaa8\ub378\uba85 \ud655\uc778, KRISS \ucd94\uc801\uc131\uc744 \uac16\ucd98 \ubaa8\ub4e0 \uce21\uc815 \uae30\uae30(\uc5f4\uc804\ub300, \uc555\ub825 \ubcc0\ud658\uae30, \uc800\uc6b8)\uc758 \uad50\uc815 \uc99d\uba85\uc11c, \uc124\ube44 \uac80\uc99d(\ub0c9\uac01\uc218 \uc628\ub3c4, \uc720\ub7c9, \uc1a1\ud48d \uc555\ub825, \uc7a5\ube44 \uc785\uad6c \uc774\uc2ac\uc810), \uc124\uce58 \uc2dc \ud074\ub9b0\ub8f8 \ud658\uacbd \uce21\uc815(\uc785\uc790 \uc218, \uc628\ub3c4, \uc2b5\ub3c4, \ucc28\uc555) \uacb0\uacfc\uac00 \ud3ec\ud568\ub429\ub2c8\ub2e4. \uc5d0\ubc84\ud30c\uc6cc(Ever-Power)\ub294 \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98 \uc758\ub8cc\uae30\uae30 IQ \ud504\ub85c\ud1a0\ucf5c \uc791\uc131\uc5d0 \ud544\uc694\ud55c \ubaa8\ub4e0 \ub370\uc774\ud130 \ud544\ub4dc\ub97c \ud3ec\ud568\ud558\ub294 \uc7a5\ube44\ubcc4 IQ \ubb38\uc11c \ud15c\ud50c\ub9bf\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\"><strong>OQ(\uc6b4\uc601 \uc801\uaca9\uc131 \ud3c9\uac00):<\/strong> \uac01 \ud575\uc2ec \uacf5\uc815 \ubcc0\uc218\uc5d0 \ub300\ud55c \uac80\uc99d\ub41c \uc791\ub3d9 \ubc94\uc704\ub97c \uacb0\uc815\ud558\uae30 \uc704\ud574, \ubcc0\uc218\uc758 \uadf9\ud55c\uac12\uc5d0\uc11c \uacf5\uc815\uc744 \uc2dc\ud5d8\ud558\uace0 \uac01 \uc218\uc900\uc5d0\uc11c \ud5c8\uc6a9 \uac00\ub2a5\ud55c \uc81c\ud488\uc774 \uc0dd\uc0b0\ub418\ub294\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4. \uc77c\ubc18\uc801\uc778 \ud55c\uad6d ISBM OQ \uc5f0\uad6c \uc608\uc2dc: \ucee8\ub514\uc154\ub2dd \uc628\ub3c4, \ube14\ub85c\uc6b0 \uc720\uc9c0 \uc2dc\uac04, \uc0ac\ucd9c \ucda9\uc804 \uc555\ub825\uc5d0 \ub300\ud574 \uac01 \ud575\uc2ec \ubcc0\uc218\ubcc4\ub85c 3\ub2e8\uacc4(\uacf5\uce6d\uac12 - 5%, \uacf5\uce6d\uac12, \uacf5\uce6d\uac12 + 5%)\ub97c \uc124\uc815\ud558\uace0, \uac01 \ubcc0\uc218 \uc218\uc900\uc5d0\uc11c 30\ubcd1 \uc0d8\ud50c\uc744 \ucc44\ucde8\ud569\ub2c8\ub2e4. \uac01 \uc218\uc900\uc5d0\uc11c \uce58\uc218 \ubc0f \ud488\uc9c8 \uce21\uc815(\uc911\ub7c9, \ub125 \uc678\uacbd, \ud5e4\uc774\uc988, 5\uac1c \uc704\uce58\uc5d0\uc11c\uc758 \ubcbd \ub450\uaed8, \uc721\uc548 \uac80\uc0ac)\uc744 \uc218\ud589\ud569\ub2c8\ub2e4. OQ \ud569\uaca9 \uae30\uc900: \ubaa8\ub4e0 \ubcc0\uc218 \uc218\uc900\uc5d0\uc11c \ubaa8\ub4e0 \ud488\uc9c8 \uc18d\uc131\uc774 \uaddc\uaca9 \ub0b4\uc5d0 \uc788\uc5b4\uc57c \ud569\ub2c8\ub2e4. \uc774\ub97c \ud1b5\ud574 \uc0dd\uc0b0\uc774 \uc774\ub8e8\uc5b4\uc838\uc57c \ud558\ub294 \uac80\uc99d\ub41c \ubcc0\uc218 \ubc94\uc704\ub97c \uc124\uc815\ud569\ub2c8\ub2e4. \uacf5\uce6d\uac12 \u00b1 5%\uc5d0\uc11c \ubd88\ub7c9\ud488\uc774 \ubc1c\uc0dd\ud558\ub294 \uacbd\uc6b0, \uacf5\uce6d \uc124\uc815\uac12\uc744 \uc7ac\ucd5c\uc801\ud654\ud558\uace0 OQ\ub97c \ubc18\ubcf5\ud574\uc57c \ud569\ub2c8\ub2e4. \uc774\ub294 \uc774\uc804\uc5d0 Class III \uc815\ubc00 \uacf5\ucc28\ub97c \uc900\uc218\ud558\uc5ec \uc0dd\uc0b0\ud55c \uacbd\ud5d8\uc774 \uc5c6\ub294 \ud55c\uad6d\uc758 Class III ISBM \uc0dd\uc0b0 \uc5c5\uccb4\uc5d0\uc11c \ud754\ud788 \ubc1c\uc0dd\ud558\ub294 OQ \uacb0\uacfc\uc785\ub2c8\ub2e4.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 0;\"><strong>PQ(\uc131\ub2a5 \uac80\uc99d):<\/strong> \ubcf8 \uc5f0\uad6c\ub294 \ud55c\uad6d ISBM \uacf5\uc815\uc774 \uc0c1\uc5c5 \uaddc\ubaa8\uc5d0\uc11c \ucd5c\uc18c 3\ud68c \uc5f0\uc18d \uc0dd\uc0b0 \uacfc\uc815\uc5d0\uc11c \uacf5\uce6d \uc870\uac74 \ud558\uc5d0 \uc77c\uad00\ub41c \uaddc\uaca9 \uc900\uc218 \uc81c\ud488\uc744 \uc0dd\uc0b0\ud568\uc744 \uc785\uc99d\ud569\ub2c8\ub2e4. PQ \uc0d8\ud50c\ub9c1 \uacc4\ud68d\uc740 \uc0dd\uc0b0 \uacfc\uc815\ub2f9 \ucd5c\uc18c 125\ubcd1(\ucd1d 3\ud68c \uc0dd\uc0b0 \uacfc\uc815 \ub3d9\uc548 \uce90\ube44\ud2f0\ub2f9 375\ubcd1)\uc744 \ub300\uc0c1\uc73c\ub85c \uce58\uc218, \uc911\ub7c9, \ud0c1\ub3c4, AQL \ub808\ubca8 II(ANSI\/ASQ Z1.4 \/ ISO 2859-1)\uc5d0 \ub530\ub978 \uc721\uc548 \uac80\uc0ac, \uc0dd\uccb4 \uc801\ud569\uc131 \uc0d8\ud50c \uc0dd\uc0b0 \ud655\uc778\uc744 \ud3ec\ud568\ud55c 9\uac00\uc9c0 \ud488\uc9c8 \uc18d\uc131\uc744 \uce21\uc815\ud558\ub294 \uac83\uc785\ub2c8\ub2e4. PQ \ud1b5\uacc4 \ubd84\uc11d \uacb0\uacfc, \uac01 \uc8fc\uc694 \ud488\uc9c8 \uc18d\uc131\uc5d0 \ub300\ud55c \uacf5\uc815 \ub2a5\ub825(Cpk)\uc740 1.33 \uc774\uc0c1\uc774\uba70, \uc774\ub294 \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA)\uc758 3\uae09 \uc81c\uc870 \ub2a5\ub825 \uac80\uc99d \uae30\uc900\uc744 \ucda9\uc871\ud569\ub2c8\ub2e4. \ud55c\uad6d EV \uc11c\ubcf4 ISBM \ud50c\ub7ab\ud3fc\uc740 \uacf5\uce6d \uc870\uac74 \ud558\uc5d0\uc11c \ubcd1 \uc911\ub7c9 \ubc0f \ub125 \uc678\uacbd\uc5d0 \ub300\ud574 \uc77c\uad00\ub418\uac8c Cpk 1.50 \uc774\uc0c1\uc744 \ub2ec\uc131\ud569\ub2c8\ub2e4. \uc77c\ubc18\uc801\uc73c\ub85c \ud55c\uad6d\uc0b0 \uc720\uc555\uc2dd \ud50c\ub7ab\ud3fc\uc740 Cpk 1.00~1.20\uc758 \uc131\ub2a5\uc744 \ubcf4\uc774\ub294\ub370, \uc774\ub294 \ud55c\uad6d Class III \ud45c\uc900\uc5d0 \ubbf8\uce58\uc9c0 \ubabb\ud558\ub294 \uc218\uce58\uc774\uba70, Class III \uacf5\uae09\uc5d0 \uc9c4\uc785\ud558\ub294 \ud55c\uad6d ISBM \uc81c\uc870\uc5c5\uccb4\ub4e4\uc774 \uc131\uacf5\uc801\uc778 PQ \uc644\ub8cc\ub97c \uc704\ud574 \uc77c\uad00\ub418\uac8c \uc694\uad6c\ud558\ub294 \uc720\uc555\uc2dd \uc11c\ubcf4\uc5d0\uc11c \uc804\uae30\uc2dd \uc11c\ubcf4\ub85c\uc758 \uc5c5\uadf8\ub808\uc774\ub4dc\uac00 \ud544\uc694\ud569\ub2c8\ub2e4.<\/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;\">\uc790\uc8fc \ubb3b\ub294 \uc9c8\ubb38<\/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 \ud55c\uad6d\uc758 2\uae09 \uccb4\uc678\uc9c4\ub2e8 \uc758\ub8cc\uae30\uae30 \ud3ec\uc7a5 \uacf5\uae09\ub9dd\uc5d0 \uc9c4\ucd9c\ud558\uae30 \uc704\ud55c \ucd5c\uc18c \ud55c\uad6d ISBM \ud22c\uc790\uc561\uc740 \uc5bc\ub9c8\uc785\ub2c8\uae4c?<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">\ud55c\uad6d ISBM \uc0dd\uc0b0\uc5c5\uccb4\uac00 \ud55c\uad6d \uc778\uc99d\uae30\uad00\uc73c\ub85c\ubd80\ud130 \uc778\uc99d\ubc1b\uc740 \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc5c5\uccb4\uc5d0 \ud55c\uad6d 2\uae09 IVD \uc2dc\uc57d \uc6a9\uae30 \uacf5\uae09\uc5c5\uccb4 \uc790\uaca9\uc744 \uc5bb\uae30 \uc704\ud55c \ucd5c\uc18c \ud22c\uc790 \uc694\uac74\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4. (1) ISO 13485:2016 \ud488\uc9c8 \uc2dc\uc2a4\ud15c \uc5c5\uadf8\ub808\uc774\ub4dc: ISO 9001:2015 \uc778\uc99d\uc744 \uc774\ubbf8 \ubcf4\uc720\ud558\uace0 \uc788\ub294 \ud55c\uad6d ISBM \uc0dd\uc0b0\uc5c5\uccb4\ub294 \ud55c\uad6d \uacf5\uc778 \uc778\uc99d\uae30\uad00\uc744 \ud1b5\ud574 6~9\uac1c\uc6d4 \ub0b4\uc5d0 800\ub9cc~1,500\ub9cc \uc6d0(\uac2d \ubd84\uc11d, \ubb38\uc11c \uac1c\uc815, \uc2ec\uc0ac, \uc778\uc99d)\uc73c\ub85c ISO 13485 \uc778\uc99d\uc744 \ud68d\ub4dd\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. ISO 13485\ub294 \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA) \uc778\uc99d \uc808\ucc28 \uc694\uac74\uc5d0 \ucc38\uc870\ub418\ub294 \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \ud488\uc9c8 \uad00\ub9ac \ud45c\uc900\uc785\ub2c8\ub2e4. (2) \uc0dd\uc0b0 \uc0d8\ud50c\uc5d0 \ub300\ud55c ISO 10993-5 \uc138\ud3ec\ub3c5\uc131 \uc2dc\ud5d8: KTR \ub610\ub294 KCL\uc5d0\uc11c 150\ub9cc~300\ub9cc \uc6d0(\uc6d0)\uc758 \ube44\uc6a9\uc73c\ub85c \ud55c\uad6d \uc778\uc99d\uae30\uad00\uc5d0\uc11c \uc694\uad6c\ud558\ub294 \uc0dd\uccb4 \uc801\ud569\uc131 \uc778\uc99d\uc11c\ub97c \ubc1c\uae09\ubc1b\uc744 \uc218 \uc788\uc2b5\ub2c8\ub2e4. (3) ISO 14644-1 8\ub4f1\uae09 \uc0dd\uc0b0\ud658\uacbd \uac1c\uc120: 80~120m\u00b2 \uaddc\ubaa8\uc758 \ud55c\uad6d ISBM \uc0dd\uc0b0\uad6c\uc5ed \uae30\uc900, HEPA \ud544\ud130 \uac1c\uc870 \ubc0f \uc591\uc555 \uad00\ub9ac \uc2dc\uc2a4\ud15c \uad6c\ucd95: \uac80\uc99d \ud3ec\ud568 1,500\ub9cc~3,000\ub9cc \uc6d0. (4) GMP \ubb38\uc11c \uc2dc\uc2a4\ud15c: \ubc30\uce58 \uae30\ub85d, \uc7a5\ube44 \uad50\uc815 \ud504\ub85c\uadf8\ub7a8, \uc218\uc9c0 \ubc0f \ub9c8\uc2a4\ud130\ubc30\uce58 \uacf5\uae09\uc5c5\uccb4 \uc790\uaca9 \uc778\uc99d, \uc5f0\uac04 \uacbd\uc601 \uac80\ud1a0. \uc2e0\uaddc \uad6c\ucd95 \uc2dc: \ubb38\uc11c \uac1c\ubc1c \ubc0f \uc9c1\uc6d0 \uad50\uc721\uc5d0 500\ub9cc~1,000\ub9cc \uc6d0. \ucd1d \ucd5c\uc18c \ud22c\uc790\uc561: 12~18\uac1c\uc6d4\uc5d0 \uac78\uccd0 3,000\ub9cc~5,800\ub9cc \uc6d0. \uc774\uc5d0 \ub530\ub978 \uc0c1\uc5c5\uc801 \uc774\uc810: \ud55c\uad6d Class II IVD \uc758\ub8cc\uae30\uae30 \uc6a9\uae30 \uac00\uaca9\uc740 \uc77c\ubc18\uc801\uc73c\ub85c \ubcd1\ub2f9 45~120\uc6d0\uc73c\ub85c, \ub3d9\uae09 \ud55c\uad6d \uc77c\ubc18 \ud3ec\uc7a5\uc7ac \ub300\ube44 \ubcd1\ub2f9 \ub9c8\uc9c4\uc774 2~4\ubc30 \ub192\uc74c. \ub610\ud55c, \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc5c5\uccb4\uc640\uc758 \uacc4\uc57d\uc740 \uc77c\ubc18\uc801\uc73c\ub85c 3~5\ub144 \uc7a5\uae30 \uacf5\uae09 \uacc4\uc57d\uc73c\ub85c, \ud55c\uad6d \uc77c\ubc18 \ud3ec\uc7a5\uc7ac \uc2dc\uc7a5\uc5d0\uc11c\ub294 \ucc3e\uc544\ubcfc \uc218 \uc5c6\ub294 \uc548\uc815\uc801\uc778 \ub9e4\ucd9c \ud655\ubcf4\uac00 \uac00\ub2a5\ud568.<\/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 \ud55c\uad6d\uc758 \uc758\ub8cc\uae30\uae30 \uaddc\uc81c \uc900\uc218\ub97c \uc704\ud55c ISBM 1\ub2e8\uacc4 \ucc98\ub9ac \ubc29\uc2dd\uc740 2\ub2e8\uacc4 SBM \ubc29\uc2dd\uacfc \uc5b4\ub5bb\uac8c \ub2e4\ub978\uac00\uc694?<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">\ud55c\uad6d\uc758 ISBM \uc6d0\uc2a4\ud15d \uacf5\uc815\uc740 \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc751\uc6a9 \ubd84\uc57c\uc5d0\uc11c 2\ub2e8\uacc4 SBM(\uc0ac\uc804 \uc81c\uc870\ub41c \ud504\ub9ac\ud3fc\uc744 \uc774\uc6a9\ud55c \uc2a4\ud2b8\ub808\uce58 \ube14\ub85c\uc6b0 \uc131\ud615)\uc5d0 \ube44\ud574 \ub450 \uac00\uc9c0 \uaddc\uc815 \uc900\uc218 \uc774\uc810\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4. \uccab\uc9f8, \uac1c\ubcc4 \uac80\uc99d\uc774 \ud544\uc694\ud55c \uacf5\uc815 \ub2e8\uacc4\uac00 \uc801\uc2b5\ub2c8\ub2e4. 2\ub2e8\uacc4 SBM\uc740 \ud504\ub9ac\ud3fc \uc0ac\ucd9c \uc131\ud615(\uc0ac\ucd9c \uc131\ud615\uae30\uc758 IQ\/OQ\/PQ)\uc5d0 \ub300\ud55c \ubcc4\ub3c4\uc758 GMP \uac80\uc99d\uacfc \uc7ac\uac00\uc5f4 SBM \uacf5\uc815\uc5d0 \ub300\ud55c \ubcc4\ub3c4\uc758 GMP \uac80\uc99d\uc774 \ud544\uc694\ud569\ub2c8\ub2e4. \uc989, ISO 14644\uc5d0 \ub530\ub77c \ub450 \ubc88\uc758 \ubcc4\ub3c4 \uac80\uc99d \uc808\ucc28, \ub450 \uc138\ud2b8\uc758 \uc7a5\ube44 \uad50\uc815, \ub450 \uac1c\uc758 \uc0dd\uc0b0 \ud658\uacbd\uc744 \ud655\ubcf4\ud574\uc57c \ud569\ub2c8\ub2e4. \ud55c\uad6d\uc758 \uc6d0\uc2a4\ud15d ISBM\uc740 \ub450 \ub2e8\uacc4\ub97c \ud558\ub098\uc758 \uac80\uc99d\ub41c \uacf5\uc815\uc73c\ub85c \ud1b5\ud569\ud558\uace0 \ud558\ub098\uc758 IQ\/OQ\/PQ \ud504\ub85c\ud1a0\ucf5c\ub9cc \uc0ac\uc6a9\ud558\uba74 \ub418\ubbc0\ub85c \uac80\uc99d\uc5d0 \ud544\uc694\ud55c \ub178\ub825\uc744 \uc57d \uc808\ubc18\uc73c\ub85c \uc904\uc77c \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ub458\uc9f8, \ud504\ub9ac\ud3fc \uc7ac\uace0 \uad00\ub9ac \ubc0f \ucde8\uae09 \uad00\ub828 \uaddc\uc815 \uc900\uc218 \uc694\uac74\uc774 \uc5c6\uc2b5\ub2c8\ub2e4. 2\ub2e8\uacc4 SBM\uc740 \uc911\uac04 \ud504\ub9ac\ud3fc \uc7ac\uace0\ub97c \uc0dd\uc131\ud558\uba70, \uc774 \uc7ac\uace0\ub294 \uc801\uaca9 \ud658\uacbd\uc5d0 \ubcf4\uad00\ud558\uace0 \ub85c\ud2b8 \ubc88\ud638\ub85c \ucd94\uc801\ud558\uba70 \ubcf4\uad00 \uae30\uac04\uc744 \uc900\uc218\ud574\uc57c \ud569\ub2c8\ub2e4(PET \ud504\ub9ac\ud3fc\uc740 \ube14\ub85c\uc6b0 \uc131\ud615 \uc804\uc5d0 \ub108\ubb34 \uc624\ub798 \ubcf4\uad00\ud558\uba74 \uacb0\uc815\uc131\uc774 \uc800\ud558\ub429\ub2c8\ub2e4). \ud55c\uad6d\uc758 \uc6d0\uc2a4\ud15d ISBM(\ud1b5\ud569 \uc131\ud615 \uc81c\uc870) \ubc29\uc2dd\uc740 \ud504\ub9ac\ud3fc \ubcf4\uad00 \uad00\ub828 \uaddc\uc815 \uc900\uc218 \uc694\uac74\uc744 \uc644\uc804\ud788 \uc5c6\uc560\uc90d\ub2c8\ub2e4. \ud504\ub9ac\ud3fc\uc744 \uc81c\uc870\ud558\uace0 \uc989\uc2dc \ube14\ub85c\uc6b0 \uc131\ud615\ud558\ub294 \ub3d9\uc77c\ud55c \uacf5\uc815\uc744 \uac70\uce58\uae30 \ub54c\ubb38\uc5d0 \ud658\uacbd \uad00\ub9ac, \ub85c\ud2b8 \ucd94\uc801\uc131, \uc720\ud6a8\uae30\uac04 \uad00\ub9ac \ub4f1\uc774 \ud544\uc694\ud55c \uc911\uac04 \uc81c\ud488\uc774 \uc5c6\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc7a5\uc810\uc740 \ud55c\uad6d \uc81c\uc57d \uc0b0\uc5c5\uc5d0\uc11c \ub110\ub9ac \uc778\uc815\ubc1b\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc758\ub8cc\uae30\uae30 \uc0b0\uc5c5\uc758 ISBM\uc5d0\ub3c4 \ub9c8\ucc2c\uac00\uc9c0\ub85c \uc801\uc6a9\ub429\ub2c8\ub2e4. \uc6d0\uc2a4\ud15d \uacf5\uc815\uc740 \uac1c\ubcc4 \uac80\uc99d\uc774 \ud544\uc694\ud55c \ud575\uc2ec \uacf5\uc815 \ub2e8\uacc4\ub97c \uc904\uc5ec\uc8fc\uae30 \ub54c\ubb38\uc5d0 \ud55c\uad6d\uc758 3\uae09 \ud5c8\uac00 \uc81c\ucd9c \uc11c\ub958\ub97c \uac04\uc18c\ud654\ud558\uace0, 2\ub2e8\uacc4 \uc0dd\uc0b0 \uacf5\uc815 \uc801\uaca9\uc131 \ud3c9\uac00\uc5d0 \ube44\ud574 IQ\/OQ\/PQ \uae30\uac04\uc744 2~4\uac1c\uc6d4 \ub2e8\ucd95\uc2dc\ucf1c \uc90d\ub2c8\ub2e4.<\/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 \uac10\ub9c8\uc120 \uc870\uc0ac\uac00 \ud55c\uad6d\uc0b0 ISBM PET \uc758\ub8cc\uae30\uae30 \uc6a9\uae30\uc758 \ucd94\ucd9c\ubb3c \uad6c\uc131\uc5d0 \ubcc0\ud654\ub97c \uac00\uc838\uc624\ub098\uc694?<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">\uc608, \uac10\ub9c8\uc120 \uc870\uc0ac\ub294 PET\uc5d0\uc11c \uc790\uc720 \ub77c\ub514\uce7c\uc744 \uc0dd\uc131\ud558\uc5ec \uc870\uc0ac \uc804 \uc5f4\ubd84\ud574 \uc0dd\uc131\ubb3c \uc678\uc5d0\ub3c4 \ubc29\uc0ac\uc120 \uc720\ub3c4 \ubd84\ud574 \uc0dd\uc131\ubb3c\uc744 \uc0dd\uc131\ud569\ub2c8\ub2e4. 25kGy \uc870\uc0ac \uc2dc \ud55c\uad6d\uc0b0 ISBM PET\uc5d0\uc11c \uc8fc\uc694 \ubc29\uc0ac\uc120 \uc720\ub3c4 \ucd94\ucd9c\ubb3c\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4. (1) \uc544\uc138\ud2b8\uc54c\ub370\ud788\ub4dc \uc99d\uac00(\uac10\ub9c8\uc120 \uc870\uc0ac\ub294 PET \uc0ac\uc2ac\uc758 \ucd94\uac00\uc801\uc778 \uc5d0\uc2a4\ud14c\ub974 \uacb0\ud569\uc744 \ub04a\uc5b4 ISBM \uacf5\uc815\uc5d0\uc11c \uc5f4\uc801\uc73c\ub85c \uc0dd\uc131\ub418\ub294 \uc544\uc138\ud2b8\uc54c\ub370\ud788\ub4dc \uc678\uc5d0 \ucd94\uac00\uc801\uc778 \uc544\uc138\ud2b8\uc54c\ub370\ud788\ub4dc\ub97c \ubc29\ucd9c\ud568); (2) \ube44\ub2d0 \uc54c\ucf54\uc62c \uc62c\ub9ac\uace0\uba38(\ub9d0\ub2e8 \ube44\ub2d0\uae30\uc758 \uac10\ub9c8\uc120 \uc808\ub2e8); (3) PET \uace0\ub9ac\ud615 \uc62c\ub9ac\uace0\uba38 \uc99d\uac00(\ubc29\uc0ac\uc120\uc740 \uc0ac\uc2ac \uc808\ub2e8\uc744 \ud1b5\ud574 \ucd94\uac00\uc801\uc778 \uc62c\ub9ac\uace0\uba38 \ud615\uc131\uc744 \ucd09\uc9c4\ud568). \uac10\ub9c8 \uba78\uade0 \ucc98\ub9ac\ub41c \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA) 3\uae09 \uc758\ub8cc\uae30\uae30 \uc6a9\uae30\uc758 \uacbd\uc6b0, \ubc29\uc0ac\uc120 \uc720\ub3c4 \ucd94\ucd9c\ubb3c\uc740 \ud658\uc790\uac00 \ub178\ucd9c\ub418\ub294 \uc6a9\uae30\uc758 \uc2e4\uc81c \ud654\ud559\uc801 \uad6c\uc131 \uc694\uc18c\uc774\ubbc0\ub85c, \ucd94\ucd9c\ubb3c \ubc0f \uc6a9\ucd9c\ub7c9(E&amp;L) \uc5f0\uad6c\ub294 \uc870\uc0ac\ub418\uc9c0 \uc54a\uc740 \uc0dd\uc0b0 \uc0d8\ud50c\uc774 \uc544\ub2cc \uc870\uc0ac\ub41c \uc0d8\ud50c\uc744 \ub300\uc0c1\uc73c\ub85c \uc218\ud589\ud574\uc57c \ud569\ub2c8\ub2e4. \ud55c\uad6d\uc758 ISBM(\uc720\uc81c\ud488 \ub2e8\uc77c \uc131\ubd84 \ubcd1) \uc81c\uc870\uc5c5\uccb4\ub4e4\uc774 \ubc29\uc0ac\uc120 \uc870\uc0ac\ub418\uc9c0 \uc54a\uc740 \ubcd1\uc73c\ub85c \ucd94\ucd9c \ubc0f \uc794\ub958\ub7c9(E&amp;L) \uc2dc\ud5d8\uc744 \uc2e4\uc2dc\ud55c \ud6c4 \uac10\ub9c8\uc120 \uba78\uade0\uc744 \ud558\ub294 \uacbd\uc6b0, \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA) \uc2b9\uc778 \uc11c\ub958\uc5d0 \ubb38\uc81c\uac00 \ubc1c\uc0dd\ud558\uc5ec KFDA \uc2ec\uc0ac \uacfc\uc815\uc5d0\uc11c\ub9cc \ub4dc\ub7ec\ub098\uac8c \ub429\ub2c8\ub2e4. \uc774\ub85c \uc778\ud574 \ubc29\uc0ac\uc120 \uc870\uc0ac\ub41c \uc0d8\ud50c\uc5d0 \ub300\ud55c E&amp;L \uc2dc\ud5d8\uc744 \ub2e4\uc2dc \uc2e4\uc2dc\ud574\uc57c \ud558\uace0, \uc2b9\uc778\uc774 3~6\uac1c\uc6d4 \uc9c0\uc5f0\ub429\ub2c8\ub2e4. \ub530\ub77c\uc11c E&amp;L \uc2dc\ud5d8 \ud504\ub85c\ud1a0\ucf5c\uc5d0 \ucc98\uc74c\ubd80\ud130 \uc0d8\ud50c\uc744 \ucd94\ucd9c \uc804 \ucd5c\ub300 \ubc29\uc0ac\uc120 \uc870\uc0ac\ud574\uc57c \ud55c\ub2e4\ub294 \ub0b4\uc6a9\uc744 \uba85\uc2dc\ud558\uba74, \uc7ac\uc2dc\ud5d8 \ube44\uc6a9\uacfc \uc2b9\uc778 \uc9c0\uc5f0\uc744 \ubc29\uc9c0\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/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 \ud55c\uad6d\uc0b0 ISBM PET\uc5d0 \ud568\uc720\ub41c \uc544\uc138\ud2b8\uc54c\ub370\ud788\ub4dc\ub294 \uc758\ub8cc\uae30\uae30 \uc2dc\uc57d \ud488\uc9c8\uc5d0 \uc5b4\ub5a4 \uc601\ud5a5\uc744 \ubbf8\uce69\ub2c8\uae4c?<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">\ud55c\uad6d\uc0b0 ISBM PET \ubcd1\uc5d0\uc11c \uc758\ub8cc\uae30\uae30 \uc2dc\uc57d\uc73c\ub85c \uc544\uc138\ud2b8\uc54c\ub370\ud788\ub4dc(AA)\uac00 \uc6a9\ucd9c\ub418\ub294 \uac83\uc740 \ud2b9\uc815 \ud55c\uad6d\uc0b0 \uccb4\uc678\uc9c4\ub2e8(IVD) \uc2dc\uc57d, \ud2b9\ud788 \ud6a8\uc18c \ud65c\uc131 \ubd80\uc704\uc640 \ubc18\uc751\ud560 \uc218 \uc788\ub294 \ud6a8\uc18c \uae30\ubc18 \uc9c4\ub2e8 \uc2dc\uc57d \ubc0f \ub9c8\uc774\uc57c\ub974 \ubc18\uc751\uc744 \ud1b5\ud574 \ud56d\uccb4 \ub2e8\ubc31\uc9c8\uacfc \ubc18\uc751\ud558\uc5ec \uac80\uc0ac \ubbfc\uac10\ub3c4\ub97c \uc800\ud558\uc2dc\ud0ac \uc218 \uc788\ub294 \uba74\uc5ed\ubd84\uc11d \uc2dc\uc57d\uc758 \ud488\uc9c8\uc5d0 \uc911\uc694\ud55c \ubb38\uc81c\ub85c \uc791\uc6a9\ud569\ub2c8\ub2e4. \ud55c\uad6d\uc0b0 IVD \uc2dc\uc57d\uc758 \uc131\ub2a5 \uc800\ud558\ub97c \uc720\ubc1c\ud558\ub294 AA \uc6a9\ucd9c \uc784\uacc4\uac12\uc740 \uc2dc\uc57d \uc885\ub958\uc5d0 \ub530\ub77c \ub2e4\ub985\ub2c8\ub2e4. \ud6a8\uc18c \uae30\ubc18 IVD \uc2dc\uc57d\uc740 \ubcf4\uad00\ub41c \uc2dc\uc57d \ub0b4 AA \ub18d\ub3c4\uac00 15ppb\ub97c \ucd08\uacfc\ud558\uba74 \uc131\ub2a5 \uc800\ud558\uac00 \ub098\ud0c0\ub098\ub294 \ubc18\uba74, \uba74\uc5ed\ubd84\uc11d \uc2dc\uc57d\uc740 \uc77c\ubc18\uc801\uc73c\ub85c \ud55c\uad6d\uc0b0 ISBM PET \ubcd1\uc758 AA \ub18d\ub3c4(\uc0c1\uc628\uc5d0\uc11c 3\uac1c\uc6d4 \ubcf4\uad00 \uc2dc 100ml PET \ubcd1 \ub0b4\ubd80 \uacf5\uac04\uc758 AA \ub18d\ub3c4 1~8ppb)\uc5d0\uc11c\ub294 \uc131\ub2a5 \uc800\ud558\uac00 \ub098\ud0c0\ub098\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \ud55c\uad6d\uc758 \uccb4\uc678\uc9c4\ub2e8\uae30\uae30 \ud68c\uc0ac\uc5d0 \uc81c\ud488\uc744 \uacf5\uae09\ud558\ub294 \ud55c\uad6d ISBM(\uad6d\uc81c \ud45c\uc900 \ubcd1\uc785) \uc81c\uc870\uc5c5\uccb4\ub294 \uc0c1\uc5c5\uc801 \uc0dd\uc0b0 \uc870\uac74(\ucee8\ub514\uc154\ub2dd \uc628\ub3c4, \ubc30\ub7f4 \uc628\ub3c4, \uc0ac\uc774\ud074 \uc2dc\uac04)\uc5d0\uc11c \uc0dd\uc0b0\ub41c \ubcd1\uc758 \ud5e4\ub4dc\uc2a4\ud398\uc774\uc2a4 \uc544\ubbf8\ub178\uc0b0(AA) \uce21\uc815\uac12\uc744 \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uace0\uac1d\uc0ac\uc758 \uc81c\ud615 \uac1c\ubc1c\ud300\uc5d0 \uacf5\uac1c\ud574\uc57c \ud558\uba70, \uacf5\uc815 \ub9e4\uac1c\ubcc0\uc218 \uad00\ub9ac \ubc0f \uc5f0\uac04 \uac80\uc99d \uc2dc\ud5d8\uc744 \ud1b5\ud574 \ubaa8\ub4e0 \uc0c1\uc5c5 \uc0dd\uc0b0\uc5d0\uc11c AA\ub97c \ud569\uc758\ub41c \ud55c\ub3c4 \uc774\ud558\ub85c \uc720\uc9c0\ud574\uc57c \ud569\ub2c8\ub2e4. \ud55c\uad6d \uc758\ub8cc\uae30\uae30\uc6a9 PET \ubcd1\uc758 AA\ub97c \uc904\uc774\uae30 \uc704\ud55c \uc8fc\uc694 ISBM \ub9e4\uac1c\ubcc0\uc218\ub294 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4. \ubc30\ub7f4 \uc628\ub3c4 \ucd5c\uc18c\ud654(\ubaa9\ud45c 265\u00b0C, 1\uad6c\uc5ed, 280\u00b0C \uc774\uc0c1\uc740 \uc9c0\uc591), \ubc30\ub7f4 \uccb4\ub958 \uc2dc\uac04 \ucd5c\uc18c\ud654(\uc815\ucc28 \uc2dc 10\ubd84 \uc774\uc0c1 \uace0\uc628\uc5d0 PET\ub97c \ubc29\uce58\ud558\uc9c0 \uc54a\ub3c4\ub85d \ud568), \ucee8\ub514\uc154\ub2dd \uc720\uc9c0 \uc2dc\uac04 \ucd5c\uc18c\ud654(\ucd5c\ub300\uac00 \uc544\ub2cc \ud488\uc9c8\uc5d0 \uc801\ud569\ud55c \ucd5c\uc18c \uc2dc\uac04).<\/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 - \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA) 3\uae09 \ud5c8\uac00\ub97c \ud68d\ub4dd\ud55c \ud6c4\uc5d0\ub294 \uc5b4\ub5a4 \ud55c\uad6d ISBM \ubcc0\uacbd \uad00\ub9ac \uc694\uac74\uc774 \uc801\uc6a9\ub418\ub098\uc694?<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">\ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA)\uc758 \ud5c8\uac00\ub97c \ubc1b\uc740 \uc758\ub8cc\uae30\uae30 \ud3ec\uc7a5\uc740 \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc5c5\uccb4\uc758 \ud5c8\uac00 \uc11c\ub958\uc5d0 \uc6a9\uae30 \uc0ac\uc591\uc774 \ud3ec\ud568\ub41c \uacbd\uc6b0, \ud55c\uad6d ISBM \ud3ec\uc7a5 \uc81c\uc870\uc5c5\uccb4\uac00 \uc900\uc218\ud574\uc57c \ud558\ub294 \ubcc0\uacbd \uad00\ub9ac \uc694\uac74\uc758 \uc801\uc6a9\uc744 \ubc1b\uc2b5\ub2c8\ub2e4. \ud55c\uad6d KFDA\uc5d0 \ubcc0\uacbd\ud5c8\uac00 \ub610\ub294 \ubcc0\uacbd\uc2e0\uace0(\uc911\uc694\ub3c4\uc5d0 \ub530\ub77c \ub2e4\ub984)\ub97c \ud574\uc57c \ud558\uba70, \uacbd\uc6b0\uc5d0 \ub530\ub77c KFDA\uc758 \uac80\ud1a0 \ubc0f \uc7ac\uc2b9\uc778\uc774 \ud544\uc694\ud560 \uc218 \uc788\ub294 ISBM \uc6a9\uae30 \ubcc0\uacbd \uc0ac\ud56d\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4. \uc218\uc9c0 \ub4f1\uae09 \ub610\ub294 \uc81c\uc870\uc5c5\uccb4 \ubcc0\uacbd; \ucc29\uc0c9\uc81c \ub610\ub294 \ub9c8\uc2a4\ud130\ubc30\uce58 \uc0ac\uc591 \ubcc0\uacbd; ISBM \uc7a5\ube44(\ubaa8\ub378, \uc77c\ub828\ubc88\ud638, \uc704\uce58) \ubcc0\uacbd; OQ\uc5d0\uc11c \uc124\uc815\ub41c \uac80\uc99d \ubc94\uc704\ub97c \ubc97\uc5b4\ub098\ub294 \uc911\uc694\ud55c \uacf5\uc815 \ub9e4\uac1c\ubcc0\uc218 \ubcc0\uacbd; \ud5c8\uac00 \uc11c\ub958\uc5d0 \uba85\uc2dc\ub41c \ud5c8\uc6a9 \uc624\ucc28\ub97c \ucd08\uacfc\ud558\ub294 \uce58\uc218 \uc0ac\uc591 \ubcc0\uacbd. \uc77c\ubc18\uc801\uc73c\ub85c KFDA \ubcc0\uacbd \uc2e0\uace0\uac00 \ud544\uc694\ud558\uc9c0 \uc54a\uc9c0\ub9cc \ub0b4\ubd80 \ubcc0\uacbd \uad00\ub9ac \ubb38\uc11c\uac00 \ud544\uc694\ud55c \ubcc0\uacbd \uc0ac\ud56d\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4. \ubc94\uc704 \ub0b4 \uacf5\uc815 \ub9e4\uac1c\ubcc0\uc218 \uc870\uc815, ISBM \uc6b4\uc601\uc790 \uc790\uaca9\uc99d \ubcc0\uacbd, \uac80\uc99d\ub41c \ud074\ub9b0\ub8f8 \ub4f1\uae09\uc744 \uc720\uc9c0\ud558\uac70\ub098 \ucd08\uacfc\ud558\ub294 \uc0dd\uc0b0 \ud658\uacbd \uac1c\uc120. \ud55c\uad6d\uc758 ISBM \ud3ec\uc7a5\uc7ac \uc81c\uc870\uc5c5\uccb4\ub4e4\uc774 \uac80\uc99d\ub41c \uc758\ub8cc\uae30\uae30 \uc6a9\uae30 \uc81c\uc870 \uacf5\uc815\uc744 \uc784\uc758\ub85c \ubcc0\uacbd\ud558\ub294 \uacbd\uc6b0, \uc989 \ubcc0\uacbd \uad00\ub9ac \uc808\ucc28 \uc5c6\uc774 \ubc30\ub7f4 \uc628\ub3c4\ub97c \uc870\uc815\ud558\uac70\ub098, \uacf5\uae09\uc5c5\uccb4 \uc790\uaca9 \uac80\uc99d \uc5c6\uc774 \uc218\uc9c0 \ub4f1\uae09\uc744 \ubcc0\uacbd\ud558\uac70\ub098, \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA)\uc5d0 \ud1b5\ubcf4 \uc5c6\uc774 ISBM \uae30\uacc4\ub97c \uc2dc\uc124 \uac04\uc5d0 \uc774\uc804\ud558\ub294 \uacbd\uc6b0, \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc5c5\uccb4\uc758 \ucc28\uae30 KFDA \uac80\uc0ac\uc5d0\uc11c \uaddc\uc815 \uc704\ubc18 \uc0ac\ud56d\uc774 \ub4dc\ub7ec\ub098 \ud3ec\uc7a5\uc7ac \uacf5\uae09\uc5c5\uccb4\uc5d0 \ub300\ud55c \uc2dc\uc815 \uc870\uce58 \uc694\uad6c\uac00 \ubc1c\uc0dd\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ub530\ub77c\uc11c \ud55c\uad6d\uc758 3\uae09 \uc758\ub8cc\uae30\uae30 \uacf5\uae09\ub9dd\uc5d0 \uc9c4\uc785\ud558\ub294 ISBM \uc81c\uc870\uc5c5\uccb4\ub294 \ud574\ub2f9 \uc758\ub8cc\uae30\uae30 \uacc4\uc57d\uc5d0 \ud2b9\ud654\ub41c \uae30\uacc4, \uae08\ud615, \uc218\uc9c0 \uacf5\uae09\ub9dd\uc744 \uad6c\ucd95\ud558\uace0, \uacf5\uc2dd\uc801\uc778 \uac80\ud1a0 \ubc0f \ud544\uc694\ud55c \uacbd\uc6b0 KFDA \ud1b5\ubcf4 \uc5c6\uc774\ub294 \uc5b4\ub5a0\ud55c \ubcc0\uacbd\ub3c4 \ud5c8\uc6a9\ub418\uc9c0 \uc54a\ub294 \ubcc0\uacbd \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc744 \ub9c8\ub828\ud574\uc57c \ud569\ub2c8\ub2e4.<\/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 \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc6a9\uae30 \ubaa9 \ubd80\ubd84 \uc678\uacbd \uaddc\uaca9 \uc900\uc218 \uce21\uba74\uc5d0\uc11c \ud55c\uad6d\uc0b0 ISBM\uc758 \uce58\uc218 \uc815\ubc00\ub3c4\ub294 \uc720\ub9ac\uc640 \ube44\uad50\ud588\uc744 \ub54c \uc5b4\ub5bb\uc2b5\ub2c8\uae4c?<\/p>\n<\/div>\n<div style=\"padding: 16px 20px;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.7;\">\ud55c\uad6d\uc0b0 ISBM PET \ubc0f PETG \ubcd1\uc740 4\uce90\ube44\ud2f0 \uc0dd\uc0b0\uc5d0\uc11c \u00b10.04mm(4-\uc2dc\uadf8\ub9c8, EV \uc11c\ubcf4 \ud50c\ub7ab\ud3fc)\uc758 \ub125 \uc678\uacbd \uce58\uc218 \uc815\ubc00\ub3c4\ub97c \ub2ec\uc131\ud569\ub2c8\ub2e4. \uc774\ub294 \uc81c\uc57d \ub4f1\uae09 \uc720\ub9ac\ubcd1 \ub125 \uc678\uacbd \uc815\ubc00\ub3c4(\uc720\ub9ac \uc131\ud615 \uacf5\uc815 \ubc0f \ub125 \ud06c\uae30\uc5d0 \ub530\ub77c \uc77c\ubc18\uc801\uc73c\ub85c \u00b10.05~0.10mm)\uc640 \ub3d9\ub4f1\ud558\uac70\ub098 \uadf8 \uc774\uc0c1\uc785\ub2c8\ub2e4. \ub204\ucd9c \ubc29\uc9c0 \ubc00\ubd09\uc744 \uc704\ud574 \ub125 \uc678\uacbd \ud5c8\uc6a9 \uc624\ucc28\uc5d0 \uc758\uc874\ud558\ub294 \ub9c8\uac1c(\uc2a4\ub0c5\ucea1, \ub8e8\uc5b4 \ucee4\ub125\ud130, \uc149\ud140)\uac00 \uc0ac\uc6a9\ub418\ub294 \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc751\uc6a9 \ubd84\uc57c\uc5d0\uc11c \ud55c\uad6d\uc0b0 ISBM\uc758 \u00b10.04mm \uc815\ubc00\ub3c4\ub294 \uc720\ub9ac\uc758 \u00b10.05~0.10mm\ubcf4\ub2e4 \ub354 \uc77c\uad00\ub41c \ubc00\ubd09 \uc131\ub2a5\uc744 \uc81c\uacf5\ud558\uba70, \uc0dd\uc0b0 \uacfc\uc815\uc5d0\uc11c \uce90\ube44\ud2f0\ubcc4\ub85c \uc815\ub7c9\uc801\uc73c\ub85c \uac80\uc99d\ud560 \uc218 \uc788\ub2e4\ub294 \ucd94\uac00\uc801\uc778 \uc774\uc810\uc774 \uc788\uc2b5\ub2c8\ub2e4(\uc720\ub9ac \uc81c\uc870\uc5c5\uccb4\ub294 \uce90\ube44\ud2f0\ubcc4\uc774 \uc544\ub2cc \ud1b5\uacc4\uc801 \uc0d8\ud50c \uc218\uc900\uc5d0\uc11c \uce58\uc218 \uc778\uc99d\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4). \uc720\ub9ac\uac00 \ud55c\uad6d\uc0b0 ISBM PET\/PETG\ubcf4\ub2e4 \uc5ec\uc804\ud788 \uc720\ub9ac\ud55c \ub450 \uac00\uc9c0 \ud55c\uad6d \uc758\ub8cc\uae30\uae30 \uc6a9\uae30 \uc694\uad6c \uc0ac\ud56d\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4. (1) \uace0\uac10\ub3c4 \uc2dc\uc57d\uc6a9 UV \ucc28\ub2e8 - \ud638\ubc15\uc0c9 \uc720\ub9ac\ub294 450nm \ubbf8\ub9cc\uc758 UV\ub97c \u226599.9% \ucc28\ub2e8\ud569\ub2c8\ub2e4. (1) \ud638\ubc15\uc0c9 PET \ub610\ub294 \ud638\ubc15\uc0c9 PETG \ube14\ub85d\uc740 95\u201399%\ub97c \ucc28\ub2e8\ud558\uc9c0\ub9cc \uac80\uc99d\ub41c \ub9c8\uc2a4\ud130\ubc30\uce58 \ubc0f \uc774\ud589 \ud14c\uc2a4\ud2b8\uac00 \ud544\uc694\ud569\ub2c8\ub2e4. (2) \uc218\uc99d\uae30 \ud22c\uacfc\uc728(WVTR) - \uc720\ub9ac\ub294 WVTR\uc774 0\uc785\ub2c8\ub2e4. PET\uc758 WVTR\uc740 38\u00b0C\/90% RH\uc5d0\uc11c \uc57d 1.5\u20133.0 g\u00b7mm\/m\u00b2\u00b7day\uc785\ub2c8\ub2e4. \uc774\ub294 \ud45c\uc900 \ud55c\uad6d \uc2e4\ud5d8\uc2e4 \ubcf4\uad00(15\u201330\u00b0C)\uc5d0\uc11c \ub300\ubd80\ubd84\uc758 \uc218\uc131 IVD \uc2dc\uc57d\uc5d0 \uc801\ud569\ud558\uc9c0\ub9cc 18\uac1c\uc6d4 \uc774\uc0c1\uc758 \ubcf4\uad00 \uae30\uac04 \ub3d9\uc548 \ub300\uae30 \uc218\ubd84 \ud761\uc218\ub85c \uc778\ud55c \ud76c\uc11d\uc5d0 \ubbfc\uac10\ud55c \uc2dc\uc57d\uc758 \uacbd\uc6b0 \uc2b5\ub3c4 \ucc28\ub2e8 \ubc00\ubd09\uc774 \ud544\uc694\ud569\ub2c8\ub2e4.<\/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;\">\uc758\ub8cc\uae30\uae30 \uc778\uc99d \uc9c0\uc6d0<\/p>\n<h2 style=\"font-size: clamp(18px,3vw,26px); font-weight: 800; color: #fff; margin: 0 0 14px;\">\ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98(KFDA) 2\uae09 \ub610\ub294 3\uae09 \uc758\ub8cc\uae30\uae30 \ud3ec\uc7a5 \uc778\uc99d\uc744 \ucde8\ub4dd\ud558\uc2dc\ub098\uc694? GMP \uc778\uc99d, ISO 10993 \uc778\uc99d, \ub610\ub294 IQ\/OQ\/PQ \uc9c0\uc6d0\uc774 \ud544\uc694\ud558\uc2e0\uac00\uc694?<\/h2>\n<p style=\"font-size: 15px; color: #e0f2fe; max-width: 480px; margin: 0 auto 26px; line-height: 1.65;\">\ud55c\uad6d\uc758 Ever-Power\ub294 KFDA 2\/3\uae09 \uc758\ub8cc\uae30\uae30 \ud3ec\uc7a5 \uc778\uc99d\uc744 \uc704\ud574 KFDA 2\/3\uae09 \ubb38\uc11c \ud15c\ud50c\ub9bf, GMP IQ\/OQ\/PQ \ud504\ub85c\ud1a0\ucf5c \uac1c\ubc1c, \uc0dd\uccb4 \uc801\ud569\uc131 \uc0d8\ud50c \uc0dd\uc0b0, KFDA Annex 11 \uc900\uc218\ub97c \uc704\ud55c EV \uc11c\ubcf4 \ud504\ub85c\uc138\uc2a4 \ub85c\uae45 \ubc0f \ud074\ub9b0\ub8f8 ISBM \uc2dc\uc6b4\uc804\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/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\/ko\/contact-us\/\">\uc758\ub8cc\uae30\uae30 \uc778\uc99d \uc9c0\uc6d0\uc744 \uc694\uccad\ud558\uc138\uc694<\/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;\">\uad00\ub828 \uc790\ub8cc<\/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;\">\ud504\ub9ac\ubbf8\uc5c4 \uc758\ub8cc\uc6a9 \ub4f1\uae09<\/span><br \/>\n<span style=\"display: block; font-size: 15px; font-weight: bold; color: #1e3a8a; margin-bottom: 8px; line-height: 1.3;\">\uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615\uae30 HGY150-V4-EV<\/span><br \/>\n<span style=\"display: block; font-size: 13px; color: #6b7280; line-height: 1.55;\">\uc644\uc804 \uc804\uae30\uc2dd EV \uc11c\ubcf4 \ubaa8\ud130 \u00b7 KFDA Annex 11 GMP \ub370\uc774\ud130 \ub85c\uae45 \u00b7 Class III PQ \uc694\uac74 \ucda9\uc871\uc744 \uc704\ud55c Cpk \u2265 1.50 \u00b7 \ud55c\uad6d \uc758\ub8cc\uae30\uae30 IQ\/OQ\/PQ \ubb38\uc11c \ud328\ud0a4\uc9c0 \uc81c\uacf5<\/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;\">\ud074\ub798\uc2a4 II IVD \ud50c\ub7ab\ud3fc<\/span><br \/>\n<span style=\"display: block; font-size: 15px; font-weight: bold; color: #1e3a8a; margin-bottom: 8px; line-height: 1.3;\">\uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615\uae30 HGY200-V4<\/span><br \/>\n<span style=\"display: block; font-size: 13px; color: #6b7280; line-height: 1.55;\">\ub2e4\uc911 \uc218\uc9c0 PET\/PETG\/PP \u00b7 \ubaa9 \ubd80\ubd84 \uc678\uacbd \uc815\ubc00\ub3c4 \u00b10.04mm \u00b7 \ud55c\uad6d ISO 13485 2\uae09 \uaddc\uaca9 \uc900\uc218 \u00b7 \ubc29\uc0ac\uc120 \uc548\uc815\ud654 PET \ub4f1\uae09 \uc778\uc99d \u00b7 IVD \uc2dc\uc57d\ubcd1 15~500ml.<\/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;\">\uace0\uc6a9\ub7c9 \uc758\ub8cc<\/span><br \/>\n<span style=\"display: block; font-size: 15px; font-weight: bold; color: #1e3a8a; margin-bottom: 8px; line-height: 1.3;\">\uc0ac\ucd9c \uc5f0\uc2e0 \ube14\ub85c\uc6b0 \uc131\ud615\uae30 HGY250-V4<\/span><br \/>\n<span style=\"display: block; font-size: 13px; color: #6b7280; line-height: 1.55;\">\ub300\uc6a9\ub7c9 \uccb4\uc678\uc9c4\ub2e8 \uc2dc\uc57d \ud0a4\ud2b8 \ubcd1 \uc0dd\uc0b0 \u00b7 \ud55c\uad6d Class II \uaddc\uaca9\uc758 6\uce90\ube44\ud2f0 \uc0dd\uc0b0 \uc124\ube44 \u00b7 \ud074\ub9b0\ub8f8 \ud638\ud658 \ubc30\ucd9c \uc2dc\uc2a4\ud15c \u00b7 \ub300\uc6a9\ub7c9 \uc9c4\ub2e8 \uc2dc\uc57d \uc6a9\uae30\uc5d0 \uc801\ud569\ud55c 86mm \ub113\uc740 \uc785\uad6c<\/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;\">\ud3b8\uc9d1\uc790: Cxm<\/p>\n<\/footer>\n<\/div>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>ISBM \uc801\uc6a9 \ubd84\uc57c \u00b7 \uc758\ub8cc\uae30\uae30 \ud3ec\uc7a5 \u00b7 \ud55c\uad6d ISBM 2026 ISBM \uc758\ub8cc\uae30\uae30 \uc6a9\uae30 \uc0dd\uc0b0: \ud55c\uad6d \uaddc\uc81c \uc9c0\uce68 \ud55c\uad6d\uc758 \uc758\ub8cc\uae30\uae30 \ud3ec\uc7a5\uc740 ISBM \uc801\uc6a9 \ubd84\uc57c \uc911 \uac00\uc7a5 \ub192\uc740 \uc218\uc900\uc758 \uaddc\uc815\uc744 \uc900\uc218\ud574\uc57c \ud569\ub2c8\ub2e4. \ubaa8\ub4e0 \uc6a9\uae30\ub294 \uc0dd\uccb4 \uc801\ud569\uc131 \uc2dc\ud5d8, \uba78\uade0 \uac80\uc99d, GMP IQ\/OQ\/PQ \uae30\uc900\uc5d0 \ub530\ub978 \uce58\uc218 \uc801\uaca9\uc131 \uac80\uc0ac\ub97c \uac70\uccd0\uc57c \ud558\uba70, \ubb38\uc11c\ud654\ub41c \uccad\uc815 \ud658\uacbd\uc5d0\uc11c \uc81c\uc870\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. \uc774 \ubd84\uc57c\uc5d0 \uc9c4\ucd9c\ud558\ub294 \ud55c\uad6d ISBM \uc0dd\uc0b0\uc5c5\uccb4\ub294 [\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\/ko\/wp-json\/wp\/v2\/posts\/966","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/isbm-blow-molding.com\/ko\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/isbm-blow-molding.com\/ko\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/ko\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/ko\/wp-json\/wp\/v2\/comments?post=966"}],"version-history":[{"count":1,"href":"https:\/\/isbm-blow-molding.com\/ko\/wp-json\/wp\/v2\/posts\/966\/revisions"}],"predecessor-version":[{"id":967,"href":"https:\/\/isbm-blow-molding.com\/ko\/wp-json\/wp\/v2\/posts\/966\/revisions\/967"}],"wp:attachment":[{"href":"https:\/\/isbm-blow-molding.com\/ko\/wp-json\/wp\/v2\/media?parent=966"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/ko\/wp-json\/wp\/v2\/categories?post=966"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/ko\/wp-json\/wp\/v2\/tags?post=966"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}