{"id":51326,"date":"2025-11-24T21:29:19","date_gmt":"2025-11-24T13:29:19","guid":{"rendered":"https:\/\/zetarmold.com\/?p=51326"},"modified":"2026-04-04T10:21:17","modified_gmt":"2026-04-04T02:21:17","slug":"%ec%9d%98%eb%a3%8c-%ea%b8%b0%ea%b8%b0-%eb%8c%80-%ed%91%9c%ec%a4%80-%ec%a0%9c%ec%a1%b0","status":"publish","type":"post","link":"https:\/\/zetarmold.com\/ko\/%ec%9d%98%eb%a3%8c-%ea%b8%b0%ea%b8%b0-%eb%8c%80-%ed%91%9c%ec%a4%80-%ec%a0%9c%ec%a1%b0\/","title":{"rendered":"\uc758\ub8cc \uae30\uae30\uc6a9 \uc0ac\ucd9c \uc131\ud615\uc740 \uc77c\ubc18 \uc81c\uc870\uc640 \uc5b4\ub5bb\uac8c \ub2e4\ub985\ub2c8\uae4c?"},"content":{"rendered":"<div class=\"callout-key\" style=\"background:#f0f7ff; border-left:4px solid #2563eb; padding:1em 1.2em; border-radius:6px; margin:1.5em 0;\">\n<strong>\uc8fc\uc694 \ub0b4\uc6a9<\/strong><br \/>\n\uc758\ub8cc\uc6a9 \uc0ac\ucd9c \uc131\ud615\uc740 \uc758\ub8cc \uc0b0\uc5c5\uc744 \uc704\ud574 \ub0b4\uad6c\uc131, \uc0dd\uccb4 \uc801\ud569\uc131 \ubc0f \uc815\ubc00\uc131\uc744 \uac16\ucd98 \ubd80\ud488\uc744 \uc0dd\uc0b0\ud558\ub3c4\ub85d \uc124\uacc4\ub41c \uc804\ubb38 \uc81c\uc870 \uacf5\uc815\uc785\ub2c8\ub2e4. \uc77c\ubc18 \ubaa9\uc801 \uc131\ud615\uacfc \ub2ec\ub9ac **ISO 13485** \ubc0f **FDA 21 CFR Part 820**\uacfc \uac19\uc740 \uc5c4\uaca9\ud55c \uaddc\uc81c \uae30\uc900\uc744 \uc900\uc218\ud574\uc57c \ud569\ub2c8\ub2e4. \uc774 \uacf5\uc815\uc740 \uc77c\ubc18\uc801\uc73c\ub85c \uc758\ub8cc\uc6a9 \ub4f1\uae09 \uc218\uc9c0(\uc608: PEEK, PC, LSR)\ub97c \uc0ac\uc6a9\ud558\uba70, \ubbf8\ub9bd\uc790 \uc624\uc5fc\uc744 \ucd5c\uc18c\ud654\ud558\uae30 \uc704\ud574 **ISO 14644** \ub4f1\uae09\uc758 \uccad\uc815\uc2e4\uc5d0\uc11c \uc6b4\uc601\ub429\ub2c8\ub2e4. \uc8fc\uc694 \uc6b0\uc120\uc21c\uc704\uc5d0\ub294 \uacf5\uc815 \uac80\uc99d(IQ\/OQ\/PQ), \uc644\uc804\ud55c \ucd94\uc801\uc131 \ubc0f \"\uc81c\ub85c \uacb0\ud568\" \ud488\uc9c8 \uad00\ub9ac\uac00 \ud3ec\ud568\ub429\ub2c8\ub2e4.\n<\/div>\n<h2>\uc815\uc758<\/h2>\n<p><strong>\uc758\ub8cc\uc6a9 \uc0ac\ucd9c \uc131\ud615<\/strong> \uc758\ub8cc\uc6a9 \ud50c\ub77c\uc2a4\ud2f1\uc744 \uc131\ud615\ud558\ub294 \uacfc\uc815 \ub610\ub294 <strong>\uc561\uc0c1 \uc2e4\ub9ac\ucf58 \uace0\ubb34(LSR)<\/strong> \uc7ac\ub8cc\ub97c \uac00\uc5f4\ub41c \ubc30\ub7f4, \ud63c\ud569 \ub098\uc0ac, \uc815\ubc00 \uae08\ud615 \ub3c4\uad6c\ub97c \uc0ac\uc6a9\ud558\uc5ec \ud2b9\uc815 \ud615\uc0c1\uc73c\ub85c \uc131\ud615\ud569\ub2c8\ub2e4.<\/p>\n<p>\uc774 \ud504\ub85c\uc138\uc2a4\ub294 \ud658\uacbd \ubc0f \uaddc\uc815 \uc900\uc218 \uc694\uad6c \uc0ac\ud56d\uc5d0 \ub530\ub77c \uad6c\ubcc4\ub429\ub2c8\ub2e4. \ucd5c\uc885 \uc81c\ud488\uc774 \ub2e4\uc74c\uc744 \ucda9\uc871\ud558\ub294\uc9c0 \ud655\uc778\ud574\uc57c \ud569\ub2c8\ub2e4. <strong>\uc0dd\uccb4 \uc801\ud569\uc131<\/strong> \ud45c\uc900(\uc608 <strong>ISO 10993<\/strong>) \uba78\uade0 \ub610\ub294 \uba78\uade0\uc131\uc744 \uc720\uc9c0\ud569\ub2c8\ub2e4. \ub300\uc6a9\ub7c9 \uc77c\ud68c\uc6a9 \uc18c\ubaa8\ud488(\uc8fc\uc0ac\uae30, \uc2dc\ud5d8\uad00)\ubd80\ud130 \uace0\uc815\ubc00 \uc774\uc2dd\ud615 \uae30\uae30 \ubc0f \uc218\uc220 \uae30\uad6c\uae4c\uc9c0 \ubaa8\ub4e0 \uac83\uc744 \ud3ec\uad04\ud569\ub2c8\ub2e4.<\/p>\n<div class=\"claim claim-true\" style=\"background-color: #eff2ef; border-color: #eff2ef; color: #5b8c70;\">\n<p><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M20 13c0 5-3.5 7.5-7.66 8.95a1 1 0 0 1-.67-.01C7.5 20.5 4 18 4 13V6a1 1 0 0 1 1-1c2 0 4.5-1.2 6.24-2.72a1.17 1.17 0 0 1 1.52 0C14.51 3.81 17 5 19 5a1 1 0 0 1 1 1z\"\/><path d=\"m9 12 2 2 4-4\"\/><\/svg> <b>\uc758\ub8cc\uc6a9 \uc0ac\ucd9c \uc131\ud615\uc740 ISO 13485 \ud488\uc9c8 \uad00\ub9ac \ud45c\uc900\uc744 \uc5c4\uaca9\ud558\uac8c \uc900\uc218\ud574\uc57c \ud569\ub2c8\ub2e4.<\/b><span class='claim-true-or-false'>True<\/span><\/p>\n<p class='claim-explanation'>ISO 13485\ub294 \uc758\ub8cc \uae30\uae30 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc758 \uae00\ub85c\ubc8c \ud45c\uc900\uc73c\ub85c \uc77c\uad00\uc131, \uc704\ud5d8 \uad00\ub9ac \ubc0f \uaddc\uc815 \uc900\uc218\ub97c \ubcf4\uc7a5\ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n<div class=\"claim claim-false\" style=\"background-color: #f7efef; border-color: #f7efef; color: #db6f85;\">\n<p><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M20 13c0 5-3.5 7.5-7.66 8.95a1 1 0 0 1-.67-.01C7.5 20.5 4 18 4 13V6a1 1 0 0 1 1-1c2 0 4.5-1.2 6.24-2.72a1.17 1.17 0 0 1 1.52 0C14.51 3.81 17 5 19 5a1 1 0 0 1 1 1z\"\/><path d=\"m14.5 9.5-5 5\"\/><path d=\"m9.5 9.5 5 5\"\/><\/svg> <b>\uc758\ub8cc \uae30\uae30\ub97c \uc81c\uc870\ud558\ub294 \ub370\ub294 \uae68\ub057\ud55c \ud658\uacbd\uc774\uba74 \ucda9\ubd84\ud569\ub2c8\ub2e4.<\/b><span class='claim-true-or-false'>False<\/span><\/p>\n<p class='claim-explanation'>\uc758\ub8cc\uc6a9 \uc131\ud615\uc740 \uc77c\ubc18\uc801\uc73c\ub85c \uacf5\uae30 \uc911 \ubbf8\ub9bd\uc790 \ub18d\ub3c4\ub97c \ud2b9\uc815 \uaddc\uc81c \ud55c\ub3c4\ub85c \uc81c\uc5b4\ud558\uae30 \uc704\ud574 \uc778\uc99d\ub41c ISO \ud074\ub798\uc2a4 7 \ub610\ub294 8 \ud074\ub9b0\ub8f8\uc774 \ud544\uc694\ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n<p><figure><img decoding=\"async\" src=\"https:\/\/zetarmold.com\/wp-content\/uploads\/2025\/04\/colorful-test-tubes.webp\" alt=\"\uc758\ub8cc\uc6a9 \uc2dc\ud5d8\uad00\"><figcaption>\uc758\ub8cc\uc6a9 \uc2dc\ud5d8\uad00<\/figcaption><\/figure>\n<\/p>\n<h2>\uc8fc\uc694 \uae30\uc220 \ud30c\ub77c\ubbf8\ud130<\/h2>\n<p>\ub2e4\uc74c \ub9e4\uac1c \ubcc0\uc218\ub294 \uace0\ud488\uc9c8 \uc758\ub8cc\uc6a9 \uc131\ud615\uc758 \uc791\uc5c5 \uae30\uac04\uc744 \uc815\uc758\ud569\ub2c8\ub2e4.<\/p>\n<table>\n<thead>\n<tr>\n<th style=\"text-align: left;\">\ub9e4\uac1c\ubcc0\uc218<\/th>\n<th style=\"text-align: left;\">\uc77c\ubc18\uc801\uc778 \ubc94\uc704\/\uc694\uad6c \uc0ac\ud56d<\/th>\n<th style=\"text-align: left;\">\ub2e8\uc704 \/ \ucc38\uace0<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td style=\"text-align: left;\"><strong>\ud074\ub7a8\ud504 \ud1a4\uc218<\/strong><\/td>\n<td style=\"text-align: left;\">30 - 500+<\/td>\n<td style=\"text-align: left;\">\ud1a4(\ubd80\ud488 \ud06c\uae30\uc5d0 \ub530\ub77c \ub2e4\ub984)<\/td>\n<\/tr>\n<tr>\n<td style=\"text-align: left;\"><strong>\ud074\ub9b0\ub8f8 \ud074\ub798\uc2a4<\/strong><\/td>\n<td style=\"text-align: left;\">\ud074\ub798\uc2a4 7(10,000) \ub610\ub294 \ud074\ub798\uc2a4 8(100,000)<\/td>\n<td style=\"text-align: left;\">ISO 14644 \ud45c\uc900<\/td>\n<\/tr>\n<tr>\n<td style=\"text-align: left;\"><strong>\uc0ac\ucd9c \uc555\ub825<\/strong><\/td>\n<td style=\"text-align: left;\">100 - 200<\/td>\n<td style=\"text-align: left;\">MPa(\uc587\uc740 \ubcbd\uc744 \uc704\ud55c \uace0\uc555)<\/td>\n<\/tr>\n<tr>\n<td style=\"text-align: left;\"><strong>\uc6a9\uc735 \uc628\ub3c4<\/strong><\/td>\n<td style=\"text-align: left;\">200 - 400<\/td>\n<td style=\"text-align: left;\">\u00b0C(\uc7ac\ub8cc\uc5d0 \ub530\ub77c \ub2e4\ub984, PEEK\uac00 \ub354 \ub192\uc74c)<\/td>\n<\/tr>\n<tr>\n<td style=\"text-align: left;\"><strong>\uae08\ud615\uac15 \uacbd\ub3c4<\/strong><\/td>\n<td style=\"text-align: left;\">48 - 56<\/td>\n<td style=\"text-align: left;\">HRC(\uc2a4\ud14c\uc778\ub9ac\uc2a4 \uc2a4\ud2f8 \ud544\uc694)<\/td>\n<\/tr>\n<tr>\n<td style=\"text-align: left;\"><strong>\uce58\uc218 \ud5c8\uc6a9 \uc624\ucc28<\/strong><\/td>\n<td style=\"text-align: left;\">\u00b10.001 ~ \u00b10.05<\/td>\n<td style=\"text-align: left;\">mm(\uc815\ubc00\ub3c4\uac00 \uc911\uc694)<\/td>\n<\/tr>\n<tr>\n<td style=\"text-align: left;\"><strong>\uc7ac\ub8cc \ub4f1\uae09<\/strong><\/td>\n<td style=\"text-align: left;\">USP \ud074\ub798\uc2a4 VI \/ ISO 10993<\/td>\n<td style=\"text-align: left;\">\uc0dd\uccb4 \uc801\ud569\uc131\uc774 \uc788\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><figure><img decoding=\"async\" src=\"https:\/\/zetarmold.com\/wp-content\/uploads\/2025\/09\/zetar6756_An_assortment_of_injection-molded_storage_box_casin_3206132e-47a6-480b-909e-9fdbc5ece0b9_0.webp\" alt=\"\uc758\ub8cc \uc0ac\ub840\"><figcaption>\uc758\ub8cc \uc0ac\ub840<\/figcaption><\/figure>\n<\/p>\n<h2>\uc7a5\uc810\uacfc \ub2e8\uc810<\/h2>\n<table>\n<thead>\n<tr>\n<th style=\"text-align: left;\">\uc7a5\uc810<\/th>\n<th style=\"text-align: left;\">\ub2e8\uc810<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td style=\"text-align: left;\"><strong>\ub192\uc740 \uc815\ubc00\ub3c4 \ubc0f \ubc18\ubcf5\uc131:<\/strong> \ubbf8\ud06c\ub860 \uc218\uc900\uc758 \uacf5\ucc28\ub85c \uc218\ubc31\ub9cc \uac1c\uc758 \ub3d9\uc77c\ud55c \ubd80\ud488\uc744 \uc0dd\uc0b0\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/td>\n<td style=\"text-align: left;\"><strong>\ub192\uc740 \ucd08\uae30 \ube44\uc6a9:<\/strong> \uae08\ud615 \ud234\ub9c1 \ubc0f \ud074\ub9b0\ub8f8 \uc124\uce58 \ube44\uc6a9\uc740 \ud45c\uc900 \uae08\ud615\ubcf4\ub2e4 \ud6e8\uc52c \ub192\uc2b5\ub2c8\ub2e4.<\/td>\n<\/tr>\n<tr>\n<td style=\"text-align: left;\"><strong>\uaddc\uc815 \uc900\uc218:<\/strong> FDA \ubc0f ISO \uc778\uc99d\uc744 \uc704\ud55c \ud655\ub9bd\ub41c \ud504\ub85c\uc138\uc2a4\ub97c \ud1b5\ud574 \ucd5c\uc885 \ub514\ubc14\uc774\uc2a4 \uc2b9\uc778\uc744 \uac04\uc18c\ud654\ud569\ub2c8\ub2e4.<\/td>\n<td style=\"text-align: left;\"><strong>\uc5c4\uaca9\ud55c \uac80\uc99d:<\/strong> \uae34 IQ\/OQ\/PQ(\uc124\uce58, \uc6b4\uc601, \uc131\ub2a5 \uac80\uc99d) \ud504\ub85c\ud1a0\ucf5c\uc774 \ud544\uc694\ud569\ub2c8\ub2e4.<\/td>\n<\/tr>\n<tr>\n<td style=\"text-align: left;\"><strong>\uc18c\uc7ac\uc758 \ub2e4\uc591\uc131:<\/strong> \ub2e4\uc74c\uacfc \uac19\uc740 \uace0\uae09 \ub808\uc9c4\uc744 \uc9c0\uc6d0\ud569\ub2c8\ub2e4. <strong>\ud3f4\ub9ac\uc5d0\ud14c\ub974\uc5d0\ud14c\ub974\ucf00\ud1a4(PEEK)<\/strong> \ubc0f \uc0dd\uccb4 \ud761\uc218\uc131 \ud3f4\ub9ac\uba38.<\/td>\n<td style=\"text-align: left;\"><strong>\uae34 \ub9ac\ub4dc \ud0c0\uc784:<\/strong> \ub3c4\uad6c \uc124\uacc4, \uc81c\uc791 \ubc0f \uac80\uc99d\uc740 \uc0dd\uc0b0 \uc2dc\uc791 \uc804 12~16\uc8fc\uac00 \uc18c\uc694\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/td>\n<\/tr>\n<tr>\n<td style=\"text-align: left;\"><strong>\ud655\uc7a5\uc131:<\/strong> \uc77c\ud68c\uc6a9\ud488\uc758 \ub300\ub7c9 \uc0dd\uc0b0\uc5d0 \uc774\uc0c1\uc801\uc785\ub2c8\ub2e4.<\/td>\n<td style=\"text-align: left;\"><strong>\uc720\uc5f0\uc131 \uc5c6\ub294 \ub514\uc790\uc778:<\/strong> \uae08\ud615 \uac80\uc99d\uc774 \uc644\ub8cc\ub41c \ud6c4\uc5d0\ub294 \uc124\uacc4 \ubcc0\uacbd\uc5d0 \ub9ce\uc740 \ube44\uc6a9\uc774 \ub4e4\uba70 \uc7ac\uac80\uc99d\uc774 \ud544\uc694\ud569\ub2c8\ub2e4.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2>\uc77c\ubc18\uc801\uc778 \uc560\ud50c\ub9ac\ucf00\uc774\uc158<\/h2>\n<ul>\n<li><strong>\uc774\uc2dd \uac00\ub2a5\ud55c \uad6c\uc131 \uc694\uc18c:<\/strong> PEEK \ub610\ub294 \uc0dd\uccb4 \ud761\uc218\uc131 \ud3f4\ub9ac\uba38\ub85c \ub9cc\ub4e0 \ub098\uc0ac, \ud50c\ub808\uc774\ud2b8 \ubc0f \ucf00\uc774\uc2a4.<\/li>\n<li><strong>\uc218\uc220 \ub3c4\uad6c:<\/strong> \uba78\uade0 \uc800\ud56d\uc131\uc774 \ud544\uc694\ud55c \uc77c\ud68c\uc6a9 \uc190\uc7a1\uc774, \uacb8\uc790 \ubc0f \ud2b8\ub85c\uce74.<\/li>\n<li><strong>\uc57d\ubb3c \uc804\ub2ec \uc2dc\uc2a4\ud15c:<\/strong> \uc8fc\uc0ac\uae30, \uc778\uc290\ub9b0 \ud39c, \ud761\uc785\uae30 \uad6c\uc131\ud488\uc744 \ud65c\uc6a9\ud55c <a href=\"https:\/\/www.sciencedirect.com\/topics\/engineering\/polycarbonate\" class=\"external-link\">\uc758\ub8cc\uc6a9 \ud3f4\ub9ac\uce74\ubcf4\ub124\uc774\ud2b8<\/a><sup id=\"fnref1:1\"><a href=\"#fn:1\" class=\"footnote-ref\">1<\/a><\/sup>.<\/li>\n<li><strong>\uc9c4\ub2e8 \uc18c\ubaa8\ud488:<\/strong> \ub192\uc740 \uad11\ud559 \uc120\uba85\ub3c4\uac00 \ud544\uc694\ud55c \ubbf8\uc138 \uc720\uccb4 \uce69, \ud398\ud2b8\ub9ac \uc811\uc2dc \ubc0f \ud53c\ud3ab.<\/li>\n<li><strong>\uce74\ud14c\ud130 \ubc0f \ud29c\ube0c \ucee4\ub125\ud130:<\/strong> \uc5f4\uac00\uc18c\uc131 \uc5d8\ub77c\uc2a4\ud1a0\uba38(TPE) \ub610\ub294 LSR\uacfc \uac19\uc740 \uc720\uc5f0\ud55c \uc18c\uc7ac\ub97c \ud65c\uc6a9\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n<div class=\"claim claim-true\" style=\"background-color: #eff2ef; border-color: #eff2ef; color: #5b8c70;\">\n<p><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M20 13c0 5-3.5 7.5-7.66 8.95a1 1 0 0 1-.67-.01C7.5 20.5 4 18 4 13V6a1 1 0 0 1 1-1c2 0 4.5-1.2 6.24-2.72a1.17 1.17 0 0 1 1.52 0C14.51 3.81 17 5 19 5a1 1 0 0 1 1 1z\"\/><path d=\"m9 12 2 2 4-4\"\/><\/svg> <b>\ubd80\uc2dd\uacfc \ubbf8\ub9bd\uc790 \uc624\uc5fc\uc744 \ubc29\uc9c0\ud558\uae30 \uc704\ud574 \uc758\ub8cc\uc6a9 \uae08\ud615\uc5d0\ub294 \uc2a4\ud14c\uc778\ub9ac\uc2a4 \uc2a4\ud2f8 \uae08\ud615\uc774 \uc120\ud638\ub429\ub2c8\ub2e4.<\/b><span class='claim-true-or-false'>True<\/span><\/p>\n<p class='claim-explanation'>\uacbd\ud654 \uc2a4\ud14c\uc778\ub9ac\uc2a4 \uc2a4\ud2f8\uc740 \uc7a6\uc740 \uba78\uade0\uc73c\ub85c \uc778\ud55c \ubd80\uc2dd\uc744 \ubc29\uc9c0\ud558\uace0 \ub179 \uc785\uc790\uac00 \uc758\ub8cc \ubd80\ud488\uc744 \uc624\uc5fc\uc2dc\ud0a4\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/p>\n<\/div>\n<div class=\"claim claim-false\" style=\"background-color: #f7efef; border-color: #f7efef; color: #db6f85;\">\n<p><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M20 13c0 5-3.5 7.5-7.66 8.95a1 1 0 0 1-.67-.01C7.5 20.5 4 18 4 13V6a1 1 0 0 1 1-1c2 0 4.5-1.2 6.24-2.72a1.17 1.17 0 0 1 1.52 0C14.51 3.81 17 5 19 5a1 1 0 0 1 1 1z\"\/><path d=\"m14.5 9.5-5 5\"\/><path d=\"m9.5 9.5 5 5\"\/><\/svg> <b>\ud45c\uc900 \uc0b0\uc5c5\uc6a9 \ud50c\ub77c\uc2a4\ud2f1\uc740 \uba78\uade0 \ucc98\ub9ac\ub41c \uacbd\uc6b0 \uc758\ub8cc \uae30\uae30\uc5d0 \uc0ac\uc6a9\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/b><span class='claim-true-or-false'>False<\/span><\/p>\n<p class='claim-explanation'>ISO 10993 \uc0dd\uccb4 \uc801\ud569\uc131 \ud14c\uc2a4\ud2b8\ub97c \ud1b5\uacfc\ud55c \uc758\ub8cc\uc6a9 \ub808\uc9c4\ub9cc\uc774 \uc778\uccb4 \uc870\uc9c1\uc774\ub098 \uccb4\uc561\uacfc \uc811\ucd09\ud574\ub3c4 \uc548\uc804\ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n<p><figure><img decoding=\"async\" src=\"https:\/\/zetarmold.com\/wp-content\/uploads\/2025\/03\/24bee485518766285859442b4f239fe6.webp\" alt=\"\uc758\ub8cc\uc6a9 \uc2dc\ud5d8\uad00\"><figcaption>\uc758\ub8cc\uc6a9 \uc2dc\ud5d8\uad00<\/figcaption><\/figure>\n<\/p>\n<h2>\ub2e8\uacc4\ubcc4 \ud504\ub85c\uc138\uc2a4: \uc758\ub8cc \uae30\uae30 \uc131\ud615 \uc8fc\uae30<\/h2>\n<p>\uc758\ub8cc\uc6a9 \ubab0\ub354\ub294 \uaddc\uc815 \uc900\uc218\uc640 \ud488\uc9c8\uc744 \ubcf4\uc7a5\ud558\uae30 \uc704\ud574 \uc5c4\uaca9\ud55c \uc6cc\ud06c\ud50c\ub85c\uc6b0\ub97c \ub530\ub985\ub2c8\ub2e4.<\/p>\n<ol>\n<li>\n<p><strong>\uc81c\uc870 \uac00\ub2a5\uc131\uc744 \uc704\ud55c \ub514\uc790\uc778(DFM):<\/strong><br \/>\n\uc5d4\uc9c0\ub2c8\uc5b4\ub294 \ubd80\ud488 \ud615\uc0c1\uc744 \ubd84\uc11d\ud558\uc5ec \uacb0\ud568 \uc5c6\uc774 \uc131\ud615\ud560 \uc218 \uc788\ub294\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4. \uc5ec\uae30\uc5d0\ub294 \uad6c\ubc30 \uac01\ub3c4, \ubcbd \ub450\uaed8 \ubc0f \uac8c\uc774\ud2b8 \uc704\uce58\ub97c \ucd5c\uc801\ud654\ud558\uc5ec \uc720\ub3d9 \uc751\ub825\uc744 \ucd5c\uc18c\ud654\ud558\ub294 \uac83\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4.<\/p>\n<\/li>\n<li>\n<p><strong>\uc7ac\ub8cc \uc120\ud0dd:<\/strong><br \/>\n\uae30\uacc4\uc801 \uc694\uad6c \uc0ac\ud56d \ubc0f \uaddc\uc81c \uc694\uac74\uc5d0 \ub530\ub77c \uc218\uc9c0\ub97c \uc120\ud0dd\ud569\ub2c8\ub2e4(\uc608, <strong>\ud3f4\ub9ac\ud504\ub85c\ud544\ub80c(PP)<\/strong> \ub0b4\ud654\ud559\uc131\uc744 \uc704\ud574 <strong>\ud3f4\ub9ac\uce74\ubcf4\ub124\uc774\ud2b8(PC)<\/strong> \ucda9\uaca9 \uac15\ub3c4\ub97c \uc704\ud574). \uc790\ub8cc\uc5d0\ub294 FDA\uc5d0 DMF(\ub514\ubc14\uc774\uc2a4 \ub9c8\uc2a4\ud130 \ud30c\uc77c)\uac00 \uc788\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<\/li>\n<li>\n<p><strong>\uae08\ud615 \ud234\ub9c1 \uc81c\uc791:<\/strong><br \/>\n\uae08\ud615\uc740 \ub179\uc744 \ubc29\uc9c0\ud558\uace0 \uc138\ucc99\uc774 \uc6a9\uc774\ud558\ub3c4\ub85d \uace0\uae09 \uc2a4\ud14c\uc778\ub9ac\uc2a4 \uc2a4\ud2f8(\uc608: 420 SS)\ub85c \uac00\uacf5\ub429\ub2c8\ub2e4. \ud45c\uba74 \ub9c8\uac10\uc740 \ubc15\ud14c\ub9ac\uc544 \ubd80\ucc29\uc744 \ubc29\uc9c0\ud558\uae30 \uc704\ud574 SPI-A2 \uc774\uc0c1\uc73c\ub85c \uc5f0\ub9c8\ud558\ub294 \uacbd\uc6b0\uac00 \ub9ce\uc2b5\ub2c8\ub2e4.<\/p>\n<\/li>\n<li>\n<p><strong>\ud504\ub85c\uc138\uc2a4 \uc720\ud6a8\uc131 \uac80\uc0ac(IQ\/OQ\/PQ):<\/strong><\/p>\n<ul>\n<li><strong>\uc124\uce58 \uc790\uaca9(IQ):<\/strong> \uc7a5\ube44\uac00 \uc62c\ubc14\ub974\uac8c \uc124\uce58\ub418\uc5c8\ub294\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4.<\/li>\n<li><strong>\uc6b4\uc601 \uc790\uaca9(OQ):<\/strong> \ud504\ub85c\uc138\uc2a4 \ucc3d \uc124\uc815(\uc628\ub3c4, \uc555\ub825, \uc2dc\uac04 \uc81c\ud55c).<\/li>\n<li><strong>\uc131\ub2a5 \uc790\uaca9(PQ):<\/strong> \ud45c\uc900 \ud504\ub85c\ub355\uc158 \uc2e4\ud589\uc744 \ud1b5\ud574 \ud504\ub85c\uc138\uc2a4 \uc548\uc815\uc131\uc744 \uac80\uc99d\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n<\/li>\n<li>\n<p><strong>\ud074\ub9b0\ub8f8 \uc0dd\uc0b0:<\/strong><br \/>\n\uc131\ud615\uc740 \ud1b5\uc81c\ub41c \ud658\uacbd(ISO \ud074\ub798\uc2a4 7 \ub610\ub294 8)\uc5d0\uc11c \uc774\ub8e8\uc5b4\uc9d1\ub2c8\ub2e4. \ub85c\ubd07\uc740 \uc77c\ubc18\uc801\uc73c\ub85c \uc0ac\ub78c\uc758 \uc624\uc5fc\uc744 \ubc29\uc9c0\ud558\uae30 \uc704\ud574 \ubd80\ud488\uc744 \uc81c\uac70\ud569\ub2c8\ub2e4.<\/p>\n<\/li>\n<li>\n<p><strong>\ud488\uc9c8 \ubcf4\uc99d \ubc0f \ud3ec\uc7a5:<\/strong><br \/>\n\ubd80\ud488\uc740 \uc790\ub3d9\ud654\ub41c \ube44\uc804 \uac80\uc0ac\ub97c \uac70\uce69\ub2c8\ub2e4. \ud3ec\uc7a5 \uc791\uc5c5\uc740 \uc885\uc885 \ud074\ub9b0\ub8f8 \ub0b4\uc5d0\uc11c \uc9c4\ud589\ub418\uc5b4 \ud130\ubbf8\ub110\uae4c\uc9c0 \uc0dd\ubb3c\ud559\uc801 \ubd80\ub2f4 \uc218\uc900\uc744 \uc720\uc9c0\ud569\ub2c8\ub2e4. <a href=\"https:\/\/www.fda.gov\/medical-devices\/general-hospital-devices-and-supplies\/sterilization-medical-devices\" class=\"external-link\">\uc0b4\uade0<\/a><sup id=\"fnref1:2\"><a href=\"#fn:2\" class=\"footnote-ref\">2<\/a><\/sup>.<\/p>\n<\/li>\n<\/ol>\n<p><figure><img decoding=\"async\" src=\"https:\/\/zetarmold.com\/wp-content\/uploads\/2025\/03\/\u3002c602fbbe9380eb5edda61f9ecf278ebf.webp\" alt=\"\uc758\ub8cc\uc6a9 \uc8fc\uc0ac \ud29c\ube0c\"><figcaption>\uc758\ub8cc\uc6a9 \uc8fc\uc0ac \ud29c\ube0c<\/figcaption><\/figure>\n<\/p>\n<h2>FAQ: \uc758\ub8cc \uae30\uae30\uc6a9 \uc0ac\ucd9c \uc131\ud615<\/h2>\n<p><strong>Q1: ISO 13485\uc640 ISO 9001\uc758 \ucc28\uc774\uc810\uc740 \ubb34\uc5c7\uc778\uac00\uc694?<\/strong><br \/>\n<strong>ISO 13485<\/strong> \ub294 \uc758\ub8cc\uae30\uae30 \uc0b0\uc5c5\uc5d0 \ud2b9\ud654\ub418\uc5b4 \uc788\uc2b5\ub2c8\ub2e4. ISO 9001(\uc77c\ubc18 \ud488\uc9c8 \uad00\ub9ac)\uc744 \uae30\ubc18\uc73c\ub85c \ud558\uc9c0\ub9cc, \uace0\uac1d \ub9cc\uc871\uacfc \uc9c0\uc18d\uc801\uc778 \uac1c\uc120\ubcf4\ub2e4\ub294 \uc704\ud5d8 \uad00\ub9ac, \ubb38\uc11c\ud654, \uba78\uade0 \ubc0f \ucd94\uc801\uc131\uc5d0 \uc911\uc810\uc744 \ub461\ub2c8\ub2e4.<\/p>\n<p><strong>Q2: \uc561\uc0c1 \uc2e4\ub9ac\ucf58 \uace0\ubb34(LSR) \ubab0\ub529\uc774\ub780 \ubb34\uc5c7\uc778\uac00\uc694?<\/strong><br \/>\n<strong>\uc561\uc0c1 \uc2e4\ub9ac\ucf58 \uace0\ubb34(LSR)<\/strong> \ubab0\ub529\uc740 \uc5f4\uac00\uc18c\uc131 \ud50c\ub77c\uc2a4\ud2f1\ucc98\ub7fc \ub0c9\uac01\ud558\uc9c0 \uc54a\uace0 \uc5f4\ub85c \uacbd\ud654(\uac00\ud669)\ud558\ub294 2\uc131\ubd84 \uc561\uccb4 \uc2dc\uc2a4\ud15c\uc744 \uc0ac\uc6a9\ud569\ub2c8\ub2e4. \uc0dd\uccb4 \uc801\ud569\uc131, \uc720\uc5f0\uc131 \ubc0f \ubc15\ud14c\ub9ac\uc544 \uc99d\uc2dd\uc5d0 \ub300\ud55c \ub0b4\uc131\uc73c\ub85c \uc778\ud574 \uc758\ub8cc\uc6a9 \uc530, \ub9c8\uc2a4\ud06c \ubc0f \uce74\ud14c\ud130\uc5d0 \uc774\uc0c1\uc801\uc785\ub2c8\ub2e4.<\/p>\n<p><strong>Q3: \uc758\ub8cc\uc6a9 \ubab0\ub529\uc758 \ud074\ub9b0\ub8f8 \uc694\uac74\uc740 \ubb34\uc5c7\uc778\uac00\uc694?<\/strong><br \/>\n\ub300\ubd80\ubd84\uc758 \uc758\ub8cc\uc6a9 \uc131\ud615\uc740 \ub2e4\uc74c\uc5d0\uc11c \uc774\ub8e8\uc5b4\uc9d1\ub2c8\ub2e4. <strong>ISO \ud074\ub798\uc2a4 8(100,000\uc785\uc790\/ft\u00b3)<\/strong> \ub610\ub294 <strong>ISO \ud074\ub798\uc2a4 7(10,000\uc785\uc790\/ft\u00b3)<\/strong> \ud074\ub9b0\ub8f8. \uc774\ub7ec\ud55c \ud658\uacbd\uc5d0\uc11c\ub294 \uc628\ub3c4, \uc2b5\ub3c4, \uc591\uc555\uc744 \uc81c\uc5b4\ud558\uc5ec \uba3c\uc9c0\uc640 \ubbf8\uc0dd\ubb3c\uc774 \ubd80\ud488\uc744 \uc624\uc5fc\uc2dc\ud0a4\ub294 \uac83\uc744 \ubc29\uc9c0\ud569\ub2c8\ub2e4.<\/p>\n<p><strong>Q4: IQ\/OQ\/PQ \uac80\uc99d\uc774\ub780 \ubb34\uc5c7\uc778\uac00\uc694?<\/strong><br \/>\n\uc774\ub294 \uaddc\uc81c \uae30\uad00\uc5d0\uc11c \uc81c\uc870 \uacf5\uc815\uc774 \ubbf8\ub9ac \uc815\ud574\uc9c4 \uc0ac\uc591\uc744 \ucda9\uc871\ud558\ub294 \uc81c\ud488\uc744 \uc77c\uad00\ub418\uac8c \uc0dd\uc0b0\ud560 \uc218 \uc788\uc74c\uc744 \uc99d\uba85\ud558\uae30 \uc704\ud574 \uc694\uad6c\ud558\ub294 3\ub2e8\uacc4 \ud504\ub85c\ud1a0\ucf5c\uc785\ub2c8\ub2e4. \uc7a5\ube44(IQ), \ud504\ub85c\uc138\uc2a4 \ub9e4\uac1c\ubcc0\uc218(OQ), \ubd80\ud558 \uc0c1\ud0dc\uc5d0\uc11c\uc758 \uc77c\uad00\ub41c \uc131\ub2a5(PQ)\uc744 \uac80\uc99d\ud569\ub2c8\ub2e4.<\/p>\n<p><strong>Q5: \uc758\ub8cc\uc6a9 \uc0ac\ucd9c \uc131\ud615 \ubd80\ud488\uc744 \uba78\uade0\ud560 \uc218 \uc788\uc2b5\ub2c8\uae4c?<\/strong><br \/>\n\uc608, \ud558\uc9c0\ub9cc \uadf8\uc5d0 \ub530\ub77c \uc218\uc9c0\ub97c \uc120\ud0dd\ud574\uc57c \ud569\ub2c8\ub2e4. \ub2e4\uc74c\uacfc \uac19\uc740 \uc7ac\ub8cc <strong>\ud3f4\ub9ac\uc124\ud3f0(PSU)<\/strong> \uadf8\ub9ac\uace0 <strong>\ud3f4\ub9ac\uc5d0\ud14c\ub974\uc774\ubbf8\ub4dc(PEI)<\/strong> \ub294 \ubc18\ubcf5\uc801\uc778 \uace0\uc555 \uba78\uade0(\uc99d\uae30 \uba78\uade0)\uc744 \uacac\ub51c \uc218 \uc788\uc9c0\ub9cc, \ub2e4\ub978 \uc81c\ud488\uc740 \uc131\ub2a5\uc774 \uc800\ud558\ub420 \uc218 \uc788\uc73c\uba70 \uac10\ub9c8 \ub610\ub294 \uc5d0\ud2f8\ub80c \uc625\uc0ac\uc774\ub4dc(EtO) \uba78\uade0\uc5d0 \ub354 \uc801\ud569\ud569\ub2c8\ub2e4.<\/p>\n<div class=\"claim claim-true\" style=\"background-color: #eff2ef; border-color: #eff2ef; color: #5b8c70;\">\n<p><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M20 13c0 5-3.5 7.5-7.66 8.95a1 1 0 0 1-.67-.01C7.5 20.5 4 18 4 13V6a1 1 0 0 1 1-1c2 0 4.5-1.2 6.24-2.72a1.17 1.17 0 0 1 1.52 0C14.51 3.81 17 5 19 5a1 1 0 0 1 1 1z\"\/><path d=\"m9 12 2 2 4-4\"\/><\/svg> <b>\uc758\ub8cc \uae30\uae30 \uc81c\uc870\uc5d0\ub294 IQ\/OQ\/PQ\uc640 \uac19\uc740 \uac80\uc99d \ud504\ub85c\uc138\uc2a4\uac00 \ubc95\uc801\uc73c\ub85c \uc694\uad6c\ub429\ub2c8\ub2e4.<\/b><span class='claim-true-or-false'>True<\/span><\/p>\n<p class='claim-explanation'>FDA \ubc0f ISO\uc640 \uac19\uc740 \uaddc\uc81c \uae30\uad00\uc740 \uc81c\uc870 \uacf5\uc815\uc774 \uc548\uc804\ud558\uace0 \ud6a8\uacfc\uc801\uc778 \uc81c\ud488\uc744 \uc77c\uad00\ub418\uac8c \uc0dd\uc0b0\ud55c\ub2e4\ub294 \uac83\uc744 \uc99d\uba85\ud558\uae30 \uc704\ud574 \uac80\uc99d\uc744 \uc694\uad6c\ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n<div class=\"claim claim-false\" style=\"background-color: #f7efef; border-color: #f7efef; color: #db6f85;\">\n<p><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewbox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M20 13c0 5-3.5 7.5-7.66 8.95a1 1 0 0 1-.67-.01C7.5 20.5 4 18 4 13V6a1 1 0 0 1 1-1c2 0 4.5-1.2 6.24-2.72a1.17 1.17 0 0 1 1.52 0C14.51 3.81 17 5 19 5a1 1 0 0 1 1 1z\"\/><path d=\"m14.5 9.5-5 5\"\/><path d=\"m9.5 9.5 5 5\"\/><\/svg> <b>\uc758\ub8cc\uc6a9 \uc0ac\ucd9c \uc131\ud615\uc740 \uc18c\ub7c9 \ud504\ub85c\ud1a0\ud0c0\uc785 \uc81c\uc791\uc5d0 \uac00\uc7a5 \uc801\ud569\ud55c \uc120\ud0dd\uc785\ub2c8\ub2e4.<\/b><span class='claim-true-or-false'>False<\/span><\/p>\n<p class='claim-explanation'>\ub192\uc740 \ud234\ub9c1 \ube44\uc6a9\uc73c\ub85c \uc778\ud574 \uc77c\ubc18\uc801\uc73c\ub85c \uc18c\ub7c9 \ud504\ub85c\ud1a0\ud0c0\uc785\uc5d0\ub294 3D \ud504\ub9b0\ud305 \ub610\ub294 CNC \uac00\uacf5\uc774 \uc120\ud638\ub418\uba70, \ub300\ub7c9 \uc0dd\uc0b0\uc5d0\ub294 \uc131\ud615\uc774 \ucd5c\uc801\ud654\ub418\uc5b4 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<\/div>\n<h2>\uc694\uc57d<\/h2>\n<p>\uc758\ub8cc \uae30\uae30\uc6a9 \uc0ac\ucd9c \uc131\ud615\uc740 \ub2e4\uc74c\uacfc \uac19\uc774 \uc815\uc758\ub418\ub294 \ubd84\uc57c\uc785\ub2c8\ub2e4. <strong>\uc704\ud5d8 \uad00\ub9ac<\/strong> \uadf8\ub9ac\uace0 <strong>\ud504\ub85c\uc138\uc2a4 \uc81c\uc5b4<\/strong>. \ubbf8\uad00\uc774\ub098 \ube44\uc6a9\uc774 \uacb0\uc815\uc744 \uc88c\uc6b0\ud560 \uc218 \uc788\ub294 \uc18c\ube44\uc7ac\uc640 \ub2ec\ub9ac \uc758\ub8cc\uc6a9 \uc131\ud615\uc740 \ub2e4\uc74c\uc744 \uc5c4\uaca9\ud558\uac8c \uc900\uc218\ud558\uc5ec \ud658\uc790 \uc548\uc804\uc744 \uc6b0\uc120\uc2dc\ud569\ub2c8\ub2e4. <a href=\"https:\/\/www.iso.org\/standard\/59752.html\" class=\"external-link\">ISO 13485<\/a><sup id=\"fnref1:3\"><a href=\"#fn:3\" class=\"footnote-ref\">3<\/a><\/sup> and material biocompatibility. By leveraging high-precision electric molding machines, automated cleanroom environments, and validated scientific molding practices, manufacturers can deliver components that are critical for modern healthcare. See our <a href=\"https:\/\/zetarmold.com\/ko\/injection-molding-supplier-sourcing-guide\/\">Supplier Sourcing Guide<\/a> for a comprehensive overview.<\/p>\n<div class=\"footnotes\">\n<hr \/>\n<ol>\n<li id=\"fn:1\">\n<p>\ud3f4\ub9ac\uce74\ubcf4\ub124\uc774\ud2b8\ub294 \ub0b4\ucda9\uaca9\uc131\uacfc \uad11\ud559\uc801 \ud22c\uba85\uc131 \ub54c\ubb38\uc5d0 \uc758\ub8cc \uae30\uae30\uc5d0 \ub110\ub9ac \uc0ac\uc6a9\ub418\ub294\ub370, \uc774 \uc790\ub8cc\uc5d0\uc11c\ub294 \ud3f4\ub9ac\uce74\ubcf4\ub124\uc774\ud2b8\uc758 \uacf5\ud559\uc801 \ud2b9\uc131\uc744 \uc790\uc138\ud788 \uc124\uba85\ud569\ub2c8\ub2e4.<a href=\"#fnref1:1\" rev=\"footnote\" class=\"footnote-backref\">&#8617;<\/a><\/p>\n<\/li>\n<li id=\"fn:2\">\n<p>\uc774 FDA \uac00\uc774\ub4dc\ub294 \uc758\ub8cc \uae30\uae30\uc5d0 \uc0dd\uc874 \uac00\ub2a5\ud55c \ubbf8\uc0dd\ubb3c\uc774 \uc5c6\ub294\uc9c0 \ud655\uc778\ud558\uae30 \uc704\ud55c \uba78\uade0 \uacf5\uc815\uc758 \uc911\uc694 \uc694\uac74\uc744 \uac04\ub7b5\ud558\uac8c \uc124\uba85\ud569\ub2c8\ub2e4.<a href=\"#fnref1:2\" rev=\"footnote\" class=\"footnote-backref\">&#8617;<\/a><\/p>\n<\/li>\n<li id=\"fn:3\">\n<p>ISO 13485\ub294 \uc758\ub8cc \uae30\uae30 \uc0b0\uc5c5\uc758 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc5d0 \ub300\ud55c \uad6d\uc81c \ud45c\uc900\uc73c\ub85c, \uaddc\uc815 \uc900\uc218\ub97c \uc704\ud55c \uae30\uc900\uc744 \uc218\ub9bd\ud569\ub2c8\ub2e4.<a href=\"#fnref1:3\" rev=\"footnote\" class=\"footnote-backref\">&#8617;<\/a><\/p>\n<\/li>\n<\/ol>\n<\/div>\n<div style=\"background:#f0f4f8;padding:20px;border-radius:8px;margin-top:30px;\">\n<p style=\"margin:0 0 10px;font-size:18px;\"><strong>Need a Quote for Your Injection Molding Project?<\/strong><\/p>\n<p style=\"margin:0 0 10px;\">Get competitive pricing, DFM feedback, and production timeline from ZetarMold&#8217;s engineering team.<\/p>\n<p style=\"margin:0;\"><a href=\"https:\/\/zetarmold.com\/ko\/%eb%ac%b8%ec%9d%98%ed%95%98%ea%b8%b0\/\" style=\"background:#2563eb;color:white;padding:12px 24px;border-radius:6px;text-decoration:none;font-weight:bold;\">Request a Free Quote \u2192<\/a><\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>\uc8fc\uc694 \uc694\uc810 \uc758\ub8cc\uc6a9 \uc0ac\ucd9c \uc131\ud615\uc740 \uc758\ub8cc \uc0b0\uc5c5\uc744 \uc704\ud574 \ub0b4\uad6c\uc131, \uc0dd\uccb4 \uc801\ud569\uc131 \ubc0f \uc815\ubc00\ud55c \uad6c\uc131 \uc694\uc18c\ub97c \uc0dd\uc0b0\ud558\ub3c4\ub85d \uc124\uacc4\ub41c \uc804\ubb38 \uc81c\uc870 \uacf5\uc815\uc785\ub2c8\ub2e4. \uc77c\ubc18 \ubaa9\uc801 \uc131\ud615\uacfc \ub2ec\ub9ac, **ISO 13485** \ubc0f **FDA 21 CFR Part 820**\uacfc \uac19\uc740 \uc5c4\uaca9\ud55c \uaddc\uc81c \uae30\uc900\uc744 \uc900\uc218\ud574\uc57c \ud569\ub2c8\ub2e4. \uc774 \uacf5\uc815\uc740 \uc77c\ubc18\uc801\uc73c\ub85c \uc758\ub8cc\uc6a9 \ub4f1\uae09 \uc218\uc9c0(\uc608: PEEK, PC, LSR)\ub97c \uc0ac\uc6a9\ud558\uba70 [\u2026] \ub0b4\uc5d0\uc11c \uc6b4\uc601\ub429\ub2c8\ub2e4.<\/p>","protected":false},"author":1,"featured_media":49125,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_seopress_robots_primary_cat":"none","_seopress_titles_title":"Injection Molding for Medical Devices Vs Standard Manufacturing","_seopress_titles_desc":"Discover specialized medical injection molding with ISO and FDA compliance, using biocompatible resins in cleanrooms for durable healthcare components.","_seopress_robots_index":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[52],"tags":[182,167,160,177,187],"meta_box":{"post-to-quiz_to":[]},"_links":{"self":[{"href":"https:\/\/zetarmold.com\/ko\/wp-json\/wp\/v2\/posts\/51326"}],"collection":[{"href":"https:\/\/zetarmold.com\/ko\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zetarmold.com\/ko\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zetarmold.com\/ko\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/zetarmold.com\/ko\/wp-json\/wp\/v2\/comments?post=51326"}],"version-history":[{"count":0,"href":"https:\/\/zetarmold.com\/ko\/wp-json\/wp\/v2\/posts\/51326\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zetarmold.com\/ko\/wp-json\/wp\/v2\/media\/49125"}],"wp:attachment":[{"href":"https:\/\/zetarmold.com\/ko\/wp-json\/wp\/v2\/media?parent=51326"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zetarmold.com\/ko\/wp-json\/wp\/v2\/categories?post=51326"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zetarmold.com\/ko\/wp-json\/wp\/v2\/tags?post=51326"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}