{"id":10267,"date":"2026-05-28T11:25:52","date_gmt":"2026-05-28T03:25:52","guid":{"rendered":"https:\/\/rysilicone.com\/?p=10267"},"modified":"2026-08-26T18:13:26","modified_gmt":"2026-08-26T10:13:26","slug":"medical-grade-silicone","status":"publish","type":"post","link":"https:\/\/rysilicone.com\/ko\/medical-grade-silicone\/","title":{"rendered":"\uc758\ub8cc\uc6a9 \uc2e4\ub9ac\ucf58: FDA, USP Class VI \ubc0f ISO 10993 \uc124\uba85"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u201c&quot;\uc758\ub8cc\uc6a9 \uc2e4\ub9ac\ucf58&quot;\uc740 B2B \uc870\ub2ec\uc5d0\uc11c \uac00\uc7a5 \uc624\uc6a9\ub418\ub294 \uc6a9\uc5b4 \uc911 \ud558\ub098\uc785\ub2c8\ub2e4. \uc544\uae30 \uc816\uaf2d\uc9c0, \uc218\uc561 \ud29c\ube0c, \uc7a5\uae30 \uc0bd\uc785\ud615 \uc784\ud50c\ub780\ud2b8 \ub4f1 \ub2e4\uc591\ud55c \uc81c\ud488\uc5d0 \ub3d9\uc77c\ud55c \ubb38\uad6c\uac00 \uc0ac\uc6a9\ub418\uc9c0\ub9cc, \uac01\uac01 \uc801\uc6a9\ub418\ub294 \uae30\uc900\uc740 \ub2e4\ub985\ub2c8\ub2e4. \ub300\ubd80\ubd84\uc758 \uc77c\ubc18\uc801\uc778 \uc81c\ud488 \uc124\uba85\uc5d0\uc11c\ub294 \uc774\ub7ec\ud55c \ucc28\uc774\uc810\uc744 \uba85\uc2dc\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\uc758\ub8cc\uc6a9 \uc2e4\ub9ac\ucf58\uc740 <a href=\"https:\/\/rysilicone.com\/ko\/platinum-vulcanization\/\" target=\"_blank\" rel=\"noreferrer noopener\">\ubc31\uae08 \uacbd\ud654 \uc2e4\ub9ac\ucf58<\/a> \ucd5c\uc18c\ud55c \ud558\ub098\uc758 \uacf5\uc778\ub41c \uc0dd\uccb4 \uc801\ud569\uc131 \ud45c\uc900(\uc77c\ubc18\uc801\uc73c\ub85c FDA 21 CFR 177.2600(\uc811\ucd09), USP Class VI(\ub2e8\uae30 \uc758\ub8cc\uc6a9) \ub610\ub294 ISO 10993(\uc784\uc0c1 \uae30\uae30 \ubd84\ub958))\uc744 \ud1b5\uacfc\ud574\uc57c \ud569\ub2c8\ub2e4. \uc801\uc6a9\ub418\ub294 \ud45c\uc900\uc740 \uc2e4\ub9ac\ucf58 \uc790\uccb4\uac00 \uc544\ub2c8\ub77c \uc811\ucd09 \uc720\ud615 \ubc0f \uc811\ucd09 \uc2dc\uac04\uc5d0 \ub530\ub77c \uacb0\uc815\ub429\ub2c8\ub2e4.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uacac\uc801 \uc694\uccad\uc11c\ub97c \ubcf4\ub0b4\uae30 \uc804\uc5d0 \uc81c\ud488\uc5d0 \uc758\ub8cc\uc6a9 \ub4f1\uae09 \uc7ac\ub8cc\uac00 \ud544\uc694\ud55c\uc9c0 \uc5ec\ubd80\ub97c \uacb0\uc815\ud574\uc57c \ud55c\ub2e4\uba74, \uc544\ub798 \uc139\uc158\uc5d0\uc11c \uae30\uc900\uc744 \ud655\uc778\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">&quot;\uc758\ub8cc\uc6a9 \uc2e4\ub9ac\ucf58&quot;\uc774\ub780 \uc2e4\uc81c\ub85c \ubb34\uc5c7\uc744 \uc758\ubbf8\ud558\ub294\uac00<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\uc804 \uc138\uacc4\uc801\uc73c\ub85c \ud1b5\uc6a9\ub418\ub294 \ub2e8\uc77c\ud55c \uc815\uc758\ub294 \uc5c6\uc2b5\ub2c8\ub2e4. \uacf5\uc7a5\uc5d0\uc11c \uc5b4\ub5a4 \ud654\ud569\ubb3c\uc744 &quot;\uc758\ub8cc\uc6a9 \ub4f1\uae09&quot;\uc774\ub77c\uace0 \ubd80\ub97c \ub54c\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \ub2e4\uc74c \uc138 \uac00\uc9c0 \uc870\uac74\uc774 \ub3d9\uc2dc\uc5d0 \ucda9\uc871\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ubc31\uae08 \uacbd\ud654(\ucca8\uac00 \uacbd\ud654) \ubc29\uc2dd\uc774\uba70, \uacfc\uc0b0\ud654\ubb3c \uacbd\ud654 \ubc29\uc2dd\uc774 \uc544\ub2c8\ubbc0\ub85c \uacfc\uc0b0\ud654\ubb3c \ubd80\uc0b0\ubb3c, \uc794\ub958 \ub0c4\uc0c8, \ud669\ubcc0 \ud604\uc0c1\uc774 \uc5c6\uc2b5\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uacf5\uc778\ub41c \uc0dd\uccb4 \uc801\ud569\uc131 \ud45c\uc900(FDA, USP \ub610\ub294 ISO 10993)\uc5d0 \ub530\ub77c \ud14c\uc2a4\ud2b8\ub97c \uac70\uce5c \uae30\ubcf8 \uace0\ubd84\uc790\ub85c \uc81c\uc870\ub418\uc5c8\uc2b5\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\ud1b5\uc81c\ub41c \uc870\uac74\uc5d0\uc11c \uc0dd\uc0b0\ub418\uba70, \uc77c\ubc18\uc801\uc73c\ub85c <a href=\"https:\/\/www.iso.org\/standard\/53394.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISO 14644-1 \ud074\ub798\uc2a4 8<\/a> \ud074\ub9b0\ub8f8(\u2248 10\ub9cc \ub4f1\uae09) \ub610\ub294 \uadf8\ubcf4\ub2e4 \ub354 \uc5c4\uaca9\ud55c \ud658\uacbd.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\ub9c8\ucf00\ud305 \ubb38\uad6c\uc640 \uad00\uacc4\uc5c6\uc774, \uc704 \uc138 \uac00\uc9c0 \uc694\uc18c \uc911 \ud558\ub098\ub77c\ub3c4 \uacb0\uc5ec\ub41c \ud654\ud569\ubb3c\uc740 \uc870\ub2ec \uad00\uc810\uc5d0\uc11c \uc758\ub8cc\uc6a9 \ub4f1\uae09\uc73c\ub85c \uac04\uc8fc\ub418\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\uc138 \uac00\uc9c0 \uaddc\uc815 \uc900\uc218 \ub2e8\uacc4(\ubc0f \uac01 \ub2e8\uacc4\uc758 \uc801\uc6a9 \ubd84\uc57c)<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\uc6a9\ub3c4\uc5d0 \ub530\ub77c \ud544\uc694\ud55c \uc778\uc99d\uc774 \ub2e4\ub985\ub2c8\ub2e4. \uc798\ubabb\ub41c \ub4f1\uae09\uc744 \uc120\ud0dd\ud558\uba74 \uc790\uc7ac \ube44\uc6a9\uc774 \uacfc\ub3c4\ud558\uac8c \ubc1c\uc0dd\ud558\uac70\ub098 \ub4f1\ub85d \uc2dc \uc2ec\uc0ac\uc5d0 \ubd88\ud569\uaca9\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><strong>\uae30\uc900<\/strong><\/th><th><strong>\ubc94\uc704<\/strong><\/th><th><strong>\uc77c\ubc18\uc801\uc778 \uc5f0\ub77d\ucc98<\/strong><\/th><th><strong>\uc0b0\uc5c5\uc6a9 HTV \ub300\ube44 \uc7ac\ub8cc\ube44 \ucd94\uc815\uce58<\/strong><\/th><\/tr><\/thead><tbody><tr><td><a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-B\/part-177\/subpart-C\/section-177.2600\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">FDA 21 CFR 177.2600<\/a><\/td><td>\uc2dd\ud488\/\uacbd\uad6c\/\ud53c\ubd80 \uc811\ucd09 \uc548\uc804\uc131<\/td><td>\uacf5\uac08\uc816\uaf2d\uc9c0, \uc816\uaf2d\uc9c0, \uc8fc\ubc29\uc6a9\ud488<\/td><td>+10\u201320%<\/td><\/tr><tr><td><a href=\"https:\/\/doi.usp.org\/USPNF\/USPNF_M98834_01_01.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">USP 6\ub4f1\uae09<\/a> (USP &lt;87&gt; \/ &lt;88&gt;)<\/td><td>\ub2e8\uae30 \uc758\ub8cc \uc811\ucd09, 30\uc77c \uc774\ud558<\/td><td>\ud29c\ube0c, \ub9c8\uc2a4\ud06c, \ub2e8\uae30\uc6a9 \uce74\ud14c\ud130<\/td><td>+30\u201350%<\/td><\/tr><tr><td><a href=\"https:\/\/www.iso.org\/standard\/68936.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISO 10993 \uc2dc\ub9ac\uc988<\/a><\/td><td>\uc784\uc0c1 \uc0dd\uccb4 \uc801\ud569\uc131 \ud3c9\uac00 \uc885\ud569 (\uc138\ud3ec \ub3c5\uc131, \uac10\uc791\uc131, \uc790\uadf9\uc131, \uc804\uc2e0 \ub3c5\uc131)<\/td><td>\uc784\ud50c\ub780\ud2b8, \uc7a5\uae30 \uc811\ucd09 \uc7a5\uce58<\/td><td>+50\u2013100%<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"800\" height=\"450\" src=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Three-medical-silicone-compliance-tiers-comparison.jpg\" alt=\"\uc758\ub8cc\uc6a9 \uc2e4\ub9ac\ucf58 \uaddc\uaca9 \uc900\uc218 \ub4f1\uae09 3\uac00\uc9c0 \ube44\uad50\" class=\"wp-image-16312\" srcset=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Three-medical-silicone-compliance-tiers-comparison.jpg 800w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Three-medical-silicone-compliance-tiers-comparison-300x169.jpg 300w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Three-medical-silicone-compliance-tiers-comparison-768x432.jpg 768w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Three-medical-silicone-compliance-tiers-comparison-18x10.jpg 18w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Three-medical-silicone-compliance-tiers-comparison-600x338.jpg 600w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\ud575\uc2ec \uc720\uc758\uc0ac\ud56d: FDA 21 CFR 177.2600\uc740 \uc2dd\ud488 \uc811\ucd09 \uad00\ub828 \uaddc\uc815\uc774\uba70 \uc758\ub8cc\uae30\uae30 \uad00\ub828 \uaddc\uc815\uc774 \uc544\ub2d9\ub2c8\ub2e4. &quot;FDA \uc2b9\uc778 \uc2e4\ub9ac\ucf58&quot;\uc73c\ub85c \uc124\uba85\ub41c \ud654\ud569\ubb3c\uc774 \uc790\ub3d9\uc73c\ub85c \uc758\ub8cc\uc6a9\uc73c\ub85c \uc2b9\uc778\ub418\ub294 \uac83\uc740 \uc544\ub2d9\ub2c8\ub2e4. \uc644\uc81c\ud488 \uc758\ub8cc\uae30\uae30 \ud3c9\uac00\uc5d0 \ub300\ud574\uc11c\ub294 \ub2e4\uc74c\uc744 \ucc38\uc870\ud558\uc2ed\uc2dc\uc624. <a href=\"https:\/\/rysilicone.com\/ko\/biocompatibility-silicone\/\">ISO 10993\uc5d0 \ub530\ub77c \uc2e4\ub9ac\ucf58\uc758 \uc0dd\uccb4 \uc801\ud569\uc131\uc744 \ud3c9\uac00\ud558\ub294 \ubc29\ubc95<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\uc2e4\uc81c\ub85c \uc758\ub8cc\uc6a9 \ub4f1\uae09\uc774 \ud544\uc694\ud560 \ub54c<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\uad6c\ub9e4 \uc2ec\uc0ac\uc5d0\uc11c \uacb0\uc815\uc740 \uc81c\ud488 \uce74\ud14c\uace0\ub9ac \uc774\ub984\uc774 \uc544\ub2c8\ub77c \uc5f0\ub77d \uc720\ud615\uacfc \uc5f0\ub77d \uae30\uac04\uc5d0 \ub530\ub77c \uc88c\uc6b0\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\ud53c\ubd80\ub098 \uc785\uc5d0 \ub2ff\uc9c0 \uc54a\ub3c4\ub85d \ud558\uc2ed\uc2dc\uc624.<\/strong> (\uc0b0\uc5c5\uc6a9 \ubc00\ubd09\uc7ac, \uc678\ubd80 \ud558\uc6b0\uc9d5, \uad6c\uc870 \ubd80\ud488): \ud45c\uc900 HTV \uc2e4\ub9ac\ucf58\uc774\uba74 \ucda9\ubd84\ud569\ub2c8\ub2e4. \uc758\ub8cc\uc6a9 \ub4f1\uae09\uc740 \uacfc\ub3c4\ud55c \uc0ac\uc591\uc785\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\ubc18\ubcf5\uc801\uc778 \uad6c\uac15 \ub610\ub294 \ud53c\ubd80 \uc811\ucd09<\/strong> (\ud131\ubc1b\uc774, \ub9e4\ud2b8, \uc8fc\ubc29 \ub3c4\uad6c, \uacf5\uac08\uc816\uaf2d\uc9c0): FDA 21 CFR 177.2600 \ud50c\ub7ec\uc2a4 <a href=\"https:\/\/www.bfr.bund.de\/en\/product-safety\/health-assessment-of-food-contact-materials\/\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">\ud55c\uad6d\uc5b4:<\/a> (EU \uc2dc\uc7a5)\uc774 \uae30\uc900\uc810\uc774 \ub429\ub2c8\ub2e4. USP Class VI\ub294 \uac10\uc0ac\uc0c1\uc758 \uc774\uc810 \uc5c6\uc774 \ube44\uc6a9\ub9cc \uc99d\uac00\uc2dc\ud0b5\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\ub2e8\uae30 \uc758\ub8cc\uae30\uae30 \uacc4\uc57d<\/strong> (\u2264 30\uc77c, \uc190\uc0c1\ub418\uc9c0 \uc54a\uc740 \ud53c\ubd80 \ub610\ub294 \uc810\ub9c9 \u2014 \uc608). <a href=\"https:\/\/rysilicone.com\/ko\/silicone-tubing-manufacturer\/\" target=\"_blank\" rel=\"noreferrer noopener\">\uc8fc\uc785 \ud29c\ube0c<\/a>, (\ud638\ud761\uae30 \ub9c8\uc2a4\ud06c): USP Class VI\ub294 \uc791\uc5c5 \ucd5c\uc18c \uae30\uc900\uc785\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\uc784\ud50c\ub780\ud2b8 \ub610\ub294 <a href=\"https:\/\/rysilicone.com\/ko\/silicone-strips-used-in-the-medical-and-pharmaceutical-fields\/\" target=\"_blank\" rel=\"noreferrer noopener\">\uc7a5\uae30\uac04 \uc870\uc9c1 \uc811\ucd09<\/a><\/strong> (&gt; 30\uc77c): ISO 10993 \ud544\uc218; <a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions-selecting-and-preparing-correct-submission\/premarket-notification-510k\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">FDA 510(k)<\/a> \ub514\ubc14\uc774\uc2a4 \uc2b9\uc778\uc740 \uc7ac\ub8cc \uc218\uc900\uc774 \uc544\ub2cc \ub514\ubc14\uc774\uc2a4 \uc218\uc900\uc5d0\uc11c \ubcc4\ub3c4\ub85c \uc9c4\ud589\ub418\ub294 \ud504\ub85c\uc138\uc2a4\uc785\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\uc81c\ud488\uc774 \uc758\ub8cc\uae30\uae30 \uacbd\uacc4\uc120 \uc544\ub798\uc5d0 \uc788\ub294 \uacbd\uc6b0, USP 6\ub4f1\uae09 \uc6d0\uc790\uc7ac \ube44\uc6a9\uc744 \uc9c0\ubd88\ud558\ub294 \uac83\uc740 \ub9e4\ucd9c \uc99d\ub300\uc5d0 \uac70\uc758 \ub3c4\uc6c0\uc774 \ub418\uc9c0 \uc54a\uc73c\uba70 \uc7ac\ub8cc\ube44\uc5d0 30~50%\ub97c \ucd94\uac00\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\uacf5\uc7a5 \uce21\uc5d0\uc11c\ub294 \uc5b4\ub5a4 \ubcc0\ud654\uac00 \uc788\ub098\uc694?<\/h2>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"800\" height=\"450\" src=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/ISO-Class-8-cleanroom-liquid-silicone-injection-production.jpg\" alt=\"ISO 8 \ub4f1\uae09 \ud074\ub9b0\ub8f8 \uc561\uccb4 \uc2e4\ub9ac\ucf58 \uc0ac\ucd9c \uc0dd\uc0b0\" class=\"wp-image-16311\" srcset=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/ISO-Class-8-cleanroom-liquid-silicone-injection-production.jpg 800w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/ISO-Class-8-cleanroom-liquid-silicone-injection-production-300x169.jpg 300w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/ISO-Class-8-cleanroom-liquid-silicone-injection-production-768x432.jpg 768w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/ISO-Class-8-cleanroom-liquid-silicone-injection-production-18x10.jpg 18w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/ISO-Class-8-cleanroom-liquid-silicone-injection-production-600x338.jpg 600w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\ud504\ub85c\uc81d\ud2b8\uac00 \uc758\ub8cc\uc6a9 \ub4f1\uae09\uc73c\ub85c \ud655\uc815\ub418\uba74 \uacac\uc801 \ub2e8\uacc4\uc5d0\uc11c \uc138 \uac00\uc9c0 \uc0ac\ud56d\uc774 \ubcc0\uacbd\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\uc7ac\ub8cc<\/strong>: \uacfc\uc0b0\ud654\ubb3c \uacbd\ud654 HTV\uc5d0\uc11c \ubc31\uae08 \uacbd\ud654 HTV\ub85c \uc804\ud658 <a href=\"https:\/\/rysilicone.com\/ko\/liquid-silicone-rubber\/\" target=\"_blank\" rel=\"noreferrer noopener\">LSR<\/a>. \uc6d0\uc790\uc7ac \uac00\uaca9\uc774 \uc57d 25~40% \uc0c1\uc2b9\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\ud234\ub9c1 \ubc0f \ub77c\uc778<\/strong>\uc0dd\uc0b0\uc740 \ud074\ub9b0\ub8f8(ISO 14644-1 \ud074\ub798\uc2a4 8 \uc774\uc0c1)\uc5d0\uc11c \uc9c4\ud589\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. \uad50\ucc28 \uc624\uc5fc \uc704\ud5d8 \ub54c\ubb38\uc5d0 \uacfc\uc0b0\ud654\uc218\uc18c \uacbd\ud654 \ud234\uc744 \uacf5\uc720\ud558\ub294 \uac83\uc740 \ud5c8\uc6a9\ub418\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\ub9ac\ub4dc\ud0c0\uc784<\/strong>\uc7ac\ub8cc \ubd84\uc11d \uc99d\uba85\uc11c(CoA), \uc0dd\uccb4 \uc801\ud569\uc131 \uc2dc\ud5d8 \ubcf4\uace0\uc11c \ubc0f \ub85c\ud2b8 \ucd94\uc801\uc131 \ud655\uc778 \uc808\ucc28\ub85c \uc778\ud574 \ucd5c\ucd08 \uc81c\ud488 \uc2b9\uc778\uae4c\uc9c0 \uc77c\ubc18\uc801\uc73c\ub85c 1~2\uc8fc\uac00 \ucd94\uac00\ub429\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\uc774\ub294 \uc120\ud0dd \uc0ac\ud56d\uc774 \uc544\ub2cc \ud45c\uc900 \uacf5\uae09\uc5c5\uccb4 \ucd94\uac00 \uc694\uae08\uc758 \uc9c1\uc811\uc801\uc778 \uacb0\uacfc\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\uacac\uc801\uc744 \ub0b4\uae30 \uc804\uc5d0 \ud53c\ud574\uc57c \ud560 \ud754\ud55c \uc624\ud574<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u201c<a href=\"https:\/\/rysilicone.com\/ko\/food-grade-silicone\/\" target=\"_blank\" rel=\"noreferrer noopener\">\uc2dd\ud488 \ub4f1\uae09<\/a>\u201d&quot;\ub294 \uc758\ub8cc\uc6a9 \ub4f1\uae09\uc744 \uc758\ubbf8\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. FDA 21 CFR 177.2600\uc740 \uc758\ub8cc\uc6a9 \uc0dd\uccb4 \uc801\ud569\uc131\uc744 \ub2e4\ub8e8\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\u201c\ub2e8\uc21c\ud788 &quot;\ud50c\ub798\ud2f0\ub118 \uacbd\ud654&quot;\ub77c\uace0\ub9cc \ud558\uba74 \uc758\ub8cc\uc6a9 \ub4f1\uae09\uc744 \ubcf4\uc7a5\ud558\ub294 \uac83\uc740 \uc544\ub2d9\ub2c8\ub2e4. \ud574\ub2f9 \ud654\ud569\ubb3c\uc740 USP \ub610\ub294 ISO 10993 \uc2dc\ud5d8 \uae30\uc900\uc744 \ud1b5\uacfc\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\u201c&quot;LSR&quot;\uc740 \uc758\ub8cc\uc6a9 \ub4f1\uae09\uc744 \uc758\ubbf8\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. LSR\uc740 \uacf5\uc815(\uc561\uccb4 \uc2e4\ub9ac\ucf58 \uc8fc\uc785)\uc744 \ub098\ud0c0\ub0b4\ub294 \uc6a9\uc5b4\uc774\uba70, \uc0ac\uc6a9\ub418\ub294 \ud654\ud569\ubb3c\uacfc \ud074\ub9b0\ub8f8 \ub4f1\uae09\uc5d0 \ub530\ub77c \uc0dd\uc0b0 \ub77c\uc778\uc740 \uc0b0\uc5c5\uc6a9 \ub610\ub294 \uc758\ub8cc\uc6a9\uc73c\ub85c \uad6c\ubd84\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uc7ac\ub8cc \ubd84\uc11d \uc99d\uba85\uc11c(CoA)\ub294 \uc6d0\ub8cc \uc2e4\ub9ac\ucf58\uc5d0\ub9cc \uc801\uc6a9\ub429\ub2c8\ub2e4. \ucd5c\uc885 \uae30\uae30 \uc778\uc99d(FDA 510(k))\uc740..., <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\/eng\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">CE MDR<\/a>\uc774\ub294 \uc2e4\ub9ac\ucf58 \uacf5\uae09\uc5c5\uccb4\uc758 \ucc45\uc784\uc774 \uc544\ub2c8\ub77c \uad6c\ub9e4\uc790\uc758 \ucc45\uc784\uc785\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">\ub2f9\uc0ac\uac00 \uc81c\uc870\ud558\ub294 \uc77c\ubc18\uc801\uc778 \uc758\ub8cc\uc6a9 \uc81c\ud488 \uc801\uc6a9 \ubd84\uc57c<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\ub2f9\uc0ac\uac00 \uacac\uc801\uc744 \uc81c\uacf5\ud558\ub294 \ub300\ubd80\ubd84\uc758 \uc758\ub8cc\uc6a9 \uc81c\ud488\uc740 \uc138 \uac00\uc9c0 \uc81c\ud488 \ub77c\uc778\uc73c\ub85c \uad6c\uc131\ub418\uc5b4 \uc788\uc2b5\ub2c8\ub2e4. \uac01 \uc81c\ud488 \ub77c\uc778\uc740 \uc11c\ub85c \ub2e4\ub978 \uaddc\uc815 \uc900\uc218 \ub4f1\uae09\uc5d0 \uc18d\ud558\uba70, \uc774\uc5d0 \ub530\ub77c \ud544\uc694\ud55c \uc2dc\ud5d8 \ubcf4\uace0\uc11c, \uc0dd\uc0b0 \ub77c\uc778, \ub2e8\uac00\uac00 \uacb0\uc815\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"800\" height=\"450\" src=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Medical-grade-silicone-product-range-overview.jpg\" alt=\"\uc758\ub8cc\uc6a9 \uc2e4\ub9ac\ucf58 \uc81c\ud488\uad70 \uac1c\uc694\" class=\"wp-image-16310\" srcset=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Medical-grade-silicone-product-range-overview.jpg 800w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Medical-grade-silicone-product-range-overview-300x169.jpg 300w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Medical-grade-silicone-product-range-overview-768x432.jpg 768w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Medical-grade-silicone-product-range-overview-18x10.jpg 18w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/10\/Medical-grade-silicone-product-range-overview-600x338.jpg 600w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><strong>\uaddc\uc815 \uc900\uc218 \ub4f1\uae09<\/strong><\/th><th><strong>\ub300\ud45c\uc801\uc778 \uc81c\ud488 \ub77c\uc778<\/strong><\/th><th><strong>\uc774 \ub4f1\uae09\uc774 \uc801\uc6a9\ub418\ub294 \uc774\uc720<\/strong><\/th><\/tr><\/thead><tbody><tr><td>FDA 21 CFR 177.2600<\/td><td><a href=\"https:\/\/rysilicone.com\/ko\/silicone-baby-pacifier\/\" target=\"_blank\" rel=\"noreferrer noopener\">\uc2e4\ub9ac\ucf58 \uc544\uae30 \uc816\uaf2d\uc9c0<\/a> \ubc0f \uae30\ud0c0 \uc2dd\ud488 \uc811\ucd09 \ubd80\uc704<\/td><td>\ubc18\ubcf5\uc801\uc778 \uad6c\uac15 \uc811\ucd09\uc774 \ubc1c\uc0dd\ud558\uc9c0\ub9cc \ub4f1\ub85d\ub41c \uc758\ub8cc\uae30\uae30\ub294 \uc544\ub2c8\uba70, \uc2dd\ud488 \ub4f1\uae09 \uae30\uc900\uc774 \uc900\uc218\ub429\ub2c8\ub2e4.<\/td><\/tr><tr><td>USP 6\ub4f1\uae09(30\uc77c \uc774\ud558)<\/td><td><a href=\"https:\/\/rysilicone.com\/ko\/silicone-hoses-manufacturer\/\" target=\"_blank\" rel=\"noreferrer noopener\">\uc2e4\ub9ac\ucf58 \ud638\uc2a4<\/a> \uc784\uc0c1 \uc7a5\ube44\uc6a9 \ud29c\ube0c \ubc0f<\/td><td>\uc758\ub8cc\uae30\uae30\uc758 \ud45c\uba74 \ub610\ub294 \ub2e8\uc2dc\uac04 \uc720\uccb4 \uacbd\ub85c \uc811\ucd09; USP &lt;87&gt; \/ &lt;88&gt; \uc138\ud3ec\ub3c5\uc131 \ubcf4\uace0\uc11c \ud544\uc694<\/td><\/tr><tr><td>ISO 10993 (\uc7a5\uae30\uac04\/\uc810\ub9c9)<\/td><td><a href=\"https:\/\/rysilicone.com\/ko\/silicone-menstrual-cup\/\" target=\"_blank\" rel=\"noreferrer noopener\">\uc758\ub8cc\uc6a9 \uc2e4\ub9ac\ucf58 \uc0dd\ub9ac\ucef5<\/a><\/td><td>\uc9c8 \ub0b4 \uc811\ucd09 \ub204\uc801 \uae30\uac04\uc774 30\uc77c \uae30\uc900\uce58\ub97c \ucd08\uacfc\ud558\ubbc0\ub85c ISO 10993-5 \ubc0f -10\uc5d0 \ub530\ub978 \uc804\uccb4 \ud14c\uc2a4\ud2b8\uac00 \ud544\uc694\ud569\ub2c8\ub2e4.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\uc774\ub294 \uc804\uccb4 \uce74\ud0c8\ub85c\uadf8\uac00 \uc544\ub2c8\ub77c, \uaddc\uc815 \uc900\uc218 \ub4f1\uae09\uc774 \uacac\uc801 \uc0b0\uc815\uc5d0 \uac00\uc7a5 \uc9c1\uc811\uc801\uc778 \uc601\ud5a5\uc744 \ubbf8\uce58\ub294 \ubd80\ubd84\uc785\ub2c8\ub2e4. \ub2e4\ub978 \uce74\ud14c\uace0\ub9ac\uc5d0\ub3c4 \ub3d9\uc77c\ud55c \uaddc\uce59\uc774 \uc801\uc6a9\ub429\ub2c8\ub2e4. \uc81c\ud488\uba85\uc774 \uc544\ub2c8\ub77c \uacc4\uc57d \uc720\ud615\uacfc \uae30\uac04\uc5d0 \ub530\ub77c \ud45c\uc900\uc774 \uacb0\uc815\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\uc790\uc8fc \ubb3b\ub294 \uc9c8\ubb38<\/h2>\n\n\n<div id=\"rank-math-faq\" class=\"rank-math-block\">\n<div class=\"rank-math-list\">\n<div id=\"faq-question-1779947514422\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\"><strong>FDA \uc2b9\uc778\uc744 \ubc1b\uc740 \uc2e4\ub9ac\ucf58\uc740 \uc758\ub8cc\uc6a9 \uc2e4\ub9ac\ucf58\uacfc \ub3d9\uc77c\ud55c\uac00\uc694?<\/strong><\/h3>\n<div class=\"rank-math-answer\">\n\n<p>\uc544\ub2c8\uc694. FDA 21 CFR 177.2600\uc740 \uc2dd\ud488 \uc811\ucd09 \uc548\uc804\uc131\uc5d0 \uad00\ud55c \uaddc\uc815\uc785\ub2c8\ub2e4. \uc758\ub8cc\uc6a9\uc73c\ub85c \uc0ac\uc6a9\ud558\ub824\uba74 USP Class VI \ub610\ub294 ISO 10993 \ud14c\uc2a4\ud2b8\ub97c \ud1b5\uacfc\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1779947524182\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\"><strong>\uc758\ub8cc\uc6a9 \uc2e4\ub9ac\ucf58\uc740 \ubc31\uae08 \uacbd\ud654 \ucc98\ub9ac\uac00 \ud544\uc694\ud55c\uac00\uc694?<\/strong><\/h3>\n<div class=\"rank-math-answer\">\n\n<p>\uc2e4\uc81c\ub85c \uadf8\ub807\uc2b5\ub2c8\ub2e4. \uacfc\uc0b0\ud654\ubb3c \uc794\ub958\ubb3c\uc740 USP 6\ub4f1\uae09 \uc138\ud3ec\ub3c5\uc131 \uc2dc\ud5d8\uc744 \ud1b5\uacfc\ud558\uc9c0 \ubabb\ud558\ubbc0\ub85c \uc624\ub298\ub0a0 \uc0dd\uc0b0\ub418\ub294 \uc758\ub8cc\uc6a9 \ud654\ud569\ubb3c\uc740 \ubc31\uae08\uc73c\ub85c \uacbd\ud654 \ucc98\ub9ac\ub429\ub2c8\ub2e4.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1779947533763\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\"><strong>\uc758\ub8cc\uc6a9 \uc2e4\ub9ac\ucf58 \ubd80\ud488\uc758 \uc77c\ubc18\uc801\uc778 \ucd5c\uc18c \uc8fc\ubb38\ub7c9(MOQ)\uc740 \uc5bc\ub9c8\uc778\uac00\uc694?<\/strong><\/h3>\n<div class=\"rank-math-answer\">\n\n<p>\ub300\ubd80\ubd84\uc758 \uacf5\uc7a5\uc5d0\uc11c\ub294 \uc758\ub8cc\uc6a9 LSR\uc744 5,000~10,000\uac1c \ub2e8\uc704\ub85c \uacac\uc801\uc744 \ub0b4\ub294\ub370, \uc774\ub294 \uc18c\ub7c9 \uc0dd\uc0b0\uc758 \uacbd\uc6b0 \ud074\ub9b0\ub8f8 \ub77c\uc778 \uc124\uce58\uac00 \uacbd\uc81c\uc801\uc774\uc9c0 \uc54a\uae30 \ub54c\ubb38\uc785\ub2c8\ub2e4.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1779947545615\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\"><strong>\ub098\uc911\uc5d0 \ube44\uc6a9 \uc808\uac10\uc744 \uc704\ud574 \uc758\ub8cc\uc6a9\uc5d0\uc11c \uc2dd\ud488\uc6a9\uc73c\ub85c \ub4f1\uae09\uc744 \ub0ae\ucd9c \uc218 \uc788\ub098\uc694?<\/strong><\/h3>\n<div class=\"rank-math-answer\">\n\n<p>\ud574\ub2f9 \uc81c\ud488\uc774 \uc758\ud559\uc801 \ud6a8\ub2a5\uc744 \uc8fc\uc7a5\ud558\uc9c0 \uc54a\ub294 \uacbd\uc6b0\uc5d0\ub9cc \ud574\ub2f9\ub429\ub2c8\ub2e4. FDA 510(k) \ub610\ub294 CE MDR\uc5d0 \ub530\ub77c \ub4f1\ub85d\ub41c \uae30\uae30\uc758 \uacbd\uc6b0, \uc7ac\ub8cc\ub97c \ub300\uccb4\ud558\ub824\uba74 \uc7ac\uac80\uc99d\uc774 \ud544\uc694\ud569\ub2c8\ub2e4.<\/p>\n\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\uacac\uc801 \uc694\uccad\uc11c\ub97c \ubcf4\ub0b4\uae30 \uc804\uc5d0<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\uc758\ub8cc\uc6a9\uc73c\ub85c \uc801\ud569\ud55c \uacac\uc801\uc744 \ubc1b\uc73c\ub824\uba74 \uc138 \uac00\uc9c0 \uc815\ubcf4\ub97c \uc0ac\uc804\uc5d0 \ud655\uc778\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc811\ucd09 \uc720\ud615 \ubc0f \uc811\ucd09 \uae30\uac04(\ud53c\ubd80\/\uc810\ub9c9\/\uc784\ud50c\ub780\ud2b8; 30\uc77c \uc774\ud558 \ub610\ub294 30\uc77c \ucd08\uacfc).<\/li>\n\n\n\n<li>\ub300\uc0c1 \uc2dc\uc7a5 \ubc0f \ud544\uc218 \uc778\uc99d(FDA 21 CFR 177.2600, USP Class VI, ISO 10993-5 \/ -10).<\/li>\n\n\n\n<li>\uad6c\ub9e4\uc790\uac00 \uae30\uae30 \ub4f1\ub85d(510(k) \/ CE MDR)\uc744 \ubcf4\uc720\ud558\uace0 \uc788\ub294\uc9c0 \ub610\ub294 \uacf5\uae09\uc5c5\uccb4\uc758 \uc9c0\uc6d0\uc744 \uae30\ub300\ud558\ub294\uc9c0 \uc5ec\ubd80.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\uc774 \uc138 \uac00\uc9c0 \uc815\ubcf4\ub97c \uc785\ub825\ud558\uc9c0 \uc54a\uc73c\uba74 \ubc1b\uac8c \ub418\ub294 \ubaa8\ub4e0 &quot;\uc758\ub8cc\uc6a9&quot; \uacac\uc801\uc740 \uc2e4\uc81c \uac00\uaca9\uc774 \uc544\ub2cc \uc784\uc2dc \uac00\uaca9\uc77c \ubfd0\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>&#8220;Medical grade silicone&#8221; is one of the most misused labels in B2B procurement. The same wording appears on baby pacifiers, infusion tubing, and long-term implants \u2014 but each one is held to a different standard. Most generic articles skip that distinction. Medical-grade silicone is platinum-cured silicone that has passed at least one recognized biocompatibility standard [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":16313,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1045],"tags":[],"class_list":["post-10267","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-silicone-materials"],"_links":{"self":[{"href":"https:\/\/rysilicone.com\/ko\/wp-json\/wp\/v2\/posts\/10267","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rysilicone.com\/ko\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rysilicone.com\/ko\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rysilicone.com\/ko\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/rysilicone.com\/ko\/wp-json\/wp\/v2\/comments?post=10267"}],"version-history":[{"count":7,"href":"https:\/\/rysilicone.com\/ko\/wp-json\/wp\/v2\/posts\/10267\/revisions"}],"predecessor-version":[{"id":20802,"href":"https:\/\/rysilicone.com\/ko\/wp-json\/wp\/v2\/posts\/10267\/revisions\/20802"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/rysilicone.com\/ko\/wp-json\/wp\/v2\/media\/16313"}],"wp:attachment":[{"href":"https:\/\/rysilicone.com\/ko\/wp-json\/wp\/v2\/media?parent=10267"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rysilicone.com\/ko\/wp-json\/wp\/v2\/categories?post=10267"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rysilicone.com\/ko\/wp-json\/wp\/v2\/tags?post=10267"}],"curies":[{"name":"\uc6cc\ub4dc\ud504\ub808\uc2a4","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}