{"id":2336,"date":"2026-07-04T17:08:13","date_gmt":"2026-07-04T17:08:13","guid":{"rendered":"https:\/\/www.fhysilicone.com\/?p=2336"},"modified":"2026-07-04T17:12:36","modified_gmt":"2026-07-04T17:12:36","slug":"medical-grade-silicone-components","status":"publish","type":"post","link":"https:\/\/www.fhysilicone.com\/ko\/medical-grade-silicone-components\/","title":{"rendered":"\uc758\ub8cc\uc6a9 \uc2e4\ub9ac\ucf58 \ubd80\ud488: \uc758\ub8cc \ubd84\uc57c \uc801\uc6a9\uc744 \uc704\ud55c \uc8fc\uc694 \uc694\uad6c \uc0ac\ud56d"},"content":{"rendered":"<h2 class=\"wp-block-heading\">1. \uc11c\ub860<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\uc758\ub8cc\uc6a9 \uc2e4\ub9ac\ucf58 \ubd80\ud488\uc740 \ub6f0\uc5b4\ub09c \uc0dd\uccb4\uc801\ud569\uc131, \ud654\ud559\uc801 \uc548\uc815\uc131 \ubc0f \uc7a5\uae30\uc801\uc778 \uc2e0\ub8b0\uc131 \ub355\ubd84\uc5d0 \ud604\ub300 \uc758\ub8cc \uc2dc\uc2a4\ud15c\uc5d0\uc11c \ub110\ub9ac \uc0ac\uc6a9\ub418\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc8fc\uc694 \uc6a9\ub3c4\ub85c\ub294 \uc218\uc220 \uae30\uad6c, \uc57d\ubb3c \uc804\ub2ec \uc2dc\uc2a4\ud15c, \uce74\ud14c\ud130, \ubc00\ubd09 \ubd80\ud488, \ud638\ud761\uae30 \uae30\uae30 \ubc0f \uc774\uc2dd\uc6a9 \ubcf4\uc870 \ubd80\ud488 \ub4f1\uc774 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uc0b0\uc5c5\uc6a9 \uc2e4\ub9ac\ucf58\uacfc\ub294 \ub2ec\ub9ac, <strong>\uc758\ub8cc\uc6a9 \uc2e4\ub9ac\ucf58\uc740 \uc5c4\uaca9\ud55c \uaddc\uc81c, \uc7ac\ub8cc \ubc0f \uc81c\uc870 \uae30\uc900\uc744 \ucda9\uc871\ud574\uc57c \ud569\ub2c8\ub2e4.<\/strong> \ud658\uc790\uc758 \uc548\uc804\uacfc \uae30\uae30\uc758 \uc2e0\ub8b0\uc131\uc744 \ubcf4\uc7a5\ud558\uae30 \uc704\ud574.<\/p>\n\n\n\n<figure class=\"wp-block-image aligncenter size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"819\" src=\"https:\/\/www.fhysilicone.com\/wp-content\/uploads\/2026\/07\/cf1b5f3e-6c47-4848-80a3-8bd2e4711ba0-1024x819.png\" alt=\"\" class=\"wp-image-2337\" srcset=\"https:\/\/www.fhysilicone.com\/wp-content\/uploads\/2026\/07\/cf1b5f3e-6c47-4848-80a3-8bd2e4711ba0-1024x819.png 1024w, https:\/\/www.fhysilicone.com\/wp-content\/uploads\/2026\/07\/cf1b5f3e-6c47-4848-80a3-8bd2e4711ba0-300x240.png 300w, https:\/\/www.fhysilicone.com\/wp-content\/uploads\/2026\/07\/cf1b5f3e-6c47-4848-80a3-8bd2e4711ba0-768x615.png 768w, https:\/\/www.fhysilicone.com\/wp-content\/uploads\/2026\/07\/cf1b5f3e-6c47-4848-80a3-8bd2e4711ba0-15x12.png 15w, https:\/\/www.fhysilicone.com\/wp-content\/uploads\/2026\/07\/cf1b5f3e-6c47-4848-80a3-8bd2e4711ba0-600x480.png 600w, https:\/\/www.fhysilicone.com\/wp-content\/uploads\/2026\/07\/cf1b5f3e-6c47-4848-80a3-8bd2e4711ba0.png 1402w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">2. \uc758\ub8cc\uc6a9 \uc2e4\ub9ac\ucf58\uc774\ub780 \ubb34\uc5c7\uc778\uac00\uc694?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\uc758\ub8cc\uc6a9 \uc2e4\ub9ac\ucf58\uc740 \uc77c\ubc18\uc801\uc73c\ub85c \ub2e4\uc74c\uc744 \uc8fc\uc131\ubd84\uc73c\ub85c \ud569\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ubc31\uae08 \uac00\uad50\ud615 \uc561\uc0c1 \uc2e4\ub9ac\ucf58 \uace0\ubb34(LSR)<\/li>\n\n\n\n<li>\uace0\uc21c\ub3c4 \uc5d8\ub77c\uc2a4\ud1a0\uba38 \uc2dc\uc2a4\ud15c<\/li>\n\n\n\n<li>\ucd94\ucd9c\uc131\uc774 \ub0ae\uace0 \ud718\ubc1c\uc131\uc774 \ub0ae\uc740 \uc81c\ud615<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\uc8fc\uc694 \ud2b9\uc9d5:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc0dd\uccb4\uc801\ud569\uc131<\/li>\n\n\n\n<li>\ubb34\ub3c5\uc131\uc774\uba70 \ube44\ubc18\uc751\uc131<\/li>\n\n\n\n<li>\uba78\uade0 \uacf5\uc815\uc5d0\uc11c\ub3c4 \uc548\uc815\uc801<\/li>\n\n\n\n<li>\uccb4\uc561 \ubc0f \ud654\ud559 \ubb3c\uc9c8\uc5d0 \ub300\ud55c \ub0b4\uc131<\/li>\n\n\n\n<li>\uc7a5\uae30\uc801\uc778 \uae30\uacc4\uc801 \uc548\uc815\uc131<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\ub2e4\uc74c \ub450 \ubd84\uc57c\uc5d0\uc11c \ubaa8\ub450 \ub110\ub9ac \uc0ac\uc6a9\ub418\uace0 \uc788\uc2b5\ub2c8\ub2e4. <strong>\ub2e8\uae30 \ud658\uc790 \uc811\ucd09\uc6a9 \uae30\uae30 \ubc0f \uc7a5\uae30 \uc758\ub8cc\uc6a9 \ubd80\ud488<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. \uc8fc\uc694 \uaddc\uc81c \uae30\uc900<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\uc758\ub8cc\uc6a9 \uc2e4\ub9ac\ucf58 \ubd80\ud488\uc740 \uad6d\uc81c \uc758\ub8cc \uaddc\uc815\uc744 \uc900\uc218\ud574\uc57c \ud569\ub2c8\ub2e4:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3.1 ISO 10993 (\uc0dd\uccb4\uc801\ud569\uc131)<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\uc758\ub8cc\uae30\uae30\uc758 \uc0dd\ubb3c\ud559\uc801 \ud3c9\uac00\ub97c \uc815\uc758\ud558\uba70, \uc5ec\uae30\uc5d0\ub294 \ub2e4\uc74c\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc138\ud3ec \ub3c5\uc131<\/li>\n\n\n\n<li>\uac10\uc791<\/li>\n\n\n\n<li>\uc790\uadf9<\/li>\n\n\n\n<li>\uc7a5\uae30 \uc774\uc2dd \uc548\uc804\uc131<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">3.2 USP Class VI<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\uc758\ub8cc\uc6a9 \ud3f4\ub9ac\uba38\uc5d0 \uc801\uc6a9\ub418\ub294 \ucd5c\uace0 \uc218\uc900\uc758 \uae30\uc900 \uc911 \ud558\ub098:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uae09\uc131 \uc804\uc2e0 \ub3c5\uc131 \uc2dc\ud5d8<\/li>\n\n\n\n<li>\ud53c\ub0b4 \ubc18\uc751\uc131<\/li>\n\n\n\n<li>\uc774\uc2dd \ud3c9\uac00<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">3.3 FDA \uc758\ub8cc\uae30\uae30 \uaddc\uc815 \uc900\uc218<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\uc758\ub8cc \ubd84\uc57c\uc5d0 \uc0ac\uc6a9\ub418\ub294 \uc2e4\ub9ac\ucf58 \uc18c\uc7ac\ub294 \ub2e4\uc74c \uc694\uac74\uc744 \uc900\uc218\ud574\uc57c \ud569\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>FDA 21 CFR 177.2600 (\uc2dd\ud488 \ubc0f \uc758\ub8cc\uc6a9 \uc811\ucd09 \uc5d8\ub77c\uc2a4\ud1a0\uba38)<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">3.4 EU MDR(\uc758\ub8cc\uae30\uae30 \uaddc\uc815)<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\ub2e4\uc74c \uc0ac\ud56d\uc744 \ubcf4\uc7a5\ud569\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc790\uc7ac \ucd94\uc801\uc131<\/li>\n\n\n\n<li>\uc704\ud5d8 \uad00\ub9ac<\/li>\n\n\n\n<li>\uc784\uc0c1 \uc548\uc804\uc131 \uac80\uc99d<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">4. \ud575\uc2ec \uc790\uc7ac \uc694\uac74<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">4.1 \ucd08\uace0\uc21c\ub3c4 \uc2e4\ub9ac\ucf58<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\uc758\ub8cc \ubd84\uc57c\uc5d0\uc11c\ub294 \ub2e4\uc74c\uc774 \ud544\uc694\ud569\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc794\ub958 \ucd09\ub9e4\uac00 \ub9e4\uc6b0 \uc801\uc740<\/li>\n\n\n\n<li>\ud718\ubc1c\uc131 \uc720\uae30 \ud654\ud569\ubb3c(VOC)\uc758 \ucd5c\uc18c\ub7c9<\/li>\n\n\n\n<li>\ubd84\uc790\ub7c9 \ubd84\ud3ec \uc81c\uc5b4<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">4.2 \ud50c\ub798\ud2f0\ub118 \uacbd\ud654 \uc2dc\uc2a4\ud15c<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\uacfc\uc0b0\ud654\ubb3c \uacbd\ud654 \ubc29\uc2dd\uacfc \ube44\uad50\ud558\uba74:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uacfc\uc0b0\ud654\uc218\uc18c \uc794\ub958\ubb3c \uc5c6\uc74c<\/li>\n\n\n\n<li>\ub354 \ub6f0\uc5b4\ub09c \uc0dd\uccb4\uc801\ud569\uc131<\/li>\n\n\n\n<li>\ub354 \ub192\uc740 \uad11\ud559\uc801 \ubc0f \ud654\ud559\uc801 \uc21c\ub3c4<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">4.3 \ucd94\ucd9c\ubb3c \ubc0f \uc6a9\ucd9c\ubb3c \uad00\ub9ac<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\uc758\ub8cc\uae30\uae30\ub294 \ub2e4\uc74c \uc0ac\ud56d\uc744 \ubcf4\uc7a5\ud574\uc57c \ud569\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc778\uccb4 \uc870\uc9c1\uc774\ub098 \uccb4\uc561\uc73c\ub85c\uc758 \uc720\ud574\ud55c \uc774\ub3d9\uc774 \uc5c6\uc74c<\/li>\n\n\n\n<li>\uba78\uade0 \uc870\uac74 \ud558\uc5d0\uc11c\ub3c4 \uc548\uc815\uc801\uc778 \uc131\ub2a5<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">5. \uc81c\uc870 \uc694\uac74<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">5.1 \uccad\uc815 \uc0dd\uc0b0 \ud658\uacbd<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\uc758\ub8cc\uc6a9 \uc2e4\ub9ac\ucf58 \ubd80\ud488\uc5d0\ub294 \ub300\uac1c \ub2e4\uc74c \uc0ac\ud56d\uc774 \uc694\uad6c\ub429\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ud074\ub9b0\ub8f8 \uc81c\uc870 (ISO Class 7\u20138 \uc774\uc0c1)<\/li>\n\n\n\n<li>\uba3c\uc9c0\uac00 \uc5c6\ub294 \uc131\ud615 \ud658\uacbd<\/li>\n\n\n\n<li>\uc2b5\ub3c4\uc640 \uc628\ub3c4\ub97c \uc870\uc808\ud55c \ud658\uacbd<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">5.2 LSR \uc0ac\ucd9c \uc131\ud615<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\uc561\uc0c1 \uc2e4\ub9ac\ucf58 \uace0\ubb34(LSR)\uac00 \uc120\ud638\ub418\ub294 \uc774\uc720\ub294 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uace0\uc815\ubc00 \uc131\ud615<\/li>\n\n\n\n<li>\ub300\ub7c9 \uc0dd\uc0b0\uc744 \uc704\ud55c \uc7ac\ud604\uc131<\/li>\n\n\n\n<li>\uc9e7\uc740 \uacbd\ud654 \uc8fc\uae30<\/li>\n\n\n\n<li>\ub6f0\uc5b4\ub09c \ubc00\ubd09 \uc131\ub2a5<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">5.3 \ud6c4\uacbd\ud654 \uacf5\uc815<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\ud6c4\uacbd\ud654 \ucc98\ub9ac\ub97c \ud1b5\ud574 \ub2e4\uc74c\uc744 \ubcf4\uc7a5\ud569\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ud718\ubc1c\uc131 \ud654\ud569\ubb3c\uc758 \uc81c\uac70<\/li>\n\n\n\n<li>\ud5a5\uae30 \uc911\ud654 \ud6a8\uacfc \ud5a5\uc0c1<\/li>\n\n\n\n<li>\ud5a5\uc0c1\ub41c \uc7a5\uae30 \uc548\uc815\uc131<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">5.4 \ucd94\uc801\uc131 \uc2dc\uc2a4\ud15c<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\uac01 \ubc30\uce58\uc5d0 \ub300\ud574\uc11c\ub294 \ucd94\uc801 \uac00\ub2a5\ud574\uc57c \ud569\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc6d0\uc790\uc7ac \ubc30\uce58 \ubc88\ud638<\/li>\n\n\n\n<li>\uc0dd\uc0b0 \ub9e4\uac1c\ubcc0\uc218<\/li>\n\n\n\n<li>\ud488\uc9c8 \uad00\ub9ac \uae30\ub85d<\/li>\n\n\n\n<li>\uba78\uade0 \ud638\ud658\uc131 \ub370\uc774\ud130<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">6. \ub300\ud45c\uc801\uc778 \uc758\ub8cc \ubd84\uc57c \uc801\uc6a9 \uc0ac\ub840<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\uc758\ub8cc\uc6a9 \uc2e4\ub9ac\ucf58 \ubd80\ud488\uc740 \ub2e4\uc74c\uacfc \uac19\uc740 \ubd84\uc57c\uc5d0 \uc0ac\uc6a9\ub429\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uce74\ud14c\ud130 \uc530 \ubc0f \ubc38\ube0c<\/li>\n\n\n\n<li>\ud638\ud761\uc6a9 \ub9c8\uc2a4\ud06c \ubc0f \uc5f0\uacb0\ubd80\ud488<\/li>\n\n\n\n<li>\uc57d\ubb3c \uc804\ub2ec \uc2dc\uc2a4\ud15c<\/li>\n\n\n\n<li>\ud38c\ud504 \ub2e4\uc774\uc5b4\ud504\ub7a8<\/li>\n\n\n\n<li>\uc218\uc220 \uae30\uad6c\uc6a9 \uc530<\/li>\n\n\n\n<li>\uc758\ub8cc\uc6a9 \ud29c\ube0c \ucee4\ub125\ud130<\/li>\n\n\n\n<li>\uc774\uc2dd\ud615 \ubcf4\uc870 \ubd80\ud488<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">7. \uc77c\ubc18\uc801\uc778 \uacf5\ud559\uc801 \uacfc\uc81c<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">7.1 \uce58\uc218 \uc548\uc815\uc131<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\uc758\ub8cc\uc6a9 \ubd80\ud488\uc740 \ub9e4\uc6b0 \uc5c4\uaca9\ud55c \uacf5\ucc28(\uacbd\uc6b0\uc5d0 \ub530\ub77c \u00b10.02\u20130.05 mm)\uac00 \uc694\uad6c\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">7.2 \uba78\uade0 \ub0b4\uc131<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\ubd80\ud488\uc740 \ub2e4\uc74c \uc870\uac74\uc744 \uacac\ub38c\uc57c \ud569\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc624\ud1a0\ud074\ub808\uc774\ube0c (\uc99d\uae30 \uba78\uade0)<\/li>\n\n\n\n<li>\uac10\ub9c8\uc120<\/li>\n\n\n\n<li>\uc5d0\ud2f8\ub80c\uc625\uc0ac\uc774\ub4dc(EtO)<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">7.3 \uc7ac\ub8cc\uc758 \ub178\ud654<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\ub2e4\uc74c\uc5d0 \uc7a5\uae30\uac04 \ub178\ucd9c\ub420 \uacbd\uc6b0:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc628\ub3c4 \ubcc0\ud654 \uc8fc\uae30<\/li>\n\n\n\n<li>\ud654\ud559 \uc18c\ub3c5\uc81c<\/li>\n\n\n\n<li>\uae30\uacc4\uc801 \uc751\ub825<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\uc131\ub2a5\uc774 \uc800\ud558\ub418\uc5b4\uc11c\ub294 \uc548 \ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">8. \uc758\ub8cc\uc6a9 \uc2e4\ub9ac\ucf58\uc758 \ud5a5\ud6c4 \ub3d9\ud5a5<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\uc758\ub8cc\uc6a9 \uc2e4\ub9ac\ucf58 \uc0b0\uc5c5\uc740 \ub2e4\uc74c\uacfc \uac19\uc740 \ubc29\ud5a5\uc73c\ub85c \ub098\uc544\uac00\uace0 \uc788\uc2b5\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>LSR \ucd08\uc815\ubc00 \uc131\ud615<\/li>\n\n\n\n<li>\ub2e4\uc911 \uc18c\uc7ac \uc624\ubc84\ubab0\ub529 (\uc2e4\ub9ac\ucf58 + \ud50c\ub77c\uc2a4\ud2f1 + \uae08\uc18d)<\/li>\n\n\n\n<li>\uc2a4\ub9c8\ud2b8 \uc758\ub8cc \uae30\uae30 \ud1b5\ud569<\/li>\n\n\n\n<li>\uaddc\uc81c \ud22c\uba85\uc131 \uc81c\uace0<\/li>\n\n\n\n<li>\ucd5c\uc18c \uce68\uc2b5\uc801 \uc758\ub8cc \uae30\uae30\uc758 \uad6c\uc131 \uc694\uc18c<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">9. \uacb0\ub860<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\uc758\ub8cc\uc6a9 \uc2e4\ub9ac\ucf58 \ubd80\ud488\uc740 \ud604\ub300 \uc758\ub8cc \uc2dc\uc2a4\ud15c\uc5d0\uc11c \ub9e4\uc6b0 \uc911\uc694\ud55c \uc5ed\ud560\uc744 \ud569\ub2c8\ub2e4. \uc131\uacf5\uc801\uc778 \uac1c\ubc1c\uc744 \uc704\ud574\uc11c\ub294 \ucca8\ub2e8 \uc18c\uc7ac\ubfd0\ub9cc \uc544\ub2c8\ub77c \ub2e4\uc74c \uc0ac\ud56d\uc5d0 \ub300\ud55c \uc5c4\uaca9\ud55c \uc900\uc218\ub3c4 \ud544\uc694\ud569\ub2c8\ub2e4. <strong>ISO, USP, FDA \ubc0f EU MDR \ud45c\uc900<\/strong>, \uadf8\ub9ac\uace0 \uc815\ubc00\ud55c \uc81c\uc870 \uad00\ub9ac\ub3c4 \ud544\uc694\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">LSR \uc5d4\uc9c0\ub2c8\uc5b4\ub9c1 \uc5ed\ub7c9\uacfc \uccad\uc815 \uc0dd\uc0b0 \uc2dc\uc2a4\ud15c\uc744 \uac16\ucd98 \uc81c\uc870\uc5c5\uccb4\ub4e4\uc740 \uae00\ub85c\ubc8c \uc758\ub8cc\uae30\uae30 \uacf5\uae09\ub9dd\uc5d0\uc11c \uc0c1\ub2f9\ud55c \uc6b0\uc704\ub97c \uc810\ud558\uac8c \ub420 \uac83\uc785\ub2c8\ub2e4.<\/p>","protected":false},"excerpt":{"rendered":"<p>1. Introduction Medical grade silicone components are widely used in modern healthcare systems due to their excellent biocompatibility, chemical stability, and long-term reliability. Applications include surgical instruments, drug delivery systems, catheters, sealing components, respiratory devices, and implantable-grade auxiliary parts. Unlike industrial silicone, medical-grade silicone must meet strict regulatory, material, and manufacturing standards to ensure patient 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