{"id":6031,"date":"2026-07-24T14:23:10","date_gmt":"2026-07-24T06:23:10","guid":{"rendered":"https:\/\/www.susoneyewear.com\/?p=6031"},"modified":"2026-07-24T14:23:10","modified_gmt":"2026-07-24T06:23:10","slug":"what-standards-apply-to-prescription-frames-us-eu-basics-for-buyers","status":"publish","type":"post","link":"https:\/\/www.susoneyewear.com\/ko\/what-standards-apply-to-prescription-frames-us-eu-basics-for-buyers\/","title":{"rendered":"\ub3c4\uc218 \uc548\uacbd\ud14c\uc5d0\ub294 \uc5b4\ub5a4 \uae30\uc900\uc774 \uc801\uc6a9\ub418\ub098\uc694? (\uad6c\ub9e4\uc790\ub97c \uc704\ud55c \ubbf8\uad6d\/\uc720\ub7fd \uae30\ubcf8 \uc0ac\ud56d)"},"content":{"rendered":"<p><img fetchpriority=\"high\" decoding=\"async\" class=\"aligncenter size-full wp-image-6033\" src=\"https:\/\/www.susoneyewear.com\/wp-content\/uploads\/2026\/07\/Black-rectangular-eyeglasses-worn-by-a-model.webp\" alt=\"\ubaa8\ub378\uc774 \ucc29\uc6a9\ud55c \uac80\uc740\uc0c9 \uc9c1\uc0ac\uac01\ud615 \uc548\uacbd\" width=\"830\" height=\"497\" srcset=\"https:\/\/www.susoneyewear.com\/wp-content\/uploads\/2026\/07\/Black-rectangular-eyeglasses-worn-by-a-model.webp 830w, https:\/\/www.susoneyewear.com\/wp-content\/uploads\/2026\/07\/Black-rectangular-eyeglasses-worn-by-a-model-300x180.webp 300w, https:\/\/www.susoneyewear.com\/wp-content\/uploads\/2026\/07\/Black-rectangular-eyeglasses-worn-by-a-model-768x460.webp 768w, https:\/\/www.susoneyewear.com\/wp-content\/uploads\/2026\/07\/Black-rectangular-eyeglasses-worn-by-a-model-18x12.webp 18w, https:\/\/www.susoneyewear.com\/wp-content\/uploads\/2026\/07\/Black-rectangular-eyeglasses-worn-by-a-model-600x359.webp 600w\" sizes=\"(max-width: 830px) 100vw, 830px\" \/><\/p>\n<p>&nbsp;<\/p>\n<p>\ucc98\ubc29 \uc548\uacbd\ud14c\ub294 \uaddc\uc81c \uc900\uc218 \uacfc\uc815\uc744 \uac70\uce58\ub294 \ub370 \uc2dc\uac04\uc774 \uc624\ub798 \uac78\ub9ac\ub294 \uc18c\ud615 \uc81c\ud488\uc785\ub2c8\ub2e4. \ud300\uc740 \uacbd\ucca9 \uac10\ucd09, \ud14c\ub450\ub9ac \ubaa8\uc591, \ub3c4\uae08 \uc0c9\uc0c1 \ubc0f \uc0d8\ud50c \uc678\uad00\uc5d0 \uc9d1\uc911\ud569\ub2c8\ub2e4. \uc2dc\uc7a5 \uc9c4\ucd9c\uc740 \uc81c\ud488 \ud3ec\uc7a5\uc774 \uc644\ub8cc\ub418\uace0 \ub204\uad70\uac00\uac00 \uc2e0\uace0\uc11c\ub098 \uc720\ud6a8\ud55c \ubcf4\uace0\uc11c\ub97c \uc694\uccad\ud560 \ub54c \ube44\ub85c\uc18c \uac00\ub2a5\ud574\uc9c8 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\uaddc\uaca9 \uc900\uc218 \uc0ac\ud56d\uc740 \uacf5\uad6c \uc81c\uc791 \uc804\uc5d0 \uc0ac\uc591\uc11c\uc5d0 \uba85\uc2dc\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<h2><strong><b>\ucc98\ubc29 \uc548\uacbd\ud14c\ub85c \uc778\uc815\ub418\ub294 \uac83\uacfc \uc774 \uac00\uc774\ub4dc\uc5d0 \ud3ec\ud568\ub418\uc9c0 \uc54a\ub294 \uac83\uc740 \ubb34\uc5c7\uc77c\uae4c\uc694?<\/b><\/strong><\/h2>\n<p>\ub3c4\uc218 \uc548\uacbd\ud14c\ub294 \uc2dc\ub825 \uad50\uc815 \ub80c\uc988\ub97c \uace0\uc815\ud558\uae30 \uc704\ud55c \ubb34\uc548\uacbd \ud504\ub808\uc784\uc785\ub2c8\ub2e4. \uc774 \ubc94\uc8fc\uc5d0\ub294 \ud480\ub9bc, \uc138\ubbf8\ub9bc, \ubb34\ub9bc, \uc811\uc774\uc2dd, 3D \ud504\ub9b0\ud305 \ubc0f \ucc9c\uc5f0 \uc18c\uc7ac\ub85c \uc81c\uc791\ub41c \uc548\uacbd\ud14c\uac00 \ud3ec\ud568\ub429\ub2c8\ub2e4.<\/p>\n<p>\uc77c\ubc18 \uc120\uae00\ub77c\uc2a4, \ubcf4\ud638 \uc548\uacbd, \ub3c4\uc218 \ub80c\uc988, \uadf8\ub9ac\uace0 \uae30\uc131\ud488 \ub3cb\ubcf4\uae30\ub294 \uac01\uac01 \ub2e4\ub978 \uae30\uc900\uc744 \ub530\ub97c \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc2ec\uc9c0\uc5b4 \ud074\ub9bd\ud615 \uc120\uae00\ub77c\uc2a4 \ub80c\uc988\uc870\ucc28\ub3c4 \uc801\uc6a9 \ubc94\uc704\uac00 \ub2ec\ub77c\uc9c8 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc5b4\ub5a4 \uae30\uc900\uc774 \uc801\uc6a9\ub418\ub294\uc9c0 \ubb3b\uae30 \uc804\uc5d0 \uc0ac\uc6a9 \ubaa9\uc801\uc744 \uba85\ud655\ud788 \uc815\uc758\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<h2><strong><b>\uc548\uacbd\ud14c \uad6c\ub9e4 \uc2dc \uc5b4\ub5a4 \uae30\uc220 \ud45c\uc900\uc744 \uc0ac\uc6a9\ud574\uc57c \ud560\uae4c\uc694?<\/b><\/strong><\/h2>\n<p>\uad6d\uc81c \uc870\ub2ec\uc5d0 \uc788\uc5b4 ISO 12870\uc740 \uc2e4\uc9c8\uc801\uc778 \uae30\uc900\uc120\uc785\ub2c8\ub2e4. \uc774\ub294 \uad6c\ub9e4\uc790, \uc0dd\uc0b0 \uacf5\uc7a5, \uadf8\ub9ac\uace0 \uc2dc\ud5d8\uc18c\uc5d0 \uacf5\ud1b5\ub41c \ucc38\uc870 \uae30\uc900\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4. \ub2e4\ub9cc, ISO 12870\uc774 \uad6d\uac00 \ubc95\uaddc\ub97c \ub300\uccb4\ud558\ub294 \uac83\uc740 \uc544\ub2d9\ub2c8\ub2e4.<\/p>\n<h3><strong><b>ISO 12870:2024\uac00 \uc8fc\uc694 \uad6d\uc81c \ud45c\uc900\uc73c\ub85c \uc9c0\uc815\ub41c \uc774\uc720\ub294 \ubb34\uc5c7\uc77c\uae4c\uc694?<\/b><\/strong><\/h3>\n<p>ISO 12870:2024\ub294 \ub3c4\uc218 \ub80c\uc988\uc6a9 \ubb34\uc548\uacbd \ud504\ub808\uc784\uc5d0 \ub300\ud55c \uc694\uad6c\uc0ac\ud56d \ubc0f \uc2dc\ud5d8 \ubc29\ubc95\uc744 \uaddc\uc815\ud569\ub2c8\ub2e4. \uc774 \ud45c\uc900\uc740 \ub300\ub7c9 \uc0dd\uc0b0\ub418\ub294 \ud480\ub9bc, \uc138\ubbf8\ub9bc, \ubb34\ub9bc, \uc811\uc774\uc2dd, \uc801\uce35 \uc81c\uc870 \ubc29\uc2dd \ubc0f \ucc9c\uc5f0 \uc18c\uc7ac \ud504\ub808\uc784\uc744 \ud3ec\ud568\ud569\ub2c8\ub2e4.<\/p>\n<p>\ud575\uc2ec\uc740 \ud14c\uc2a4\ud2b8 \uc0d8\ud50c\uc774 \uc8fc\ubb38 \uc81c\ud488\uc744 \ub300\ud45c\ud558\ub294\uc9c0 \uc5ec\ubd80\uc785\ub2c8\ub2e4. \uc548\uacbd\ud14c \uc8fc\ubcc0\uc758 \uc587\uc740 \uc544\uc138\ud14c\uc774\ud2b8, \ub0a9\ub55c\ub41c \ube0c\ub9bf\uc9c0 \ub610\ub294 \uad74\uace1\ubd80 \uadfc\ucc98\uc758 \ub3c4\uae08\uc740 \uc131\ub2a5\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce60 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ud504\ub808\uc784\uc774 \uac89\ubcf4\uae30\uc5d0\ub294 \uc644\ubcbd\ud574 \ubcf4\uc5ec\ub3c4 \ub80c\uc988\ub97c \ub07c\uc6b0\ub294 \uacfc\uc815\uc5d0\uc11c \uc81c\ub300\ub85c \uc791\ub3d9\ud558\uc9c0 \uc54a\uc744 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<h3><strong><b>\uad6c\ub9e4 \uc8fc\ubb38\uc11c\uc5d0 \uc815\ud655\ud55c \uc5d0\ub514\uc158 \uc774\ub984\uc744 \uba85\uc2dc\ud574\uc57c \ud558\ub294 \uc774\uc720\ub294 \ubb34\uc5c7\uc785\ub2c8\uae4c?<\/b><\/strong><\/h3>\n<p>\"ISO 12870\uc5d0 \ub530\ub978 \uc2dc\ud5d8\"\uc774\ub77c\ub294 \ud45c\ud604\uc740 \ubd88\uc644\uc804\ud569\ub2c8\ub2e4. \ud45c\uc900\uc740 \uac1c\uc815\ub418\uc9c0\ub9cc, \uc2dc\ud5d8\uc18c\uc640 \uacf5\uae09\uc5c5\uccb4\ub294 \uc5ec\uc804\ud788 \uc774\uc804 \uc591\uc2dd\uc744 \uc0ac\uc6a9\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\uad6c\ub9e4 \uc8fc\ubb38\uc11c\uc5d0\ub294 \ub2e4\uc74c \uc0ac\ud56d\uc774 \uba85\uc2dc\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<ul>\n<li>\uc815\ud655\ud55c \uc5d0\ub514\uc158<\/li>\n<li>\ubaa8\ub378, \ud06c\uae30, \uc18c\uc7ac \ubc0f \ub9c8\uac10\uc5d0 \ub300\ud55c \ub0b4\uc6a9\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4.<\/li>\n<li>\uc2dc\ub8cc\ub7c9 \ubc0f \uc2e4\ud5d8\uc2e4<\/li>\n<li>\uc218\uc6a9 \uae30\uc900<\/li>\n<li>\uc7ac\ub8cc, \ud78c\uc9c0, \ub3c4\uae08, \ub0a9\ub55c \ub610\ub294 \uc124\uacc4 \ubcc0\uacbd \ud6c4 \uc7ac\uc2dc\ud5d8 \ud2b8\ub9ac\uac70<\/li>\n<\/ul>\n<p>\ub3c4\uae08\ub41c \ud504\ub808\uc784\uacfc \ucf54\ud305\ub418\uc9c0 \uc54a\uc740 \ubc84\uc804\uc774 \uc790\ub3d9\uc73c\ub85c \ub3d9\uc77c\ud55c \ud14c\uc2a4\ud2b8 \uc81c\ud488\uad70\uc5d0 \uc18d\ud558\ub294 \uac83\uc740 \uc544\ub2d9\ub2c8\ub2e4.<\/p>\n<p><img decoding=\"async\" class=\"aligncenter size-full wp-image-6032\" src=\"https:\/\/www.susoneyewear.com\/wp-content\/uploads\/2026\/07\/Black-rectangular-eyeglasses-on-a-model.webp\" alt=\"\ubaa8\ub378\uc774 \uac80\uc740\uc0c9 \uc9c1\uc0ac\uac01\ud615 \uc548\uacbd\uc744 \uc4f0\uace0 \uc788\ub2e4.\" width=\"830\" height=\"448\" srcset=\"https:\/\/www.susoneyewear.com\/wp-content\/uploads\/2026\/07\/Black-rectangular-eyeglasses-on-a-model.webp 830w, https:\/\/www.susoneyewear.com\/wp-content\/uploads\/2026\/07\/Black-rectangular-eyeglasses-on-a-model-300x162.webp 300w, https:\/\/www.susoneyewear.com\/wp-content\/uploads\/2026\/07\/Black-rectangular-eyeglasses-on-a-model-768x415.webp 768w, https:\/\/www.susoneyewear.com\/wp-content\/uploads\/2026\/07\/Black-rectangular-eyeglasses-on-a-model-18x10.webp 18w, https:\/\/www.susoneyewear.com\/wp-content\/uploads\/2026\/07\/Black-rectangular-eyeglasses-on-a-model-600x324.webp 600w\" sizes=\"(max-width: 830px) 100vw, 830px\" \/><\/p>\n<p>&nbsp;<\/p>\n<h2><strong><b>\ubbf8\uad6d\uc5d0\uc11c \ucc98\ubc29 \uc548\uacbd\ud14c\ub97c \uad6c\ub9e4\ud558\uae30 \uc704\ud55c \uae30\ubcf8\uc801\uc778 \uc694\uac74\uc740 \ubb34\uc5c7\uc778\uac00\uc694?<\/b><\/strong><\/h2>\n<p>\ubbf8\uad6d\uc5d0\uc11c\ub294 \uc77c\ubc18 \uc548\uacbd\ud14c\uac00 \uc2dc\ud310 \uc804 \uc2e0\uace0 \ub300\uc0c1\uc5d0\uc11c \uc81c\uc678\ub418\ub294 \uacbd\uc6b0\uac00 \ub9ce\uc544 \uc808\ucc28\uac00 \uac04\ub2e8\ud558\ub2e4\uace0\ub4e4 \ud558\uc9c0\ub9cc, \uc774\ub294 \uc798\ubabb\ub41c \ud45c\ud604\uc785\ub2c8\ub2e4. \uc548\uacbd\ud14c \uc5ed\uc2dc \uc5ec\uc804\ud788 FDA \uc758\ub8cc\uae30\uae30 \uc2ec\uc0ac \ub300\uc0c1\uc5d0 \ud3ec\ud568\ub418\uc5b4 \uc788\uae30 \ub54c\ubb38\uc785\ub2c8\ub2e4.<\/p>\n<h3><strong><b>\ucc98\ubc29\uc804\uc6a9 \uc548\uacbd\ud14c\ub294 FDA \uc2b9\uc778\uc744 \ubc1b\uc558\ub098\uc694?<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>\uaddc\uc81c \ub300\uc0c1 \uc758\ub8cc\uae30\uae30?<\/b><\/strong><\/h3>\n<p>\uc608. 21 CFR 886.5842\uc5d0 \ub530\ub974\uba74 \uc548\uacbd\ud14c\ub294 \ucc98\ubc29 \ub80c\uc988\ub97c \uace0\uc815\ud558\uae30 \uc704\ud55c 1\uae09 \uc758\ub8cc\uae30\uae30\uc785\ub2c8\ub2e4. \ub530\ub77c\uc11c \uc77c\ubc18\uc801\uc73c\ub85c 510(k) \uaddc\uc815\uc758 \uc801\uc6a9 \ub300\uc0c1\uc5d0\uc11c \uc81c\uc678\ub418\uc9c0\ub9cc, \ud574\ub2f9 \uaddc\uc815\uc758 \uc81c\ud55c \uc0ac\ud56d\uc774 \uc801\uc6a9\ub429\ub2c8\ub2e4.<\/p>\n<p>\uc720\uc6a9\ud55c \uc18c\uc2f1 \uc9c8\ubb38\uc740 \"\ubc95\uc801 \uc81c\uc870\uc5c5\uccb4\ub294 \ub204\uad6c\uc778\uac00?\"\uc785\ub2c8\ub2e4. \uacf5\uc7a5, \ube0c\ub79c\ub4dc \uc18c\uc720\uc790, \uc218\uc785\uc5c5\uccb4\ub294 \uac01\uae30 \ub2e4\ub978 \ucc45\uc784\uc744 \uc9c8 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<h3><strong><b>FDA\uc758 \uc5b4\ub5a4 \uc758\ubb34 \uc0ac\ud56d\uc774 \uc5ec\uc804\ud788 \uc801\uc6a9\ub418\ub098\uc694?<\/b><\/strong><\/h3>\n<p>\uc694\uad6c \uc0ac\ud56d\uc5d0\ub294 \uc2dc\uc124 \ub4f1\ub85d, \uc758\ub8cc\uae30\uae30 \ubaa9\ub85d \ub4f1\uc7ac, \ud574\uc678 \uc81c\uc870\uc5c5\uccb4\ub97c \uc704\ud55c \ubbf8\uad6d \ub300\ub9ac\uc778 \uc9c0\uc815, \ub77c\ubca8\ub9c1 \uad00\ub9ac, \ubd88\ub9cc \ucc98\ub9ac, \ubcf4\uace0 \ubc0f \ud488\uc9c8 \uc2dc\uc2a4\ud15c \uc900\uc218 \ub4f1\uc774 \ud3ec\ud568\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\ud488\uc9c8\uacbd\uc601\uc2dc\uc2a4\ud15c \uaddc\uc815\uc740 2026\ub144 2\uc6d4 2\uc77c\uc5d0 \ubc1c\ud6a8\ub418\uc5c8\uc2b5\ub2c8\ub2e4. \uc774 \uaddc\uc815\uc740 21 CFR Part 820\uc744 \uac1c\uc815\ud558\uace0 ISO 13485:2016\uc744 \ucc38\uc870\ud558\uc5ec \ud3ec\ud568\ud558\uba70, FDA \uc694\uad6c\uc0ac\ud56d\uc774 \ucd94\uac00\ub418\uc5c8\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\ubcbd\uc5d0 \uac78\ub9b0 \uc778\uc99d\uc11c\ub294 \ubcc0\uacbd \uad00\ub9ac\ub9cc\ud07c \ub9ce\uc740 \uc815\ubcf4\ub97c \uc81c\uacf5\ud558\uc9c0 \ubabb\ud569\ub2c8\ub2e4. \uacbd\ucca9 \uacf5\uae09\uc5c5\uccb4\uac00 \ubcc0\uacbd\ub420 \uacbd\uc6b0, \uc790\uc7ac \uba85\uc138\uc11c, \uac80\uc0ac \uae30\uc900 \ubc0f \uc2dc\ud5d8 \uc99d\uac70\ub3c4 \ud568\uaed8 \ubcc0\uacbd\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<h3><strong><b>FDA \ucda9\uaca9 \uc2dc\ud5d8\uc774 \ud574\ub2f9 \ud504\ub808\uc784\uc5d0\ub3c4 \uc801\uc6a9\ub418\ub098\uc694?<\/b><\/strong><\/h3>\n<p>21 CFR 801.410\uc758 \ucda9\uaca9 \uc800\ud56d \uc694\uac74\uc740 \uc548\uacbd \ub80c\uc988\uc640 \uc120\uae00\ub77c\uc2a4\uc5d0 \uc801\uc6a9\ub418\uba70, \ube48 \uc548\uacbd\ud14c\uc5d0\ub294 \uc801\uc6a9\ub418\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. FDA\ub294 \ubbf8\uad6d\uc5d0\uc11c \ud310\ub9e4\ub418\ub294 \ub80c\uc988\ub294 \ucda9\uaca9 \uc800\ud56d \ub80c\uc988 \uaddc\uc815\uc744 \ucda9\uc871\ud558\uace0 \uad00\ub828 \uc778\uc99d\uc11c\ub97c \ubcf4\uc720\ud574\uc57c \ud55c\ub2e4\uace0 \uba85\uc2dc\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\uc644\ubcbd\ud55c \uc548\uacbd\uc744 \uc704\ud574\uc11c\ub294 \ud504\ub808\uc784\uacfc \ub80c\uc988\uc758 \uc801\ud569\uc131 \uae30\uc900\uc774 \uc11c\ub85c \ubc00\uc811\ud558\uac8c \uc5f0\uad00\ub418\uc5b4 \uc788\uc2b5\ub2c8\ub2e4. \ud2bc\ud2bc\ud55c \ud504\ub808\uc784\ub3c4 \uc778\uc99d\ub418\uc9c0 \uc54a\uc740 \ub80c\uc988\ub97c \ub300\uccb4\ud560 \uc218\ub294 \uc5c6\uc2b5\ub2c8\ub2e4.<\/p>\n<h2><strong><b>\ucc98\ubc29 \uc548\uacbd\ud14c\uc5d0 \ub300\ud55c EU\uc758 \uae30\ubcf8 \uc694\uac74\uc740 \ubb34\uc5c7\uc778\uac00\uc694?<\/b><\/strong><\/h2>\n<p>EU\uc5d0\uc11c \uc2dc\ub825 \uad50\uc815\uc6a9 \uc548\uacbd\ud14c\ub294 1\uae09 \uc758\ub8cc\uae30\uae30\ub85c \ubd84\ub958\ub429\ub2c8\ub2e4. \uc0ac\uc6a9 \ubaa9\uc801, \ubd84\ub958, \uae30\uc220 \ubb38\uc11c, \ub77c\ubca8\ub9c1, \ucd94\uc801\uc131 \ubc0f \uc2dc\ud310 \ud6c4 \uad00\ub9ac \ubaa8\ub450 \ub3d9\uc77c\ud55c \uc81c\ud488\uc744 \uc9c0\uce6d\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<h3><strong><b>\ub3c4\uc218 \uc548\uacbd\ud14c\uc5d0\ub3c4 CE \ub9c8\ud06c\uac00 \ud544\uc694\ud55c\uac00\uc694?<\/b><\/strong><\/h3>\n<p>\uc77c\ubc18\uc801\uc778 \ube44\uba78\uade0, \ube44\uce21\uc815\ud615 1\ub4f1\uae09 \uc548\uacbd\ud14c\ub294 \uc758\ub8cc\uae30\uae30 \uaddc\uc815\uc5d0 \ub530\ub77c \uc81c\uc870\uc5c5\uccb4 \uc790\uccb4 \ud3c9\uac00\ub97c \uac70\uce69\ub2c8\ub2e4. \uc81c\uc870\uc5c5\uccb4\ub294 \uae30\uc220 \ubb38\uc11c\ub97c \uc791\uc131\ud558\uace0 EU \uc801\ud569\uc131 \uc120\uc5b8\uc11c\ub97c \ubc1c\ud589\ud558\uba70 CE \ub9c8\ud06c\ub97c \ubd80\ucc29\ud569\ub2c8\ub2e4. \uc77c\ubc18\uc801\uc73c\ub85c \uc778\uc99d\uae30\uad00\uc758 \uac1c\uc785\uc740 \uc5c6\uc2b5\ub2c8\ub2e4.<\/p>\n<p>CE \ub9c8\ud06c\ub294 \uc2e4\ud5d8\uc2e4 \uc778\uc99d\uc11c\uac00 \uc544\ub2d9\ub2c8\ub2e4. \uc774\ub294 \uc81c\uc870\uc5c5\uccb4\uac00 \uae30\uc220 \uc790\ub8cc\ub85c \ub4b7\ubc1b\uce68\ub418\ub294 \uc120\uc5b8\uc785\ub2c8\ub2e4.<\/p>\n<p><img decoding=\"async\" class=\"aligncenter size-full wp-image-6037\" src=\"https:\/\/www.susoneyewear.com\/wp-content\/uploads\/2026\/07\/Front-view-of-black-rectangular-eyeglass-frames.webp\" alt=\"\uac80\uc740\uc0c9 \uc9c1\uc0ac\uac01\ud615 \uc548\uacbd\ud14c\uc758 \uc815\uba74 \ubaa8\uc2b5\" width=\"831\" height=\"399\" srcset=\"https:\/\/www.susoneyewear.com\/wp-content\/uploads\/2026\/07\/Front-view-of-black-rectangular-eyeglass-frames.webp 831w, https:\/\/www.susoneyewear.com\/wp-content\/uploads\/2026\/07\/Front-view-of-black-rectangular-eyeglass-frames-300x144.webp 300w, https:\/\/www.susoneyewear.com\/wp-content\/uploads\/2026\/07\/Front-view-of-black-rectangular-eyeglass-frames-768x369.webp 768w, https:\/\/www.susoneyewear.com\/wp-content\/uploads\/2026\/07\/Front-view-of-black-rectangular-eyeglass-frames-18x9.webp 18w, https:\/\/www.susoneyewear.com\/wp-content\/uploads\/2026\/07\/Front-view-of-black-rectangular-eyeglass-frames-600x288.webp 600w\" sizes=\"(max-width: 831px) 100vw, 831px\" \/><\/p>\n<p>&nbsp;<\/p>\n<h3><strong><b>\ube44EU \uc81c\uc870\uc5c5\uccb4\uc640 \uc218\uc785\uc5c5\uccb4\ub294 \ubb34\uc5c7\uc744 \uc900\ube44\ud574\uc57c \ud560\uae4c\uc694?<\/b><\/strong><\/h3>\n<p>EU \uc678\ubd80 \uc81c\uc870\uc5c5\uccb4\ub294 EU \uacf5\uc778 \ub300\ub9ac\uc778\uc774 \ud544\uc694\ud569\ub2c8\ub2e4. \uc218\uc785\uc5c5\uccb4\ub294 \ud504\ub808\uc784\uc744 \uc2dc\uc7a5\uc5d0 \ucd9c\uc2dc\ud558\uae30 \uc804\uc5d0 \uc8fc\uc694 \uaddc\uc815 \uc900\uc218 \uc694\uc18c\ub97c \ud655\uc778\ud574\uc57c \ud569\ub2c8\ub2e4. \uc2dd\ubcc4, \ub77c\ubca8\ub9c1, \ubd88\ub9cc \ucc98\ub9ac \uc808\ucc28, \ucd94\uc801\uc131 \ubc0f \uc2dc\ud310 \ud6c4 \uac10\uc2dc\uc5d0 \ub300\ud55c \uad8c\ud55c\uc740 \uc11c\uba74\uc73c\ub85c \uc704\uc784\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<p>UDI\uc5d0\ub3c4 \uc8fc\uc758\ub97c \uae30\uc6b8\uc5ec\uc57c \ud569\ub2c8\ub2e4. 2026\ub144 3\uc6d4\uc5d0 \uac1c\uc815\ub41c EU \uc9c0\uce68\uc740 \uc548\uacbd\ud14c\uc6a9 \ub9c8\uc2a4\ud130 UDI-DI\ub97c \ub2e4\ub8e8\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ud574\ub2f9 \uaddc\uc815\uc740 2028\ub144 11\uc6d4 1\uc77c\ubd80\ud130 \uc801\uc6a9\ub418\uc9c0\ub9cc, EUDAMED \uad00\ub828 \uc0ac\ud56d\uc740 \uc9c0\uc18d\uc801\uc778 \ubaa8\ub2c8\ud130\ub9c1\uc774 \ud544\uc694\ud569\ub2c8\ub2e4.<\/p>\n<p>\uae30\uc874 \ub77c\ubca8 \ub514\uc790\uc778\uc740 \uaddc\uc815 \uc900\uc218 \uc804\ub7b5\uc774 \uc544\ub2d9\ub2c8\ub2e4.<\/p>\n<h3><strong><b>ISO \uc2dc\ud5d8 \ubcf4\uace0\uc11c\ub9cc\uc73c\ub85c CE \ub9c8\ud06c\ub97c \ubc1b\uc744 \uc218 \uc788\uc744\uae4c\uc694?<\/b><\/strong><\/h3>\n<p>\uc544\ub2c8\uc694. ISO 12870 \ubcf4\uace0\uc11c\ub294 \uae30\uc220 \ud30c\uc77c\uc744 \ubcf4\uc644\ud560 \uc218\ub294 \uc788\uc9c0\ub9cc, \ubd84\ub958, \uc704\ud5d8 \uad00\ub9ac, \ub77c\ubca8 \uac80\ud1a0, \uc2dc\ud310 \ud6c4 \uacc4\ud68d \ub610\ub294 \uc801\ud569\uc131 \uc120\uc5b8\uc744 \ub300\uccb4\ud558\uc9c0\ub294 \uc54a\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\ubcf4\uace0\uc11c \ubc94\uc704\ub294 \uc911\uc694\ud569\ub2c8\ub2e4. \uccab \ud398\uc774\uc9c0\uc5d0 \uc788\ub294 \ubaa8\ub378\uba85\ubcf4\ub2e4 \ud14c\uc2a4\ud2b8\ub41c \uad6c\uc870, \uc7ac\uc9c8, \ub9c8\uac10 \ubc0f \ud06c\uae30 \ubc94\uc704\uac00 \ub354 \uc911\uc694\ud569\ub2c8\ub2e4. \ud604\uc7ac \uc790\uc7ac \uba85\uc138\uc11c\uc640 \uc5f0\uacb0\ud560 \uc218 \uc5c6\ub294 \uc99d\uac70\ub294 \uc2e0\ub8b0\ub3c4\uac00 \ub5a8\uc5b4\uc9d1\ub2c8\ub2e4.<\/p>\n<h2><strong><b>\ubbf8\uad6d\uacfc \uc720\ub7fd\uc758 \ucc98\ubc29\uc804\uc740 \uc5b4\ub5bb\uac8c \ubc1c\ud589\ub418\ub098\uc694?<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>\ud504\ub808\uc784 \uc694\uad6c \uc0ac\ud56d\uc774 \ub2e4\ub978\uac00\uc694?<\/b><\/strong><\/h2>\n<p>\ub450 \uc2dc\uc7a5\uc740 \uc5d4\uc9c0\ub2c8\uc5b4\ub9c1 \uad00\ub828 \uc0ac\ud56d\uc744 \uacf5\uc720\ud558\uc9c0\ub9cc, \uad00\ub828 \uc11c\ub958\ub294 \uc11c\ub85c \ud638\ud658\ub418\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/p>\n<table style=\"width: 100%; border-collapse: collapse;\" border=\"1\">\n<tbody>\n<tr>\n<td style=\"width: 19.6998%;\" width=\"99\"><strong><b>\uaddc\uc815 \uc900\uc218 \uc8fc\uc81c<\/b><\/strong><\/td>\n<td style=\"width: 36.0225%;\" width=\"184\"><strong><b>\ubbf8\uad6d<\/b><\/strong><\/td>\n<td style=\"width: 44.2777%;\" width=\"227\"><strong><b>\uc720\ub7fd \u200b\u200b\uc5f0\ud569<\/b><\/strong><\/td>\n<\/tr>\n<tr>\n<td style=\"width: 19.6998%;\" width=\"99\">\uaddc\uc81c \ud604\ud669<\/td>\n<td style=\"width: 36.0225%;\" width=\"184\">FDA 1\ub4f1\uae09 \uc758\ub8cc\uae30\uae30<\/td>\n<td style=\"width: 44.2777%;\" width=\"227\">MDR \ud074\ub798\uc2a4 I \uc7a5\uce58<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 19.6998%;\" width=\"99\">\uc0ac\uc804 \uc2dc\uc7a5 \uacbd\ub85c<\/td>\n<td style=\"width: 36.0225%;\" width=\"184\">\uc77c\ubc18\uc801\uc73c\ub85c 510(k) \uba74\uc81c \ub300\uc0c1\uc785\ub2c8\ub2e4.<\/td>\n<td style=\"width: 44.2777%;\" width=\"227\">\uc77c\ubc18\uc801\uc73c\ub85c \uc790\uae30 \ud3c9\uac00<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 19.6998%;\" width=\"99\">\ud575\uc2ec \uae30\ub85d<\/td>\n<td style=\"width: 36.0225%;\" width=\"184\">\ub4f1\ub85d, \ubaa9\ub85d \ub4f1\uc7ac, \ubbf8\uad6d \ub300\ub9ac\uc778 \uc120\uc784(\ud574\ub2f9\ub418\ub294 \uacbd\uc6b0)<\/td>\n<td style=\"width: 44.2777%;\" width=\"227\">\uae30\uc220 \uc790\ub8cc, \uc2e0\uace0\uc11c, CE \ub9c8\ud06c, EU \ub300\ub9ac\uc778<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 19.6998%;\" width=\"99\">\ud488\uc9c8 \uad00\ub9ac<\/td>\n<td style=\"width: 36.0225%;\" width=\"184\">FDA QMSR<\/td>\n<td style=\"width: 44.2777%;\" width=\"227\">MDR \ud488\uc9c8 \uad00\ub9ac \ud504\ub85c\uc138\uc2a4<\/td>\n<\/tr>\n<tr>\n<td style=\"width: 19.6998%;\" width=\"99\">\ucd94\uc801\uc131<\/td>\n<td style=\"width: 36.0225%;\" width=\"184\">FDA \uae30\uae30 \uad00\ub9ac<\/td>\n<td style=\"width: 44.2777%;\" width=\"227\">\uc6b4\uc601\uc790, UDI \ubc0f EUDAMED \uc81c\uc5b4<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\"\ud574\ub2f9 \ubaa8\ub378\uc740 EU \ud14c\uc2a4\ud2b8\ub97c \ud1b5\uacfc\ud588\uc73c\ubbc0\ub85c \ubbf8\uad6d\uc5d0\uc11c\ub3c4 \uc0ac\uc6a9 \uac00\ub2a5\ud569\ub2c8\ub2e4\"\ub77c\ub294 \ub2f5\ubcc0\uc740 \ubd88\uc644\uc804\ud569\ub2c8\ub2e4.<\/p>\n<h2><strong><b>OEM\/ODM \uc8fc\ubb38\uc744 \uc2b9\uc778\ud558\uae30 \uc804\uc5d0 \uad6c\ub9e4\uc790\ub294 \uc5b4\ub5a4 \uc11c\ub958\ub97c \uc694\uccad\ud574\uc57c \ud560\uae4c\uc694?<\/b><\/strong><\/h2>\n<p>\uc694\uccad \ub0b4\uc6a9\uc740 \uc81c\ud488 \ubc0f \uc2dc\uc7a5\uacfc \uc77c\uce58\ud574\uc57c \ud569\ub2c8\ub2e4. \ud30c\uc77c \uc218\uac00 \ub9ce\ub2e4\uace0 \ud574\uc11c \ubc18\ub4dc\uc2dc \uc88b\uc740 \uac83\uc740 \uc544\ub2d9\ub2c8\ub2e4. \uc911\uc694\ud55c \uac83\uc740 \uad00\ub828\uc131 \uc788\ub294 \ud30c\uc77c\uc785\ub2c8\ub2e4.<\/p>\n<ul>\n<li>\uc0ac\uc6a9 \ubaa9\uc801, \uad6d\uac00, \uaddc\uc815 \ubc0f \ud45c\uc900\uc744 \ud3ec\uad04\ud558\ub294 \uaddc\uc815 \uc900\uc218 \ub9e4\ud2b8\ub9ad\uc2a4<\/li>\n<li>\uc815\ud655\ud55c \uad6c\uc870, \uc7ac\ub8cc, \ub9c8\uac10 \ubc0f \uc5d0\ub514\uc158\uacfc \uad00\ub828\ub41c \ud14c\uc2a4\ud2b8 \ubcf4\uace0\uc11c<\/li>\n<li>FDA \ub4f1\ub85d, \ubaa9\ub85d \ubc0f \ubbf8\uad6d \ub300\ub9ac\uc778 \uc815\ubcf4(\ud574\ub2f9\ub418\ub294 \uacbd\uc6b0)<\/li>\n<li>EU \uc2e0\uace0\uc11c, CE \ub77c\ubca8 \ub808\uc774\uc544\uc6c3 \ubc0f \ub300\ud45c\uc790 \uc815\ubcf4<\/li>\n<li>\ubb3c\uc9c8 \uc2e0\uace0 \ubc0f \uc81c\ud55c \ubb3c\uc9c8 \uc99d\uac70<\/li>\n<li>\uac80\uc0ac \uacc4\ud68d, \uc2b9\uc778\ub41c \uc0d8\ud50c, \ubc30\uce58 \ucd94\uc801\uc131 \ubc0f \ubcc0\uacbd \uad00\ub9ac \uaddc\uce59<\/li>\n<\/ul>\n<p>\uc720\uc6a9\ud55c \uacf5\uc7a5 \uc810\uac80 \ubc29\ubc95: \uc0c1\uc790 \ud558\ub098\ub97c \uc120\ud0dd\ud558\uc5ec \uc790\uc7ac \ub85c\ud2b8 \ubc88\ud638, \uac80\uc0ac \uae30\ub85d \ubc0f \uc2b9\uc778\ub41c \uc0d8\ud50c\uacfc \ub300\uc870\ud574 \ubcf4\uc2ed\uc2dc\uc624. \uc2a4\ud504\ub808\ub4dc\uc2dc\ud2b8 \ub0b4\uc6a9\uc774 \uc77c\uce58\ud558\uc9c0 \uc54a\uc73c\uba74 \uaddc\uc815 \uc900\uc218 \ud30c\uc77c\uc774 \uc544\uc9c1 \uc644\uc131\ub418\uc9c0 \uc54a\uc740 \uac83\uc785\ub2c8\ub2e4.<\/p>\n<h2><strong><b>\uacb0\ub860: \ud504\ub808\uc784 \uc0ac\uc591\uc5d0 \uaddc\uc815 \uc900\uc218 \uc694\uc18c\ub97c \ud3ec\ud568\uc2dc\ud0a4\uc2ed\uc2dc\uc624.<\/b><\/strong><\/h2>\n<p>\uc2e0\ub8b0\ud560 \uc218 \uc788\ub294 \uc0ac\uc591\uc11c\uc5d0\ub294 \uc2dc\uc7a5, \uc6a9\ub3c4, \ud45c\uc900 \ubc84\uc804, \uc7ac\ub8cc, \ub9c8\uac10, \uc911\uc694 \uce58\uc218, \uac80\uc0ac \uc9c0\uc810, \ud544\uc218 \ubb38\uc11c \ubc0f \ubcc0\uacbd \uad00\ub9ac \ud2b8\ub9ac\uac70\uac00 \uba85\uc2dc\ub418\uc5b4 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>OEM\/ODM \ud504\ub85c\uadf8\ub7a8\uc758 \uacbd\uc6b0, <a href=\"https:\/\/www.susoneyewear.com\/ko\/\"><strong><u><b>\uc218\uc2a8<\/b><\/u><\/strong><\/a>\u00a0\uc0d8\ud50c\ub9c1 \uc804\uc5d0 \uc774\ub7ec\ud55c \uc785\ub825\uac12\uc744 \uac80\ud1a0\ud558\uace0 \uac1c\ubc1c, \ud14c\uc2a4\ud2b8, \uc0dd\uc0b0 \uad00\ub9ac \ubc0f \uaddc\uc815 \uc900\uc218 \uae30\ub85d\uc744 \ub3d9\uc77c\ud55c \uc81c\ud488 \uc815\uc758\uc5d0 \ub9de\ucdb0 \uc870\uc815\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub294 \ud3ec\uc7a5 \ud6c4 \"\ub300\ud45c \ubaa8\ub378\"\uc744 \ud14c\uc2a4\ud2b8\ud558\ub294 \uac83\ubcf4\ub2e4 \ub354 \uc548\uc804\ud569\ub2c8\ub2e4.<\/p>\n<h2><strong><b>FAQ\ub294<\/b><\/strong><\/h2>\n<p><strong>\uc9c8\ubb38: <\/strong><strong>ISO 12870\uc740 \ubaa8\ub4e0 \ucc98\ubc29 \uc548\uacbd\ud14c\uc5d0 \uc758\ubb34 \uc0ac\ud56d\uc778\uac00\uc694?<\/strong><\/p>\n<p>\uc790\ub3d9\uc73c\ub85c \uc694\uad6c\ub418\ub294 \uac83\uc740 \uc544\ub2d9\ub2c8\ub2e4. \uad6d\uac00 \ucc44\ud0dd, \uc801\ud569\uc131 \uc804\ub7b5 \ub610\ub294 \uad6c\ub9e4 \uacc4\uc57d\uc744 \ud1b5\ud574 \uc694\uad6c\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p><strong>\uc9c8\ubb38: <\/strong><strong>510(k) \uba74\uc81c \ud504\ub808\uc784\ub3c4 FDA \uaddc\uc81c \ub300\uc0c1\uc774 \ub418\uc5b4\uc57c \ud558\ub098\uc694?<\/strong><\/p>\n<p>\uc608. 510(k) \uba74\uc81c\ub294 \uc801\uc6a9\ub420 \uc218 \uc788\ub294 \ub2e4\ub978 FDA \uc758\ubb34\ub97c \uba74\uc81c\ud558\ub294 \uac83\uc740 \uc544\ub2d9\ub2c8\ub2e4.<\/p>\n<p><strong>\uc9c8\ubb38: <\/strong><strong>\ud558\ub098\uc758 \ubcf4\uace0\uc11c\ub85c \uc5ec\ub7ec \uc0c9\uc0c1\uacfc \ud06c\uae30\ub97c \ub2e4\ub8f0 \uc218 \uc788\ub098\uc694?<\/strong><\/p>\n<p>\uacbd\uc6b0\uc5d0 \ub530\ub77c \ub2e4\ub985\ub2c8\ub2e4. \uc7ac\uc9c8, \ucf54\ud305, \ud615\uc0c1, \ud78c\uc9c0 \ub514\uc790\uc778 \ubc0f \ud06c\uae30\uac00 \uc131\ub2a5\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce60 \uc218 \uc788\uc73c\ubbc0\ub85c \uadf8\ub8f9\ud654\uc5d0\ub294 \uae30\uc220\uc801\uc778 \ud0c0\ub2f9\uc131\uc774 \ud544\uc694\ud569\ub2c8\ub2e4.<\/p>\n<p><strong>\uc9c8\ubb38: <\/strong><strong>CE \ub9c8\ud06c\ub294 \ubaa8\ub4e0 \uc0dd\uc0b0 \ubc30\uce58\uc5d0 \ub300\ud55c \uac80\uc0ac\uac00 \uc644\ub8cc\ub418\uc5c8\uc74c\uc744 \uc99d\uba85\ud558\ub294 \uac83\uc778\uac00\uc694?<\/strong><\/p>\n<p>\uc544\ub2c8\uc694. \ubc30\uce58 \uac80\uc0ac \ubc0f \ucd94\uc801\uc131\uc740 \uc0dd\uc0b0 \uad00\ub9ac \ubd80\uc11c\uc758 \ucc45\uc784\uc785\ub2c8\ub2e4.<\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>&nbsp; A prescription frame is a small product with a long compliance trail. Teams focus on hinge feel, rim shape, plating color, and sample appearance. Market access may appear only when cartons are packed and someone asks for a declaration or valid report. Compliance belongs in the specification before tooling. What Counts as a Prescription [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":6040,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,47],"tags":[],"class_list":["post-6031","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-buyer-guides"],"_links":{"self":[{"href":"https:\/\/www.susoneyewear.com\/ko\/wp-json\/wp\/v2\/posts\/6031","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.susoneyewear.com\/ko\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.susoneyewear.com\/ko\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.susoneyewear.com\/ko\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.susoneyewear.com\/ko\/wp-json\/wp\/v2\/comments?post=6031"}],"version-history":[{"count":1,"href":"https:\/\/www.susoneyewear.com\/ko\/wp-json\/wp\/v2\/posts\/6031\/revisions"}],"predecessor-version":[{"id":6042,"href":"https:\/\/www.susoneyewear.com\/ko\/wp-json\/wp\/v2\/posts\/6031\/revisions\/6042"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.susoneyewear.com\/ko\/wp-json\/wp\/v2\/media\/6040"}],"wp:attachment":[{"href":"https:\/\/www.susoneyewear.com\/ko\/wp-json\/wp\/v2\/media?parent=6031"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.susoneyewear.com\/ko\/wp-json\/wp\/v2\/categories?post=6031"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.susoneyewear.com\/ko\/wp-json\/wp\/v2\/tags?post=6031"}],"curies":[{"name":"WP","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}