{"id":7918,"date":"2025-09-23T10:39:29","date_gmt":"2025-09-23T01:39:29","guid":{"rendered":"https:\/\/hansem.com\/?post_type=blog&#038;p=7918"},"modified":"2025-09-23T10:39:29","modified_gmt":"2025-09-23T01:39:29","slug":"fda-%ec%8a%b9%ec%9d%b8%ec%9a%a9-ifu-%ec%9e%91%ec%84%b1","status":"publish","type":"blog","link":"https:\/\/hansem.com\/ko\/blog\/fda-%ec%8a%b9%ec%9d%b8%ec%9a%a9-ifu-%ec%9e%91%ec%84%b1\/","title":{"rendered":"FDA \uc2b9\uc778\uc6a9 IFU \uc81c\uc791 \uc2e4\ubb34 \uac00\uc774\ub4dc"},"content":{"rendered":"\n<p>\ubbf8\uad6d \uc2dc\uc7a5 \uc9c4\ucd9c\uc744 \uc900\ube44\ud558\ub294 \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc0ac\uc5d0\uac8c \uc0ac\uc6a9\uc124\uba85\uc11c(IFU, Instructions for Use)\ub294 \ub2e8\uc21c\ud55c \uc81c\ud488 \uc548\ub0b4 \ubb38\uc11c\uac00 \uc544\ub2d9\ub2c8\ub2e4. IFU\ub294 <a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noreferrer noopener\">FDA<\/a>\uac00 \uc694\uad6c\ud558\ub294 \ubc95\uc801 \ub77c\ubca8\ub9c1 \uc694\uac74\uc758 \ud575\uc2ec \ubb38\uc11c\uc774\uc790, \uc81c\ud488\uc758 \uc548\uc804\uc131\uacfc \uaddc\uc815 \uc801\ud569\uc131\uc744 \uc785\uc99d\ud558\ub294 \uacf5\uc2dd \uc790\ub8cc\uc785\ub2c8\ub2e4. \uc798 \uc900\ube44\ub41c IFU\ub294 \uc81c\ud488\uc758 \ud5c8\uac00 \uc2ec\uc0ac \uacfc\uc815\uc5d0\uc11c \uae0d\uc815\uc801\uc73c\ub85c \uc791\uc6a9\ud560 \uc218 \uc788\uc9c0\ub9cc, \ubd88\uc644\uc804\ud558\uac70\ub098 \ub204\ub77d\ub41c IFU\ub294 \uc2ec\uc0ac \uc9c0\uc5f0\uc774\ub098 \ud5a5\ud6c4 \ubc95\uc801 \ucc45\uc784 \ubb38\uc81c\ub85c \uc774\uc5b4\uc9c8 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p>Hansem Global\uc740 \ub2e4\uad6d\uc5b4 \ubb38\uc11c\ud654 \ubc0f \uc0ac\uc6a9\uc790 \uc911\uc2ec\uc758 IFU \uac1c\ubc1c \uacbd\ud5d8\uc744, <a href=\"https:\/\/awglaw.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">Amin Wasserman Gurnani LLP<\/a>(AWG)\ub294 FDA \ub77c\ubca8\ub9c1 \uaddc\uc815, \uc81c\ucd9c \uc808\ucc28, \uaddc\uc81c \uc9d1\ud589 \ub9ac\uc2a4\ud06c\uc5d0 \ub300\ud55c \ubc95\ub960\uc801 \uc804\ubb38\uc131\uc744 \ubcf4\uc720\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc591\uc0ac\uc758 \ud611\uc5c5\uc740 \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc0ac\uac00 <strong>\ud6a8\uacfc\uc801\uc774\uba74\uc11c \ub3d9\uc2dc\uc5d0 FDA \uaddc\uc815\uc744 \ucda9\uc871\ud558\uace0, \uc81c\ucd9c\uc5d0 \ubc14\ub85c \ud65c\uc6a9 \uac00\ub2a5\ud558\uba70, \ubc95\uc801 \ubc29\uc5b4\ub825\uae4c\uc9c0 \uac16\ucd98 IFU<\/strong>\ub97c \uc81c\uc791\ud560 \uc218 \uc788\ub3c4\ub85d \uc9c0\uc6d0\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\ubcf8 \uae00\uc740 <a href=\"https:\/\/www.iso.org\/standard\/67943.html\" target=\"_blank\" rel=\"noreferrer noopener\">ISO 20417:2021<\/a>\uc5d0 \uaddc\uc815\ub41c \uae30\uc900\uc744 \ubc14\ud0d5\uc73c\ub85c, IFU\uc5d0 \ubc18\ub4dc\uc2dc \ud3ec\ud568\ud574\uc57c \ud560 \ub300\ud45c\uc801\uc778 11\uac1c \ud56d\ubaa9\uc744 \uc815\ub9ac\ud55c \uac83\uc785\ub2c8\ub2e4. \uc774 \ud56d\ubaa9\ub4e4\uc740 \uc81c\ud488\uc758 \ub4f1\uae09(Class)\uc774\ub098 \uc0ac\uc6a9 \ud658\uacbd\uc5d0 \ub530\ub77c \uc801\uc6a9 \uc5ec\ubd80\uac00 \ub2ec\ub77c\uc9c8 \uc218 \uc788\uc9c0\ub9cc, FDA\uc758 \uc77c\ubc18 \uc758\ub8cc\uae30\uae30 \ub77c\ubca8\ub9c1 \uc694\uac74(<a href=\"https:\/\/www.fda.gov\/medical-devices\/device-labeling\/general-device-labeling-requirements?trk=public_post_comment-text#:~:text=The%20general%20labeling%20requirements%20for%20medical%20devices%20are,additional%20requirements%20needed%20for%20specific%20categories%20of%20devices.\" target=\"_blank\" rel=\"noreferrer noopener\">21 C.F.R. Part 80<\/a>1)\uacfc \uccb4\uc678\uc9c4\ub2e8\uae30\uae30 \ucd94\uac00 \uc694\uac74(<a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-H\/part-809\" target=\"_blank\" rel=\"noreferrer noopener\">21 C.F.R. Part 809<\/a>)\uc744 \ucda9\uc871\ud558\ub294 \ub370 \uc788\uc5b4 \uae30\ubcf8\uc774 \ub418\ub294 \uccb4\ud06c\ub9ac\uc2a4\ud2b8\ub85c \ud65c\uc6a9\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-ifu\uc5d0-\ubc18\ub4dc\uc2dc-\ud3ec\ud568\ud574\uc57c-\ud560-11\uac00\uc9c0-\ud575\uc2ec-\ud56d\ubaa9\">IFU\uc5d0 \ubc18\ub4dc\uc2dc \ud3ec\ud568\ud574\uc57c \ud560 11\uac00\uc9c0 \ud575\uc2ec \ud56d\ubaa9<\/h3>\n\n\n\n<p>\uc774 \ud56d\ubaa9\ub4e4\uc740 \uc8fc\ub85c ISO 20417\uc5d0\uc11c \uaddc\uc815\ud558\ub294 \uc815\ubcf4 \uc81c\uacf5 \uc694\uac74\uc744 \ub530\ub985\ub2c8\ub2e4. \ub2e8, \uc81c\ud488\uc758 \ud2b9\uc131\uc5d0 \ub530\ub77c \ud3ec\ud568\ud574\uc57c \ud560 \ud56d\ubaa9\uc740 \uc77c\ubd80 \ub2ec\ub77c\uc9c8 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc544\ub798\uc5d0 \uc81c\uc2dc\ub41c 11\uac00\uc9c0\ub294 \ub2e4\uc591\ud55c \uc758\ub8cc\uae30\uae30 \uc720\ud615\uc5d0\uc11c \uacf5\ud1b5\uc801\uc73c\ub85c \uc694\uad6c\ub418\uba70, \uadc0\uc0ac\uc758 \uc81c\ud488\uc5d0 \ud574\ub2f9\ub41c\ub2e4\uba74 \ubc18\ub4dc\uc2dc \ud3ec\ud568\ub418\uc5b4\uc57c \ud558\ub294 \ud575\uc2ec \ud56d\ubaa9\ub4e4\uc785\ub2c8\ub2e4. \uc791\uc131 \uc804, \uc81c\ud488\uc758 \ub4f1\uae09(Class), \uc0ac\uc6a9 \ud658\uacbd, \uc0ac\uc6a9\uc790 \uc720\ud615 \ub4f1\uc744 \uace0\ub824\ud558\uc5ec \ud574\ub2f9 \ud56d\ubaa9\uc774 \ud544\uc694 \uc5c6\ub294 \uacbd\uc6b0 \uc0dd\ub7b5\ud558\uac70\ub098, \ubc18\ub300\ub85c \ucd94\uac00 \ud56d\ubaa9\uc774 \ud544\uc694\ud55c\uc9c0\ub3c4 \ubc18\ub4dc\uc2dc \uac80\ud1a0\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\uc81c\ud488\uba85, \ubaa8\ub378\uba85, \uc81c\uc870\uc790 \uc815\ubcf4<\/strong>\n<ul class=\"wp-block-list\">\n<li>\uc81c\ud488\uc758 <strong>\uc77c\ubc18\uba85<\/strong>\uacfc \ud568\uaed8 <strong>\uc815\ud655\ud55c \ubaa8\ub378 \ubc88\ud638<\/strong>\ub97c \uba85\uc2dc\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\uc81c\uc870\uc5c5\uccb4\uba85\uacfc \uc8fc\uc18c<\/strong>, \ubbf8\uad6d \uc2dc\uc7a5\uc6a9\uc77c \uacbd\uc6b0 \uc218\uc785\uc790 \uc815\ubcf4\ub3c4 \ud3ec\ud568\ud574\uc57c \ud569\ub2c8\ub2e4. \uc0ac\uc6a9\uc790\uc640 \uaddc\uc81c\uae30\uad00\uc774 \uc81c\ud488\uc744 \uc815\ud655\ud788 \uc2dd\ubcc4\ud560 \uc218 \uc788\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uc774\ub7ec\ud55c \uc815\ubcf4\ub294 IFU\uc758 \uc55e\ud45c\uc9c0 \ub610\ub294 \ub4b7\ud45c\uc9c0\uc5d0 \ud45c\uae30\ub418\ub294 \uac83\uc774 \uc77c\ubc18\uc801\uc785\ub2c8\ub2e4.<\/li>\n\n\n\n<li>IFU\uc5d0 \ud45c\uae30\ub418\ub294 \uc774 \uac19\uc740 \uc815\ubcf4\ub294 \uc81c\ud488 \ub77c\ubca8(Label), \uae30\uae30 \ubcf8\uccb4, \ud3ec\uc7a5 \ubc15\uc2a4, UDI \ubc14\ucf54\ub4dc\uc640 \ud568\uaed8 \uc81c\uacf5\ub418\ub294 \ub370\uc774\ud130 \uc2dc\ud2b8 \ub4f1\uc5d0\ub3c4 \ub3d9\uc77c\ud558\uac8c \uc0ac\uc6a9\ub418\uc5b4\uc57c \ud558\uba70, \ud45c\uae30 \ubd88\uc77c\uce58\uac00 \uc788\uc744 \uacbd\uc6b0 \uc2b9\uc778 \uac70\ubd80 \uc0ac\uc720\uac00 \ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Intended Use \/ Intended Purpose<\/strong>\n<ul class=\"wp-block-list\">\n<li>\uc81c\ud488\uc774 <strong>\uc5b4\ub5a4 \uc758\ub8cc\uc801 \ubaa9\uc801<\/strong>\uc73c\ub85c \uc0ac\uc6a9\ub418\ub294\uc9c0\ub97c \uba85\ud655\ud558\uac8c \uc124\uba85\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\ub204\uac00 \uc0ac\uc6a9\ud560 \uc218 \uc788\ub294\uc9c0<\/strong>(\uc608: \uc758\ub8cc \uc804\ubb38\uac00, \uc77c\ubc18 \uc0ac\uc6a9\uc790 \ub4f1), <strong>\uc5b4\ub5a4 \ud658\uacbd\uc5d0\uc11c \uc0ac\uc6a9\ub418\ub294\uc9c0\ub3c4<\/strong> \ud568\uaed8 \uae30\uc220\ud569\ub2c8\ub2e4. \ub2e8\uc21c\ud55c \uae30\ub2a5 \uc124\uba85\uc774 \uc544\ub2c8\ub77c, \uc81c\ud488\uc758 <strong>\ubc95\uc801\u00b7\uc784\uc0c1\uc801 \uc0ac\uc6a9 \ubc94\uc704<\/strong>\ub97c \uc815\uc758\ud558\ub294 \ud575\uc2ec \uc815\ubcf4\uc785\ub2c8\ub2e4. (\uc608: \u201c\uc774 \uae30\uae30\ub294 \uc758\ub8cc \uc804\ubb38\uac00\uc5d0 \uc758\ud574 \ubcd1\uc6d0 \ud658\uacbd\uc5d0\uc11c \uc2ec\uc804\ub3c4\ub97c \uce21\uc815\ud558\ub294 \ub370 \uc0ac\uc6a9\ub429\ub2c8\ub2e4.\u201d)<\/li>\n\n\n\n<li>\uc77c\ubc18\uc801\uc73c\ub85c IFU\uc758 \uc11c\ub450(Introduction \ub610\ub294 Intended Use \uc139\uc158)\uc5d0 \ud3ec\ud568\ub418\uba70, \uc774 \ub0b4\uc6a9\uc740 \uc81c\ud488 \ub4f1\ub85d\uc774\ub098 \uc2b9\uc778\uc5d0 \uc0ac\uc6a9\ub418\ub294 \ub2e4\ub978 \ubb38\uc11c\ub4e4\uacfc \ub0b4\uc6a9\uc774 \uc77c\uce58\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\uc0ac\uc6a9 \ubc29\ubc95 (\uc870\ub9bd, \uc791\ub3d9, \uc720\uc9c0\ubcf4\uc218, \ud3d0\uae30)<\/strong>\n<ul class=\"wp-block-list\">\n<li>\uc774 \uae30\uae30\uc758 \uc804\uccb4 \uc0ac\uc6a9 \uc808\ucc28\ub97c \uc124\uba85\ud574\uc57c \ud569\ub2c8\ub2e4. \uc0ac\uc6a9\uc790\uac00 \uc81c\ud488\uc744 \uc62c\ubc14\ub974\uac8c \uc870\ub9bd\ud558\uace0 \uc791\ub3d9\ud55c \ud6c4, \uc138\ucc99, \ubcf4\uad00, \uc720\uc9c0\ubcf4\uc218, \ud3d0\uae30\uae4c\uc9c0 \uc804 \uacfc\uc815\uc5d0 \uac78\uccd0 \ud544\uc694\ud55c \uc870\uce58\ub97c \uc774\ud574\ud558\uace0 \uc218\ud589\ud560 \uc218 \uc788\ub3c4\ub85d \uc548\ub0b4\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\ud2b9\ud788 \ud3d0\uae30 \ubc29\ubc95\uc740 \uc885\uc885 \uac04\uacfc\ub418\uae30 \uc26c\uc6b4 \ud56d\ubaa9\uc774\uc9c0\ub9cc, \uac10\uc5fc \uc704\ud5d8, \uc804\uc790\uae30\uae30 \ubd84\ub9ac\uc218\uac70, \ubc30\ud130\ub9ac \uc548\uc804 \ucc98\ub9ac \ub4f1 \ubc95\uc801\u00b7\ud658\uacbd\uc801 \uce21\uba74\uc5d0\uc11c\ub3c4 \ub9e4\uc6b0 \uc911\uc694\ud558\ubbc0\ub85c \ubc18\ub4dc\uc2dc \ud3ec\ud568\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<br>\u2192 \uc0ac\uc6a9\uc790\uac00 \ud3d0\uae30 \uc2dc\uc810\uc5d0\ub3c4 \uc81c\ud488\uc758 \ud2b9\uc131\uc744 \uace0\ub824\ud574 \uc548\uc804\ud558\uace0 \ucc45\uc784 \uc788\uac8c \ucc98\ub9ac\ud560 \uc218 \uc788\ub3c4\ub85d \uc548\ub0b4\ud558\ub294 \uac83\uc774 \ubb38\uc11c\uc758 \uc5ed\ud560\uc785\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uc81c\ud488\uc5d0 \ub530\ub77c \uc694\uad6c\ub418\ub294 \uc791\uc5c5\uc758 \uc885\ub958\uc640 \uc21c\uc11c\ub294 \ub2e4\ub97c \uc218 \uc788\uc2b5\ub2c8\ub2e4.<br>&#8211; \uc870\ub9bd\uc774 \ud544\uc694\ud55c \uacbd\uc6b0\uc5d0\ub294 \uc870\ub9bd \ubc29\ubc95,<br>&#8211; \ucd08\uae30 \uc124\uc815\uc774 \ud544\uc694\ud55c \uacbd\uc6b0\uc5d0\ub294 \uc124\uc815 \uc808\ucc28,<br>&#8211; \ubc18\ubcf5\uc801\uc778 \uad00\ub9ac\uac00 \ud544\uc694\ud55c \uacbd\uc6b0\uc5d0\ub294 \uc720\uc9c0\ubcf4\uc218 \uc9c0\uce68,<br>&#8211; \uc77c\ud68c\uc6a9 \ubd80\ud488\uc774 \uc788\ub2e4\uba74 \uad50\uccb4 \ubc0f \ud3d0\uae30 \uae30\uc900\uae4c\uc9c0 \ud3ec\ud568\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uc774 \ub0b4\uc6a9\uc740 \uc77c\ubc18\uc801\uc73c\ub85c IFU\uc758 \ubcf8\ubb38(Body Section)\uc5d0 \ud3ec\ud568\ub418\uba70, \uc81c\ud488\uc758 \uc0ac\uc6a9 \ubc29\uc2dd\uc774 \ubcf5\uc7a1\ud560\uc218\ub85d \ub2e8\uacc4\ubcc4\ub85c \uc138\ubd84\ud654\ud558\uc5ec \uad6c\uc131\ud558\ub294 \uac83\uc774 \ubc14\ub78c\uc9c1\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\uae08\uae30\uc0ac\ud56d \ubc0f \uc81c\ud55c\uc0ac\ud56d<\/strong>\n<ul class=\"wp-block-list\">\n<li>\uc81c\ud488\uc744 \uc0ac\uc6a9\ud574\uc11c\ub294 \uc548 \ub418\ub294 \uc870\uac74(\uc608: \ud2b9\uc815 \uc9c8\ud658, \uc5f0\ub839, \ud658\uc790\uad70, \ud658\uacbd \ub4f1)\uc744 \uba85\ud655\ud558\uac8c \uba85\uc2dc\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uc548\uc804\uc131\uc744 \uace0\ub824\ud55c \uc0ac\uc6a9 \uc81c\ud55c, \uc608\uc678 \uc0ac\ud56d\ub3c4 \ud568\uaed8 \ud3ec\ud568\ud574\uc57c \ud569\ub2c8\ub2e4. <strong>\ud658\uc790 \uc548\uc804 \ud655\ubcf4\uc640 \uc81c\ud488 \uc624\uc6a9 \ubc29\uc9c0<\/strong>\ub97c \uc704\ud55c \ud544\uc218 \uc815\ubcf4\ub85c, \ud3ec\ud568\ub418\uc9c0 \uc54a\uac70\ub098 \ubd88\uba85\ud655\ud560 \uacbd\uc6b0 \uc2b9\uc778 \uc9c0\uc5f0 \ub610\ub294 \ubc95\uc801 \ubd84\uc7c1\uc758 \uc6d0\uc778\uc774 \ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\ubcf4\ud1b5 Intended Use\uc640 \uac00\uae4c\uc6b4 \uc704\uce58 \ud639\uc740 \ubcc4\ub3c4\uc758 \u201cContraindications\u201d \uc139\uc158\uc73c\ub85c \ubd84\ub9ac\ud558\uc5ec \ubc30\uce58\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\uacbd\uace0\ubb38 \ubc0f \uc8fc\uc758\uc0ac\ud56d<\/strong>\n<ul class=\"wp-block-list\">\n<li><strong>\uc81c\ud488\uc758 \uc548\uc804\ud55c \uc0ac\uc6a9\uc744 \uc704\ud574 \ud544\uc694\ud55c \uacbd\uc6b0<\/strong><strong>,<\/strong> \uacbd\uace0\ubb38\uc740 \ubc18\ub4dc\uc2dc \ud3ec\ud568\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\ud615\uc2dd\uc774\ub098 \ubc30\uce58 \uc704\uce58\ub294 ANSI Z535.6\uc744 \ub530\ub974\uba74 \ub429\ub2c8\ub2e4:<br>\uc989 \uacbd\uace0 \uba54\uc2dc\uc9c0\ub294 \ub2e4\uc74c 4\uac00\uc9c0 \uc694\uc18c\ub97c \ud3ec\ud568\ud574 \uad6c\uc131\ud574\uc57c \ud569\ub2c8\ub2e4:\n<ol class=\"wp-block-list\">\n<li>Signal Word (DANGER, WARNING, CAUTION, NOTICE)<\/li>\n\n\n\n<li>Hazard (\uc5b4\ub5a4 \uc704\ud5d8\uc774 \uc788\ub294\uc9c0)<\/li>\n\n\n\n<li>How to Avoid (\uc5b4\ub5bb\uac8c \ud53c\ud560 \uc218 \uc788\ub294\uc9c0)<\/li>\n\n\n\n<li>Consequence (\uc9c0\ud0a4\uc9c0 \uc54a\uc558\uc744 \uacbd\uc6b0 \uc5b4\ub5a4 \uacb0\uacfc\uac00 \ubc1c\uc0dd\ud558\ub294\uc9c0)<\/li>\n<\/ol>\n<\/li>\n\n\n\n<li>\uac01 \uc808\ucc28 \uc2dc\uc791 \uc804\uc5d0 \ud574\ub2f9 \ub2e8\uacc4\uc5d0 \uad00\ub828\ub41c \uacbd\uace0\ubb38\uc744 \ubc30\uce58\ud569\ub2c8\ub2e4.<br>\u2192 \uc774\ub294 \uc81c\ud488 \ucc45\uc784 \ub9ac\uc2a4\ud06c\ub97c \uc904\uc774\uace0, \uc0ac\uc6a9\uc790 \uc0ac\uace0\ub97c \uc608\ubc29\ud558\uae30 \uc704\ud55c <strong>\ubc95\uc801 \ubcf4\ud638 \uc218\ub2e8<\/strong>\uc774\uae30\ub3c4 \ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\uba78\uade0\u00b7\uc7ac\uba78\uade0 \uc815\ubcf4, \ubcf4\uad00 \uc870\uac74<\/strong>\n<ul class=\"wp-block-list\">\n<li>\uba78\uade0 \uc81c\ud488\uc758 \uacbd\uc6b0 \uba78\uade0 \ubc29\ubc95(\uc608: EO, \uc99d\uae30, \ubc29\uc0ac\uc120 \ub4f1), \uc7ac\uba78\uade0 \uac00\ub2a5 \uc5ec\ubd80\uc640 \uc870\uac74\uc744 \uba85\uc2dc\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\ubcf4\uad00 \uc2dc \uad8c\uc7a5 \uc628\ub3c4, \uc2b5\ub3c4, \ube5b, \uc9c4\ub3d9 \ub4f1 \ud658\uacbd \uc870\uac74\ub3c4 \uc0ac\uc6a9\uc790 \uad00\uc810\uc5d0\uc11c \uba85\ud655\ud788 \uc548\ub0b4\ud574\uc57c \ud569\ub2c8\ub2e4. \uba78\uade0 \uc0c1\ud0dc \uc720\uc9c0, \ud488\uc9c8 \ubcf4\uc99d, \uc81c\ud488 \ud30c\uc190 \uc608\ubc29 \ub4f1\uc744 \uc704\ud55c <strong>\ud658\uacbd \uc815\ubcf4 \uc81c\uacf5 \uc758\ubb34<\/strong>\uc785\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\ubcf8\ubb38 \ub0b4 \ubcc4\ub3c4 \u201cStorage and Sterilization\u201d \uc139\uc158\uc73c\ub85c \uad6c\uc131\ub418\uba70, \ud574\ub2f9 \uc870\uac74\uc744 \uc704\ubc18\ud588\uc744 \ub54c\uc758 \uc601\ud5a5\ub3c4 \ud568\uaed8 \uae30\uc220\ud558\ub294 \uac83\uc774 \uc88b\uc2b5\ub2c8\ub2e4. \uba78\uade0 \uc5ec\ubd80\uc640 \ubc29\uc2dd, \uc7ac\uba78\uade0 \uac00\ub2a5\uc131 \ubc0f \uc870\uac74\uc744 \uba85\ud655\ud788 \uae30\uc220\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\uc81c\ud488 \uad6c\uc131 \ubc0f \uc561\uc138\uc11c\ub9ac<\/strong>\n<ul class=\"wp-block-list\">\n<li>\uae30\ubcf8 \ud328\ud0a4\uc9c0\uc5d0 \ud3ec\ud568\ub41c \uad6c\uc131\ud488, \uc120\ud0dd\ud615 \uc561\uc138\uc11c\ub9ac, \uc0ac\uc6a9 \uc2dc \ud544\uc694\ud55c \ubcf4\uc870 \uae30\uae30 \ub4f1\uc744 \ubaa8\ub450 \ub098\uc5f4\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uac01 \uad6c\uc131\ud488\uc740 \uba85\uce6d\uacfc \uc218\ub7c9, \uac04\ub2e8\ud55c \uc6a9\ub3c4 \uc124\uba85\uc744 \ud3ec\ud568\ud558\ub294 \uac83\uc774 \ubc14\ub78c\uc9c1\ud569\ub2c8\ub2e4. \uad6c\uc131\ud488 \ub204\ub77d \ub610\ub294 \uc624\uc0ac\uc6a9\uc744 \ubc29\uc9c0\ud558\uace0, \uc0ac\uc6a9\uc790 \ud63c\uc120\uc744 \uc904\uc774\uae30 \uc704\ud55c <strong>\uae30\ubcf8 \uc815\ubcf4 \uc81c\uacf5 \ud56d\ubaa9<\/strong>\uc785\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\ub3c4\uc2dd\ud654\ub41c \uad6c\uc131\ud488 \uc548\ub0b4 \uc774\ubbf8\uc9c0\ub098 \ub9ac\uc2a4\ud2b8 \ud615\ud0dc\ub85c \uc81c\uacf5\ub418\uba70, IFU\uc758 \uc11c\ub450 \ub610\ub294 \ubcc4\ub3c4 \uc139\uc158\uc5d0 \ubc30\uce58\ub429\ub2c8\ub2e4.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\uc0ac\uc6a9 \ud658\uacbd \uc870\uac74<\/strong>\n<ul class=\"wp-block-list\">\n<li>\uc81c\ud488\uc774 \uc815\uc0c1 \uc791\ub3d9\ud558\uae30 \uc704\ud574 \ud544\uc694\ud55c \uc804\uc6d0, \uc804\uc555, \uc8fc\ud30c\uc218, \ucda9\uc804 \ubc29\uc2dd \ub4f1 \uae30\uc220\uc801 \uc870\uac74\uc744 \uae30\uc7ac\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\ubcd1\uc6d0, \uac00\uc815, \uc774\ub3d9\ud615 \ud658\uacbd \ub4f1 \uc0ac\uc6a9 \uac00\ub2a5\ud55c \ubb3c\ub9ac\uc801\u00b7\uc784\uc0c1\uc801 \uc7a5\uc18c \uc870\uac74\ub3c4 \ud3ec\ud568\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. \u00a0\uc774 \uc815\ubcf4\ub294 \uc81c\ud488\uc774 <strong>\uc624\uc791\ub3d9 \uc5c6\uc774 \uc0ac\uc6a9 \uac00\ub2a5\ud55c \uc870\uac74\uc744 \uc815\uc758<\/strong>\ud558\uba70, \uc0ac\uc6a9 \ubd80\uc801\ud569 \ud658\uacbd\uc744 \ubc29\uc9c0\ud558\ub294 \uc5ed\ud560\uc744 \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uae30\uc220 \uc0ac\uc591(Technical Specifications) \uc139\uc158 \ub610\ub294 \uc124\uce58\/\uc791\ub3d9 \uc139\uc158\uacfc \ud568\uaed8 \uad6c\uc131\ud558\ub294 \uac83\uc774 \uc77c\ubc18\uc801\uc785\ub2c8\ub2e4.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\uc720\ud6a8\uae30\uac04, \uc81c\uc870\uc77c\uc790, \uace0\uac1d \uc9c0\uc6d0 \uc815\ubcf4<\/strong>\n<ul class=\"wp-block-list\">\n<li>\uc18c\ubaa8\uc131 \uc81c\ud488\uc774\ub098 \uba78\uade0 \uc81c\ud488\uc758 \uacbd\uc6b0 \uc81c\uc870\uc77c\uc790 \ubc0f \uc0ac\uc6a9\uae30\ud55c(Use-by date)\uc744 \uba85\uc2dc\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uc0ac\uc6a9\uc790 \ubb38\uc758 \ub300\uc751\uc744 \uc704\ud55c \uace0\uac1d \uc9c0\uc6d0 \uc5f0\ub77d\ucc98(\uc804\ud654, \uc774\uba54\uc77c, \uc6f9\uc0ac\uc774\ud2b8 \ub4f1)\ub97c \uc81c\uacf5\ud574\uc57c \ud569\ub2c8\ub2e4. <strong>\uc815\ud655\ud55c \uc0ac\uc6a9 \uc2dc\uc810 \ud30c\uc545\uacfc \uc0ac\ud6c4 \ub300\uc751 \uc9c0\uc6d0<\/strong>\uc744 \uc704\ud55c \ud56d\ubaa9\uc774\uba70, \ub9ac\ucf5c, A\/S \ub4f1\uc5d0\uc11c\ub3c4 \uc911\uc694\ud55c \uc815\ubcf4\uc785\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uc77c\ubc18\uc801\uc73c\ub85c IFU\uc758 \ub4b7\ud45c\uc9c0 \ub610\ub294 \ub9c8\uc9c0\ub9c9 \ud398\uc774\uc9c0\uc5d0 \ubc30\uce58\ub418\uba70, \ub77c\ubca8 \ub610\ub294 \ud3ec\uc7a5\uc9c0\uc640 \ub3d9\uc77c\ud55c \ud45c\uae30\uac00 \uc694\uad6c\ub429\ub2c8\ub2e4.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\uaddc\uc81c \uc778\uc99d \ub9c8\ud06c \ubc0f \uae30\ud638 \uc124\uba85<\/strong>\n<ul class=\"wp-block-list\">\n<li>CE, FDA \ub4f1\ub85d\ubc88\ud638, FCC, ISO \uc778\uc99d, UDI \ub4f1 \uc81c\ud488\uc5d0 \ubd80\uc5ec\ub41c \uaddc\uc81c \uc778\uc99d \ub9c8\ud06c\ub97c \uba85\ud655\ud788 \ud45c\uae30\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>ISO 15223-1 \ub610\ub294 IEC 60417\uc5d0\uc11c \uc815\uc758\ub41c \uae30\ud638\ub97c \uc0ac\uc6a9\ud558\ub294 \uacbd\uc6b0, \uc758\ubbf8\ub97c \ud14d\uc2a4\ud2b8\ub85c \ubcd1\uae30\ud574\uc57c \ud569\ub2c8\ub2e4. <br>\uc608: <img loading=\"lazy\" decoding=\"async\" width=\"50\" height=\"42\" class=\"wp-image-7919\" style=\"width: 50px;\" src=\"http:\/\/hansem.com\/wp-content\/uploads\/2025\/09\/\uadf8\ub9bc1.png\" alt=\"\">: \u201cConsult instructions for use\u201d<\/li>\n\n\n\n<li>\uc758\ub8cc\uae30\uae30 \uaddc\uc81c\uae30\uad00\uc5d0\uc11c \uc694\uad6c\ud558\ub294 <strong>\uc81c\ud488 \uc801\ud569\uc131\uc758 \uc99d\uac70\ub85c \uac04\uc8fc\ub418\ub294 \ud56d\ubaa9<\/strong>\uc774\uba70, \ud45c\uae30 \ub204\ub77d \uc2dc \uc2b9\uc778\uc774 \uac70\ubd80\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uc77c\ubc18\uc801\uc73c\ub85c \uc55e\ud45c\uc9c0 \ud558\ub2e8 \ub610\ub294 \ubcc4\ub3c4\uc758 \u201cSymbols and Regulatory Information\u201d \uc139\uc158\uc5d0 \uad6c\uc131\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\uc804\uc790 IFU \uc548\ub0b4 (\ud574\ub2f9 \uc2dc)<\/strong>\n<ul class=\"wp-block-list\">\n<li>IFU\ub97c \uc885\uc774 \ud615\ud0dc\uac00 \uc544\ub2cc \uc804\uc790\ubb38\uc11c(e-IFU)\ub85c \uc81c\uacf5\ud558\ub294 \uacbd\uc6b0, \uc0ac\uc6a9\uc790\uac00 \ud574\ub2f9 \ubb38\uc11c\uc5d0 <strong>\uc27d\uace0 \uc548\uc815\uc801\uc73c\ub85c \uc811\uadfc\ud560 \uc218 \uc788\ub294 \ubc29\ubc95<\/strong>\uc744 \uc548\ub0b4\ud574\uc57c \ud569\ub2c8\ub2e4. (\uc608: \uc6f9\uc0ac\uc774\ud2b8 \uc8fc\uc18c, QR\ucf54\ub4dc, \uc804\uc6a9 \uc571 \ub4f1)<\/li>\n\n\n\n<li>\ub610\ud55c \uc5f4\ub78c \uc870\uac74(\uc778\ud130\ub137 \uc5f0\uacb0, \uacc4\uc815 \ub85c\uadf8\uc778 \ud544\uc694 \uc5ec\ubd80 \ub4f1)\uacfc \ud568\uaed8, <strong>\uc885\uc774 \uc124\uba85\uc11c\ub97c \uc694\uccad\ud558\ub294 \uc808\ucc28\uc640 \ubc29\ubc95<\/strong>\ub3c4 \uba85\ud655\ud788 \uc548\ub0b4\ud574\uc57c \ud569\ub2c8\ub2e4. \uc77c\ubd80 \uc2dc\uc7a5(\ubbf8\uad6d, EU \ub4f1)\uc5d0\uc11c\ub294 \uc804\uc790 IFU\ub85c \uc81c\uacf5\ud560 \uc218 \uc788\ub294 \uacbd\uc6b0\uac00 <strong>\ubc95\uc801\uc73c\ub85c \uc81c\ud55c<\/strong>\ub418\uc5b4 \uc788\uc73c\uba70, <strong>\uc0ac\uc6a9\uc790\uac00 \uc6d0\ud560 \uacbd\uc6b0 \ubb34\ub8cc\ub85c \uc885\uc774 \ubb38\uc11c\ub97c \uc81c\uacf5\ud574\uc57c \ud55c\ub2e4\ub294 \uc870\uac74<\/strong>\uc774 \ubd99\ub294 \uacbd\uc6b0\ub3c4 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\uc804\uc790 IFU \uc81c\uacf5\uc774 \uac00\ub2a5\ud55c \ub300\ud45c\uc801\uc778 \uc0ac\ub840\ub294 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4:<\/strong><strong><br><\/strong>\u2003- <strong>\uc804\ubb38 \uc758\ub8cc\uc778\ub9cc \uc0ac\uc6a9\ud558\ub294 \uc81c\ud488<\/strong> (\uc608: \uc218\uc220 \uc7a5\ube44, \ubcd1\uc6d0 \uc804\uc6a9 \uae30\uae30)<br>\u2003- <strong>\uace0\uc815 \uc124\uce58\ud615 \ub610\ub294 \ub300\ud615 \uc7a5\ube44<\/strong> (\uc608: MRI, \ubcd1\uc6d0\uc6a9 \ubd84\uc11d\uae30\uae30)<br>\u2003- <strong>\uc804\uc6a9 \uc2dc\uc2a4\ud15c\uc744 \ud1b5\ud574 IFU \uc5f4\ub78c\uc774 \uac00\ub2a5\ud55c SaMD<\/strong> (\uc608: \ud074\ub77c\uc6b0\ub4dc \uae30\ubc18 \uc758\ub8cc SW)<br>\uc774\ucc98\ub7fc \uc81c\ud488\uc758 \uc0ac\uc6a9\uc790\uac00 \ubb38\uc11c\ub97c \uc804\uc790\uc801\uc73c\ub85c \uc5f4\ub78c\ud560 \uc218 \uc788\ub294 \ud658\uacbd\uc5d0 \uc788\uac70\ub098, \uc81c\ud488 \ud2b9\uc131\uc0c1 \uc885\uc774 \ubb38\uc11c \uc81c\uacf5\uc774 \ube44\ud6a8\uc728\uc801\uc778 \uacbd\uc6b0\uc5d0\ub9cc \uc81c\ud55c\uc801\uc73c\ub85c \ud5c8\uc6a9\ub429\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uc804\uc790 IFU\ub294 \uc77c\ubc18\uc801\uc73c\ub85c <strong>IFU <\/strong><strong>\uc55e \ub610\ub294 \ub4b7\ud398\uc774\uc9c0<\/strong>\uc5d0 \ud574\ub2f9 \uc548\ub0b4\uac00 \uba85\ud655\ud788 \ud45c\uae30\ub418\uba70, <strong>\uc6f9 \uc811\uadfc\uc131, \ub370\uc774\ud130 \ubc31\uc5c5, \uc2dc\uc2a4\ud15c \uc5f0\uacc4<\/strong> \uc5ec\ubd80\ub3c4 \ud568\uaed8 \uae30\uc220\ud558\ub294 \uac83\uc774 \uc88b\uc2b5\ub2c8\ub2e4. \uc804\uc790\ubb38\uc11c\ub97c \ud1b5\ud55c IFU \uc81c\uacf5\uc740 \ub2e8\uc21c\ud788 \ud3ec\ub9f7\uc744 \ubc14\uafb8\ub294 \uac83\uc774 \uc544\ub2c8\ub77c, <strong>\uc811\uadfc\uc131, \ubc95\uc801 \ucc45\uc784, \uc0ac\uc6a9\uc790 \uc2e0\ub8b0 \ud655\ubcf4\ub97c \uc804\uc81c\ub85c \ud55c \uccb4\uacc4\uc801\uc778 \uc548\ub0b4 \uccb4\uacc4<\/strong>\uac00 \uc694\uad6c\ub429\ub2c8\ub2e4.<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-\uc791\uc131-\ud301-ifu\ub97c-\ub354-\uba85\ud655\ud558\uace0-\ud6a8\uacfc\uc801\uc73c\ub85c-\ub9cc\ub4dc\ub294-\ubc29\ubc95\">\uc791\uc131 \ud301: IFU\ub97c \ub354 \uba85\ud655\ud558\uace0 \ud6a8\uacfc\uc801\uc73c\ub85c \ub9cc\ub4dc\ub294 \ubc29\ubc95<\/h3>\n\n\n\n<p>IFU\uc5d0 \uc5b4\ub5a4 \uc815\ubcf4\ub97c \ub2f4\ub294\uc9c0\uac00 \uc911\uc694\ud558\ub2e4\uba74, <strong>\uadf8 \uc815\ubcf4\ub97c \uc5b4\ub5bb\uac8c \uc804\ub2ec\ud558\ub294\uc9c0\ub3c4 \uadf8\uc5d0 \ubabb\uc9c0\uc54a\uac8c \uc911\uc694\ud569\ub2c8\ub2e4. <\/strong>\uc544\ub798\uc758 \ud301\uc740 \uc2e4\ubb34\uc790\uac00 IFU\ub97c \ub354 \uba85\ud655\ud558\uace0 \uc77c\uad00\uc131 \uc788\uac8c \uad6c\uc131\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub420 \uc218 \uc788\ub294 \uae30\ubcf8 \uc6d0\uce59\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\ud55c \ubb38\ub2e8\uc5d0\ub294 \ud558\ub098\uc758 \ud575\uc2ec \uba54\uc2dc\uc9c0\ub9cc \ub2f4\uc73c\uc138\uc694: <\/strong>\uc0ac\uc6a9\uc790\ub294 \ud544\uc694\ud55c \uc815\ubcf4\ub97c \ube60\ub974\uac8c \ucc3e\uae30\ub97c \uc6d0\ud569\ub2c8\ub2e4. \uc815\ubcf4\ub294 \uc9e7\uac8c \ub098\ub204\uace0 \uc81c\ubaa9\uc744 \ubd99\uc774\uc138\uc694.<\/li>\n\n\n\n<li><strong>\uc77c\uad00\ub41c \uc6a9\uc5b4\ub97c \uc0ac\uc6a9\ud558\uc138\uc694: <\/strong>\uac19\uc740 \uc758\ubbf8\uc758 \ub2e8\uc5b4\ub098 \ubb38\uc7a5\uc744 \ubb38\uc11c \uc804\uccb4\uc5d0\uc11c \ud1b5\uc77c\ub418\uac8c \uc0ac\uc6a9\ud574\uc57c \uc624\ud574\ub97c \uc904\uc77c \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\ubb38\uc7a5\uc740 \uc9e7\uace0 \uac04\uacb0\ud558\uac8c: <\/strong>\u201cPress START.\u201d\ucc98\ub7fc \uc0ac\uc6a9\uc790 \ud589\ub3d9\uc744 \uc9c1\uc811 \uc720\ub3c4\ud558\ub294 \uba85\ub839\ubb38\uc774 \ud6a8\uacfc\uc801\uc785\ub2c8\ub2e4. \u201cPlease press the button in order to\u2026\u201d \uac19\uc740 \uc7a5\ud669\ud55c \ubb38\uc7a5\uc740 \ud53c\ud558\uc138\uc694.<\/li>\n\n\n\n<li><strong>\uceec\ub7ec\ubcf4\ub2e4 \ub77c\uc778\uc544\ud2b8(line art)\ub85c \uc81c\uc791\ub41c \uc77c\ub7ec\uc2a4\ud2b8\ub97c \ud65c\uc6a9\ud558\uc138\uc694: <\/strong>\uc2dc\uac01 \uc790\ub8cc\ub294 \uae30\uc5b5\uc744 \ub3d5\ub294 \uc7a5\uc2dd\uc774 \uc544\ub2c8\ub77c, <strong>\uae30\ub2a5\uc744 \uc815\ud655\ud788 \uc804\ub2ec\ud558\ub294 \ub3c4\uad6c<\/strong>\uc5ec\uc57c \ud569\ub2c8\ub2e4. \ud751\ubc31 \uc778\uc1c4 \ud658\uacbd\uae4c\uc9c0 \uace0\ub824\ud574 \uc120\uba85\ud558\uace0 \ub2e8\uc21c\ud55c \ub77c\uc778 \ub4dc\ub85c\uc789\uc774 \uc774\uc0c1\uc801\uc785\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\uacbd\uace0 \uba54\uc2dc\uc9c0\ub294 \ubc18\ubcf5\uc744 \ub450\ub824\uc6cc\ud558\uc9c0 \ub9c8\uc138\uc694: <\/strong>\uc0ac\uc6a9\uc790\uac00 \uc2e4\uc218\ud560 \uac00\ub2a5\uc131\uc774 \uc788\ub294 \uc9c0\uc810\uc5d0\uc11c\ub294 \uac19\uc740 \uacbd\uace0\ub77c\ub3c4 \ubc18\ubcf5\uc801\uc73c\ub85c \ubc30\uce58\ud558\ub294 \uac83\uc774 \uc548\uc804\ud569\ub2c8\ub2e4. \uacbd\uace0\ubb38\uc758 \uc704\uce58\uc640 \ud615\uc2dd\uc740 \ubb38\uc11c \uc2e0\ub8b0\ub3c4\uc5d0 \uc9c1\uc811 \uc601\ud5a5\uc744 \ubbf8\uce69\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<p>IFU\ub294 \u201c\uc815\ubcf4\ub97c \uc804\ub2ec\ud558\ub294 \uae30\uc220\ubb38\uc11c\u201d\uc778 \ub3d9\uc2dc\uc5d0, <strong>\uc0ac\uc6a9\uc790 \ud589\ub3d9\uc744 \uc124\uacc4\ud558\ub294 \uc548\uc804 \ubb38\uc11c<\/strong>\uc785\ub2c8\ub2e4. \ud615\uc2dd\uc744 \uafb8\ubbf8\uae30 \uc804\uc5d0, <strong>\uc77d\ub294 \uc0ac\ub78c\uc758 \uc785\uc7a5\uc5d0\uc11c \uc5bc\ub9c8\ub098 \uba85\ud655\ud558\uac8c \uc4f0\uc600\ub294\uc9c0\ub97c \uba3c\uc800 \uc810\uac80\ud574 \ubcf4\uc138\uc694.<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-\ub9c8\ubb34\ub9ac-ifu\ub294-\uaddc\uc81c-\ub300\uc751\uc774\uc790-\uc81c\ud488-\uc2e0\ub8b0\uc758-\ucd9c\ubc1c\uc810\uc785\ub2c8\ub2e4\">\ub9c8\ubb34\ub9ac: IFU\ub294 \uaddc\uc81c \ub300\uc751\uc774\uc790 \uc81c\ud488 \uc2e0\ub8b0\uc758 \ucd9c\ubc1c\uc810\uc785\ub2c8\ub2e4<\/h3>\n\n\n\n<p>IFU\uc5d0 \uc5b4\ub5a4 \uc815\ubcf4\ub97c \ud3ec\ud568\ud558\ub290\ub0d0\ub294 \ub2e8\uc9c0 \ubb38\uc11c\uc758 \ud615\uc2dd \ubb38\uc81c\uac00 \uc544\ub2d9\ub2c8\ub2e4. <strong>FDA <\/strong><strong>\uc2b9\uc778 \uacb0\uacfc<\/strong>, <strong>\uc81c\ud488\uc758 \ubc95\uc801 \ucc45\uc784<\/strong>, <strong>\uc0ac\uc6a9\uc790 \uc548\uc804 \ud655\ubcf4<\/strong>\uc5d0 \uc9c1\uc811\uc801\uc778 \uc601\ud5a5\uc744 \ubbf8\uce58\ub294 \ud575\uc2ec \uc694\uc18c\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc774 \uae00\uc5d0\uc11c \uc815\ub9ac\ud55c 11\uac00\uc9c0 \ud56d\ubaa9\uc740<br>\u2705 \uaddc\uc815 \ub204\ub77d\uc73c\ub85c \uc778\ud55c <strong>\uc2b9\uc778 \uc9c0\uc5f0\uc744 \uc608\ubc29\ud558\uace0<\/strong>,<br>\u2705 \uc0ac\uc6a9\uc790\uc640\uc758 <strong>\uc2e0\ub8b0\ub97c \ub192\uc774\uba70<\/strong>,<br>\u2705 <strong>\uc81c\ud488 \ub9ac\uc2a4\ud06c\ub97c \uc0ac\uc804\uc5d0 \uad00\ub9ac\ud560 \uc218 \uc788\ub294 \uae30\uc900\uc120<\/strong>\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<p>IFU\ub97c \ucc98\uc74c\ubd80\ud130 \uc798 \ub9cc\ub4e4\uace0 \uc2f6\ub2e4\uba74, \ubcf5\uc7a1\ud55c \ud615\uc2dd\ubcf4\ub2e4 \uba3c\uc800 \uc774 \uc9c8\ubb38\ubd80\ud130 \uc2dc\uc791\ud574\uc57c \ud569\ub2c8\ub2e4: \u201c\uc6b0\ub9ac \uc81c\ud488 \uc124\uba85\uc11c\uc5d0 \ubc18\ub4dc\uc2dc \uc788\uc5b4\uc57c \ud560 \ub0b4\uc6a9\uc774 \ube60\uc838 \uc788\uc9c0\ub294 \uc54a\uc740\uac00?\u201d<\/p>\n\n\n\n<p>\ud55c\uc0d8\uae00\ub85c\ubc8c\uc740 35\ub144 \uc774\uc0c1 \ub2e4\uc591\ud55c \uc0b0\uc5c5 \ubd84\uc57c\uc5d0\uc11c \uc0ac\uc6a9\uc790 \uc911\uc2ec\uc758 \ub9e4\ub274\uc5bc\uc744 \uc124\uacc4\ud574\uc654\uc73c\uba70, 50\uac1c \uc5b8\uc5b4 \uc774\uc0c1\uc73c\ub85c\uc758 \ub2e4\uad6d\uc5b4 \ud604\uc9c0\ud654 \uacbd\ud5d8\uc744 \ud1b5\ud574 \uae00\ub85c\ubc8c \uaddc\uc81c \ub300\uc751 \ubb38\uc11c\uc5d0\ub3c4 \uc548\uc815\uc801\uc73c\ub85c \ub300\uc751\ud574\uc654\uc2b5\ub2c8\ub2e4. \ud2b9\ud788,<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ubcf5\uc7a1\ud55c \uc81c\ud488 \uc815\ubcf4\ub97c \uaddc\uc81c \uac80\ud1a0\uc5d0 \ub9de\uac8c \uad6c\uc870\ud654\ud558\uace0,<\/li>\n\n\n\n<li>\uc5b8\uc5b4\uc640 \ubb38\uc11c \ud615\uc2dd \uc804\ubc18\uc758 \uc77c\uad00\uc131\uc744 \ubcf4\uc7a5\ud558\uba70,<\/li>\n\n\n\n<li>\ub2e4\uad6d\uc5b4 \ub77c\ubca8\ub9c1\uacfc \uae00\ub85c\ubc8c \uc2dc\uc7a5 \uc9c4\ucd9c\uc5d0 \ud544\uc694\ud55c IFU \uc81c\uc791\uc744 \uc9c0\uc6d0\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<p>\uc774 \uacfc\uc815\uc5d0\uc11c, <a href=\"https:\/\/awglaw.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">Amin Wasserman Gurnani LLP<\/a>(AWG)\ub294 FDA \uaddc\uc815 \ud574\uc11d, \uc81c\ucd9c \uc804\ub7b5 \uc218\ub9bd, \ubc95\uc801 \ub9ac\uc2a4\ud06c \uad00\ub9ac \uce21\uba74\uc5d0\uc11c \uc804\ubb38\uc801\uc778 \uc790\ubb38\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\ub530\ub77c\uc11c \ud55c\uc0d8\uae00\ub85c\ubc8c\uacfc AWG\uc758 \ud611\uc5c5\uc740 \ub2e8\uc21c\ud788 \uc77d\uae30 \uc88b\uc740 \ubb38\uc11c\ub97c \ub118\uc5b4, <strong>\uc2ec\uc0ac \ub300\uc751\uc5d0 \uc900\ube44\ub41c(IFU review-ready), \uaddc\uc81c \ub9ac\uc2a4\ud06c\uc5d0 \ub300\uc751\ud560 \uc218 \uc788\uc73c\uba70(risk-aware), \uae00\ub85c\ubc8c \uc2dc\uc7a5\uae4c\uc9c0 \ud655\uc7a5 \uac00\ub2a5\ud55c IFU<\/strong>\ub97c \uc81c\uc791\ud558\ub294 \ub370 \ucd08\uc810\uc744 \ub9de\ucd94\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p>FDA \uc81c\ucd9c\uc6a9 IFU\ub294 \ubb3c\ub860 \ud574\uc678 \uc2dc\uc7a5 \ud604\uc9c0\ud654\ub97c \uc704\ud55c IFU\uae4c\uc9c0, \ud55c\uc0d8\uae00\ub85c\ubc8c\uacfc AWG\ub294 \uae30\ud68d, \uc9d1\ud544, \ub514\uc790\uc778, \ubc88\uc5ed, \uadf8\ub9ac\uace0 \ubc95\ub960 \uc790\ubb38\uc5d0 \uc774\ub974\uae30\uae4c\uc9c0 \uc804 \uacfc\uc815\uc744 \ud568\uaed8 \uc9c0\uc6d0\ud569\ub2c8\ub2e4.<\/p>\n","protected":false},"featured_media":7909,"parent":0,"menu_order":0,"template":"","blog-types":[126],"class_list":["post-7918","blog","type-blog","status-publish","has-post-thumbnail","hentry","blog-types-user-manuals-content-creation-ko"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA \uc2b9\uc778\uc6a9 IFU \uc791\uc131 \uac00\uc774\ub4dc: ISO 20417 \uae30\ubc18 \ud575\uc2ec \ud56d\ubaa9 11\uac00\uc9c0 \uc815\ub9ac<\/title>\n<meta name=\"description\" content=\"\ubbf8\uad6d \uc2dc\uc7a5\uc5d0 \uc758\ub8cc\uae30\uae30\ub97c \uc218\ucd9c\ud558\ub824\uba74, \uc0ac\uc6a9\uc124\uba85\uc11c(IFU)\uac00 \ub2e8\uc21c\ud55c \uc81c\ud488 \uc548\ub0b4\ub97c \ub118\uc5b4 \uaddc\uc81c \uc694\uac74\uc744 \ucda9\uc871\ud558\ub294 \ud575\uc2ec \ubb38\uc11c\uac00 \ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. \uc774 \uae00\uc740 ISO 20417 \uae30\uc900\uc744 \ubc14\ud0d5\uc73c\ub85c, FDA \uc2b9\uc778 \uc2ec\uc0ac\uc5d0\uc11c \uc694\uad6c\ub418\ub294 IFU\uc758 \ud575\uc2ec \ud56d\ubaa9 11\uac00\uc9c0\ub97c \uad6c\uccb4\uc801\uc73c\ub85c \uc815\ub9ac\ud588\uc2b5\ub2c8\ub2e4.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/hansem.com\/ko\/blog\/fda-%ec%8a%b9%ec%9d%b8%ec%9a%a9-ifu-%ec%9e%91%ec%84%b1\/\" \/>\n<meta property=\"og:locale\" content=\"ko_KR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA \uc2b9\uc778\uc6a9 IFU \uc81c\uc791 \uc2e4\ubb34 \uac00\uc774\ub4dc\" \/>\n<meta property=\"og:description\" content=\"\ubbf8\uad6d \uc2dc\uc7a5\uc5d0 \uc758\ub8cc\uae30\uae30\ub97c \uc218\ucd9c\ud558\ub824\uba74, \uc0ac\uc6a9\uc124\uba85\uc11c(IFU)\uac00 \ub2e8\uc21c\ud55c \uc81c\ud488 \uc548\ub0b4\ub97c \ub118\uc5b4 \uaddc\uc81c \uc694\uac74\uc744 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name=\"twitter:label1\" content=\"\uc608\uc0c1 \ub418\ub294 \ud310\ub3c5 \uc2dc\uac04\" \/>\n\t<meta name=\"twitter:data1\" content=\"9\ubd84\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/hansem.com\\\/ko\\\/blog\\\/fda-%ec%8a%b9%ec%9d%b8%ec%9a%a9-ifu-%ec%9e%91%ec%84%b1\\\/\",\"url\":\"https:\\\/\\\/hansem.com\\\/ko\\\/blog\\\/fda-%ec%8a%b9%ec%9d%b8%ec%9a%a9-ifu-%ec%9e%91%ec%84%b1\\\/\",\"name\":\"FDA \uc2b9\uc778\uc6a9 IFU \uc791\uc131 \uac00\uc774\ub4dc: ISO 20417 \uae30\ubc18 \ud575\uc2ec \ud56d\ubaa9 11\uac00\uc9c0 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