{"id":7423,"date":"2025-07-21T10:31:43","date_gmt":"2025-07-21T01:31:43","guid":{"rendered":"https:\/\/hansem.com\/?post_type=blog&#038;p=7423"},"modified":"2025-07-22T10:03:08","modified_gmt":"2025-07-22T01:03:08","slug":"fda-ifu-%ec%a0%9c%ec%9e%91-%ea%b7%9c%ec%a0%95","status":"publish","type":"blog","link":"https:\/\/hansem.com\/ko\/blog\/fda-ifu-%ec%a0%9c%ec%9e%91-%ea%b7%9c%ec%a0%95\/","title":{"rendered":"FDA \uc2b9\uc778\uc6a9 IFU: \ubc18\ub4dc\uc2dc \uc801\uc6a9\ud574\uc57c \ud560 \uaddc\uc815"},"content":{"rendered":"\n<p>\ud55c\uad6d\uc5d0\uc11c\ub3c4 \uae00\ub85c\ubc8c \uacbd\uc7c1\ub825\uc744 \uac16\ucd98 \uc758\ub8cc\uae30\uae30\uc640 \ub514\uc9c0\ud138 \ud5ec\uc2a4 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uac00 \ube60\ub974\uac8c \uc99d\uac00\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ucd08\uc74c\ud30c \uc9c4\ub2e8\uae30\uae30, \ubdf0\ud2f0\u00b7\ud53c\ubd80 \uce58\ub8cc\uae30\uae30, \uc7ac\ud65c\u00b7\ubb3c\ub9ac\uce58\ub8cc\uae30\uae30\ub294 \ubb3c\ub860, \uc6e8\uc5b4\ub7ec\ube14 \ud5ec\uc2a4\uae30\uae30\uc758 \uc778\uc9c0\ub3c4\ub3c4 \ub192\uc544\uc9c0\uace0 \uc788\uc73c\uba70, AI \uae30\ubc18 \uc6d0\uaca9\uc9c4\ub2e8\uc774 \uac00\ub2a5\ud55c SaMD(Software as a Medical Device) \ubd84\uc57c\uc5d0 \uc9c4\ucd9c\ud558\ub294 \uc2a4\ud0c0\ud2b8\uc5c5\ub3c4 \uafb8\uc900\ud788 \ub298\uc5b4\ub098\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc774\ucc98\ub7fc \uae30\uc220 \uacbd\uc7c1\ub825\uc744 \uac16\ucd98 \uc81c\ud488\uc774 \ud574\uc678 \uc2dc\uc7a5\uc73c\ub85c \ub098\uc544\uac00\uae30 \uc704\ud574\uc11c\ub294, \ubb38\uc11c \uacbd\uc7c1\ub825 \ub610\ud55c \ud568\uaed8 \uac16\ucdb0\uc57c \ud569\ub2c8\ub2e4. \ud2b9\ud788 \ubbf8\uad6d \uc758\ub8cc\uae30\uae30 \uc2dc\uc7a5\uc5d0 \uc9c4\ucd9c\ud558\ub824\uba74, \uae4c\ub2e4\ub85c\uc6b4 \uaddc\uc81c\uc640 \ubb38\uc11c \uc694\uac74\uc744 \ucda9\uc871\ud574\uc57c \ud558\uba70, \uadf8 \uc911\uc2ec\uc5d0 \uc788\ub294 \uac83\uc774 \ubc14\ub85c <strong>\uc0ac\uc6a9\uc124\uba85\uc11c(IFU, Instructions for Use)<\/strong>\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<p>IFU\ub294 \ub2e8\uc21c\ud55c \uc0ac\uc6a9 \uc548\ub0b4\uc11c\ub97c \ub118\uc5b4, \uc81c\ud488\uc758 <strong>\uc548\uc804\uc131\uacfc \uaddc\uc815 \uc801\ud569\uc131<\/strong>\uc744 \uc785\uc99d\ud558\ub294 \ud575\uc2ec \ubb38\uc11c\ub85c\uc11c <strong>FDA \uc2ec\uc0ac \uacfc\uc815\uc5d0\uc11c \uc911\uc694\ud55c \ud3c9\uac00 \ub300\uc0c1<\/strong>\uc774 \ub429\ub2c8\ub2e4. \ud2b9\ud788 \ubbf8\uad6d \uc2dc\uc7a5\uc5d0\uc11c\ub294 IFU\uac00 \uad6d\uc81c\ud45c\uc900\uacfc FDA \uace0\uc720 \uaddc\uc815 \ubaa8\ub450\ub97c \ubc18\uc601\ud574 \uc791\uc131\ub418\uc5b4\uc57c \ud558\uba70, \uc774\ub97c \uc704\ud574 \ubb38\uc11c \uc81c\uc791\uc790\ub294 \uad00\ub828 \uc9c0\uce68\uc744 \uc815\ud655\ud788 \uc774\ud574\ud558\uace0 \uc801\uc6a9\ud560 \uc218 \uc788\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc774 \uae00\uc5d0\uc11c\ub294 FDA \uc2b9\uc778\uc6a9 IFU\ub97c \uc900\ube44\ud558\ub294 \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc0ac\uc640 \ubb38\uc11c \ub2f4\ub2f9\uc790\ub97c \uc704\ud574,<\/p>\n\n\n\n<ul class=\"wp-block-list check\">\n<li>\ubc18\ub4dc\uc2dc \ud559\uc2b5\ud558\uace0 \uc801\uc6a9\ud574\uc57c \ud560 4\uac00\uc9c0 \uc8fc\uc694 \uaddc\uc815 \ubc0f \uad6d\uc81c\ud45c\uc900,<\/li>\n\n\n\n<li>\uac01 \uc9c0\uce68\uc774 \uc694\uad6c\ud558\ub294 \ud575\uc2ec \ub0b4\uc6a9,<\/li>\n\n\n\n<li>\uadf8\ub9ac\uace0 \uc5b4\ub5a4 \ud56d\ubaa9\uc5d0 \uc5b4\ub5bb\uac8c \uc801\uc6a9\ub418\ub294\uc9c0\ub97c \uac1c\uc694 \uc218\uc900\uc5d0\uc11c \uc815\ub9ac\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-iso-20417-ifu\uc5d0-\ud3ec\ud568\ub418\uc5b4\uc57c-\ud560-\ud544\uc218-\uc815\ubcf4-\uc815\uc758\">1. ISO 20417: IFU\uc5d0 \ud3ec\ud568\ub418\uc5b4\uc57c \ud560 \ud544\uc218 \uc815\ubcf4 \uc815\uc758<\/h3>\n\n\n\n<p><strong>ISO 20417:2021<\/strong>\uc740 \uc758\ub8cc\uae30\uae30 \ub77c\ubca8\uacfc IFU\uc5d0 \ud3ec\ud568\ub418\uc5b4\uc57c \ud560 <strong>\uc815\ubcf4 \ud56d\ubaa9\uc744 \uad6d\uc81c\uc801\uc73c\ub85c \ud1b5\uc77c\ub41c \uae30\uc900\uc73c\ub85c \uc815\ub9ac<\/strong>\ud55c \ud45c\uc900\uc785\ub2c8\ub2e4. \uc81c\ud488\uba85, \uc81c\uc870\uc790 \uc815\ubcf4, \uc0ac\uc6a9 \ubaa9\uc801, \uae08\uae30\uc0ac\ud56d, \uacbd\uace0\ubb38, \ubcf4\uad00 \uc870\uac74, \uba78\uade0 \uc5ec\ubd80 \ub4f1 <strong>\ubaa8\ub4e0 \ud575\uc2ec \uc815\ubcf4\uac00 \ub204\ub77d \uc5c6\uc774 \ud3ec\ud568\ub418\uc5b4\uc57c \ud558\uba70<\/strong>, \uc774\ub97c \ud1b5\ud574 \uc0ac\uc6a9\uc790\ub294 \uc81c\ud488\uc744 \uc548\uc804\ud558\uac8c \uc774\ud574\ud558\uace0 \uc0ac\uc6a9\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc608\ub97c \ub4e4\uc5b4, \ucd08\uc74c\ud30c \uc9c4\ub2e8\uae30\uae30\uc640 \uac19\uc740 Class II \uc758\ub8cc\uae30\uae30\uc758 \uacbd\uc6b0, \uc9c4\ub2e8 \ubaa9\uc801\uc5d0 \ub530\ub978 \uc0ac\uc6a9 \uc81c\ud55c, \ud504\ub85c\ube0c \ubcc4 \uc801\uc6a9 \ubc94\uc704, \uac10\uc5fc \uc608\ubc29\uc744 \uc704\ud55c \uc18c\ub3c5 \uc9c0\uce68 \ub4f1\uc774 \uba85\ud655\ud788 \ud3ec\ud568\ub418\uc5b4\uc57c \ud558\uba70, \uc774\ub294 ISO 20417\uc5d0\uc11c \uaddc\uc815\ud558\ub294 \ud56d\ubaa9\uacfc \uc815\ud655\ud788 \uc77c\uce58\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc774 \uae30\uc900\uc740 \u201c\ubb34\uc5c7\uc744 \ub123\uc5b4\uc57c \ud558\ub294\uac00?\u201d\ub97c \uc815\uc758\ud574\uc8fc\ub294 IFU\uc758 \uc2dc\uc791\uc810\uc73c\ub85c \ubb38\uc11c\uc758 &#8216;\ub0b4\uc6a9 \uae30\uc900&#8217;\uc744 \uc81c\uacf5\ud558\uba70, \ubbf8\uad6d\ubfd0 \uc544\ub2c8\ub77c EU MDR, \uc911\uad6d NMPA \ub4f1 \ub300\ubd80\ubd84\uc758 \uaddc\uc81c\uae30\uad00\uc5d0\ub3c4 \uc801\uc6a9\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-2-iec-82079-1-\uc0ac\uc6a9\uc790-\uc911\uc2ec\uc758-\uc815\ubcf4-\uad6c\uc870\uc640-\ubb38\uc11c-\uc124\uacc4\">2. IEC 82079-1: \uc0ac\uc6a9\uc790 \uc911\uc2ec\uc758 \uc815\ubcf4 \uad6c\uc870\uc640 \ubb38\uc11c \uc124\uacc4<\/h3>\n\n\n\n<p><strong>IEC 82079-1:2019<\/strong>\ub294 IFU\uc758 <strong>\uc791\uc131 \ubc29\uc2dd, \uc815\ubcf4 \uad6c\uc870, \ud45c\ud604 \uc6d0\uce59<\/strong>\uc744 \uaddc\uc815\ud558\ub294 \uad6d\uc81c\ud45c\uc900\uc785\ub2c8\ub2e4. \ub2e8\uc21c\ud788 \uc815\ubcf4\ub97c \ub098\uc5f4\ud558\ub294 \uac83\uc774 \uc544\ub2c8\ub77c, \uc0ac\uc6a9\uc790\uc758 <strong>\ud589\ub3d9 \ud750\ub984\uc5d0 \ub9de\ucdb0 \uc815\ubcf4\uac00 \uc124\uacc4<\/strong>\ub418\uc5b4\uc57c \ud558\uba70, \uc2dc\uac01 \uc790\ub8cc\uc758 \uc0ac\uc6a9, \uacbd\uace0\ubb38 \uc0bd\uc785 \uc704\uce58, \uc6a9\uc5b4 \ud1b5\uc77c \ub4f1\uc758 \uc138\ubd80 \uc0ac\ud56d\uc774 \uc694\uad6c\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc608\ub97c \ub4e4\uc5b4, \uc2a4\ud0a8\ucf00\uc5b4\/\ubdf0\ud2f0\uae30\uae30\ucc98\ub7fc \ud53c\ubd80 \uc811\ucd09\uacfc \uc5d0\ub108\uc9c0 \ucd9c\ub825\uc774 \uc911\uc694\ud55c \uc81c\ud488\uc740, \uc0ac\uc6a9\uc790\uc758 \uc791\uc5c5 \ub2e8\uacc4\ubcc4\ub85c \uc815\ud655\ud55c \uc870\uc791 \uc21c\uc11c\uc640 \uc8fc\uc758\uc0ac\ud56d\uc774 \uc2dc\uac01 \uc790\ub8cc\uc640 \ud568\uaed8 \uc124\uacc4\ub418\uc5b4\uc57c \ud558\uba70, \uacbd\uace0 \ubb38\uad6c\ub294 \ud574\ub2f9 \uc791\uc5c5 \uc9c1\uc804\uc5d0 \uba85\ud655\ud558\uac8c \ubc30\uce58\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p><strong>\uc774 \ud45c\uc900\uc740 \u201c\uc5b4\ub5bb\uac8c \ubcf4\uc5ec\uc918\uc57c \ud558\ub294\uac00?\u201d\ub97c \uacb0\uc815\ud569\ub2c8\ub2e4.<\/strong> IEC 82079-1\uc740 <strong>\uac00\ub3c5\uc131\uacfc \uc774\ud574\ub3c4 \ud5a5\uc0c1 \uce21\uba74\uc5d0\uc11c \ub9e4\uc6b0 \uc720\ud6a8<\/strong>\ud558\uba70, FDA \uc2ec\uc0ac\uad00\uc774 \uc2e4\uc81c \uc0ac\uc6a9\uc790\uc758 \uc548\uc804\uc744 \uc5b4\ub5bb\uac8c \uace0\ub824\ud588\ub294\uc9c0 \ud3c9\uac00\ud560 \ub54c \ucc38\uace0 \uae30\uc900\uc774 \ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-3-21-cfr-part-801-\ubbf8\uad6d-fda\uc758-\ubc95\uc801-\ub77c\ubca8\ub9c1-\uc694\uac74\">3. 21 CFR Part 801: \ubbf8\uad6d FDA\uc758 \ubc95\uc801 \ub77c\ubca8\ub9c1 \uc694\uac74<\/h3>\n\n\n\n<p><strong>21 CFR Part 801<\/strong>\uc740 \ubbf8\uad6d FDA\uac00 \uaddc\uc815\ud55c <strong>\ub77c\ubca8\ub9c1 \ubc0f \uc0ac\uc6a9\uc124\uba85\uc11c\uc758 \ubc95\uc801 \uae30\uc900<\/strong>\uc785\ub2c8\ub2e4. IFU\ub294 \ubc18\ub4dc\uc2dc <strong>\uc601\uc5b4\ub85c \uc81c\uacf5<\/strong>\ub418\uc5b4\uc57c \ud558\uba70, <strong>\uc0ac\uc6a9\uc790\uc758 \uc774\ud574 \uc218\uc900\uc5d0 \ub9de\ucd98 \uc124\uba85<\/strong>, <strong>\uc624\ud574 \uc18c\uc9c0\ub97c \uc904\uc774\uae30 \uc704\ud55c \uba85\ud655\ud55c \ubb38\uc7a5 \uad6c\uc131<\/strong>, \uadf8\ub9ac\uace0 <strong>\uc798\ubabb\ub41c \uc0ac\uc6a9\uc73c\ub85c \uc778\ud55c \uc704\ud574 \ubc29\uc9c0\ub97c \uc704\ud55c \uacbd\uace0 \ud3ec\ud568<\/strong>\uc774 \uc694\uad6c\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc608\ub97c \ub4e4\uc5b4, \ud608\uc555 \uce21\uc815 \uae30\uae30\uc640 \uac19\uc774 \uc77c\ubc18 \uc18c\ube44\uc790\uac00 \uc9c1\uc811 \uc0ac\uc6a9\ud558\ub294 \uc81c\ud488\uc740, \uae30\uae30\uc758 \ubd80\ucc29 \uc704\uce58, \uce21\uc815 \uc2dc \uc720\uc758\uc0ac\ud56d, \ubc30\ud130\ub9ac \uacbd\uace0, \uc571 \uc5f0\ub3d9 \ubc29\uc2dd \ub4f1 \ubaa8\ub4e0 \uc815\ubcf4\uac00 Plain Language\ub85c \uc81c\uacf5\ub418\uc5b4\uc57c \ud558\uba70, \ub77c\ubca8 \ubc0f IFU\uac00 \ubaa8\ub450 CFR \uae30\uc900\uc744 \ucda9\uc871\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>FDA\ub294 \uc774 \uaddc\uc815\uc744 \uae30\uc900\uc73c\ub85c IFU\ub97c \ubc95\uc801 \ubb38\uc11c\ub85c \uac04\uc8fc\ud558\uace0 \uc2ec\uc0ac\ud558\uba70, \uc694\uad6c\uc0ac\ud56d\uc744 \ucda9\uc871\ud558\uc9c0 \ubabb\ud560 \uacbd\uc6b0 \uc2b9\uc778\uc774 \uc9c0\uc5f0\ub418\uac70\ub098 \ubd88\uc2b9\uc778 \ucc98\ubd84\uc744 \ubc1b\uc744 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-4-ansi-z535-6-\uc548\uc804-\uba54\uc2dc\uc9c0\uc758-\uad6c\uc131\uacfc-\ud615\uc2dd\">4. ANSI Z535.6: \uc548\uc804 \uba54\uc2dc\uc9c0\uc758 \uad6c\uc131\uacfc \ud615\uc2dd<\/h3>\n\n\n\n<p><strong>ANSI Z535.6<\/strong>\ub294 \ubbf8\uad6d \ub0b4\uc5d0\uc11c \uc0ac\uc6a9\uc124\uba85\uc11c \ub0b4\uc758 <strong>\uc548\uc804 \uad00\ub828 \uacbd\uace0 \uba54\uc2dc\uc9c0 \ud615\uc2dd\uc744 \uaddc\uc815\ud558\ub294 \ud45c\uc900<\/strong>\uc785\ub2c8\ub2e4. \uc704\ud5d8\uc758 \uc885\ub958(DANGER, WARNING, CAUTION, NOTICE)\ub97c \uba85\ud655\ud788 \uad6c\ubd84\ud558\uace0, \uac01 \uba54\uc2dc\uc9c0\ub294 \ub2e4\uc74c \ub124 \uac00\uc9c0 \uc694\uc18c\ub85c \uad6c\uc131\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Signal Word<\/strong> (\uc608: WARNING, DANGER, CAUTION, NOTICE)<\/li>\n\n\n\n<li><strong>Hazard Description<\/strong> (\ubb34\uc5c7\uc774 \uc704\ud5d8\ud55c\uac00)<\/li>\n\n\n\n<li><strong>How to Avoid<\/strong> (\uc5b4\ub5bb\uac8c \ud53c\ud560 \uc218 \uc788\ub294\uac00)<\/li>\n\n\n\n<li><strong>Consequence<\/strong> (\ud53c\ud558\uc9c0 \uc54a\uc558\uc744 \uacbd\uc6b0 \uacb0\uacfc)<\/li>\n<\/ul>\n\n\n\n<p>\uc608\uc2dc \uba54\uc2dc\uc9c0:<br><strong>WARNING<\/strong><br>Electric shock hazard. Do not use the device near water. Failure to follow this instruction may result in serious injury.<\/p>\n\n\n\n<p>ANSI Z535.6\ub294 \ubbf8\uad6d \ub0b4\uc5d0\uc11c \uc81c\ud488 \ucc45\uc784\uc18c\uc1a1\uacfc\ub3c4 \uc5f0\uacc4\ub420 \uc218 \uc788\uae30 \ub54c\ubb38\uc5d0, <strong>\uacbd\uace0\ubb38\uc744 \ub2e8\uc21c\ud788 \uc791\uc131\ud558\ub294 \uc218\uc900\uc744 \ub118\uc5b4, \uaddc\uc815\ub41c \ud615\uc2dd\uc73c\ub85c \uc81c\uacf5<\/strong>\ud558\ub294 \uac83\uc774 \ubbf8\uad6d \uc2dc\uc7a5\uc5d0\uc11c\uc758 \ub9ac\uc2a4\ud06c\ub97c \uc904\uc774\ub294 \ud575\uc2ec \uc804\ub7b5\uc774 \ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-5-\ubc88\uc5ed-\uc2dc-\ubc18\ub4dc\uc2dc-\uace0\ub824\ud574\uc57c-\ud560-\uc694\uc18c\ub4e4-plain-language\ubd80\ud130-\uae30\ud638-\ud45c\uae30\uae4c\uc9c0\">5. \ubc88\uc5ed \uc2dc \ubc18\ub4dc\uc2dc \uace0\ub824\ud574\uc57c \ud560 \uc694\uc18c\ub4e4: Plain Language\ubd80\ud130 \uae30\ud638 \ud45c\uae30\uae4c\uc9c0<\/h3>\n\n\n\n<p>\ubbf8\uad6d FDA \uc2b9\uc778\uc744 \uc704\ud55c IFU\ub294 \uc601\uc5b4\ub85c \uc791\uc131\ub418\uc5b4\uc57c \ud558\uba70, \uadf8 \ubc88\uc5ed \uacfc\uc815 \uc5ed\uc2dc <strong>\uaddc\uc815\uc5d0 \ubd80\ud569\ud558\uace0 \uc0ac\uc6a9\uc790 \uce5c\ud654\uc801\uc778 \ud488\uc9c8<\/strong>\uc744 \uac16\ucd94\uc5b4\uc57c \ud569\ub2c8\ub2e4. \ub2e8\uc21c\ud55c \ubc88\uc5ed\uc774 \uc544\ub2cc, <strong>\ubc95\uc801 \uc801\ud569\uc131\uacfc \uc0ac\uc6a9\uc790 \uc774\ud574\ub3c4<\/strong>\ub97c \ubaa8\ub450 \uace0\ub824\ud55c <strong>\uc804\ubb38\ud654\ub41c \ud604\uc9c0\ud654 \uc791\uc5c5<\/strong>\uc774 \ud544\uc694\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc8fc\uc694 \uace0\ub824\uc0ac\ud56d:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Plain Language <\/strong><strong>\uc0ac\uc6a9<\/strong><br>\ud658\uc790 \ub610\ub294 \uc77c\ubc18 \uc18c\ube44\uc790\uac00 \uc0ac\uc6a9\ud558\ub294 \uae30\uae30\uc758 \uacbd\uc6b0, <strong>\uc804\ubb38 \uc6a9\uc5b4\ub97c \ubb34\uc791\uc815 \uadf8\ub300\ub85c \uc62e\uae30\uae30\ubcf4\ub2e4<\/strong>, \uc26c\uc6b4 \ud45c\ud604\uacfc \uc9e7\uc740 \ubb38\uc7a5\uc73c\ub85c \uad6c\uc131\ud574 \ub204\uad6c\ub098 \uc774\ud574\ud560 \uc218 \uc788\uc5b4\uc57c \ud569\ub2c8\ub2e4.<br>\uc608: \u201cCommence operation\u201d \u2192 \u201cStart the device\u201d<\/li>\n\n\n\n<li><strong>ISO 17100 <\/strong><strong>\uae30\ubc18 \ubc88\uc5ed \ud488\uc9c8\uad00\ub9ac \uccb4\uacc4 \uc801\uc6a9<\/strong><br>FDA \uc81c\ucd9c \ubb38\uc11c\uc5d0 \uc0ac\uc6a9\ub418\ub294 \ubc88\uc5ed\uc740 <strong>\ubc88\uc5ed\uc790\uc758 \uc790\uaca9, \ub9ac\ubdf0 \uacfc\uc815, \ud488\uc9c8 \uac80\uc218 \uc808\ucc28<\/strong>\uac00 \uba85\ud655\ud788 \ubb38\uc11c\ud654\ub41c \uccb4\uacc4\ub97c \uae30\ubc18\uc73c\ub85c \uc774\ub8e8\uc5b4\uc838\uc57c \ud558\uba70, \uad6d\uc81c \ubc88\uc5ed \ud488\uc9c8\ud45c\uc900\uc778 <strong>ISO 17100<\/strong>\uc740 \uc774\ub97c \uc704\ud55c \ub300\ud45c\uc801\uc778 \uae30\uc900\uc785\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\uc758\ub8cc\uae30\uae30 \ub3c4\uba54\uc778 \uc804\ubb38\uc131 \ud655\ubcf4<\/strong><br>\uc81c\ud488 \uc0ac\uc6a9 \uc870\uac74, \uc0dd\uccb4 \uad00\ub828 \ud45c\ud604, \uacbd\uace0\ubb38 \uc791\uc131 \ub4f1\uc740 <strong>\ub2e8\uc21c \uc5b8\uc5b4 \uc5ed\ub7c9\ub9cc\uc73c\ub85c\ub294 \ubd80\uc871<\/strong>\ud569\ub2c8\ub2e4. \uc758\ub8cc\uae30\uae30\uc758 \uc791\ub3d9 \uc6d0\ub9ac, \uc0ac\uc6a9\uc790 \ud658\uacbd, FDA \uc6a9\uc5b4 \uccb4\uacc4\uc5d0 \uc775\uc219\ud55c \uc804\ubb38 \ubc88\uc5ed\uc790\uac00 \ud22c\uc785\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\uae30\ud638 \uc0ac\uc6a9 \uc2dc \uc8fc\uc11d \ubcd1\uae30<\/strong><br>ISO 15223-1\uacfc \uac19\uc740 \uad6d\uc81c \ud45c\uc900 \uae30\ud638\ub97c \uc0ac\uc6a9\ud560 \uacbd\uc6b0, <strong>\ubbf8\uad6d\uc5d0\uc11c\ub294 \ud574\ub2f9 \uae30\ud638\uc758 \uc758\ubbf8\ub97c \ud14d\uc2a4\ud2b8\ub85c \uba85\uc2dc<\/strong>\ud574\uc57c \ud569\ub2c8\ub2e4.<br>\uc608: &nbsp;<img loading=\"lazy\" decoding=\"async\" width=\"60\" height=\"50\" class=\"wp-image-7424\" style=\"width: 60px;\" src=\"http:\/\/hansem.com\/wp-content\/uploads\/2025\/07\/11.png\" alt=\"\">\u2192 \u201cConsult instructions for use\u201d<\/li>\n<\/ul>\n\n\n\n<p><strong>\uc815\ud655\ud55c \ubc88\uc5ed\uc740 \ub2e8\uc9c0 \ud488\uc9c8\uc758 \ubb38\uc81c\uac00 \uc544\ub2c8\ub77c, \uc2b9\uc778\uacfc \ucc45\uc784\uc758 \ubb38\uc81c\uc774\uae30\ub3c4 \ud569\ub2c8\ub2e4.<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-\ub9c8\ubb34\ub9ac-ifu\ub294-\uaddc\uc81c-\ub300\uc751\uc774\uc790-\uc0ac\uc6a9\uc790-\uc2e0\ub8b0\uc758-\ucd9c\ubc1c\uc810\">\ub9c8\ubb34\ub9ac: IFU\ub294 \uaddc\uc81c \ub300\uc751\uc774\uc790 \uc0ac\uc6a9\uc790 \uc2e0\ub8b0\uc758 \ucd9c\ubc1c\uc810<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>FDA \uc2b9\uc778\uc6a9 IFU\ub97c \uc81c\uc791\ud560 \ub54c\ub294 \ub2e8\uc21c\ud55c \ubb38\uc11c \uc791\uc131\uc774 \uc544\ub2cc,<br>\uad6d\uc81c\ud45c\uc900\uc5d0 \uae30\ubc18\ud55c <strong>\uc815\ubcf4 \uc644\uacb0\uc131<\/strong>,<\/li>\n\n\n\n<li>\uc0ac\uc6a9\uc790 \uad00\uc810\uc758 <strong>\uc815\ubcf4 \uad6c\uc870 \uc124\uacc4<\/strong>,<\/li>\n\n\n\n<li>\ubbf8\uad6d \uaddc\uc81c\uc5d0 \ubd80\ud569\ud558\ub294 <strong>\ubc95\uc801 \uc694\uac74 \ucda9\uc871<\/strong>,<\/li>\n\n\n\n<li>\uc548\uc804\uc0ac\uace0 \uc608\ubc29\uc744 \uc704\ud55c <strong>\ucc45\uc784 \uc788\ub294 \uba54\uc2dc\uc9c0 \uc791\uc131<\/strong>\uc774 \ubaa8\ub450 \uc694\uad6c\ub429\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<p>\ud55c\uc0d8\uae00\ub85c\ubc8c\uc740 \uc774\ub7ec\ud55c \uaddc\uc815 \uae30\ubc18\uc758 IFU \uc81c\uc791\uacfc \ub2e4\uad6d\uc5b4 \ubc88\uc5ed\uc744 \uc218\ud589\ud55c \uacbd\ud5d8\uc744 \ubc14\ud0d5\uc73c\ub85c, \ubbf8\uad6d \uc2dc\uc7a5 \uc9c4\ucd9c\uc744 \uc900\ube44\ud558\ub294 \uae30\uc5c5\uc758 \ub4e0\ub4e0\ud55c \ubb38\uc11c \ud30c\ud2b8\ub108\uac00 \ub418\uc5b4 \ub4dc\ub9b4 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n","protected":false},"featured_media":7414,"parent":0,"menu_order":0,"template":"","blog-types":[126],"class_list":["post-7423","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 \uc81c\uc791 \uac00\uc774\ub4dc: \ubc18\ub4dc\uc2dc \uc54c\uc544\uc57c \ud560 \uad6d\uc81c\ud45c\uc900\uacfc \ubbf8\uad6d \uaddc\uc815<\/title>\n<meta name=\"description\" content=\"\ucd08\uc74c\ud30c \uc9c4\ub2e8\uae30\uae30, \ubdf0\ud2f0\uae30\uae30, \uc6e8\uc5b4\ub7ec\ube14 \ub4f1 \ubbf8\uad6d \uc2dc\uc7a5 \uc9c4\ucd9c\uc744 \uc704\ud55c \uc758\ub8cc\uae30\uae30 \uc81c\uc870\uc0ac\ub77c\uba74 \ubc18\ub4dc\uc2dc \uc54c\uc544\uc57c \ud560 IFU \uc81c\uc791 \uaddc\uc815! 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