{"id":2772,"date":"2024-01-29T10:29:14","date_gmt":"2024-01-29T01:29:14","guid":{"rendered":"https:\/\/alm.engineering\/?p=2772"},"modified":"2024-01-29T10:29:15","modified_gmt":"2024-01-29T01:29:15","slug":"iec-62304-%ea%b4%80%eb%a0%a8-%ec%8b%ac%ec%b8%b5-%ea%b0%80%ec%9d%b4%eb%93%9c-%ec%9d%98%eb%a3%8c-%ea%b8%b0%ea%b8%b0%ec%9a%a9-%ec%86%8c%ed%94%84%ed%8a%b8%ec%9b%a8%ec%96%b4-%ec%88%98%eb%aa%85-%ec%a3%bc","status":"publish","type":"post","link":"https:\/\/alm.engineering\/?p=2772","title":{"rendered":"IEC 62304 \uad00\ub828 \uc2ec\uce35 \uac00\uc774\ub4dc: \uc758\ub8cc \uae30\uae30\uc6a9 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc218\uba85 \uc8fc\uae30 \ud504\ub85c\uc138\uc2a4"},"content":{"rendered":"\n<p>\ud604\ub300 \uc758\ud559 \ubc0f \ud5ec\uc2a4\ucf00\uc5b4 \ubd84\uc57c\uc5d0\uc11c \uc18c\ud504\ud2b8\uc6e8\uc5b4\ub294 \uc758\ub8cc \uae30\uae30\uc758 \uae30\ub2a5, \ubaa8\ub2c8\ud130\ub9c1 \ubc0f \uad00\ub9ac\uc5d0 \ud544\uc218\uc801\uc778 \uc5ed\ud560\uc744 \ud569\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uad6c\uc131 \uc694\uc18c\ub294 \ub2e8\uc21c\ud55c \uc778\ud130\ud398\uc774\uc2a4\ubd80\ud130 \uc911\uc694\ud55c \uc758\ud559\uc801 \uacb0\uc815\uc744 \ub0b4\ub9ac\ub294 \ubcf5\uc7a1\ud55c \uc54c\uace0\ub9ac\uc998\uae4c\uc9c0 \ub2e4\uc591\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc774\ub7ec\ud55c \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uad6c\uc131 \uc694\uc18c\uc758 \uc548\uc804\uc131\uacfc \ud6a8\uc728\uc131\uc744 \ubcf4\uc7a5\ud558\ub294 \uac83\uc774 \uac00\uc7a5 \uc911\uc694\ud558\uae30 \ub54c\ubb38\uc5d0 \uc758\ub8cc \uae30\uae30 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc758 \uc218\uba85 \uc8fc\uae30 \uc694\uad6c \uc0ac\ud56d\uc744 \uc815\uc758\ud558\ub294 IEC 62304\uc640 \uac19\uc740 \ud45c\uc900\uc774 \ub9cc\ub4e4\uc5b4\uc84c\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">\uc758\ub8cc \uae30\uae30\uc5d0\uc11c \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc758 \uc911\uc694\uc131 \uc774\ud574 <\/h4>\n\n\n\n<p>\uc758\ub8cc \uae30\uae30\ub294 \uc18c\ud504\ud2b8\uc6e8\uc5b4\ub97c \ud575\uc2ec \uae30\ub2a5\uc5d0 \ud1b5\ud569\ud558\uba74\uc11c \ud06c\uac8c \ubc1c\uc804\ud574 \uc654\uc2b5\ub2c8\ub2e4. \uc2ec\ubc15\uc870\uc728\uae30\ubd80\ud130 \uc9c4\ub2e8 \uc7a5\ube44, \uc2ec\uc9c0\uc5b4 \ubaa8\ubc14\uc77c \uac74\uac15 \uc560\ud50c\ub9ac\ucf00\uc774\uc158\uc5d0 \uc774\ub974\uae30\uae4c\uc9c0 \uc18c\ud504\ud2b8\uc6e8\uc5b4\ub294 \uc815\ud655\ud55c \uc9c4\ub2e8, \ud658\uc790 \ubaa8\ub2c8\ud130\ub9c1, \uce58\ub8cc \uc804\ub2ec\uc5d0 \uae30\uc5ec\ud569\ub2c8\ub2e4. \uc774\ub7ec\ud55c \ud1b5\ud569\uc740 \uc758\ub8cc \uae30\uae30\uc758 \uae30\ub2a5\uc744 \ud5a5\uc0c1\uc2dc\ud0a4\uc9c0\ub9cc, \uc81c\ub300\ub85c \uac1c\ubc1c \ubc0f \uc720\uc9c0 \uad00\ub9ac\ub418\uc9c0 \uc54a\uc73c\uba74 \uc7a0\uc7ac\uc801\uc778 \uc704\ud5d8\uc744 \ucd08\ub798\ud558\uae30\ub3c4 \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">IEC 62304 \uac1c\uc694 <\/h4>\n\n\n\n<p>&#8220;\uc758\ub8cc\uae30\uae30 \uc18c\ud504\ud2b8\uc6e8\uc5b4 &#8211; \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc218\uba85 \uc8fc\uae30 \ud504\ub85c\uc138\uc2a4&#8221;\ub77c\ub294 \uc81c\ubaa9\uc758 IEC 62304\ub294 \uace0\ud488\uc9c8 \uc758\ub8cc\uae30\uae30 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uac1c\ubc1c\uc744 \uc704\ud55c \ud504\ub808\uc784\uc6cc\ud06c\ub97c \uc81c\uacf5\ud558\ub294 \uad6d\uc81c \ud45c\uc900\uc785\ub2c8\ub2e4. \uc774 \ud45c\uc900\uc740 \uc758\ub8cc \uae30\uae30 \uac1c\ubc1c\uc758 \ub9e5\ub77d\uc5d0\uc11c \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uac1c\ubc1c, \uac80\uc99d, \uc720\ud6a8\uc131 \uac80\uc0ac \ubc0f \uc720\uc9c0\ubcf4\uc218\ub97c \uad00\ub9ac\ud558\uae30 \uc704\ud55c \ud45c\uc900\uc744 \uc218\ub9bd\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc774 \uc804\uc790\ucc45\uc740 IEC 62304\uc640 \uadf8 \uad6c\uc131 \uc694\uc18c, \uad6c\ud604 \uc804\ub7b5 \ubc0f \uc774\uc810\uc744 \uc790\uc138\ud788 \uc124\uba85\ud558\uc5ec \ub3c5\uc790\uac00 \uc5c4\uaca9\ud55c \ud488\uc9c8 \ubc0f \uc548\uc804 \ud45c\uc900\uc744 \uc900\uc218\ud558\ub294 \uc758\ub8cc \uae30\uae30 \uc18c\ud504\ud2b8\uc6e8\uc5b4\ub97c \uac1c\ubc1c\ud558\ub294 \ubc29\ubc95\uc744 \ud3ec\uad04\uc801\uc73c\ub85c \uc774\ud574\ud560 \uc218 \uc788\ub3c4\ub85d \ub3c4\uc640\uc90d\ub2c8\ub2e4.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">IEC 62304\uc758 \ubc94\uc704 \ubc0f 2 \uc801\uc6a9<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>\uc5b4\ub5a4 \uc758\ub8cc \uae30\uae30\uac00 \uc801\uc6a9\ub418\ub098\uc694? <\/strong><\/h4>\n\n\n\n<p>IEC 62304\ub294 \uc18c\ud504\ud2b8\uc6e8\uc5b4\ub97c \ud1b5\ud569\ud558\ub294 \uad11\ubc94\uc704\ud55c \uc758\ub8cc \uae30\uae30\uc5d0 \uc801\uc6a9\ub418\uba70, \uc18c\ud504\ud2b8\uc6e8\uc5b4\ub294 \uadf8 \uc790\uccb4\ub85c \uc758\ub8cc \uae30\uae30(SaMD)\uc774\uac70\ub098 \ub2e4\ub978 \uc758\ub8cc \uae30\uae30\uc758 \ud544\uc218\uc801\uc778 \ubd80\ubd84(SiMD)\uc774\uae30\ub3c4 \ud569\ub2c8\ub2e4. \uc5ec\uae30\uc5d0\ub294 \ub3c5\ub9bd\ud615 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uae30\uae30\uc640 \ub354 \ud070 \uc758\ub8cc \uae30\uae30\uc758 \uc77c\ubd80\uc778 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uac00 \ubaa8\ub450 \ud3ec\ud568\ub429\ub2c8\ub2e4. \uc774\ub7ec\ud55c \ub514\ubc14\uc774\uc2a4\uc5d0\ub294 \uac04\ub2e8\ud55c \ubaa8\ubc14\uc77c \uac74\uac15 \uc571\ubd80\ud130 \ubcf5\uc7a1\ud55c \uc758\ub8cc \uc601\uc0c1 \uc2dc\uc2a4\ud15c\uae4c\uc9c0 \ubaa8\ub4e0 \uac83\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc608\ub97c \ub4e4\uc5b4 \uc784\uc0c1 \uc758\uc0ac \uacb0\uc815 \uc9c0\uc6d0 \uc18c\ud504\ud2b8\uc6e8\uc5b4, \uc778\uc290\ub9b0 \ud38c\ud504\uc758 \uc804\ub2ec\ub7c9\uc744 \ud14c\uc2a4\ud2b8\ud558\ub294 \ub370 \uc0ac\uc6a9\ub418\ub294 \uc81c\uc870 \uc18c\ud504\ud2b8\uc6e8\uc5b4, \uc720\uc804\uc790 \ub370\uc774\ud130 \ubd84\uc11d\uc5d0 \uc0ac\uc6a9\ub418\ub294 \uc18c\ud504\ud2b8\uc6e8\uc5b4, \uc2ec\ubc15 \uc870\uc728\uae30 \ub0b4 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \ub4f1\uc774 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">\uc5b4\ub5a4 \uc720\ud615\uc758 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uac00 \ud3ec\ud568\ub418\ub098\uc694? <\/h4>\n\n\n\n<p>\uc774 \ud45c\uc900\uc740 \uc758\ub8cc \uae30\uae30 \uc124\uacc4, \uac1c\ubc1c, \uc0dd\uc0b0, \uc124\uce58 \ubc0f \uc11c\ube44\uc2a4\uc5d0 \uc0ac\uc6a9\ub418\ub294 \uc18c\ud504\ud2b8\uc6e8\uc5b4\ub97c \ud3ec\uad04\ud569\ub2c8\ub2e4. \uc5ec\uae30\uc5d0\ub294 \ud658\uc790\uc640 \uc9c1\uc811 \uc778\ud130\ud398\uc774\uc2a4\ud558\uac70\ub098 \uc758\ub8cc \uae30\ub2a5\uc744 \uc81c\uacf5\ud558\ub294 \uc18c\ud504\ud2b8\uc6e8\uc5b4\ubfd0\ub9cc \uc544\ub2c8\ub77c \uc81c\uc870 \ubc0f \ud488\uc9c8 \uad00\ub9ac\uc5d0 \uc0ac\uc6a9\ub418\ub294 \uc9c0\uc6d0 \uc18c\ud504\ud2b8\uc6e8\uc5b4\ub3c4 \ud3ec\ud568\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\uc8fc\uc694 \uac1c\ub150 \ubc0f \uc6a9\uc5b4<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\">\uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc548\uc804 \ub4f1\uae09<\/h4>\n\n\n\n<p>IEC 62304\ub294 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc624\ub958\ub85c \uc778\ud55c \uc7a0\uc7ac\uc801 \ud53c\ud574\uc5d0 \ub530\ub77c \ubd84\ub958 \uc2dc\uc2a4\ud15c\uc744 \ub3c4\uc785\ud588\uc2b5\ub2c8\ub2e4. \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc548\uc804 \ub4f1\uae09\uc5d0 \ub530\ub77c \uc694\uad6c \uc0ac\ud56d\uc774 \ub2ec\ub77c\uc9d1\ub2c8\ub2e4. \uc138 \uac00\uc9c0 \ub4f1\uae09\uc774 \uc788\uc2b5\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ud074\ub798\uc2a4 A: \ubd80\uc0c1 \ub610\ub294 \uc190\uc0c1 \uc5c6\uc74c<\/li>\n\n\n\n<li>\ud074\ub798\uc2a4 B: \uc2ec\uac01\ud558\uc9c0 \uc54a\uc740 \ubd80\uc0c1<\/li>\n\n\n\n<li>\ud074\ub798\uc2a4 C: \uc2ec\uac01\ud55c \ubd80\uc0c1<\/li>\n<\/ul>\n\n\n\n<p>\uc774\ub7ec\ud55c \ub4f1\uae09\uc740 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uac1c\ubc1c \ud504\ub85c\uc138\uc2a4\uc5d0 \ud544\uc694\ud55c \uc5c4\uaca9\uc131 \uc218\uc900\uc744 \uacb0\uc815\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">\uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc218\uba85 \uc8fc\uae30 \ud504\ub85c\uc138\uc2a4:<\/h4>\n\n\n\n<p>\uc774 \ud45c\uc900\uc740 \uacc4\ud68d, \uc694\uad6c\uc0ac\ud56d \ubd84\uc11d, \uc124\uacc4, \uad6c\ud604, \uac80\uc99d, \uc720\ud6a8\uc131 \uac80\uc0ac \ubc0f \uc720\uc9c0\ubcf4\uc218\ub97c \ud3ec\ud568\ud55c \uc804\uccb4 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc218\uba85 \uc8fc\uae30\uc5d0 \uac78\uce5c \ud504\ub85c\uc138\uc2a4\ub97c \uac1c\uad04\uc801\uc73c\ub85c \uc124\uba85\ud569\ub2c8\ub2e4. \uc694\uad6c \uc0ac\ud56d\uc740 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc548\uc804 \ubd84\ub958\uc5d0 \ub530\ub77c \ub2e4\ub985\ub2c8\ub2e4.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">\uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc548\uc804 \uc694\uac74 <\/h4>\n\n\n\n<p>\uc758\ub8cc \uae30\uae30 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc758 \uc548\uc804\uc744 \ubcf4\uc7a5\ud558\ub824\uba74 \uc7a0\uc7ac\uc801 \uc704\ud5d8\uc744 \uc2dd\ubcc4\ud558\uace0 \ud574\uacb0\ud574\uc57c \ud569\ub2c8\ub2e4. IEC 62304\ub294 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc548\uc804 \ubd84\ub958\uc5d0 \ub530\ub77c \uc124\uacc4 \uc81c\uc5b4 \ud504\ub85c\uc138\uc2a4 \ubc0f \ubb38\uc11c\ud654\uc758 \uc5c4\uaca9\uc131\uc744 \uac15\ud654\ud558\ub3c4\ub85d \uaddc\uc815\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">\uc18c\ud504\ud2b8\uc6e8\uc5b4 \ud56d\ubaa9<\/h4>\n\n\n\n<p>\uc18c\ud504\ud2b8\uc6e8\uc5b4 \ud56d\ubaa9\uc740 \uc758\ub8cc \uae30\uae30 \uc18c\ud504\ud2b8\uc6e8\uc5b4\ub97c \uad6c\uc131\ud558\ub294 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uad6c\uc131 \uc694\uc18c\uc785\ub2c8\ub2e4. \uc81c\uc870\uc5c5\uccb4\ub294 \uc18c\ud504\ud2b8\uc6e8\uc5b4\ub97c \uac1c\ubcc4 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \ud56d\ubaa9\uc73c\ub85c \ubd84\ud574\ud558\uc5ec \uace0\uc7a5 \uc9c0\uc810 \ubc0f \uc778\ud130\ud398\uc774\uc2a4\ub97c \ubd84\uc11d\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ub610\ud55c \uc81c\uc870\uc5c5\uccb4\ub294 \uc774\ub7ec\ud55c \ud558\uc704 \uad6c\uc131 \uc694\uc18c\ub97c \ub3c5\ub9bd\uc801\uc73c\ub85c \ubd84\ub958\ud558\uace0 \ubb38\uc11c\ud654\ud558\uc5ec \ud5a5\ud6c4 \uc81c\ud488\uc5d0\uc11c \uc774\ub7ec\ud55c \ud558\uc704 \uad6c\uc131 \uc694\uc18c\ub97c \uc7ac\uc0ac\uc6a9\ud560 \uc218 \uc788\uc73c\uba70, \uc774\ub7ec\ud55c \ud56d\ubaa9\uc744 \uc801\uc808\ud788 \uad00\ub9ac\ud558\uba74 \ucd94\uc801\uc131\uc744 \ubcf4\uc7a5\ud558\uace0 \uc704\ud5d8 \uad00\ub9ac\ub97c \uc6a9\uc774\ud558\uac8c \ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">IEC 62304 \uad6c\ud604\uc758 \uc774\uc810<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\">\uc18c\ud504\ud2b8\uc6e8\uc5b4 \ud488\uc9c8 \ud5a5\uc0c1<\/h4>\n\n\n\n<p>IEC 62304\ub97c \uc900\uc218\ud558\uba74 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \ud488\uc9c8\uc774 \ud06c\uac8c \ud5a5\uc0c1\ub429\ub2c8\ub2e4.<br>\uc758\ub8cc \uae30\uae30 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc758 \uac1c\ubc1c, \uc720\uc9c0 \uad00\ub9ac \ubc0f \uac80\uc99d\uc744 \uc548\ub0b4\ud558\ub294 \ud3ec\uad04\uc801\uc778 \ud504\ub808\uc784\uc6cc\ud06c\ub97c \uc81c\uacf5\ud568\uc73c\ub85c\uc368 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \ud488\uc9c8\uc744 \ud06c\uac8c \ud5a5\uc0c1\uc2dc\ud0b5\ub2c8\ub2e4. \uc774 \uac00\uc774\ub4dc\ub77c\uc778\uc744 \uc900\uc218\ud568\uc73c\ub85c\uc368 \ud300\uc740 \uad6c\uc870\ud654\ub41c \uc811\uadfc \ubc29\uc2dd\uc744 \ub530\ub77c\uc57c \ud558\uba70, \uadf8 \uacb0\uacfc \uc18c\ud504\ud2b8\uc6e8\uc5b4 \ud488\uc9c8\uc774 \ud5a5\uc0c1\ub429\ub2c8\ub2e4. \uc774 \ud45c\uc900\uc740 \uc694\uad6c \uc0ac\ud56d, \uc544\ud0a4\ud14d\ucc98, \uc124\uacc4 \ubc0f \uac80\uc99d \ud65c\ub3d9\uc5d0 \ub300\ud55c \uba85\ud655\ud55c \ubb38\uc11c\ud654\ub97c \uc758\ubb34\ud654\ud558\uc5ec \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uac1c\ubc1c \uc218\uba85 \uc8fc\uae30 \uc804\ubc18\uc5d0 \uac78\uccd0 \ud22c\uba85\uc131\uacfc \ucd94\uc801\uc131\uc744 \ucd09\uc9c4\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc774\ub807\uac8c \uaf3c\uaf3c\ud558\uac8c \ubb38\uc11c\ud654\ud558\uba74 \uc7a0\uc7ac\uc801\uc778 \ubb38\uc81c\uc640 \ud3b8\ucc28\ub97c \uc870\uae30\uc5d0 \uc2dd\ubcc4\ud558\uace0 \ud574\uacb0\ud558\uc5ec \uacb0\ud568 \ubc0f \ucde8\uc57d\uc131\uc774 \ucd5c\uc885 \uc81c\ud488\uc5d0 \ubc18\uc601\ub420 \uac00\ub2a5\uc131\uc744 \uc904\uc77c \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc774 \ud45c\uc900\uc740 \uc81c\uc870\uc5c5\uccb4\uac00 \uc18c\ud504\ud2b8\uc6e8\uc5b4\ub97c \uac1c\ubc1c\ud558\ub294 \ubc29\ubc95\ubfd0\ub9cc \uc544\ub2c8\ub77c \uc720\uc9c0\ubcf4\uc218 \ubc0f \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc758 \uc218\uba85 \uc885\ub8cc\uc5d0 \ub300\ud55c \uace0\ub824 \uc0ac\ud56d\ub3c4 \uace0\ub824\ud558\ub3c4\ub85d \uac15\uc81c\ud569\ub2c8\ub2e4. \uacb0\uacfc\uc801\uc73c\ub85c IEC 62304\ub97c \uc900\uc218\ud558\ub294 \uc18c\ud504\ud2b8\uc6e8\uc5b4\ub294 \uc2e0\ub8b0\uc131, \uc548\uc804\uc131 \ubc0f \uc804\ubc18\uc801\uc778 \ud488\uc9c8\uc774 \ub354 \ub192\uc73c\uba70, \uc774\ub294 \ud658\uc790 \uc548\uc804\uc774 \uac00\uc7a5 \uc911\uc694\ud55c \uc758\ub8cc \uae30\uae30\uc5d0\uc11c \ub9e4\uc6b0 \uc911\uc694\ud55c \uc694\uc18c\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\ub610\ud55c IEC 62304\ub294 \uc5c4\uaca9\ud55c \uc704\ud5d8 \uad00\ub9ac \uad00\ud589(\uc608: ISO14971 \uc6d0\uce59 \ub4f1)\uc744 \ucc38\uc870\ud558\uc5ec \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc640 \uad00\ub828\ub41c \uc7a0\uc7ac\uc801 \uc704\ud5d8\uc744 \uc2dd\ubcc4\ud558\uace0 \uc644\ud654\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. IEC 62304\ub294 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uac1c\ubc1c \uc218\uba85 \uc8fc\uae30, \ud504\ub85c\uc138\uc2a4 \ubc0f \ubb38\uc11c\ud654\uc5d0 \uc911\uc810\uc744 \ub461\ub2c8\ub2e4. \uc774 \ud45c\uc900\uc740 \uc7a0\uc7ac\uc801 \uc704\ud5d8\uc5d0 \ub530\ub77c \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uad6c\uc131 \uc694\uc18c\ub97c \ubd84\ub958\ud558\uc5ec \ud14c\uc2a4\ud2b8 \ubc0f \uac80\uc99d \ub178\ub825\uc5d0 \ub300\ud55c \ubaa9\ud45c \uc9c0\ud5a5\uc801 \uc811\uadfc \ubc29\uc2dd\uc744 \ucd09\uc9c4\ud569\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc704\ud5d8 \uc911\uc2ec \uc811\uadfc \ubc29\uc2dd\uc740 \ub9ac\uc18c\uc2a4\ub97c \ud6a8\uacfc\uc801\uc73c\ub85c \ud560\ub2f9\ud558\uc5ec \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc758 \uac00\uc7a5 \uc911\uc694\ud55c \uce21\uba74\uc5d0 \ub178\ub825\uc744 \uc9d1\uc911\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\ub610\ud55c IEC 62304\ub294 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc758 \uac80\uc99d \ubc0f \uc720\ud6a8\uc131 \uac80\uc0ac\ub97c \uc704\ud55c \uacc4\ud68d\uc744 \uc218\ub9bd\ud560 \uac83\uc744 \uc694\uad6c\ud569\ub2c8\ub2e4. \uc9c0\uc5ed\ub9c8\ub2e4 \uc694\uad6c \uc0ac\ud56d\uc774 \uc870\uae08\uc529 \ub2e4\ub97c \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc608\ub97c \ub4e4\uc5b4, FDA\ub294 &#8220;\uc18c\ud504\ud2b8\uc6e8\uc5b4 \uac80\uc99d\uc758 \uc77c\ubc18 \uc6d0\uce59&#8221; \uc9c0\uce68\uc744 \ubc1c\ud45c\ud588\uc2b5\ub2c8\ub2e4.&#8221; \uc774\ub7ec\ud55c \uac80\uc99d \ubc0f \uc720\ud6a8\uc131 \uac80\uc0ac \ud65c\ub3d9\uc740 \ubc84\uadf8, \ubcf4\uc548 \ucde8\uc57d\uc131, \uae30\ub2a5\uc801 \ubb38\uc81c\ub97c \uc2dd\ubcc4\ud558\uace0 \uc218\uc815\ud558\ub294 \ub370 \ud544\uc218\uc801\uc785\ub2c8\ub2e4. \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uac1c\ubc1c\uc790\ub294 \ucca0\uc800\ud55c \ud14c\uc2a4\ud2b8 \ubc0f \uac80\uc99d \ud65c\ub3d9\uc744 \uc218\ud589\ud568\uc73c\ub85c\uc368 \uc81c\ud488\uc758 \uc131\ub2a5, \uc2e0\ub8b0\uc131, \uc548\uc815\uc131\uc744 \ud5a5\uc0c1\uc2dc\ucf1c \uc804\ubc18\uc801\uc778 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \ud488\uc9c8 \ud5a5\uc0c1\uc5d0 \uae30\uc5ec\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">\ud658\uc790 \uc548\uc804 \uac15\ud654<\/h4>\n\n\n\n<p>IEC 62304 \uc900\uc218\ub294 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uac1c\ubc1c\uc5d0 \ub300\ud55c \uccb4\uacc4\uc801\uc774\uace0 \ud1b5\uc81c\ub41c \uc811\uadfc \ubc29\uc2dd\uc744 \uc758\ubb34\ud654\ud558\uace0 \uc704\ud5d8 \uad00\ub9ac \ubc0f \uc644\ud654 \uc804\ub7b5\uc744 \uac15\uc870\ud558\ub294 \uc5c4\uaca9\ud55c \uc9c0\uce68 \ub355\ubd84\uc5d0 \ud658\uc790 \uc548\uc804\uc744 \ud5a5\uc0c1\uc2dc\ud0a4\ub294 \ub370 \uc911\ucd94\uc801\uc778 \uc5ed\ud560\uc744 \ud569\ub2c8\ub2e4. \uc758\ub8cc\uae30\uae30 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc640 \uad00\ub828\ub41c \uc7a0\uc7ac\uc801 \uc704\ud5d8\uc5d0 \ub300\ud55c \ucca0\uc800\ud55c \ud3c9\uac00\ub97c \uc694\uad6c\ud568\uc73c\ub85c\uc368 IEC 62304\ub294 \uac1c\ubc1c\uc790\uac00 \uac1c\ubc1c \ud504\ub85c\uc138\uc2a4 \ucd08\uae30\uc5d0 \uc548\uc804 \uc704\ud5d8\uc744 \uc2dd\ubcc4\ud558\uace0 \ud574\uacb0\ud560 \uc218 \uc788\ub3c4\ub85d \ubcf4\uc7a5\ud569\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc0ac\uc804 \uc608\ubc29\uc801 \uc811\uadfc \ubc29\uc2dd\uc740 \uc801\uc808\ud55c \uc81c\uc5b4 \ubc0f \uc548\uc804 \uc7a5\uce58\ub97c \uad6c\ud604\ud558\uc5ec \ud658\uc790\uc758 \uac74\uac15\uc744 \uc704\ud611\ud560 \uc218 \uc788\ub294 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uad00\ub828 \uc624\ub958\uc758 \uac00\ub2a5\uc131\uc744 \ucd5c\uc18c\ud654\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>IEC 62304\ub294 \ubb38\uc11c\ud654 \ubc0f \ucd94\uc801\uc131\uc744 \uac15\uc870\ud558\uc5ec \ud658\uc790 \uc548\uc804\uc744 \ub354\uc6b1 \uac15\ud654\ud569\ub2c8\ub2e4. \uc774 \ud45c\uc900\uc740 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc694\uad6c\uc0ac\ud56d, \uc124\uacc4 \uc0ac\uc591, \uac80\uc99d \ubc0f \uc720\ud6a8\uc131 \uac80\uc0ac \ud65c\ub3d9\uc5d0 \ub300\ud55c \ud3ec\uad04\uc801\uc778 \ubb38\uc11c\ud654\ub97c \uc758\ubb34\ud654\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc218\uc900\uc758 \ud22c\uba85\uc131\uc744 \ud1b5\ud574 \uaddc\uc81c \uae30\uad00, \uc758\ub8cc \uc804\ubb38\uac00, \uae30\uae30 \uc0ac\uc6a9\uc790\ub294 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc758 \uae30\ub2a5 \ubc0f \uc548\uc804 \uae30\ub2a5\uc744 \ucca0\uc800\ud788 \ud3c9\uac00\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ubb38\uc81c\ub098 \uc6b0\ub824 \uc0ac\ud56d \ubc1c\uc0dd \uc2dc \ud45c\uc900\ud654\ub41c \ubb38\uc11c\ub97c \ud1b5\ud574 \ubb38\uc81c\uc758 \uadfc\ubcf8 \uc6d0\uc778\uc744 \uc2e0\uc18d\ud558\uac8c \ud30c\uc545\ud558\uc5ec \uc7a0\uc7ac\uc801\uc778 \ud53c\ud574\ub97c \uc608\ubc29\ud560 \uc218 \uc788\ub294 \uc2e0\uc18d\ud55c \ud574\uacb0\uc774 \uac00\ub2a5\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\ub610\ud55c IEC 62304\ub97c \uc900\uc218\ud568\uc73c\ub85c\uc368 \uac1c\ubc1c\uc790\ub294 \uc9c0\uc18d\uc801\uc778 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc720\uc9c0\ubcf4\uc218 \ubc0f \uc5c5\ub370\uc774\ud2b8\ub97c \uc704\ud55c \uae30\ubc18\uc744 \ub9c8\ub828\ud558\uc5ec \ubaa8\ub4e0 \ubcc0\uacbd \uc0ac\ud56d\uc744 \ud658\uc790 \uc548\uc804\uc744 \uc5fc\ub450\uc5d0 \ub450\uace0 \uccb4\uacc4\uc801\uc73c\ub85c \uad00\ub9ac\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc804\ubc18\uc801\uc73c\ub85c IEC 62304\uc758 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uac1c\ubc1c\uc5d0 \ub300\ud55c \uad6c\uc870\ud654\ub41c \uc811\uadfc \ubc29\uc2dd\uacfc \uc704\ud5d8 \uad00\ub9ac \ubc0f \ubb38\uc11c\ud654\uc5d0 \uc911\uc810\uc744 \ub450\uc5b4 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uad00\ub828 \uc704\ud5d8\uc744 \uc904\uc774\uace0 \uc758\ub8cc \uae30\uae30 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc758 \ud6a8\uacfc\uc801\uc778 \ubb38\uc81c \ud574\uacb0\uc744 \ucd09\uc9c4\ud568\uc73c\ub85c\uc368 \ud658\uc790 \uc548\uc804\uc744 \ud06c\uac8c \ud5a5\uc0c1\uc2dc\ud0b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">\uaddc\uc815 \uc900\uc218<\/h4>\n\n\n\n<p>FDA\uc640 \uc720\ub7fd\uc758\uc57d\ud488\uccad\uc744 \ube44\ub86f\ud55c \uc804 \uc138\uacc4 \uaddc\uc81c \ub2f9\uad6d\uc740 IEC 62304\ub97c \uc548\uc804\ud558\uace0 \ud6a8\uacfc\uc801\uc778 \uc758\ub8cc\uae30\uae30 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uac1c\ubc1c\uc744 \uc704\ud55c \uc2e0\ub8b0\ud560 \uc218 \uc788\ub294 \ud504\ub808\uc784\uc6cc\ud06c\ub85c \uc778\uc815\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uac1c\ubc1c\uc790\ub294 \uc774 \ud45c\uc900\uc744 \uc900\uc218\ud568\uc73c\ub85c\uc368 \uae30\uc874 \uc5c5\uacc4 \ud45c\uc900\uc5d0 \ub9de\ucdb0 \uc5c5\ubb34\ub97c \uc9c4\ud589\ud558\uc5ec \uaddc\uc81c \uc2b9\uc778\uc744 \ubc1b\ub294 \uacfc\uc815\uc744 \uac04\uc18c\ud654\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p>IEC 62304\uac00 \uaddc\uc815 \uc900\uc218\ub97c \uc9c0\uc6d0\ud558\ub294 \uc8fc\uc694 \ubc29\ubc95 \uc911 \ud558\ub098\ub294 \uc704\ud5d8 \uae30\ubc18 \uac1c\ubc1c \ubc0f \uc124\uacc4 \uc81c\uc5b4\uc5d0 \ub300\ud55c \uc704\ud5d8 \uae30\ubc18 \uac1c\ubc1c \ubc0f \uc124\uacc4 \uc81c\uc5b4\ub97c \uac15\uc870\ud558\uae30 \ub54c\ubb38\uc785\ub2c8\ub2e4. \uc5c4\uaca9\ud568\uc758 \uc218\uc900\uc740 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc758 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc758 \uc548\uc804 \ubd84\ub958\uc5d0 \ub530\ub77c \ub2ec\ub77c\uc9d1\ub2c8\ub2e4. \uc774\ub294 \uaddc\uc81c \ub2f9\uad6d\uc774 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uad00\ub828 \uc704\ud5d8\uc774 \ud658\uc790 \uc548\uc804\uc5d0 \ubbf8\uce60 \uc218 \uc788\ub294 \uc7a0\uc7ac\uc801 \uc601\ud5a5\uc744 \ud3c9\uac00\ud558\uae30 \uc704\ud574 \ud3ec\uad04\uc801\uc778 \uc704\ud5d8 \ubd84\uc11d\uc744 \uc694\uad6c\ud558\ub294 \uacbd\uc6b0\uac00 \ub9ce\uae30 \ub54c\ubb38\uc5d0 \uaddc\uc81c \uae30\ub300\uce58\uc640 \uc798 \ubd80\ud569\ud569\ub2c8\ub2e4. IEC 62304\uc758 \uc704\ud5d8 \uc911\uc2ec \uc811\uadfc \ubc29\uc2dd\uc740 \uc704\ud5d8\uc744 \uc2dd\ubcc4\ud558\uace0 \uc644\ud654\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub420 \ubfd0\ub9cc \uc544\ub2c8\ub77c \uaddc\uc81c \uc81c\ucd9c\uc5d0 \ud544\uc694\ud55c \ubb38\uc11c\ub97c \uc81c\uacf5\ud558\uc5ec \ucca0\uc800\ud55c \uc704\ud5d8 \ud3c9\uac00\uac00 \uc218\ud589\ub418\uace0 \uc801\uc808\ud55c \ud1b5\uc81c\uac00 \uc774\ub8e8\uc5b4\uc9c0\uace0 \uc788\uc74c\uc744 \uc785\uc99d\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>IEC 62304\uc758 \uad6c\uc870\ud654\ub41c \uac1c\ubc1c \uc218\uba85 \uc8fc\uae30\uc5d0\ub294 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc758 \ub2e8\uacc4\uac00 \ud3ec\ud568\ub429\ub2c8\ub2e4. \uacc4\ud68d, \uac1c\ubc1c, \uac80\uc99d, \uc720\ud6a8\uc131 \uac80\uc0ac \ubc0f \uc720\uc9c0\ubcf4\uc218 \ub2e8\uacc4\ub97c \ud3ec\ud568\ud558\ub294 IEC 62304\uc758 \uad6c\uc870\ud654\ub41c \uac1c\ubc1c \ub77c\uc774\ud504\uc0ac\uc774\ud074\uc740\uba85\ud655\ud558\uace0 \uc77c\uad00\ub41c \ub85c\ub4dc\ub9f5\uc744 \uc81c\uacf5\ud558\uc5ec \uaddc\uc815 \uc900\uc218\ub97c \uc9c0\uc6d0\ud569\ub2c8\ub2e4. \uc774\ub97c \ud1b5\ud574 \ud544\uc218 \uac1c\ubc1c \ub2e8\uacc4\ub97c \ub530\ub974\uace0 \uc801\uc808\ud558\uac8c \ubb38\uc11c\ud654\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uaddc\uc81c \uae30\uad00\uc740 \uc2b9\uc778 \uacfc\uc815\uc5d0\uc11c \uc774\ub7ec\ud55c \uce21\uba74\uc744 \uba74\ubc00\ud788 \uac80\ud1a0\ud558\ub294 \uacbd\uc6b0\uac00 \ub9ce\uc73c\uba70, IEC 62304\ub97c \uc900\uc218\ud558\uba74 \ud544\uc694\ud55c \ubaa8\ub4e0 \ud504\ub85c\uc138\uc2a4\uac00 \uccb4\uacc4\uc801\uc73c\ub85c<br>\ud504\ub85c\uc138\uc2a4\uac00 \uccb4\uacc4\uc801\uc73c\ub85c \uc218\ud589\ub418\uc5c8\uc74c\uc744 \uc785\uc99d\ud558\ub294 \ub370 \ud070 \ub3c4\uc6c0\uc774 \ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">IEC 62304 \uc218\uba85 \uc8fc\uae30 \ud504\ub85c\uc138\uc2a4 \ub2e8\uacc4<\/h4>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\uc18c\ud504\ud2b8\uc6e8\uc5b4 \uac1c\ubc1c \uacc4\ud68d<\/strong>: \uc774 \ub2e8\uacc4\uc5d0\uc11c\ub294 \uc5ed\ud560, \ucc45\uc784 \ubc0f \uc804\ubc18\uc801\uc778 \uc811\uadfc \ubc29\uc2dd\uc744 \uc124\uba85\ud558\ub294 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uac1c\ubc1c\uc5d0 \ub300\ud55c \ud3ec\uad04\uc801\uc778 \uacc4\ud68d\uc744 \uc218\ub9bd\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc694\uad6c\uc0ac\ud56d \ubd84\uc11d<\/strong>: \uae30\ub2a5\uc801 \uce21\uba74\uacfc \ube44\uae30\ub2a5\uc801 \uce21\uba74\uc744 \ud3ec\ud568\ud55c \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc694\uad6c\uc0ac\ud56d\uc744 \ud30c\uc545\ud558\uace0 \ubb38\uc11c\ud654\ud558\uc5ec \uac1c\ubc1c\uc758 \ud1a0\ub300\ub97c \ub9c8\ub828\ud569\ub2c8\ub2e4. \uac1c\ubc1c\uc758 \ud1a0\ub300\ub97c \ub9c8\ub828\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc544\ud0a4\ud14d\ucc98 \uc124\uacc4<\/strong>: \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc544\ud0a4\ud14d\ucc98 \uc124\uacc4\ub294 \ub2e4\uc74c\uc744 \uc815\uc758\ud569\ub2c8\ub2e4.\uad6c\uc131 \uc694\uc18c\uc758 \uc0c1\ud638 \uc791\uc6a9 \ubc29\uc2dd\uc744 \uc815\uc758\ud558\uace0 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uac00 \uc758\ub3c4\ud55c \ubaa9\uc801\uc744 \ub2ec\uc131\ud560 \uc218 \uc788\ub3c4\ub85d \ubcf4\uc7a5\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc0c1\uc138 \uc124\uacc4<\/strong>: \uc774 \ub2e8\uacc4\uc5d0\uc11c\ub294 \uc544\ud0a4\ud14d\ucc98 \uc124\uacc4\ub97c \uae30\ubc18\uc73c\ub85c \uc138\ubd80 \uc124\uacc4 \uc0ac\uc591\uc774 \uc544\ud0a4\ud14d\ucc98 \uc124\uacc4\ub97c \uae30\ubc18\uc73c\ub85c \uc138\ubd80 \uc124\uacc4 \uc0ac\uc591\uc744 \uc791\uc131\ud558\uace0, \uad6c\ud604\uc744 \uc704\ud55c \ub85c\ub4dc\ub9f5\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\uc18c\ud504\ud2b8\uc6e8\uc5b4 \ub2e8\uc704 \uad6c\ud604 \ubc0f \uac80\uc99d<\/strong>: \uac1c\ubc1c\uc790\ub294 \uac1c\ubcc4 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc720\ub2db\uc744 \uc791\uc131\ud558\uace0 \ud14c\uc2a4\ud2b8\ud558\uc5ec \uac1c\ubcc4 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc720\ub2db\uc744 \uc791\uc131\ud558\uace0 \ud14c\uc2a4\ud2b8\ud558\uc5ec \uc815\uc758\ub41c \uc694\uad6c \uc0ac\ud56d\uc744 \ucda9\uc871\ud558\ub294\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\uc18c\ud504\ud2b8\uc6e8\uc5b4 \ud1b5\ud569 \ubc0f \ud1b5\ud569 \ud14c\uc2a4\ud2b8<\/strong>: \uc720\ub2db\uc744 \ud558\ub098\uc758 \uc77c\uad00\ub41c \uc804\uccb4\ub85c \ud1b5\ud569\ud55c \ub2e4\uc74c, \uc6d0\ud65c\ud558\uac8c \ud568\uaed8 \uc791\ub3d9\ud558\ub294\uc9c0 \ud14c\uc2a4\ud2b8\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc2dc\uc2a4\ud15c \ud14c\uc2a4\ud2b8<\/strong>: \uc804\uccb4 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc2dc\uc2a4\ud15c\uc5d0 \ub300\ud55c \uc5c4\uaca9\ud55c \uacb0\ud568\uc744 \uc2dd\ubcc4\ud558\uace0 \uc218\uc815\ud558\uae30 \uc704\ud55c \uc5c4\uaca9\ud55c \ud14c\uc2a4\ud2b8\ub97c \uac70\uce69\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\uc18c\ud504\ud2b8\uc6e8\uc5b4 \ub9b4\ub9ac\uc2a4:<\/strong> \uc18c\ud504\ud2b8\uc6e8\uc5b4\ub294 \ud328\ud0a4\uc9d5\uc744 \ud3ec\ud568\ud558\uc5ec \ucd9c\uc2dc \uc900\ube44\uac00 \uc644\ub8cc\ub429\ub2c8\ub2e4, \ubb38\uc11c\ud654 \ubc0f \ud544\uc694\ud55c \ubaa8\ub4e0 \uaddc\uc81c \uc81c\ucd9c\uc744 \ud3ec\ud568\ud558\uc5ec \uc18c\ud504\ud2b8\uc6e8\uc5b4\ub97c \ucd9c\uc2dc\ud560 \uc900\ube44\ub97c \ud569\ub2c8\ub2e4.<\/li>\n<\/ol>\n\n\n\n<h4 class=\"wp-block-heading\">\uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc548\uc804 \ub4f1\uae09 \ubd84\ub958<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\ud074\ub798\uc2a4 A<\/strong>: \ubd80\uc0c1 \ub610\ub294 \uc190\uc0c1 \uc5c6\uc74c \ud074\ub798\uc2a4 &#8211; \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uc624\ub958\ub85c \uc778\ud574 \ud658\uc790 \ub610\ub294 \uc0ac\uc6a9\uc790\uc5d0\uac8c \ubd80\uc0c1\uc774\ub098 \uc190\uc0c1\uc774 \ubc1c\uc0dd\ud560 \uac00\ub2a5\uc131\uc740 \uac70\uc758 \uc5c6\uc2b5\ub2c8\ub2e4. \uc608\ub97c \ub4e4\uc5b4 \uae30\uae30\uc758 \uae30\ub2a5\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce58\uc9c0 \uc54a\ub294 \ub514\uc2a4\ud50c\ub808\uc774 \uc624\ub958\uac00 \uc788\uc744 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\ud074\ub798\uc2a4 B<\/strong>: \uc2ec\uac01\ud558\uc9c0 \uc54a\uc740 \ubd80\uc0c1 &#8211; \ud074\ub798\uc2a4 B \uc624\ub958\ub294 \uc7a0\uc7ac\uc801\uc73c\ub85c \ud658\uc790 \ub610\ub294 \uc0ac\uc6a9\uc790\uc5d0\uac8c \uc2ec\uac01\ud558\uc9c0 \uc54a\uc740 \ubd80\uc0c1, \ubd88\ud3b8\ud568 \ub610\ub294 \ubd88\ud3b8\uc744 \ucd08\ub798\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc608\uc2dc: \uc798\ubabb\ub41c \uacbd\ubcf4\uc74c\uc774 \uc6b8\ub824 \uc77c\uc2dc\uc801\uc778 \uc2a4\ud2b8\ub808\uc2a4\ub97c \uc720\ubc1c\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\ud074\ub798\uc2a4 C<\/strong>: \uc2ec\uac01\ud55c \ubd80\uc0c1 &#8211; \ud074\ub798\uc2a4 C \uace0\uc7a5\uc740 \ud658\uc790 \ub610\ub294 \uc0ac\uc6a9\uc790\uc5d0\uac8c \uc2ec\uac01\ud55c \ubd80\uc0c1\uc744 \ucd08\ub798\ud560 \uac00\ub2a5\uc131\uc774 \uc788\uc2b5\ub2c8\ub2e4. \uc608\ub97c \ub4e4\uc5b4 \uc758\ub8cc\uc6a9 \uc218\uc561 \ud38c\ud504\uc758 \uc798\ubabb\ub41c \uc6a9\ub7c9 \uacc4\uc0b0\uc774 \uc774 \ub4f1\uae09\uc5d0 \ud574\ub2f9\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<p>\uc18c\uc2a4: <a href=\"https:\/\/www.jamasoftware.com\/blog\/an-in-depth-guide-to-iec-62304-software-lifecycle-processes-for-medical-devices\" data-type=\"link\" data-id=\"https:\/\/www.jamasoftware.com\/blog\/an-in-depth-guide-to-iec-62304-software-lifecycle-processes-for-medical-devices\">An In-Depth Guide to IEC 62304: Software Lifecycle Processes for Medical Devices<\/a><\/p>\n\n\n","protected":false},"excerpt":{"rendered":"<p>\uc758\ub8cc \uae30\uae30 \uc18c\ud504\ud2b8\uc6e8\uc5b4\uc758 \uc218\uba85 \uc8fc\uae30 \uc694\uad6c \uc0ac\ud56d\uc744 \uc815\uc758\ud558\ub294 IEC 62304\uc640 \uac19\uc740 \ud45c\uc900\uc774 \ub9cc\ub4e4\uc5b4\uc84c\uc2b5\ub2c8\ub2e4.<\/p>\n","protected":false},"author":7,"featured_media":2773,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[48],"tags":[45,51,93,52],"class_list":["post-2772","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-jama","tag-alm","tag-jama","tag-medical-devices","tag-requirements-management"],"_links":{"self":[{"href":"https:\/\/alm.engineering\/index.php?rest_route=\/wp\/v2\/posts\/2772","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/alm.engineering\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/alm.engineering\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/alm.engineering\/index.php?rest_route=\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/alm.engineering\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2772"}],"version-history":[{"count":1,"href":"https:\/\/alm.engineering\/index.php?rest_route=\/wp\/v2\/posts\/2772\/revisions"}],"predecessor-version":[{"id":2774,"href":"https:\/\/alm.engineering\/index.php?rest_route=\/wp\/v2\/posts\/2772\/revisions\/2774"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/alm.engineering\/index.php?rest_route=\/wp\/v2\/media\/2773"}],"wp:attachment":[{"href":"https:\/\/alm.engineering\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2772"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/alm.engineering\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2772"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/alm.engineering\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2772"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}