![\"\uc804\uc790\uacf5\uc7a5](\"https:\/\/www.besterpcba.com\/wp-content\/uploads\/2025\/11\/real-time-dhr-data-capture.jpg\" "\\"\uc758\ub8cc\uae30\uae30")
\uc131\uc219\ud55c ISO 13485 \uc6b4\uc601\uc740 \uc2e4\uc2dc\uac04\uc73c\ub85c DHR \ub370\uc774\ud130\ub97c \ucea1\ucc98\ud558\ub294 \ud1b5\ud569 \uc18c\ud504\ud2b8\uc6e8\uc5b4\ub97c \uc0ac\uc6a9\ud558\uba70, \uc774\ub294 \uc0dd\uc0b0\uc758 \uc790\uc5f0\uc2a4\ub7ec\uc6b4 \ubd80\uc0b0\ubb3c\uc785\ub2c8\ub2e4. \uc6b4\uc601\uc790\uac00 \ubd80\ud488 \ub9b4\uc744 \ud53c\ud06c \uc564 \ud50c\ub808\uc774\uc2a4 \uba38\uc2e0\uc5d0 \uc2a4\uce94\ud560 \ub54c, \uc2dc\uc2a4\ud15c\uc740 \uc790\ub3d9\uc73c\ub85c \ub85c\ud2b8 \ubc88\ud638\uc640 \ud0c0\uc784\uc2a4\ud0ec\ud504\ub97c \uae30\ub85d\ud569\ub2c8\ub2e4. \ud68c\ub85c\ud310\uc774 \ub9ac\ud50c\ub85c\uc6b0 \uc624\ube10\uc744 \ub098\uc62c \ub54c, \uc5f4 \ud504\ub85c\ud30c\uc77c \ub370\uc774\ud130\uac00 \ubc30\uce58\uc5d0 \uc5f0\uacb0\ub429\ub2c8\ub2e4. \uae30\ub2a5 \ud14c\uc2a4\ud2b8\uac00 \uc2e4\ud589\ub420 \ub54c, \uacb0\uacfc\uac00 \uc9c1\uc811 DHR \ub370\uc774\ud130\ubca0\uc774\uc2a4\uc5d0 \uae30\ub85d\ub429\ub2c8\ub2e4. \uc0dd\uc0b0\uc774 \uc885\ub8cc\ub418\ub294 \uc21c\uac04 DHR\uc774 \uc644\uc131\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n
\uc774 \uac74\ucd95\uc801 \ucc28\uc774\uc810\uc740 \ub0a9\uae30 \uc2dc\uac04 \uc99d\uac00\uc758 \uac00\uc7a5 \ud070 \uc6d0\uc778\uc778 \ubb38\uc11c \uc900\ube44 \uc2dc\uae30\ub97c \uc81c\uac70\ud569\ub2c8\ub2e4. \uc218\uc791\uc5c5 \uc2dc\uc2a4\ud15c\uc744 \uc0ac\uc6a9\ud558\ub294 \uc2dc\uc124\uc5d0\uc11c\ub294 \uae30\ub85d\uc744 \uc815\ub9ac\ud558\uace0 \ucc28\uc774\uc810\uc744 \ud574\uacb0\ud558\ub294 \ub370 \uba70\uce60 \ub610\ub294 \uba87 \uc8fc\uac00 \uac78\ub9b4 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc81c\ud488\uc740 \uc644\uc131\ub418\uc5c8\uc9c0\ub9cc \uc11c\ub958\uac00 \uc5c6\uae30 \ub54c\ubb38\uc5d0 \ubc30\uc1a1\ud560 \uc218 \uc5c6\uc2b5\ub2c8\ub2e4. \uc2e4\uc2dc\uac04 DHR \uc2dc\uc2a4\ud15c\uc5d0\uc11c\ub294 \uc0dd\uc0b0\uacfc \ubb38\uc11c\ud654\uac00 \ub3d9\uae30\ud654\ub429\ub2c8\ub2e4. \ub9c8\uc9c0\ub9c9 \ud68c\ub85c\uac00 \ud14c\uc2a4\ud2b8\ub418\uba74 DHR\uc774 \uc900\ube44\ub429\ub2c8\ub2e4. \uc774\uac83\uc774 \uaddc\uc728\uc774 \uc18d\ub3c4\ub97c \uac00\ub2a5\ud558\uac8c \ud558\ub294 \ubc29\uc2dd\uc785\ub2c8\ub2e4.<\/p>\n\n\n
UDI \ub77c\ubca8\ub9c1: \uc6cc\ud06c\ud50c\ub85c\uc6b0 \uaddc\uc728, \ucd5c\uc885 \ub2e8\uacc4\uac00 \uc544\ub2d8<\/h2>\n\n\n
\uace0\uc720\uc7a5\uce58\uc2dd\ubcc4(UDI) \uc2dc\uc2a4\ud15c\uc740 \uc758\ub8cc\uae30\uae30\ub97c \ucd94\uc801\ud558\uae30 \uc704\ud55c \uc138\uacc4\uc801\uc778 \uaddc\uc81c \ud504\ub808\uc784\uc6cc\ud06c\uc785\ub2c8\ub2e4. PCB \uc870\ub9bd \uc2dc, UDI \ub77c\ubca8\ub9c1\uc740 \ub2e8\uc21c\ud788 \ub77c\uc778 \ub05d\uc5d0 \ubc14\ucf54\ub4dc\ub97c \uc778\uc1c4\ud558\ub294 \uac83 \uc774\uc0c1\uc785\ub2c8\ub2e4. \uc774\ub294 \uc5c4\uaca9\ud55c \ub370\uc774\ud130 \ubb34\uacb0\uc131 \uad00\ub9ac\ub97c \uac16\ucd98 \uc0dd\uc0b0 \ud504\ub85c\uc138\uc2a4\uc5d0 \ud1b5\ud569\ub418\uc5b4\uc57c \ud558\ub294 \uc791\uc5c5 \ud750\ub984 \uaddc\uc728\ub85c\uc11c, \uac01 \uc7a5\uce58\uc758 \uc815\uccb4\uc131\uc744 \uc815\ud655\ud558\uac8c \ud655\ub9bd\ud558\uace0 DHR\uacfc \uc5f0\uacb0\ud558\ub294 \uac83\uc744 \ubcf4\uc7a5\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n
UDI\ub294 \ub0b4\ubd80 \uc77c\ub828\ubc88\ud638\uac00 \uc544\ub2cc \uaddc\uc81c \uc2dd\ubcc4\uc790\uc785\ub2c8\ub2e4. \uc774\ub294 \uae00\ub85c\ubc8c \uc870\ud654 \ud615\uc2dd(\uc77c\ubc18\uc801\uc73c\ub85c GS1 \ub610\ub294 HIBCC)\uc744 \ub530\ub974\uba70, \uc81c\ud488 \ubaa8\ub378\uc6a9 \uc7a5\uce58 \uc2dd\ubcc4\uc790(DI)\uc640 \ub85c\ud2b8 \ubc88\ud638, \uc77c\ub828\ubc88\ud638 \ub610\ub294 \uc81c\uc870\uc77c\uc790\ub97c \ud3ec\ud568\ud558\ub294 \uc0dd\uc0b0 \uc2dd\ubcc4\uc790(PI)\ub97c \ud3ec\ud568\ud569\ub2c8\ub2e4. \ud615\uc2dd\uc740 \uaddc\uc81c \uae30\uad00\uc5d0 \uc758\ud574 \uacb0\uc815\ub418\ubbc0\ub85c \uace0\uac1d\uc740 UDI \ub370\uc774\ud130 \ubc0f \ub77c\ubca8\ub9c1 \uc0ac\uc591\uc744 \uc81c\uacf5\ud574\uc57c \ud558\uba70, \uc81c\uc870\uc5c5\uccb4\ub294 \uc774\ub97c \uc815\ubc00\ud558\uac8c \uc2e4\ud589\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n
\uc870\ub9bd \uacfc\uc815\uc5d0\uc11c UDI \ud1b5\ud569\uc774 \ubc1c\uc0dd\ud560 \ub54c<\/h3>\n\n\n
UDI \ub77c\ubca8\uc774 \ubd80\ucc29\ub418\ub294 \uc2dc\uc810\uc740 \uc7a5\uce58\uc5d0 \ub530\ub77c \ub2e4\ub985\ub2c8\ub2e4. \uc77c\ubd80 \uc81c\ud488\uc758 \uacbd\uc6b0, \ub77c\ubca8\uc740 \ucd5c\uc885 \ud14c\uc2a4\ud2b8 \ud6c4 PCBA\uc5d0 \uc9c1\uc811 \ubd80\ucc29\ub429\ub2c8\ub2e4. \ub2e4\ub978 \uc81c\ud488\uc758 \uacbd\uc6b0, PCBA\uac00 \ud558\uc704 \uc870\ub9bd\ud488\uc774\uba70 \ucd5c\uc885 UDI \ub77c\ubca8\uc740 \ub098\uc911\uc5d0 \uace0\uac1d\uc774 \ubd80\ucc29\ud569\ub2c8\ub2e4. \uc804\uc790\uc758 \uacbd\uc6b0, PCBA \uc81c\uc870\uc5c5\uccb4\ub294 \uc6cc\ud06c\ud50c\ub85c\uc6b0 \ub0b4\uc5d0\uc11c UDI \uc0dd\uc131, \ubd80\ucc29 \ubc0f \uac80\uc99d\uc744 \ud1b5\uc81c\ub41c \ub2e8\uacc4\ub85c \uad00\ub9ac\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n
\uc77c\ubc18\uc801\uc778 \uc2e4\uc218\ub294 UDI \ub77c\ubca8\ub9c1\uc744 \ubc30\uc1a1 \ubd80\uc11c\uc5d0\uc11c \ucc98\ub9ac\ud558\ub294 \uc0ac\ud6c4 \uc0dd\uc0b0 \uc791\uc5c5\uc73c\ub85c \uac04\uc8fc\ud558\ub294 \uac83\uc785\ub2c8\ub2e4. \uc774\ub294 \ud5c8\uc6a9\ud560 \uc218 \uc5c6\ub294 \uc704\ud5d8\uc744 \uc57c\uae30\ud569\ub2c8\ub2e4. \ub77c\ubca8\uc774 \uc218\uc791\uc5c5\uc73c\ub85c \ubd80\ucc29\ub418\uace0 DHR \uc2dc\uc2a4\ud15c\uc5d0 \uc5f0\uacb0\ub418\uc5b4 \uc788\uc9c0 \uc54a\uc73c\uba74, \uc62c\ubc14\ub978 \ub77c\ubca8\uc774 \uc62c\ubc14\ub978 \uc720\ub2db\uc5d0 \ubd80\ucc29\ub418\uc5c8\ub294\uc9c0 \uc790\ub3d9\uc73c\ub85c \ud655\uc778\ud558\ub294 \uac80\uc0ac\uac00 \uc5c6\uc2b5\ub2c8\ub2e4. \ucd5c\uc120\uc758 \ubc29\ubc95\uc740 \ubc14\ucf54\ub4dc \uc2a4\uce94 \ub610\ub294 \ube44\uc804 \uc2dc\uc2a4\ud15c\uc744 \ud1b5\ud574 \ub77c\ubca8 \ub0b4\uc6a9\uc774 \uc720\ub2db\uc758 DHR \uae30\ub85d\uacfc \uc77c\uce58\ud558\ub294\uc9c0 \ud655\uc778\ud558\uba74\uc11c \uc0dd\uc0b0 \ub77c\uc778\uc5d0 UDI \uc778\uc1c4 \ubc0f \ubd80\ucc29\uc744 \uc9c1\uc811 \ud1b5\ud569\ud558\ub294 \uac83\uc785\ub2c8\ub2e4.<\/p>\n\n\n
\uc9c1\ub82c\ud654 \ubc0f \ub77c\ubca8 \uac80\uc99d\uc758 \uae30\ubc95<\/h3>\n\n\n![\"\ucee8\ubca0\uc774\uc5b4](\"https:\/\/www.besterpcba.com\/wp-content\/uploads\/2025\/11\/udi-label-verification-scan.jpg\" "\\"\uc758\ub8cc")
UDI \ub77c\ubca8\uc758 \uc989\uac01\uc801\uc778 \uac80\uc99d\uc740 \ubaa8\ub4e0 \uc9c1\ub82c\ud654 \uc758\ub8cc\uae30\uae30\uc758 \ub370\uc774\ud130 \ubb34\uacb0\uc131\uacfc \ucd94\uc801 \uac00\ub2a5\uc131\uc744 \ubcf4\uc7a5\ud558\ub294 \ub370 \uc911\uc694\ud55c \ub2e8\uacc4\uc785\ub2c8\ub2e4.<\/figcaption><\/figure>\n<\/div>\n\n\n\uc720\ub2db \ub808\ubca8 \uc9c1\ub82c\ud654\uac00 \uc694\uad6c\ub420 \ub54c, \uc81c\uc870\uc5c5\uccb4\ub294 \uac01 \ud68c\ub85c\ud310\uc5d0 \uace0\uc720\ud55c \uc77c\ub828\ubc88\ud638\ub97c \uc0dd\uc131\ud558\uace0 \uc774\ub97c UDI \ub77c\ubca8\uc5d0 \uc778\ucf54\ub529\ud574\uc57c \ud569\ub2c8\ub2e4. \uc774\ub294 \uc911\ubcf5\uc744 \ubc29\uc9c0\ud558\uace0 \uac01 \uc77c\ub828\ubc88\ud638\ub97c \ud2b9\uc815 \uc720\ub2db \uc774\ub825\uacfc \uc601\uad6c\uc801\uc73c\ub85c \uc5f0\uacb0\ud558\ub294 DHR \ub370\uc774\ud130\ubca0\uc774\uc2a4\uc640 \uc778\ud130\ud398\uc774\uc2a4\ud558\ub294 \uc9c1\ub82c\ud654 \uc2dc\uc2a4\ud15c\uc774 \ud544\uc694\ud569\ub2c8\ub2e4. \uac80\uc99d \ub2e8\uacc4\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \uc801\uc6a9 \ud6c4 \uc989\uc2dc \uc2a4\uce94\ud558\uc5ec \ub77c\ubca8\uc774 \uc77d\uc744 \uc218 \uc788\uace0 \uc815\ud655\ud55c\uc9c0 \ud655\uc778\ud558\uba70, \uc2e4\ud328\ud558\ub294 \uc720\ub2db\uc740 \uc790\ub3d9\uc73c\ub85c \ud45c\uc2dc\ub429\ub2c8\ub2e4. \uc131\uc219\ud55c \ud30c\ud2b8\ub108\ub294 \uc0dd\uc0b0 \uc2dc\uc791 \uc804\uc5d0 \ubaa8\ub4e0 UDI \uc0ac\uc591\uc758 \uc644\uc804\uc131\uc744 \uac80\uc99d\ud558\ub294 \uc124\uacc4 \uc774\uc804 \uc804\ub2ec \ud504\ub85c\uc138\uc2a4\ub97c \uac16\ucd94\uace0 \uc788\uc5b4, \ube44\uc6a9\uc774 \ub9ce\uc774 \ub4dc\ub294 \ub2e4\uc6b4\uc2a4\ud2b8\ub9bc \ubc29\ud574\ub97c \ubc29\uc9c0\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n
\ud504\ub85c\uc138\uc2a4 \uac80\uc99d: \ubc18\ubcf5 \uac00\ub2a5\uc131 \uad6c\ucd95<\/h2>\n\n\n
\ud504\ub85c\uc138\uc2a4 \uac80\uc99d\uc740 \uc81c\uc870 \uacf5\uc815\uc774 \ubaa8\ub4e0 \uc694\uad6c \uc0ac\ud56d\uc744 \uc9c0\uc18d\uc801\uc73c\ub85c \ucda9\uc871\ud558\ub294 \uc870\ub9bd\ud488\uc744 \uc77c\uad00\ub418\uac8c \uc0dd\uc0b0\ud560 \uac83\uc784\uc744 \uacf5\uc2dd\uc801\uc73c\ub85c \uc785\uc99d\ud558\ub294 \ubb38\uc11c\ud654\ub41c \uc99d\uac70\uc785\ub2c8\ub2e4. \uc774\ub294 \uacf5\uc815 \uac1c\ubc1c\uc774 \uc544\ub2c8\ub77c, \uc815\uc758\ub41c \ub9e4\uac1c\ubcc0\uc218 \ub0b4\uc5d0\uc11c \uc791\ub3d9\ud558\ub294 \uacf5\uc815\uc774 \ub9e4\ubc88 \uc801\ud569\ud55c \ucd9c\ub825\ubb3c\uc744 \ub9cc\ub4e4\uc5b4\ub0bc \uac83\uc784\uc744 \ucd5c\uc885\uc801\uc73c\ub85c \ubcf4\uc5ec\uc8fc\ub294 \uc99d\uba85\uc785\ub2c8\ub2e4. ISO 13485 \ud558\uc5d0\uc11c, \uc911\uc694 \uacf5\uc815\uc740 \uc77c\uc0c1 \uc0dd\uc0b0\uc5d0 \uc0ac\uc6a9\ub418\uae30 \uc804\uc5d0 \uac80\uc99d\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n
PCB \uc870\ub9bd \uc81c\uc870\uc758 \uacbd\uc6b0, \uc7ac\ud50c\ub85c\uc6b0 \uc194\ub354\ub9c1, \ucee8\ud3ec\uba40 \ucf54\ud305, \uc790\ub3d9 \uac80\uc0ac\uc640 \uac19\uc740 \uacf5\uc815\uc740 \uac80\uc99d\uc774 \ud544\uc694\ud569\ub2c8\ub2e4. \uadf8 \uc774\uc720\ub294, \uc194\ub354 \uc870\uc778\ud2b8 \ub0b4\ubd80 \uc644\uc804\uc131 \uac19\uc740 \uacb0\uacfc\uc758 \ud488\uc9c8\uc744 \uc0ac\ud6c4 \uac80\uc99d\ud560 \uc218 \uc5c6\ub2e4\uba74, \uacf5\uc815 \uc790\uccb4\uac00 \uac80\uc99d \uac00\ub2a5\ud558\ub2e4\ub294 \uac83\uc744 \uc99d\uba85\ud574\uc57c \ud558\uae30 \ub54c\ubb38\uc785\ub2c8\ub2e4. \ud488\uc9c8\uc744 \uac80\uc0ac\ud560 \uc218 \uc5c6\uc744 \ub54c\ub294, \ud488\uc9c8\uc744 \ub0b4\uc7ac\ud654\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n
\ud504\ub85c\uc138\uc2a4 \uac80\uc99d\uc774 \uc99d\uba85\ud558\ub294 \uac83\uacfc \ubc1c\uc0dd\ud558\ub294 \uc2dc\uae30<\/h3>\n\n\n
\uc804\uccb4 \ud504\ub85c\uc138\uc2a4 \uac80\uc99d\uc740 \uacf5\uc2dd \ud504\ub85c\ud1a0\ucf5c\uc744 \ub530\ub985\ub2c8\ub2e4: \uc124\ube44 \uc801\ud569\uc131 \uc2dc\ud5d8 (IQ), \uc791\ub3d9 \uc801\ud569\uc131 \uc2dc\ud5d8 (OQ), \uc131\ub2a5 \uc801\ud569\uc131 \uc2dc\ud5d8 (PQ). IQ\ub294 \uc7a5\ube44\uac00 \uc62c\ubc14\ub974\uac8c \uc124\uce58\ub418\uace0 \ubb38\uc11c\ud654\ub418\uc5c8\uc74c\uc744 \ud655\uc778\ud569\ub2c8\ub2e4. OQ\ub294 \uc7a5\ube44\uac00 \uc758\ub3c4\ub41c \ud30c\ub77c\ubbf8\ud130 \ubc94\uc704 \ub0b4\uc5d0\uc11c \uc81c\ub300\ub85c \uc791\ub3d9\ud558\ub294\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4. PQ\ub294 \uac00\uc7a5 \uc5c4\uaca9\ud55c \ub2e8\uacc4\ub85c, \uc0dd\uc0b0\uc744 \ub300\ud45c\ud558\ub294 \uc870\ub9bd\ud488\uc744 \uacf5\uc815\uc744 \ud1b5\ud574 \ud14c\uc2a4\ud2b8\ud558\uc5ec \ucd9c\ub825\uc774 \ubaa8\ub4e0 \uc218\uc6a9 \uae30\uc900\uc744 \uc77c\uad00\ub418\uac8c \ucda9\uc871\ud558\ub294\uc9c0 \uc785\uc99d\ud558\ub294 \uacfc\uc815\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n
\uc774 \uac80\uc99d\uc740 \uc0c1\uc5c5\uc801 \uc0dd\uc0b0\uc5d0 \uacf5\uc815\uc744 \uc0ac\uc6a9\ud558\uae30 \uc804\uc5d0 \uc644\ub8cc\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. \uc774\ub294 \uc0c8\ub85c\uc6b4 \uc81c\ud488\uc5d0 \ub300\ud55c \uc120\ud589 \uc2dc\uac04 \ud22c\uc790\ub97c \uc694\uad6c\ud558\uc9c0\ub9cc, \uac80\uc99d\ub41c \uacf5\uc815\uc740 \uc774\ud6c4 \uc18d\ub3c4\ub97c \uac00\ub2a5\ud558\uac8c \ud569\ub2c8\ub2e4. \uc774 \uacf5\uc815\uc740 \uc77c\uc0c1 \uc0ac\uc6a9\uc744 \uc704\ud574 \uc801\uaca9\ud558\uba70, \ud3ec\uad04\uc801\uc778 \uac1c\ubcc4 \uc720\ub2db \uac80\uc99d \uc5c6\uc774 \uc0dd\uc0b0\uc744 \uc9c4\ud589\ud560 \uc218 \uc788\ub3c4\ub85d \ud5c8\uc6a9\ud569\ub2c8\ub2e4.<\/p>\n\n\n
\uac80\uc99d\uacfc \uc720\uc5f0\uc131\uc758 \uad00\uacc4<\/h3>\n\n\n
\uac80\uc99d\ub41c \uacf5\uc815\uc740 \uc7a0\uae08\ub41c \uacf5\uc815\uc774 \uc544\ub2c8\uc9c0\ub9cc, \uc5b4\ub5a4 \ubcc0\uacbd\uc774\ub77c\ub3c4 \uacf5\uc2dd\uc801\uc778 \ubcc0\uacbd \ud1b5\uc81c \uc808\ucc28\ub97c \ud1b5\ud574 \uad00\ub9ac\ud574\uc57c \ud569\ub2c8\ub2e4. \ubb34\uc2dc\ud560 \uc218 \uc5c6\ub294 \uc791\uc740 \uc870\uc815\uc740 \uc870\uce58\uac00 \ud544\uc694 \uc5c6\uc744 \uc218 \uc788\uc9c0\ub9cc, \uc0c8\ub85c\uc6b4 \ubd80\ud488 \uc720\ud615 \ub3c4\uc785\uc774\ub098 \uc194\ub354 \ud398\uc774\uc2a4\ud2b8 \uad50\uccb4\uc640 \uac19\uc740 \ud070 \ubcc0\uacbd\uc740 \uc7ac\uac80\uc99d\uc744 \uc694\uad6c\ud558\uac8c \ub429\ub2c8\ub2e4.<\/p>\n\n\n\n
\uc131\uc219\ud55c \uac80\uc99d \ud504\ub85c\uadf8\ub7a8\uc744 \uac00\uc9c4 \uc81c\uc870\uc5c5\uccb4\ub294 \uc774\ub7ec\ud55c \ubcc0\uacbd\uc744 \ud3c9\uac00\ud558\uace0 \uc7ac\uac80\uc99d\uc744 \ud6a8\uc728\uc801\uc73c\ub85c \uc218\ud589\ud558\ub294 \uba85\ud655\ud55c \uc808\ucc28\ub97c \uac16\ucd94\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uadf8\ub4e4\uc740 \uc7ac\uac80\uc99d\uc774 \ud544\uc694\ud560 \ub54c \uc2e0\uc18d\ud558\uac8c \ub300\uc751\ud560 \uc218 \uc788\ub3c4\ub85d \uacfc\uac70 \ub370\uc774\ud130\ub97c \ud65c\uc6a9\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uaddc\uc728\uc774 \uc57d\ud55c \uc81c\uc870\uc5c5\uccb4\ub294 \ubaa8\ub4e0 \ubcc0\ud654\ub97c \uc704\uae30\ucc98\ub7fc \ub2e4\ub8e8\uba70, \uae34 \uc7ac\uac80\uc99d \uc808\ucc28\ub85c \uc0dd\uc0b0\uc744 \uc9c0\uc5f0\uc2dc\ud0a4\ub294 \uacbd\ud5a5\uc774 \uc788\uc2b5\ub2c8\ub2e4. \ucc28\uc774\uc810\uc740 \uaddc\uc81c \uadf8 \uc790\uccb4\uac00 \uc544\ub2c8\ub77c, \uc774\ub97c \ucda9\uc871\uc2dc\ud0a4\uae30 \uc704\ud574 \uc124\uacc4\ub41c \uc2dc\uc2a4\ud15c\uc758 \uc131\uc219\ub3c4\uc785\ub2c8\ub2e4.<\/p>\n\n\n
\ud1b5\uc81c\ub41c \uc800\uc7a5 \ubc0f \ud658\uacbd \ubaa8\ub2c8\ud130\ub9c1<\/h2>\n\n\n
\uc758\ub8cc\uae30\uae30 \uc870\ub9bd\ud488\uc740 \uc0dd\uc0b0 \ub77c\uc778\uc744 \ub5a0\ub09c \ud6c4\uc5d0\ub3c4 \ube44\ud65c\uc131 \uc0c1\ud0dc\uac00 \uc544\ub2c8\uba70, \ud488\uc9c8\uc744 \uc800\ud558\uc2dc\ud0a4\ub294 \ud658\uacbd\uc801 \uc704\ud5d8\uc5d0 \uacc4\uc18d \ub178\ucd9c\ub429\ub2c8\ub2e4. \ud1b5\uc81c\ub41c \uc800\uc7a5\uc740 \uc804\uc790\uae30 \ubc29\uc804(ESD), \uc2b5\uae30, \uc624\uc5fc, \ud63c\ub3d9\uc73c\ub85c\ubd80\ud130 \uc870\ub9bd\ud488\uc744 \ubcf4\ud638\ud558\ub294 \ud3ec\uc2a4\ud2b8-\uc0dd\uc0b0 \ub2e8\uacc4\uc758 \ud488\uc9c8 \uc2dc\uc2a4\ud15c\uc744 \uc5f0\uc7a5\ud558\uc5ec, \ubc30\uc1a1\ub420 \ub54c\uae4c\uc9c0 \uc774\ub97c \ubcf4\ud638\ud569\ub2c8\ub2e4.<\/p>\n\n\n
\n![\"\uae54\ub054\ud558\uace0](\"https:\/\/www.besterpcba.com\/wp-content\/uploads\/2025\/11\/controlled-storage-medical-pcba.jpg\" "\\"\uc758\ub8cc")
ISO 13485\uc5d0 \ub530\ub978 \ud1b5\uc81c\ub41c \uc800\uc7a5\uc740 \uc644\uc131\ub41c \uc870\ub9bd\ud488\uc744 ESD, \uc2b5\uae30, \uc624\uc5fc\uc73c\ub85c\ubd80\ud130 \ubcf4\ud638\ud558\uc5ec \ucd9c\ud558\ub420 \ub54c\uae4c\uc9c0 \ud488\uc9c8\uc744 \uc720\uc9c0\ud569\ub2c8\ub2e4.<\/figcaption><\/figure>\n<\/div>\n\n\nISO 13485\ub294 \uc800\uc7a5 \uc870\uac74\uc744 \uc815\uc758\ud558\uace0 \ubaa8\ub2c8\ud130\ub9c1\ud558\uba70 \uae30\ub85d\ud560 \uac83\uc744 \uc694\uad6c\ud569\ub2c8\ub2e4. PCBAs\uc758 \uacbd\uc6b0, \uc774\ub294 \uac15\ub825\ud55c ESD \ubcf4\ud638, \uc2b5\uae30 \ubbfc\uac10 \ubd80\ud488\uc744 \uc704\ud55c \uc628\ub3c4 \ubc0f \uc2b5\ub3c4 \uad00\ub9ac, \uc785\uc790 \uc624\uc5fc \ubc29\uc9c0\ub97c \uc704\ud55c \uccad\uacb0 \ud504\ub85c\ud1a0\ucf5c\uc744 \uc758\ubbf8\ud569\ub2c8\ub2e4. \uc774\ub7ec\ud55c \ud1b5\uc81c \uac15\ub3c4\ub294 \uae30\uae30\uc758 \uc704\ud5d8 \ud504\ub85c\ud30c\uc77c\uc5d0 \ub530\ub77c \ub2ec\ub77c\uc9d1\ub2c8\ub2e4.<\/p>\n\n\n
\ud1b5\uc81c \ubc94\uc8fc: ESD, \ud658\uacbd, \uc624\uc5fc<\/h3>\n\n\n
ESD\ub294 \uc798 \uc54c\ub824\uc9c4 \uc704\ud5d8\uc774\uc9c0\ub9cc, \uc7a0\uc7ac \uacb0\ud568\uc774 \uc784\uc0c1 \uc0ac\uc6a9\uae4c\uc9c0 \ub4dc\ub7ec\ub098\uc9c0 \uc54a\uc744 \uc218 \uc788\ub294 \uc758\ub8cc \uae30\uae30\uc5d0\uc11c\ub294 \ub354 \uc911\uc694\ud55c \uc758\ubbf8\ub97c \uac00\uc9d1\ub2c8\ub2e4. \uc800\uc7a5 \uacf5\uac04\uc740 ESD \ubcf4\ud638\uac00 \ub418\uc5b4\uc57c \ud558\uba70, \uc870\ub9bd\ud488\uc740 \ub2e4\ub978 \ud1b5\uc81c\ub41c \ud658\uacbd\uc5d0 \ub3c4\ub2ec\ud560 \ub54c\uae4c\uc9c0 \ubcf4\ud638 \ud3ec\uc7a5 \uc0c1\ud0dc\ub97c \uc720\uc9c0\ud574\uc57c \ud569\ub2c8\ub2e4. \uc2b5\uae30 \ubbfc\uac10 \ubd80\ud488\uc774\ub098 \ud2b9\uc815 \uacbd\ud654 \uc870\uac74\uc774 \ud544\uc694\ud55c \ucf54\ud305\uc5d0 \ub300\ud574 \uc628\ub3c4 \ubc0f \uc2b5\ub3c4 \uc870\uc808\uc774 \ub9e4\uc6b0 \uc911\uc694\ud569\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uad6c\uc5ed\uc740 \ud658\uacbd \ub370\uc774\ud130\ub97c \uc9c0\uc18d\uc801\uc73c\ub85c \uae30\ub85d\ud558\uace0 \uae30\uc900 \ucd08\uacfc \uc0c1\ud0dc\uc5d0 \ub300\ud574 \uacbd\ubcf4\ub97c \uc6b8\ub9ac\ub294 \uc2dc\uc2a4\ud15c\uc744 \uac16\ucd94\uc5b4\uc57c \ud569\ub2c8\ub2e4. \uc624\uc5fc \ubc29\uc9c0\ub294 \uc774\uc2dd \uac00\ub2a5\ud558\uac70\ub098 \uba78\uade0\ub41c \uc7a5\uce58\uc5d0 \uc0ac\uc6a9\ub418\ub294 \uc870\ub9bd\ud488\uc5d0 \ud544\uc218\uc801\uc774\uba70, \uc804\uc6a9 \uc800\uc7a5 \uacf5\uac04\uacfc \ud1b5\uc81c\ub41c \ucd9c\uc785 \ubc0f \uacf5\uae30 \uc5ec\uacfc \uc2dc\uc2a4\ud15c\uc744 \uac16\ucd94\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n
\uc800\uc7a5 \ucd94\uc801\uc131: \ub85c\ud2b8 \uad6c\ubd84 \ubc0f FIFO<\/h3>\n\n\n
\ud658\uacbd \uc694\uc18c\ub97c \ub118\uc5b4\uc11c, \uc800\uc7a5\uc740 \ucd94\uc801\uc131 \uccb4\ud06c\ud3ec\uc778\ud2b8\uc785\ub2c8\ub2e4. \uc870\ub9bd\ud488\uc740 \ub85c\ud2b8 \ub610\ub294 \uc81c\ud488 \ubc84\uc804 \uac04 \ud63c\ub3d9\uc744 \ubc29\uc9c0\ud558\ub3c4\ub85d \uc800\uc7a5\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. \uc774\ub294 \ubb3c\ub9ac\uc801 \uad6c\ubd84, \uba85\ud655\ud55c \ub77c\ubca8\ub9c1, \ub85c\ud2b8 \uc2dd\ubcc4\uc744 \uac15\uc81c\ud558\ub294 \uc7ac\uace0 \uc2dc\uc2a4\ud15c\uc774 \ud544\uc694\ud569\ub2c8\ub2e4. \uc120\uc785\uc120\ucd9c(FIFO) \uc6d0\uce59\uc740 \uc720\ud1b5\uae30\ud55c \uc704\ud5d8\uc744 \ucd5c\uc18c\ud654\ud558\uae30 \uc704\ud55c \ud45c\uc900 \uad00\ud589\uc785\ub2c8\ub2e4. \uc785\uace0\ubd80\ud130 \ucd9c\ud558\uae4c\uc9c0 \ubaa8\ub4e0 \uc800\uc7a5 \uc774\ubca4\ud2b8\ub294 \uae30\ub85d\ub418\uc5b4\uc57c \ud558\uba70 DHR\uacfc \uc5f0\uacc4\ub418\uc5b4\uc57c \ud558\uba70, \uc774\ub97c \ud1b5\ud574 \uc2dc\uc7a5 \uc774\ud6c4 \ubb38\uc81c\uc5d0 \uc2e0\uc18d\ud558\uace0 \uc815\ud655\ud558\uac8c \ub300\uc751\ud560 \uc218 \uc788\ub294 \ub04a\uae40 \uc5c6\ub294 \uccb4\uc778 \uad6c\uc131\uc774 \uc774\ub8e8\uc5b4\uc9d1\ub2c8\ub2e4.<\/p>\n\n\n
\uc9c0\uc18d\uc801\uc778 \uac10\uc0ac \uc900\ube44: \uc911\ub2e8\uc744 \ubc29\uc9c0\ud558\ub294 \uc2dc\uc2a4\ud15c<\/h2>\n\n\n
ISO 13485 \uac10\uc0ac\ub294 \uae5c\uc9dd \uc774\ubca4\ud2b8\uac00 \uc544\ub2d9\ub2c8\ub2e4. \uc778\uc99d \uae30\uad00\uc758 \uac10\uc2dc \uac10\uc0ac\uc640 FDA \uac19\uc740 \uaddc\uc81c \uae30\uad00\uc758 \uaddc\uc81c \uac10\uc0ac\ub294 \uc77c\uc815\uc5d0 \ub530\ub77c \ub610\ub294 \uc720\ubc1c \uc0ac\uac74\uc5d0 \ub300\uc751\ud558\uc5ec \ubc1c\uc0dd\ud569\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uac10\uc0ac\uc758 \ub0b4\uc6a9\ub3c4 \ube44\ubc00\uc774 \uc544\ub2c8\uba70, \uac10\uc0ac\uc790\ub294 \uae30\ub85d\uc744 \uac80\ud1a0\ud558\uace0, \ud504\ub85c\uc138\uc2a4\ub97c \uad00\ucc30\ud558\uba70, \ubb38\uc11c\ud654\ub41c \uc808\ucc28\uac00 \uc900\uc218\ub418\uace0 \uc788\ub294\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n
\uc6d0\ud65c\ud55c \uac10\uc0ac\uc640 \ubc29\ud574\uac00 \ub418\ub294 \uac10\uc0ac\uc758 \ucc28\uc774\ub294 \uc6b4\uc601 \uc0c1\ud0dc\uc5d0 \uc788\uc2b5\ub2c8\ub2e4. \uc9c0\uc18d\uc801\uc778 \uaddc\uc815 \uc900\uc218 \uc0c1\ud0dc\uc5d0\uc11c \uc6b4\uc601\ub418\ub294 \uc81c\uc870\uc5c5\uccb4\ub294 - \ubaa8\ub4e0 \ud504\ub85c\uc138\uc2a4\uac00 \uc2e4\uc2dc\uac04\uc73c\ub85c \uac10\uc0ac \uc900\ube44\ub41c \uae30\ub85d\uc744 \uc0dd\uc131\ud558\uace0 \ud3b8\ucc28\ub97c \uc989\uc2dc \ucc98\ub9ac\ud558\ub294 \uacbd\uc6b0 - \uac10\uc0ac\uac00 \ubc1c\uacac\uc774 \uc544\ub2cc \uac80\uc99d\uc774 \ub429\ub2c8\ub2e4. \uc0dd\uc0b0\uc740 \uba48\ucd94\uc9c0 \uc54a\uace0, \uc5d4\uc9c0\ub2c8\uc5b4\ub4e4\uc740 \ud5c8\ub465\uc9c0\ub465 \ubb38\uc11c \uac80\uc0c9\uc5d0 \ubab0\ub450\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \uac10\uc0ac\uad00\uc758 \uc9c8\ubb38\uc5d0 \ub300\ud55c \ub2f5\ubcc0\uc740 \uc774\ubbf8 \ucde8\ud569\ub418\uc5b4 \uc811\uadfc \uac00\ub2a5\ud55c \ub370\uc774\ud130\ub85c \uc81c\uacf5\ub429\ub2c8\ub2e4.<\/p>\n\n\n
\uc77c\uc77c \uaddc\uc728\uc774 \uc5b4\ub5bb\uac8c \uc601\uad6c\uc801\uc778 \uac10\uc0ac \uc900\ube44\ub97c \ub9cc\ub4e4\uc5b4\ub0b4\ub294\uac00<\/h3>\n\n\n
\uc9c0\uc18d\uc801 \uac10\uc0ac \uc900\ube44 \uc0c1\ud0dc\ub780 \ud488\uc9c8 \uc2dc\uc2a4\ud15c\uc774 \uc5b8\uc81c\ub4e0\uc9c0 \ub3cc\ubc1c \uac80\uc0ac\uc5d0 \ub300\ube44\ud560 \uc218 \uc788\uc74c\uc744 \uc758\ubbf8\ud569\ub2c8\ub2e4. '\ud2b9\ubcc4 \uc900\ube44 \ubaa8\ub4dc'\ub294 \uc5c6\uc2b5\ub2c8\ub2e4. \uac10\uc0ac\uc790\uac00 \uc694\uccad\ud558\ub294 \uae30\ub85d\ub4e4 - DHR, \uc2dc\uc815 \ubc0f \uc608\ubc29 \uc870\uce58(CAPA), \uac80\uc99d \ud504\ub85c\ud1a0\ucf5c, \uad50\uc721 \ud589\ub82c, \ubcf4\uc815 \ub85c\uadf8 - \uc740 \uc77c\uc0c1 \uc5c5\ubb34\uc758 \uc77c\ubd80\ub85c \uc720\uc9c0\ub418\uba70, \uac10\uc0ac\uac00 \uc608\uc815\ub420 \ub54c \uae09\ud558\uac8c \uc900\ube44\ud558\ub294 \uac83\uc774 \uc544\ub2d9\ub2c8\ub2e4.<\/p>\n\n\n\n
\uc774 \uc0c1\ud0dc\ub294 \uc790\ub3d9\ud654\uc640 \uaddc\uc728\uc744 \ud1b5\ud574 \ub2ec\uc131\ub429\ub2c8\ub2e4. \ub514\uc9c0\ud138 DHR \uc2dc\uc2a4\ud15c\uc740 \ubc31\ub85c\uadf8\ub97c \uc81c\uac70\ud569\ub2c8\ub2e4. \uc790\ub3d9 \ubcf4\uc815 \ucd94\uc801\uc740 \uc7a5\ube44\uc758 \ub9cc\ub8cc \uc804\uc5d0 \uc54c\ub9bd\ub2c8\ub2e4. \uad50\uc721 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc740 \uc790\uaca9\uc744 \uac16\ucd98 \uc778\ub825\ub9cc\uc774 \uc791\uc5c5\uc744 \uc218\ud589\ud558\ub3c4\ub85d \ubcf4\uc7a5\ud569\ub2c8\ub2e4. CAPA \uc2dc\uc2a4\ud15c\uc740 \ubb38\uc81c\uc758 \uc2dd\ubcc4\ubd80\ud130 \uc885\ub8cc\uae4c\uc9c0 \ucd94\uc801\ud569\ub2c8\ub2e4. \uc774\ub4e4\uc740 \uac10\uc0ac \ub3c4\uad6c\uac00 \uc544\ub2c8\ub77c, \uac10\uc0ac \uc900\ube44\uac00 \ub41c \uc0b0\ucd9c\ubb3c\uc744 \uc0dd\uc131\ud558\ub294 \uc0dd\uc0b0 \ub3c4\uad6c\uc785\ub2c8\ub2e4.<\/p>\n\n\n
\uac10\ub3c5\uad00\uc774 \uc0b4\ud3b4\ubcf4\ub294 \uac83\uacfc \uc2dc\uc2a4\ud15c\uc774 \uc5b4\ub5bb\uac8c \ubc18\uc751\ud558\ub294\uc9c0<\/h3>\n\n\n
\uac10\uc0ac\uad00\uc774 PCB \uacf5\uc7a5\uc5d0 \ub4e4\uc5b4\uc624\uba74, \uadf8\ub4e4\uc740 DHR, \uac80\uc99d \uae30\ub85d \ubc0f \ubcc0\uacbd \ud1b5\uc81c \uc99d\uac70\ub97c \uc694\uccad\ud569\ub2c8\ub2e4. \uadf8\ub4e4\uc740 \uc0dd\uc0b0 \ud604\uc7a5\uc744 \uad00\ucc30\ud558\uace0 \uc9c1\uc6d0\ub4e4\uacfc \uc778\ud130\ubdf0\ub97c \ud569\ub2c8\ub2e4. \uc9c0\uc18d\uc801\uc73c\ub85c \uaddc\uc815\uc744 \uc900\uc218\ud558\ub294 \uc2dc\uc2a4\ud15c\uc740 \uc9c0\uc5f0 \uc5c6\uc774 \ub300\uc751\ud569\ub2c8\ub2e4. DHR\uc740 \uba87 \ubd84 \ub9cc\uc5d0 \ub370\uc774\ud130\ubca0\uc774\uc2a4\uc5d0\uc11c \uac00\uc838\uc624\uba70, \uac80\uc99d \uae30\ub85d\uc740 \uad6c\uc870\ud654\ub41c \uc800\uc7a5\uc18c\uc5d0 \uc788\uc2b5\ub2c8\ub2e4. CAPA \ub370\uc774\ud130\ubca0\uc774\uc2a4\ub294 \ubb38\uc81c\uac00 \uc885\ub8cc\ub420 \ub54c\uae4c\uc9c0 \ucd94\uc801\ub428\uc744 \ubcf4\uc5ec\uc90d\ub2c8\ub2e4. \uac10\uc0ac\uad00\uc758 \ubc29\ubb38\uc740 \uac80\uc99d\uc774 \ub418\uba70, \uc870\uc0ac\ub85c \uc774\uc5b4\uc9c0\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n
\uc774\uc0c1\uc801\uc73c\ub85c, \uc900\uc218\uc131\uc774 \uc8fc\uae30\uc801\uc778 \uc6b4\uc601\uacfc\ub294 \ub300\uc870\uc801\uc785\ub2c8\ub2e4. \uac10\uc0ac\ub294 \ud63c\ub780\uc744 \uc57c\uae30\ud569\ub2c8\ub2e4. \uc5d4\uc9c0\ub2c8\uc5b4\ub4e4\uc740 \uc624\ub798\ub41c \ubcf4\uace0\uc11c\ub97c \ucc3e\uae30 \uc704\ud574 \ud5e4\ub9e4\uace0, \uc11c\ub958 \uc815\ub9ac\ub97c \uc704\ud574 \uc0dd\uc0b0\uc774 \uc77c\uc2dc \uc911\ub2e8\ub429\ub2c8\ub2e4. \ub0b4\ubd80 \uc2dc\uc2a4\ud15c\uc774 \ubc1c\uacac\ud588\uc5b4\uc57c \ud560 \ucc28\uc774\uc810\uc744 \uac10\uc0ac\uac00 \ub4dc\ub7ec\ub0b4\ub294 \uacbd\uc6b0\ub3c4 \ub9ce\uc73c\uba70, \uc774\ub294 \uc9c0\uc5f0\uacfc \ube44\uc6a9\uc774 \ub9ce\uc774 \ub4dc\ub294 \uc218\uc815 \uc870\uce58\ub97c \ucd08\ub798\ud569\ub2c8\ub2e4. \uc774\ub294 \uac10\uc0ac\uad00\uc774 \uc801\ub300\uc801\uc774\uae30 \ub54c\ubb38\uc774 \uc544\ub2c8\uba70, \uc2dc\uc2a4\ud15c\uc774 \uc900\ube44\ub418\uc9c0 \uc54a\uc558\uae30 \ub54c\ubb38\uc785\ub2c8\ub2e4. \uc774\ub7ec\ud55c \ubc29\uc2dd\uc73c\ub85c, \ud488\uc9c8 \uc2dc\uc2a4\ud15c\uc774 \uc77c\uc0c1 \uc6b4\uc601\uc5d0 \ub0b4\uc7ac\ud654\ub41c \uc81c\uc870\uc5c5\uccb4\ub294 \uc911\ub2e8\uc744 \ud53c\ud558\uace0 \ub9ac\ub4dc \ud0c0\uc784\uc744 \ubcf4\ud638\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n
ISO 13485 PCBA \ud30c\ud2b8\ub108 \ud3c9\uac00: \uc911\uc694\ud55c \uae30\uc900<\/h2>\n\n\n
\uc81c\uc870\uc5c5\uccb4\ub294 \uc720\ud6a8\ud55c ISO 13485 \uc778\uc99d\uc11c\ub97c \uac16\uace0 \uc788\uac70\ub098 \uadf8\ub807\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \uadf8\ub7ec\ub098 \uc6b4\uc601\uc801 \uc131\uc219\ub3c4\ub294 \uc2a4\ud399\ud2b8\ub7fc\uc0c1\uc5d0 \uc788\uc73c\uba70, \uadf8 \uc2a4\ud399\ud2b8\ub7fc\uc5d0 \ub530\ub77c \ud30c\ud2b8\ub108\uac00 \ud504\ub85c\uadf8\ub7a8\uc744 \uac00\uc18d\ud654\ud558\uac70\ub098 \uc7a5\uc560\ub97c \uc720\ubc1c\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ud3c9\uac00\ub294 \uc9c4\uc815\ud55c \uaddc\uc728\uc744 \ub4dc\ub7ec\ub0b4\ub294 \uc2dc\uc2a4\ud15c\uc5d0 \ucd08\uc810\uc744 \ub9de\ucdb0\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n
\uc778\uc99d\uacfc \uc131\uc219\ub3c4:<\/strong> \ucd5c\uc2e0 \uac10\uc2dc \uac10\uc0ac \ubcf4\uace0\uc11c\ub97c \ud655\uc778\ud558\uc2ed\uc2dc\uc624. \uc8fc\uc694 \ubd80\uc801\ud569 \uc0ac\ud56d\uc774 \uc5c6\ub294 \uac83\uc740 \uc88b\uc740 \uc2e0\ud638\uc785\ub2c8\ub2e4. \uc81c\uc870\uc0ac\uac00 \uc778\uc99d\uc744 \uc720\uc9c0\ud55c \uae30\uac04\uc744 \ubb3c\uc5b4\ubcf4\uc2ed\uc2dc\uc624; \uc7a5\uae30\uc131\uc740 \ub0b4\uc7ac\ub41c \uaddc\uc728\uc744 \uc758\ubbf8\ud569\ub2c8\ub2e4. \uc778\uc99d\uc11c\uc758 \ubc94\uc704\uc5d0 PCB Contract Manufacturing\uc774 \uba85\uc2dc\ub418\uc5b4 \uc788\ub294\uc9c0 \uba85\ud655\ud788 \ud655\uc778\ud558\uc2ed\uc2dc\uc624.<\/p>\n\n\n\n\uc2dc\uc2a4\ud15c \ud1b5\ud569:<\/strong> DHR \uc2dc\uc2a4\ud15c\uc758 \uc2e4\uc2dc\uac04 \ub370\ubaa8\ub97c \uc694\uccad\ud558\uc138\uc694. \ud2b9\uc815 \ub85c\ud2b8\uc758 \uc804\uccb4 \uae30\ub85d\uc744 \uc2e4\uc2dc\uac04\uc73c\ub85c \uac00\uc838\uc624\ub294 \ub2a5\ub825\uc740 \uac15\ub825\ud55c \uc9c0\ud45c\uc785\ub2c8\ub2e4. UDI \ub77c\ubca8\ub9c1\uc774 \uc5b4\ub5bb\uac8c \ud1b5\ud569\ub418\uace0 \uac80\uc99d\ub418\ub294\uc9c0 \uc9c8\ubb38\ud558\uc138\uc694. \uc720\uc0ac \uc81c\ud488\uc5d0 \ub300\ud55c \ud504\ub85c\uc138\uc2a4 \uac80\uc99d \ubcf4\uace0\uc11c\ub97c \uac80\ud1a0\ud558\uc138\uc694. \uadf8 \uae4a\uc774\uc640 \uba85\ud655\uc131\uc740 \ud504\ub85c\uadf8\ub7a8\uc758 \uc131\uc219\ub3c4\ub97c \ubcf4\uc5ec\uc90d\ub2c8\ub2e4.<\/p>\n\n\n\n\ub514\uc790\uc778 \uc774\uad00\uc758 \ud22c\uba85\uc131:<\/strong> \ub514\uc790\uc778 \uc774\uad00 \uacfc\uc815\uc5d0\uc11c \uc560\ub9e4\ubaa8\ud638\ud568\uc774 \ud6c4\uc18d \uc9c0\uc5f0\uc744 \uc57c\uae30\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc131\uc219\ud55c \ud30c\ud2b8\ub108\ub294 \uc0dd\uc0b0 \uc2dc\uc791 \uc804\uc5d0 UDI \uc694\uad6c\uc0ac\ud56d, \ud575\uc2ec \uacf5\uc815 \ub9e4\uac1c\ubcc0\uc218, \uc2dc\ud5d8 \uae30\uc900\uc744 \uac80\uc99d\ud558\ub294 \uacf5\uc2dd \uccb4\ud06c\ub9ac\uc2a4\ud2b8\ub97c \uac16\ucd94\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc774 \uc808\ucc28\ub97c \ubcf4\uc5ec\ub2ec\ub77c\uace0 \uc694\uccad\ud558\uc138\uc694. \uadf8 \uc5c4\uaca9\ud568\uc740 \ud30c\ud2b8\ub108\uc2ed\uc758 \uc131\uacf5\uc744 \uc608\uce21\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n\uacbd\uace0 \uc2e0\ud638:<\/strong> DHR\uc744 \ube60\ub974\uac8c \uc0dd\uc0b0\ud558\uc9c0 \ubabb\ud558\uac70\ub098 \uc911\uc694 \uae30\ub85d\uc5d0 \uc885\uc774 \uae30\ubc18 \uc2dc\uc2a4\ud15c\uc744 \uc0ac\uc6a9\ud558\ub294 \uc81c\uc870\uc5c5\uccb4\ub294 \uc8fc\uc758\ud558\uc138\uc694. \ud658\uacbd \ubaa8\ub2c8\ud130\ub9c1\uc774 \uc218\ub3d9\uc801\uc774\uace0 \ub4dc\ubb3c\uac8c \uc774\ub8e8\uc5b4\uc9c0\ub294 \uc2dc\uc124\ub3c4 \uc8fc\uc758\ud558\uc138\uc694. \ubcc0\uacbd \ud1b5\uc81c \uacfc\uc815\uc744 \uba85\ud655\ud788 \uc124\uba85\ud558\uc9c0 \ubabb\ud558\uac70\ub098 \uc778\uc99d\uc5d0 \ub204\ub77d\uc774 \uc788\uc5c8\ub358 \ud30c\ud2b8\ub108\ub3c4 \uc8fc\uc758\ud558\uc138\uc694. \uc774\ub294 \ud488\uc9c8 \uc2dc\uc2a4\ud15c\uc774 \ubb38\uc11c\uc0c1\uc73c\ub85c\ub9cc \uc874\uc7ac\ud558\uace0 \uc2e4\uc81c\ub85c\ub294 \uc791\uc6a9\ud558\uc9c0 \uc54a\ub294 \uc2e0\ud638\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n\uc81c\uc870 \ud30c\ud2b8\ub108\uc758 \uc120\ud0dd\uc740 \uc81c\ud488\uc758 \ud488\uc9c8\ubfd0\ub9cc \uc544\ub2c8\ub77c \uc2dc\uc7a5 \ucd9c\uc2dc \uc18d\ub3c4\uc5d0\ub3c4 \uc601\ud5a5\uc744 \ubbf8\uce69\ub2c8\ub2e4. ISO 13485 \uc2dc\uc2a4\ud15c\uc774 \uc2e4\uc81c\ub85c \uc6b4\uc601\uc5d0 \ub0b4\uc7ac\ub41c \ud30c\ud2b8\ub108\ub294 \uaddc\uc815 \uc900\uc218\uc758 \ubd80\ub2f4\uc73c\ub85c \uc778\ud574 \uc18d\ub3c4\uac00 \ub290\ub824\uc9c0\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \ub300\uc2e0 \uc7ac\uc791\uc5c5\uacfc \uae34\uae09 \uc870\uce58\ub97c \uc81c\uac70\ud558\uc5ec \ud504\ub85c\uadf8\ub7a8\uc744 \uac00\uc18d\ud654\ud569\ub2c8\ub2e4. \uc774 \uaddc\uc728\uc774 \uc18d\ub3c4\ub97c \uac00\ub2a5\ud558\uac8c \ud569\ub2c8\ub2e4.<\/p>","protected":false},"excerpt":{"rendered":"
\ub9ce\uc740 \uc0ac\ub78c\ub4e4\uc774 ISO 13485\uc758 \uc5c4\uaca9\ud55c \uaddc\uc81c \uaddc\uc728\uc774 \uc758\ub8cc\uae30\uae30 PCBA \uc81c\uc870\ub97c \ub290\ub9ac\uac8c \ub9cc\ub4e0\ub2e4\uace0 \uc0dd\uac01\ud569\ub2c8\ub2e4. \uc774\uac83\uc740 \uc624\ud574\uc785\ub2c8\ub2e4. \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc774 \uc6b4\uc601\uc758 \ud575\uc2ec\uc5d0 \uad6c\ucd95\ub418\uc5b4 \uc788\uc744 \ub54c, \uc2e4\uc2dc\uac04 \uc7a5\uce58 \uc774\ub825 \uae30\ub85d\uacfc \uac80\uc99d\ub41c \ud504\ub85c\uc138\uc2a4\uc640 \uac19\uc740 \ucd94\uc801 \uac00\ub2a5\uc131\uacfc \ubc18\ubcf5 \uac00\ub2a5\uc131\uc744 \ubcf4\uc7a5\ud558\ub294 \uba54\ucee4\ub2c8\uc998\uc774 \uc18d\ub3c4\uc640 \ud6a8\uc728\uc131\uc744 \ub192\uc774\ub294 \ucd09\ub9e4\uc81c\uac00 \ub418\uc5b4 \uc9c0\uc5f0\uc744 \uc81c\uac70\ud558\uace0 \uc9c0\uc18d\uc801\uc778 \uac10\uc0ac \uc900\ube44\ud0dc\uc138\ub97c \ubcf4\uc7a5\ud569\ub2c8\ub2e4.<\/p>","protected":false},"author":1,"featured_media":9793,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"article_term":"","article_term_alternate":"","article_term_def":"","article_hook":"","auto_links":"","article_topic":"","article_fact_check":"","mt_social_share":"","mt_content_meta":"","mt_glossary_display":"","glossary_heading":"","glossary":"","glossary_alter":"","glossary_def":"","article_task":"Medical device builds at Bester PCBA with ISO 13485 discipline and speed","footnotes":""},"categories":[12],"tags":[],"class_list":["post-9794","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"_links":{"self":[{"href":"https:\/\/www.besterpcba.com\/ko\/wp-json\/wp\/v2\/posts\/9794","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.besterpcba.com\/ko\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.besterpcba.com\/ko\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.besterpcba.com\/ko\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.besterpcba.com\/ko\/wp-json\/wp\/v2\/comments?post=9794"}],"version-history":[{"count":1,"href":"https:\/\/www.besterpcba.com\/ko\/wp-json\/wp\/v2\/posts\/9794\/revisions"}],"predecessor-version":[{"id":9800,"href":"https:\/\/www.besterpcba.com\/ko\/wp-json\/wp\/v2\/posts\/9794\/revisions\/9800"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.besterpcba.com\/ko\/wp-json\/wp\/v2\/media\/9793"}],"wp:attachment":[{"href":"https:\/\/www.besterpcba.com\/ko\/wp-json\/wp\/v2\/media?parent=9794"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.besterpcba.com\/ko\/wp-json\/wp\/v2\/categories?post=9794"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.besterpcba.com\/ko\/wp-json\/wp\/v2\/tags?post=9794"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\uc720\ub2db \ub808\ubca8 \uc9c1\ub82c\ud654\uac00 \uc694\uad6c\ub420 \ub54c, \uc81c\uc870\uc5c5\uccb4\ub294 \uac01 \ud68c\ub85c\ud310\uc5d0 \uace0\uc720\ud55c \uc77c\ub828\ubc88\ud638\ub97c \uc0dd\uc131\ud558\uace0 \uc774\ub97c UDI \ub77c\ubca8\uc5d0 \uc778\ucf54\ub529\ud574\uc57c \ud569\ub2c8\ub2e4. \uc774\ub294 \uc911\ubcf5\uc744 \ubc29\uc9c0\ud558\uace0 \uac01 \uc77c\ub828\ubc88\ud638\ub97c \ud2b9\uc815 \uc720\ub2db \uc774\ub825\uacfc \uc601\uad6c\uc801\uc73c\ub85c \uc5f0\uacb0\ud558\ub294 DHR \ub370\uc774\ud130\ubca0\uc774\uc2a4\uc640 \uc778\ud130\ud398\uc774\uc2a4\ud558\ub294 \uc9c1\ub82c\ud654 \uc2dc\uc2a4\ud15c\uc774 \ud544\uc694\ud569\ub2c8\ub2e4. \uac80\uc99d \ub2e8\uacc4\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \uc801\uc6a9 \ud6c4 \uc989\uc2dc \uc2a4\uce94\ud558\uc5ec \ub77c\ubca8\uc774 \uc77d\uc744 \uc218 \uc788\uace0 \uc815\ud655\ud55c\uc9c0 \ud655\uc778\ud558\uba70, \uc2e4\ud328\ud558\ub294 \uc720\ub2db\uc740 \uc790\ub3d9\uc73c\ub85c \ud45c\uc2dc\ub429\ub2c8\ub2e4. \uc131\uc219\ud55c \ud30c\ud2b8\ub108\ub294 \uc0dd\uc0b0 \uc2dc\uc791 \uc804\uc5d0 \ubaa8\ub4e0 UDI \uc0ac\uc591\uc758 \uc644\uc804\uc131\uc744 \uac80\uc99d\ud558\ub294 \uc124\uacc4 \uc774\uc804 \uc804\ub2ec \ud504\ub85c\uc138\uc2a4\ub97c \uac16\ucd94\uace0 \uc788\uc5b4, \ube44\uc6a9\uc774 \ub9ce\uc774 \ub4dc\ub294 \ub2e4\uc6b4\uc2a4\ud2b8\ub9bc \ubc29\ud574\ub97c \ubc29\uc9c0\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n
\ud504\ub85c\uc138\uc2a4 \uac80\uc99d: \ubc18\ubcf5 \uac00\ub2a5\uc131 \uad6c\ucd95<\/h2>\n\n\n
\ud504\ub85c\uc138\uc2a4 \uac80\uc99d\uc740 \uc81c\uc870 \uacf5\uc815\uc774 \ubaa8\ub4e0 \uc694\uad6c \uc0ac\ud56d\uc744 \uc9c0\uc18d\uc801\uc73c\ub85c \ucda9\uc871\ud558\ub294 \uc870\ub9bd\ud488\uc744 \uc77c\uad00\ub418\uac8c \uc0dd\uc0b0\ud560 \uac83\uc784\uc744 \uacf5\uc2dd\uc801\uc73c\ub85c \uc785\uc99d\ud558\ub294 \ubb38\uc11c\ud654\ub41c \uc99d\uac70\uc785\ub2c8\ub2e4. \uc774\ub294 \uacf5\uc815 \uac1c\ubc1c\uc774 \uc544\ub2c8\ub77c, \uc815\uc758\ub41c \ub9e4\uac1c\ubcc0\uc218 \ub0b4\uc5d0\uc11c \uc791\ub3d9\ud558\ub294 \uacf5\uc815\uc774 \ub9e4\ubc88 \uc801\ud569\ud55c \ucd9c\ub825\ubb3c\uc744 \ub9cc\ub4e4\uc5b4\ub0bc \uac83\uc784\uc744 \ucd5c\uc885\uc801\uc73c\ub85c \ubcf4\uc5ec\uc8fc\ub294 \uc99d\uba85\uc785\ub2c8\ub2e4. ISO 13485 \ud558\uc5d0\uc11c, \uc911\uc694 \uacf5\uc815\uc740 \uc77c\uc0c1 \uc0dd\uc0b0\uc5d0 \uc0ac\uc6a9\ub418\uae30 \uc804\uc5d0 \uac80\uc99d\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n
PCB \uc870\ub9bd \uc81c\uc870\uc758 \uacbd\uc6b0, \uc7ac\ud50c\ub85c\uc6b0 \uc194\ub354\ub9c1, \ucee8\ud3ec\uba40 \ucf54\ud305, \uc790\ub3d9 \uac80\uc0ac\uc640 \uac19\uc740 \uacf5\uc815\uc740 \uac80\uc99d\uc774 \ud544\uc694\ud569\ub2c8\ub2e4. \uadf8 \uc774\uc720\ub294, \uc194\ub354 \uc870\uc778\ud2b8 \ub0b4\ubd80 \uc644\uc804\uc131 \uac19\uc740 \uacb0\uacfc\uc758 \ud488\uc9c8\uc744 \uc0ac\ud6c4 \uac80\uc99d\ud560 \uc218 \uc5c6\ub2e4\uba74, \uacf5\uc815 \uc790\uccb4\uac00 \uac80\uc99d \uac00\ub2a5\ud558\ub2e4\ub294 \uac83\uc744 \uc99d\uba85\ud574\uc57c \ud558\uae30 \ub54c\ubb38\uc785\ub2c8\ub2e4. \ud488\uc9c8\uc744 \uac80\uc0ac\ud560 \uc218 \uc5c6\uc744 \ub54c\ub294, \ud488\uc9c8\uc744 \ub0b4\uc7ac\ud654\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n
\ud504\ub85c\uc138\uc2a4 \uac80\uc99d\uc774 \uc99d\uba85\ud558\ub294 \uac83\uacfc \ubc1c\uc0dd\ud558\ub294 \uc2dc\uae30<\/h3>\n\n\n
\uc804\uccb4 \ud504\ub85c\uc138\uc2a4 \uac80\uc99d\uc740 \uacf5\uc2dd \ud504\ub85c\ud1a0\ucf5c\uc744 \ub530\ub985\ub2c8\ub2e4: \uc124\ube44 \uc801\ud569\uc131 \uc2dc\ud5d8 (IQ), \uc791\ub3d9 \uc801\ud569\uc131 \uc2dc\ud5d8 (OQ), \uc131\ub2a5 \uc801\ud569\uc131 \uc2dc\ud5d8 (PQ). IQ\ub294 \uc7a5\ube44\uac00 \uc62c\ubc14\ub974\uac8c \uc124\uce58\ub418\uace0 \ubb38\uc11c\ud654\ub418\uc5c8\uc74c\uc744 \ud655\uc778\ud569\ub2c8\ub2e4. OQ\ub294 \uc7a5\ube44\uac00 \uc758\ub3c4\ub41c \ud30c\ub77c\ubbf8\ud130 \ubc94\uc704 \ub0b4\uc5d0\uc11c \uc81c\ub300\ub85c \uc791\ub3d9\ud558\ub294\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4. PQ\ub294 \uac00\uc7a5 \uc5c4\uaca9\ud55c \ub2e8\uacc4\ub85c, \uc0dd\uc0b0\uc744 \ub300\ud45c\ud558\ub294 \uc870\ub9bd\ud488\uc744 \uacf5\uc815\uc744 \ud1b5\ud574 \ud14c\uc2a4\ud2b8\ud558\uc5ec \ucd9c\ub825\uc774 \ubaa8\ub4e0 \uc218\uc6a9 \uae30\uc900\uc744 \uc77c\uad00\ub418\uac8c \ucda9\uc871\ud558\ub294\uc9c0 \uc785\uc99d\ud558\ub294 \uacfc\uc815\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n
\uc774 \uac80\uc99d\uc740 \uc0c1\uc5c5\uc801 \uc0dd\uc0b0\uc5d0 \uacf5\uc815\uc744 \uc0ac\uc6a9\ud558\uae30 \uc804\uc5d0 \uc644\ub8cc\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. \uc774\ub294 \uc0c8\ub85c\uc6b4 \uc81c\ud488\uc5d0 \ub300\ud55c \uc120\ud589 \uc2dc\uac04 \ud22c\uc790\ub97c \uc694\uad6c\ud558\uc9c0\ub9cc, \uac80\uc99d\ub41c \uacf5\uc815\uc740 \uc774\ud6c4 \uc18d\ub3c4\ub97c \uac00\ub2a5\ud558\uac8c \ud569\ub2c8\ub2e4. \uc774 \uacf5\uc815\uc740 \uc77c\uc0c1 \uc0ac\uc6a9\uc744 \uc704\ud574 \uc801\uaca9\ud558\uba70, \ud3ec\uad04\uc801\uc778 \uac1c\ubcc4 \uc720\ub2db \uac80\uc99d \uc5c6\uc774 \uc0dd\uc0b0\uc744 \uc9c4\ud589\ud560 \uc218 \uc788\ub3c4\ub85d \ud5c8\uc6a9\ud569\ub2c8\ub2e4.<\/p>\n\n\n
\uac80\uc99d\uacfc \uc720\uc5f0\uc131\uc758 \uad00\uacc4<\/h3>\n\n\n
\uac80\uc99d\ub41c \uacf5\uc815\uc740 \uc7a0\uae08\ub41c \uacf5\uc815\uc774 \uc544\ub2c8\uc9c0\ub9cc, \uc5b4\ub5a4 \ubcc0\uacbd\uc774\ub77c\ub3c4 \uacf5\uc2dd\uc801\uc778 \ubcc0\uacbd \ud1b5\uc81c \uc808\ucc28\ub97c \ud1b5\ud574 \uad00\ub9ac\ud574\uc57c \ud569\ub2c8\ub2e4. \ubb34\uc2dc\ud560 \uc218 \uc5c6\ub294 \uc791\uc740 \uc870\uc815\uc740 \uc870\uce58\uac00 \ud544\uc694 \uc5c6\uc744 \uc218 \uc788\uc9c0\ub9cc, \uc0c8\ub85c\uc6b4 \ubd80\ud488 \uc720\ud615 \ub3c4\uc785\uc774\ub098 \uc194\ub354 \ud398\uc774\uc2a4\ud2b8 \uad50\uccb4\uc640 \uac19\uc740 \ud070 \ubcc0\uacbd\uc740 \uc7ac\uac80\uc99d\uc744 \uc694\uad6c\ud558\uac8c \ub429\ub2c8\ub2e4.<\/p>\n\n\n\n
\uc131\uc219\ud55c \uac80\uc99d \ud504\ub85c\uadf8\ub7a8\uc744 \uac00\uc9c4 \uc81c\uc870\uc5c5\uccb4\ub294 \uc774\ub7ec\ud55c \ubcc0\uacbd\uc744 \ud3c9\uac00\ud558\uace0 \uc7ac\uac80\uc99d\uc744 \ud6a8\uc728\uc801\uc73c\ub85c \uc218\ud589\ud558\ub294 \uba85\ud655\ud55c \uc808\ucc28\ub97c \uac16\ucd94\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uadf8\ub4e4\uc740 \uc7ac\uac80\uc99d\uc774 \ud544\uc694\ud560 \ub54c \uc2e0\uc18d\ud558\uac8c \ub300\uc751\ud560 \uc218 \uc788\ub3c4\ub85d \uacfc\uac70 \ub370\uc774\ud130\ub97c \ud65c\uc6a9\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uaddc\uc728\uc774 \uc57d\ud55c \uc81c\uc870\uc5c5\uccb4\ub294 \ubaa8\ub4e0 \ubcc0\ud654\ub97c \uc704\uae30\ucc98\ub7fc \ub2e4\ub8e8\uba70, \uae34 \uc7ac\uac80\uc99d \uc808\ucc28\ub85c \uc0dd\uc0b0\uc744 \uc9c0\uc5f0\uc2dc\ud0a4\ub294 \uacbd\ud5a5\uc774 \uc788\uc2b5\ub2c8\ub2e4. \ucc28\uc774\uc810\uc740 \uaddc\uc81c \uadf8 \uc790\uccb4\uac00 \uc544\ub2c8\ub77c, \uc774\ub97c \ucda9\uc871\uc2dc\ud0a4\uae30 \uc704\ud574 \uc124\uacc4\ub41c \uc2dc\uc2a4\ud15c\uc758 \uc131\uc219\ub3c4\uc785\ub2c8\ub2e4.<\/p>\n\n\n
\ud1b5\uc81c\ub41c \uc800\uc7a5 \ubc0f \ud658\uacbd \ubaa8\ub2c8\ud130\ub9c1<\/h2>\n\n\n
\uc758\ub8cc\uae30\uae30 \uc870\ub9bd\ud488\uc740 \uc0dd\uc0b0 \ub77c\uc778\uc744 \ub5a0\ub09c \ud6c4\uc5d0\ub3c4 \ube44\ud65c\uc131 \uc0c1\ud0dc\uac00 \uc544\ub2c8\uba70, \ud488\uc9c8\uc744 \uc800\ud558\uc2dc\ud0a4\ub294 \ud658\uacbd\uc801 \uc704\ud5d8\uc5d0 \uacc4\uc18d \ub178\ucd9c\ub429\ub2c8\ub2e4. \ud1b5\uc81c\ub41c \uc800\uc7a5\uc740 \uc804\uc790\uae30 \ubc29\uc804(ESD), \uc2b5\uae30, \uc624\uc5fc, \ud63c\ub3d9\uc73c\ub85c\ubd80\ud130 \uc870\ub9bd\ud488\uc744 \ubcf4\ud638\ud558\ub294 \ud3ec\uc2a4\ud2b8-\uc0dd\uc0b0 \ub2e8\uacc4\uc758 \ud488\uc9c8 \uc2dc\uc2a4\ud15c\uc744 \uc5f0\uc7a5\ud558\uc5ec, \ubc30\uc1a1\ub420 \ub54c\uae4c\uc9c0 \uc774\ub97c \ubcf4\ud638\ud569\ub2c8\ub2e4.<\/p>\n\n\n
ISO 13485\ub294 \uc800\uc7a5 \uc870\uac74\uc744 \uc815\uc758\ud558\uace0 \ubaa8\ub2c8\ud130\ub9c1\ud558\uba70 \uae30\ub85d\ud560 \uac83\uc744 \uc694\uad6c\ud569\ub2c8\ub2e4. PCBAs\uc758 \uacbd\uc6b0, \uc774\ub294 \uac15\ub825\ud55c ESD \ubcf4\ud638, \uc2b5\uae30 \ubbfc\uac10 \ubd80\ud488\uc744 \uc704\ud55c \uc628\ub3c4 \ubc0f \uc2b5\ub3c4 \uad00\ub9ac, \uc785\uc790 \uc624\uc5fc \ubc29\uc9c0\ub97c \uc704\ud55c \uccad\uacb0 \ud504\ub85c\ud1a0\ucf5c\uc744 \uc758\ubbf8\ud569\ub2c8\ub2e4. \uc774\ub7ec\ud55c \ud1b5\uc81c \uac15\ub3c4\ub294 \uae30\uae30\uc758 \uc704\ud5d8 \ud504\ub85c\ud30c\uc77c\uc5d0 \ub530\ub77c \ub2ec\ub77c\uc9d1\ub2c8\ub2e4.<\/p>\n\n\n
\ud1b5\uc81c \ubc94\uc8fc: ESD, \ud658\uacbd, \uc624\uc5fc<\/h3>\n\n\n
ESD\ub294 \uc798 \uc54c\ub824\uc9c4 \uc704\ud5d8\uc774\uc9c0\ub9cc, \uc7a0\uc7ac \uacb0\ud568\uc774 \uc784\uc0c1 \uc0ac\uc6a9\uae4c\uc9c0 \ub4dc\ub7ec\ub098\uc9c0 \uc54a\uc744 \uc218 \uc788\ub294 \uc758\ub8cc \uae30\uae30\uc5d0\uc11c\ub294 \ub354 \uc911\uc694\ud55c \uc758\ubbf8\ub97c \uac00\uc9d1\ub2c8\ub2e4. \uc800\uc7a5 \uacf5\uac04\uc740 ESD \ubcf4\ud638\uac00 \ub418\uc5b4\uc57c \ud558\uba70, \uc870\ub9bd\ud488\uc740 \ub2e4\ub978 \ud1b5\uc81c\ub41c \ud658\uacbd\uc5d0 \ub3c4\ub2ec\ud560 \ub54c\uae4c\uc9c0 \ubcf4\ud638 \ud3ec\uc7a5 \uc0c1\ud0dc\ub97c \uc720\uc9c0\ud574\uc57c \ud569\ub2c8\ub2e4. \uc2b5\uae30 \ubbfc\uac10 \ubd80\ud488\uc774\ub098 \ud2b9\uc815 \uacbd\ud654 \uc870\uac74\uc774 \ud544\uc694\ud55c \ucf54\ud305\uc5d0 \ub300\ud574 \uc628\ub3c4 \ubc0f \uc2b5\ub3c4 \uc870\uc808\uc774 \ub9e4\uc6b0 \uc911\uc694\ud569\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uad6c\uc5ed\uc740 \ud658\uacbd \ub370\uc774\ud130\ub97c \uc9c0\uc18d\uc801\uc73c\ub85c \uae30\ub85d\ud558\uace0 \uae30\uc900 \ucd08\uacfc \uc0c1\ud0dc\uc5d0 \ub300\ud574 \uacbd\ubcf4\ub97c \uc6b8\ub9ac\ub294 \uc2dc\uc2a4\ud15c\uc744 \uac16\ucd94\uc5b4\uc57c \ud569\ub2c8\ub2e4. \uc624\uc5fc \ubc29\uc9c0\ub294 \uc774\uc2dd \uac00\ub2a5\ud558\uac70\ub098 \uba78\uade0\ub41c \uc7a5\uce58\uc5d0 \uc0ac\uc6a9\ub418\ub294 \uc870\ub9bd\ud488\uc5d0 \ud544\uc218\uc801\uc774\uba70, \uc804\uc6a9 \uc800\uc7a5 \uacf5\uac04\uacfc \ud1b5\uc81c\ub41c \ucd9c\uc785 \ubc0f \uacf5\uae30 \uc5ec\uacfc \uc2dc\uc2a4\ud15c\uc744 \uac16\ucd94\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n
\uc800\uc7a5 \ucd94\uc801\uc131: \ub85c\ud2b8 \uad6c\ubd84 \ubc0f FIFO<\/h3>\n\n\n
\ud658\uacbd \uc694\uc18c\ub97c \ub118\uc5b4\uc11c, \uc800\uc7a5\uc740 \ucd94\uc801\uc131 \uccb4\ud06c\ud3ec\uc778\ud2b8\uc785\ub2c8\ub2e4. \uc870\ub9bd\ud488\uc740 \ub85c\ud2b8 \ub610\ub294 \uc81c\ud488 \ubc84\uc804 \uac04 \ud63c\ub3d9\uc744 \ubc29\uc9c0\ud558\ub3c4\ub85d \uc800\uc7a5\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. \uc774\ub294 \ubb3c\ub9ac\uc801 \uad6c\ubd84, \uba85\ud655\ud55c \ub77c\ubca8\ub9c1, \ub85c\ud2b8 \uc2dd\ubcc4\uc744 \uac15\uc81c\ud558\ub294 \uc7ac\uace0 \uc2dc\uc2a4\ud15c\uc774 \ud544\uc694\ud569\ub2c8\ub2e4. \uc120\uc785\uc120\ucd9c(FIFO) \uc6d0\uce59\uc740 \uc720\ud1b5\uae30\ud55c \uc704\ud5d8\uc744 \ucd5c\uc18c\ud654\ud558\uae30 \uc704\ud55c \ud45c\uc900 \uad00\ud589\uc785\ub2c8\ub2e4. \uc785\uace0\ubd80\ud130 \ucd9c\ud558\uae4c\uc9c0 \ubaa8\ub4e0 \uc800\uc7a5 \uc774\ubca4\ud2b8\ub294 \uae30\ub85d\ub418\uc5b4\uc57c \ud558\uba70 DHR\uacfc \uc5f0\uacc4\ub418\uc5b4\uc57c \ud558\uba70, \uc774\ub97c \ud1b5\ud574 \uc2dc\uc7a5 \uc774\ud6c4 \ubb38\uc81c\uc5d0 \uc2e0\uc18d\ud558\uace0 \uc815\ud655\ud558\uac8c \ub300\uc751\ud560 \uc218 \uc788\ub294 \ub04a\uae40 \uc5c6\ub294 \uccb4\uc778 \uad6c\uc131\uc774 \uc774\ub8e8\uc5b4\uc9d1\ub2c8\ub2e4.<\/p>\n\n\n
\uc9c0\uc18d\uc801\uc778 \uac10\uc0ac \uc900\ube44: \uc911\ub2e8\uc744 \ubc29\uc9c0\ud558\ub294 \uc2dc\uc2a4\ud15c<\/h2>\n\n\n
ISO 13485 \uac10\uc0ac\ub294 \uae5c\uc9dd \uc774\ubca4\ud2b8\uac00 \uc544\ub2d9\ub2c8\ub2e4. \uc778\uc99d \uae30\uad00\uc758 \uac10\uc2dc \uac10\uc0ac\uc640 FDA \uac19\uc740 \uaddc\uc81c \uae30\uad00\uc758 \uaddc\uc81c \uac10\uc0ac\ub294 \uc77c\uc815\uc5d0 \ub530\ub77c \ub610\ub294 \uc720\ubc1c \uc0ac\uac74\uc5d0 \ub300\uc751\ud558\uc5ec \ubc1c\uc0dd\ud569\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uac10\uc0ac\uc758 \ub0b4\uc6a9\ub3c4 \ube44\ubc00\uc774 \uc544\ub2c8\uba70, \uac10\uc0ac\uc790\ub294 \uae30\ub85d\uc744 \uac80\ud1a0\ud558\uace0, \ud504\ub85c\uc138\uc2a4\ub97c \uad00\ucc30\ud558\uba70, \ubb38\uc11c\ud654\ub41c \uc808\ucc28\uac00 \uc900\uc218\ub418\uace0 \uc788\ub294\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n
\uc6d0\ud65c\ud55c \uac10\uc0ac\uc640 \ubc29\ud574\uac00 \ub418\ub294 \uac10\uc0ac\uc758 \ucc28\uc774\ub294 \uc6b4\uc601 \uc0c1\ud0dc\uc5d0 \uc788\uc2b5\ub2c8\ub2e4. \uc9c0\uc18d\uc801\uc778 \uaddc\uc815 \uc900\uc218 \uc0c1\ud0dc\uc5d0\uc11c \uc6b4\uc601\ub418\ub294 \uc81c\uc870\uc5c5\uccb4\ub294 - \ubaa8\ub4e0 \ud504\ub85c\uc138\uc2a4\uac00 \uc2e4\uc2dc\uac04\uc73c\ub85c \uac10\uc0ac \uc900\ube44\ub41c \uae30\ub85d\uc744 \uc0dd\uc131\ud558\uace0 \ud3b8\ucc28\ub97c \uc989\uc2dc \ucc98\ub9ac\ud558\ub294 \uacbd\uc6b0 - \uac10\uc0ac\uac00 \ubc1c\uacac\uc774 \uc544\ub2cc \uac80\uc99d\uc774 \ub429\ub2c8\ub2e4. \uc0dd\uc0b0\uc740 \uba48\ucd94\uc9c0 \uc54a\uace0, \uc5d4\uc9c0\ub2c8\uc5b4\ub4e4\uc740 \ud5c8\ub465\uc9c0\ub465 \ubb38\uc11c \uac80\uc0c9\uc5d0 \ubab0\ub450\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \uac10\uc0ac\uad00\uc758 \uc9c8\ubb38\uc5d0 \ub300\ud55c \ub2f5\ubcc0\uc740 \uc774\ubbf8 \ucde8\ud569\ub418\uc5b4 \uc811\uadfc \uac00\ub2a5\ud55c \ub370\uc774\ud130\ub85c \uc81c\uacf5\ub429\ub2c8\ub2e4.<\/p>\n\n\n
\uc77c\uc77c \uaddc\uc728\uc774 \uc5b4\ub5bb\uac8c \uc601\uad6c\uc801\uc778 \uac10\uc0ac \uc900\ube44\ub97c \ub9cc\ub4e4\uc5b4\ub0b4\ub294\uac00<\/h3>\n\n\n
\uc9c0\uc18d\uc801 \uac10\uc0ac \uc900\ube44 \uc0c1\ud0dc\ub780 \ud488\uc9c8 \uc2dc\uc2a4\ud15c\uc774 \uc5b8\uc81c\ub4e0\uc9c0 \ub3cc\ubc1c \uac80\uc0ac\uc5d0 \ub300\ube44\ud560 \uc218 \uc788\uc74c\uc744 \uc758\ubbf8\ud569\ub2c8\ub2e4. '\ud2b9\ubcc4 \uc900\ube44 \ubaa8\ub4dc'\ub294 \uc5c6\uc2b5\ub2c8\ub2e4. \uac10\uc0ac\uc790\uac00 \uc694\uccad\ud558\ub294 \uae30\ub85d\ub4e4 - DHR, \uc2dc\uc815 \ubc0f \uc608\ubc29 \uc870\uce58(CAPA), \uac80\uc99d \ud504\ub85c\ud1a0\ucf5c, \uad50\uc721 \ud589\ub82c, \ubcf4\uc815 \ub85c\uadf8 - \uc740 \uc77c\uc0c1 \uc5c5\ubb34\uc758 \uc77c\ubd80\ub85c \uc720\uc9c0\ub418\uba70, \uac10\uc0ac\uac00 \uc608\uc815\ub420 \ub54c \uae09\ud558\uac8c \uc900\ube44\ud558\ub294 \uac83\uc774 \uc544\ub2d9\ub2c8\ub2e4.<\/p>\n\n\n\n
\uc774 \uc0c1\ud0dc\ub294 \uc790\ub3d9\ud654\uc640 \uaddc\uc728\uc744 \ud1b5\ud574 \ub2ec\uc131\ub429\ub2c8\ub2e4. \ub514\uc9c0\ud138 DHR \uc2dc\uc2a4\ud15c\uc740 \ubc31\ub85c\uadf8\ub97c \uc81c\uac70\ud569\ub2c8\ub2e4. \uc790\ub3d9 \ubcf4\uc815 \ucd94\uc801\uc740 \uc7a5\ube44\uc758 \ub9cc\ub8cc \uc804\uc5d0 \uc54c\ub9bd\ub2c8\ub2e4. \uad50\uc721 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc740 \uc790\uaca9\uc744 \uac16\ucd98 \uc778\ub825\ub9cc\uc774 \uc791\uc5c5\uc744 \uc218\ud589\ud558\ub3c4\ub85d \ubcf4\uc7a5\ud569\ub2c8\ub2e4. CAPA \uc2dc\uc2a4\ud15c\uc740 \ubb38\uc81c\uc758 \uc2dd\ubcc4\ubd80\ud130 \uc885\ub8cc\uae4c\uc9c0 \ucd94\uc801\ud569\ub2c8\ub2e4. \uc774\ub4e4\uc740 \uac10\uc0ac \ub3c4\uad6c\uac00 \uc544\ub2c8\ub77c, \uac10\uc0ac \uc900\ube44\uac00 \ub41c \uc0b0\ucd9c\ubb3c\uc744 \uc0dd\uc131\ud558\ub294 \uc0dd\uc0b0 \ub3c4\uad6c\uc785\ub2c8\ub2e4.<\/p>\n\n\n
\uac10\ub3c5\uad00\uc774 \uc0b4\ud3b4\ubcf4\ub294 \uac83\uacfc \uc2dc\uc2a4\ud15c\uc774 \uc5b4\ub5bb\uac8c \ubc18\uc751\ud558\ub294\uc9c0<\/h3>\n\n\n
\uac10\uc0ac\uad00\uc774 PCB \uacf5\uc7a5\uc5d0 \ub4e4\uc5b4\uc624\uba74, \uadf8\ub4e4\uc740 DHR, \uac80\uc99d \uae30\ub85d \ubc0f \ubcc0\uacbd \ud1b5\uc81c \uc99d\uac70\ub97c \uc694\uccad\ud569\ub2c8\ub2e4. \uadf8\ub4e4\uc740 \uc0dd\uc0b0 \ud604\uc7a5\uc744 \uad00\ucc30\ud558\uace0 \uc9c1\uc6d0\ub4e4\uacfc \uc778\ud130\ubdf0\ub97c \ud569\ub2c8\ub2e4. \uc9c0\uc18d\uc801\uc73c\ub85c \uaddc\uc815\uc744 \uc900\uc218\ud558\ub294 \uc2dc\uc2a4\ud15c\uc740 \uc9c0\uc5f0 \uc5c6\uc774 \ub300\uc751\ud569\ub2c8\ub2e4. DHR\uc740 \uba87 \ubd84 \ub9cc\uc5d0 \ub370\uc774\ud130\ubca0\uc774\uc2a4\uc5d0\uc11c \uac00\uc838\uc624\uba70, \uac80\uc99d \uae30\ub85d\uc740 \uad6c\uc870\ud654\ub41c \uc800\uc7a5\uc18c\uc5d0 \uc788\uc2b5\ub2c8\ub2e4. CAPA \ub370\uc774\ud130\ubca0\uc774\uc2a4\ub294 \ubb38\uc81c\uac00 \uc885\ub8cc\ub420 \ub54c\uae4c\uc9c0 \ucd94\uc801\ub428\uc744 \ubcf4\uc5ec\uc90d\ub2c8\ub2e4. \uac10\uc0ac\uad00\uc758 \ubc29\ubb38\uc740 \uac80\uc99d\uc774 \ub418\uba70, \uc870\uc0ac\ub85c \uc774\uc5b4\uc9c0\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n
\uc774\uc0c1\uc801\uc73c\ub85c, \uc900\uc218\uc131\uc774 \uc8fc\uae30\uc801\uc778 \uc6b4\uc601\uacfc\ub294 \ub300\uc870\uc801\uc785\ub2c8\ub2e4. \uac10\uc0ac\ub294 \ud63c\ub780\uc744 \uc57c\uae30\ud569\ub2c8\ub2e4. \uc5d4\uc9c0\ub2c8\uc5b4\ub4e4\uc740 \uc624\ub798\ub41c \ubcf4\uace0\uc11c\ub97c \ucc3e\uae30 \uc704\ud574 \ud5e4\ub9e4\uace0, \uc11c\ub958 \uc815\ub9ac\ub97c \uc704\ud574 \uc0dd\uc0b0\uc774 \uc77c\uc2dc \uc911\ub2e8\ub429\ub2c8\ub2e4. \ub0b4\ubd80 \uc2dc\uc2a4\ud15c\uc774 \ubc1c\uacac\ud588\uc5b4\uc57c \ud560 \ucc28\uc774\uc810\uc744 \uac10\uc0ac\uac00 \ub4dc\ub7ec\ub0b4\ub294 \uacbd\uc6b0\ub3c4 \ub9ce\uc73c\uba70, \uc774\ub294 \uc9c0\uc5f0\uacfc \ube44\uc6a9\uc774 \ub9ce\uc774 \ub4dc\ub294 \uc218\uc815 \uc870\uce58\ub97c \ucd08\ub798\ud569\ub2c8\ub2e4. \uc774\ub294 \uac10\uc0ac\uad00\uc774 \uc801\ub300\uc801\uc774\uae30 \ub54c\ubb38\uc774 \uc544\ub2c8\uba70, \uc2dc\uc2a4\ud15c\uc774 \uc900\ube44\ub418\uc9c0 \uc54a\uc558\uae30 \ub54c\ubb38\uc785\ub2c8\ub2e4. \uc774\ub7ec\ud55c \ubc29\uc2dd\uc73c\ub85c, \ud488\uc9c8 \uc2dc\uc2a4\ud15c\uc774 \uc77c\uc0c1 \uc6b4\uc601\uc5d0 \ub0b4\uc7ac\ud654\ub41c \uc81c\uc870\uc5c5\uccb4\ub294 \uc911\ub2e8\uc744 \ud53c\ud558\uace0 \ub9ac\ub4dc \ud0c0\uc784\uc744 \ubcf4\ud638\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n
ISO 13485 PCBA \ud30c\ud2b8\ub108 \ud3c9\uac00: \uc911\uc694\ud55c \uae30\uc900<\/h2>\n\n\n
\uc81c\uc870\uc5c5\uccb4\ub294 \uc720\ud6a8\ud55c ISO 13485 \uc778\uc99d\uc11c\ub97c \uac16\uace0 \uc788\uac70\ub098 \uadf8\ub807\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \uadf8\ub7ec\ub098 \uc6b4\uc601\uc801 \uc131\uc219\ub3c4\ub294 \uc2a4\ud399\ud2b8\ub7fc\uc0c1\uc5d0 \uc788\uc73c\uba70, \uadf8 \uc2a4\ud399\ud2b8\ub7fc\uc5d0 \ub530\ub77c \ud30c\ud2b8\ub108\uac00 \ud504\ub85c\uadf8\ub7a8\uc744 \uac00\uc18d\ud654\ud558\uac70\ub098 \uc7a5\uc560\ub97c \uc720\ubc1c\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ud3c9\uac00\ub294 \uc9c4\uc815\ud55c \uaddc\uc728\uc744 \ub4dc\ub7ec\ub0b4\ub294 \uc2dc\uc2a4\ud15c\uc5d0 \ucd08\uc810\uc744 \ub9de\ucdb0\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n
\uc778\uc99d\uacfc \uc131\uc219\ub3c4:<\/strong> \ucd5c\uc2e0 \uac10\uc2dc \uac10\uc0ac \ubcf4\uace0\uc11c\ub97c \ud655\uc778\ud558\uc2ed\uc2dc\uc624. \uc8fc\uc694 \ubd80\uc801\ud569 \uc0ac\ud56d\uc774 \uc5c6\ub294 \uac83\uc740 \uc88b\uc740 \uc2e0\ud638\uc785\ub2c8\ub2e4. \uc81c\uc870\uc0ac\uac00 \uc778\uc99d\uc744 \uc720\uc9c0\ud55c \uae30\uac04\uc744 \ubb3c\uc5b4\ubcf4\uc2ed\uc2dc\uc624; \uc7a5\uae30\uc131\uc740 \ub0b4\uc7ac\ub41c \uaddc\uc728\uc744 \uc758\ubbf8\ud569\ub2c8\ub2e4. \uc778\uc99d\uc11c\uc758 \ubc94\uc704\uc5d0 PCB Contract Manufacturing\uc774 \uba85\uc2dc\ub418\uc5b4 \uc788\ub294\uc9c0 \uba85\ud655\ud788 \ud655\uc778\ud558\uc2ed\uc2dc\uc624.<\/p>\n\n\n\n \uc2dc\uc2a4\ud15c \ud1b5\ud569:<\/strong> DHR \uc2dc\uc2a4\ud15c\uc758 \uc2e4\uc2dc\uac04 \ub370\ubaa8\ub97c \uc694\uccad\ud558\uc138\uc694. \ud2b9\uc815 \ub85c\ud2b8\uc758 \uc804\uccb4 \uae30\ub85d\uc744 \uc2e4\uc2dc\uac04\uc73c\ub85c \uac00\uc838\uc624\ub294 \ub2a5\ub825\uc740 \uac15\ub825\ud55c \uc9c0\ud45c\uc785\ub2c8\ub2e4. UDI \ub77c\ubca8\ub9c1\uc774 \uc5b4\ub5bb\uac8c \ud1b5\ud569\ub418\uace0 \uac80\uc99d\ub418\ub294\uc9c0 \uc9c8\ubb38\ud558\uc138\uc694. \uc720\uc0ac \uc81c\ud488\uc5d0 \ub300\ud55c \ud504\ub85c\uc138\uc2a4 \uac80\uc99d \ubcf4\uace0\uc11c\ub97c \uac80\ud1a0\ud558\uc138\uc694. \uadf8 \uae4a\uc774\uc640 \uba85\ud655\uc131\uc740 \ud504\ub85c\uadf8\ub7a8\uc758 \uc131\uc219\ub3c4\ub97c \ubcf4\uc5ec\uc90d\ub2c8\ub2e4.<\/p>\n\n\n\n \ub514\uc790\uc778 \uc774\uad00\uc758 \ud22c\uba85\uc131:<\/strong> \ub514\uc790\uc778 \uc774\uad00 \uacfc\uc815\uc5d0\uc11c \uc560\ub9e4\ubaa8\ud638\ud568\uc774 \ud6c4\uc18d \uc9c0\uc5f0\uc744 \uc57c\uae30\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc131\uc219\ud55c \ud30c\ud2b8\ub108\ub294 \uc0dd\uc0b0 \uc2dc\uc791 \uc804\uc5d0 UDI \uc694\uad6c\uc0ac\ud56d, \ud575\uc2ec \uacf5\uc815 \ub9e4\uac1c\ubcc0\uc218, \uc2dc\ud5d8 \uae30\uc900\uc744 \uac80\uc99d\ud558\ub294 \uacf5\uc2dd \uccb4\ud06c\ub9ac\uc2a4\ud2b8\ub97c \uac16\ucd94\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uc774 \uc808\ucc28\ub97c \ubcf4\uc5ec\ub2ec\ub77c\uace0 \uc694\uccad\ud558\uc138\uc694. \uadf8 \uc5c4\uaca9\ud568\uc740 \ud30c\ud2b8\ub108\uc2ed\uc758 \uc131\uacf5\uc744 \uc608\uce21\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n \uacbd\uace0 \uc2e0\ud638:<\/strong> DHR\uc744 \ube60\ub974\uac8c \uc0dd\uc0b0\ud558\uc9c0 \ubabb\ud558\uac70\ub098 \uc911\uc694 \uae30\ub85d\uc5d0 \uc885\uc774 \uae30\ubc18 \uc2dc\uc2a4\ud15c\uc744 \uc0ac\uc6a9\ud558\ub294 \uc81c\uc870\uc5c5\uccb4\ub294 \uc8fc\uc758\ud558\uc138\uc694. \ud658\uacbd \ubaa8\ub2c8\ud130\ub9c1\uc774 \uc218\ub3d9\uc801\uc774\uace0 \ub4dc\ubb3c\uac8c \uc774\ub8e8\uc5b4\uc9c0\ub294 \uc2dc\uc124\ub3c4 \uc8fc\uc758\ud558\uc138\uc694. \ubcc0\uacbd \ud1b5\uc81c \uacfc\uc815\uc744 \uba85\ud655\ud788 \uc124\uba85\ud558\uc9c0 \ubabb\ud558\uac70\ub098 \uc778\uc99d\uc5d0 \ub204\ub77d\uc774 \uc788\uc5c8\ub358 \ud30c\ud2b8\ub108\ub3c4 \uc8fc\uc758\ud558\uc138\uc694. \uc774\ub294 \ud488\uc9c8 \uc2dc\uc2a4\ud15c\uc774 \ubb38\uc11c\uc0c1\uc73c\ub85c\ub9cc \uc874\uc7ac\ud558\uace0 \uc2e4\uc81c\ub85c\ub294 \uc791\uc6a9\ud558\uc9c0 \uc54a\ub294 \uc2e0\ud638\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n \uc81c\uc870 \ud30c\ud2b8\ub108\uc758 \uc120\ud0dd\uc740 \uc81c\ud488\uc758 \ud488\uc9c8\ubfd0\ub9cc \uc544\ub2c8\ub77c \uc2dc\uc7a5 \ucd9c\uc2dc \uc18d\ub3c4\uc5d0\ub3c4 \uc601\ud5a5\uc744 \ubbf8\uce69\ub2c8\ub2e4. ISO 13485 \uc2dc\uc2a4\ud15c\uc774 \uc2e4\uc81c\ub85c \uc6b4\uc601\uc5d0 \ub0b4\uc7ac\ub41c \ud30c\ud2b8\ub108\ub294 \uaddc\uc815 \uc900\uc218\uc758 \ubd80\ub2f4\uc73c\ub85c \uc778\ud574 \uc18d\ub3c4\uac00 \ub290\ub824\uc9c0\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \ub300\uc2e0 \uc7ac\uc791\uc5c5\uacfc \uae34\uae09 \uc870\uce58\ub97c \uc81c\uac70\ud558\uc5ec \ud504\ub85c\uadf8\ub7a8\uc744 \uac00\uc18d\ud654\ud569\ub2c8\ub2e4. \uc774 \uaddc\uc728\uc774 \uc18d\ub3c4\ub97c \uac00\ub2a5\ud558\uac8c \ud569\ub2c8\ub2e4.<\/p>","protected":false},"excerpt":{"rendered":" \ub9ce\uc740 \uc0ac\ub78c\ub4e4\uc774 ISO 13485\uc758 \uc5c4\uaca9\ud55c \uaddc\uc81c \uaddc\uc728\uc774 \uc758\ub8cc\uae30\uae30 PCBA \uc81c\uc870\ub97c \ub290\ub9ac\uac8c \ub9cc\ub4e0\ub2e4\uace0 \uc0dd\uac01\ud569\ub2c8\ub2e4. \uc774\uac83\uc740 \uc624\ud574\uc785\ub2c8\ub2e4. \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc774 \uc6b4\uc601\uc758 \ud575\uc2ec\uc5d0 \uad6c\ucd95\ub418\uc5b4 \uc788\uc744 \ub54c, \uc2e4\uc2dc\uac04 \uc7a5\uce58 \uc774\ub825 \uae30\ub85d\uacfc \uac80\uc99d\ub41c \ud504\ub85c\uc138\uc2a4\uc640 \uac19\uc740 \ucd94\uc801 \uac00\ub2a5\uc131\uacfc \ubc18\ubcf5 \uac00\ub2a5\uc131\uc744 \ubcf4\uc7a5\ud558\ub294 \uba54\ucee4\ub2c8\uc998\uc774 \uc18d\ub3c4\uc640 \ud6a8\uc728\uc131\uc744 \ub192\uc774\ub294 \ucd09\ub9e4\uc81c\uac00 \ub418\uc5b4 \uc9c0\uc5f0\uc744 \uc81c\uac70\ud558\uace0 \uc9c0\uc18d\uc801\uc778 \uac10\uc0ac \uc900\ube44\ud0dc\uc138\ub97c \ubcf4\uc7a5\ud569\ub2c8\ub2e4.<\/p>","protected":false},"author":1,"featured_media":9793,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"article_term":"","article_term_alternate":"","article_term_def":"","article_hook":"","auto_links":"","article_topic":"","article_fact_check":"","mt_social_share":"","mt_content_meta":"","mt_glossary_display":"","glossary_heading":"","glossary":"","glossary_alter":"","glossary_def":"","article_task":"Medical device builds at Bester PCBA with ISO 13485 discipline and speed","footnotes":""},"categories":[12],"tags":[],"class_list":["post-9794","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"_links":{"self":[{"href":"https:\/\/www.besterpcba.com\/ko\/wp-json\/wp\/v2\/posts\/9794","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.besterpcba.com\/ko\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.besterpcba.com\/ko\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.besterpcba.com\/ko\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.besterpcba.com\/ko\/wp-json\/wp\/v2\/comments?post=9794"}],"version-history":[{"count":1,"href":"https:\/\/www.besterpcba.com\/ko\/wp-json\/wp\/v2\/posts\/9794\/revisions"}],"predecessor-version":[{"id":9800,"href":"https:\/\/www.besterpcba.com\/ko\/wp-json\/wp\/v2\/posts\/9794\/revisions\/9800"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.besterpcba.com\/ko\/wp-json\/wp\/v2\/media\/9793"}],"wp:attachment":[{"href":"https:\/\/www.besterpcba.com\/ko\/wp-json\/wp\/v2\/media?parent=9794"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.besterpcba.com\/ko\/wp-json\/wp\/v2\/categories?post=9794"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.besterpcba.com\/ko\/wp-json\/wp\/v2\/tags?post=9794"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}