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¿µ¹®Ç¥Áظí Software Development Process for Functional Safety of Electronic Medical Device
Çѱ۳»¿ë¿ä¾à ¾ÈÀüÇÑ ÀÇ·á ±â±â ¼ÒÇÁÆ®¿þ¾î¸¦ °³¹ßÇÏ°í À¯Áö º¸¼öÇÏ·Á¸é ÀûÀýÇÑ ¼ÒÇÁÆ®¿þ¾î ¿£Áö´Ï¾î¸µ ¹æ¹ý ¹× ±â¼ú¿¡ ´ëÇÑ ÀüüÀûÀΠüÁ¦·Î¼­ÀÇ Ç°Áú °ü¸® ½Ã½ºÅÛÀÇ ÀϺημ­ À§Çè °ü¸®¸¦ È®¸³ÇÏ¿©¾ß ÇÑ´Ù. ÀÌ·¯ÇÑ ¼¼ °¡Áö °³³äÀ» Á¶ÇÕÇϸé ÀÇ·á ±â±â Á¦Á¶¾÷ü°¡ Àß ±¸¼ºµÇ°í ÀÏ°ü¼º ÀÖ°Ô ¹Ýº¹ Á¤¹Ðµµ°¡ ³ôÀº ÀÇ»ç°áÁ¤ ÇÁ·Î¼¼½º¸¦ »ç¿ëÇÏ¿© ÀÇ·á ±â±â ¼ÒÇÁÆ®¿þ¾îÀÇ ¾ÈÀü¼ºÀ» Çâ»ó½Ãų ¼ö ÀÖ´Ù. º» Ç¥ÁØÀº ÀÇ·á ±â±â ¼ÒÇÁÆ®¿þ¾îÀÇ ¾ÈÀüÇÑ ¼³°è¿Í À¯Áö º¸¼ö¿¡ ÇÊ¿äÇÑ È°µ¿°ú ¾÷¹«¿¡ °ü·ÃµÈ ¼ö¸í ÁÖ±â ÇÁ·Î¼¼½º¸¦ Á¤ÀÇÇϸç, °¢ ¼ö¸í ÁÖ±â ÇÁ·Î¼¼½º¿¡ ´ëÇÑ ¿ä±¸ »çÇ×À» Á¦°øÇÑ´Ù.
¿µ¹®³»¿ë¿ä¾à In order to develop and maintain safe electronic medical device software, we need to define the specific software development process which could play the role of the safety verified software products. This standard provides both the development process that can be acquired and verified the safety of electronic medical device software.
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