2010Äê11Ô£¬ÒøºÓ¼¯ÍŹÙÍø»ñµÃISO13485ÈÏÖ¤¡£ISO13485£º2003±ê×¼µÄÈ«³ÆÊÇ¡¶Ò½ÁÆÆ÷е ÖÊÁ¿¹ÜÀíϵͳ ÓÃÓÚ¹æÔòµÄÒªÇó¡·£¨Medical device-Quality management system-requirements for regulatory £©£¬¸Ã±ê×¼ÓÉSCA/TC221Ò½ÁÆÆ÷еÖÊÁ¿¹ÜÀíºÍͨÓÃÒªÇó±ê×¼»¯ÊÖÒÕίԱ»áÖÆ¶©¡£ ÕâÊǹ«Ë¾Ôھ߱¸ISO9001ºÍISO4001ÈÏÖ¤ºóÁíһеÄÍ»ÆÆ£¬Îª¹«Ë¾¹æÄ£½øÈëÒ½Áƶ¨ÖƵçÔ´·¿ª´óÃÅ¡£