KS P ISO TR 18112-2009 临床实验室试验和在实验室条件下诊断试验系统.实验室条件下诊断用的专用医学设备.制造商提供信息的管理要求概要
Clinical laboratory testing and in vitro diagnostic test systems-In vitro diagnostic medical devices for professional use-Summary of regulatory requirements for information supplied by the manufacturer