LST EN ISO 18113-2-2012 体外诊断医疗器械. 制造商提供的信息(标示). 第2部分: 专业用体外诊断试剂(ISO 18113-2-2009)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)