In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
体外诊断医疗器械 - 制造商提供的信息(标签) - 第1部分:术语 定义和一般要求(ISO 18113-1:2009)
发布日期:
2011-10-19
实施日期:
2011-10-19
ISO 18113-1:2009定义概念,确定一般原则,并规定体外诊断(IVD)医疗设备制造商提供的信息的基本要求
ISO 18113-1:2009 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) medical devices.