In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
体外诊断医疗设备 - 制造商提供的信息(标签) - 第3部分:专业使用的体外诊断仪器(ISO 18113-3:2009)
发布日期:
2011-10-19
实施日期:
2011-10-19
ISO 18113-3:2009规定了制造商提供的用于专业使用的体外帝斯曼(IVD)仪器的信息的要求。
ISO 18113-3:2009也适用于专门用于IVD仪器的设备和设备。
ISO 18113-3:2009也适用于配件
ISO 18113-3:2009 specifies requirements for information supplied by the manufacturer of in vitro dignostic (IVD) instruments for professional use.
ISO 18113-3:2009 also applies to apparatus and equipment intended to be used with IVD instruments for professional use.
ISO 18113-3:2009 can also be applied to accessories, where appropriate.