ISO 18113-3:2009 体外诊断医疗器械 厂商提供的信息(标签) 第3部分:专业用体外诊断仪器

标准编号:ISO 18113-3:2009

中文名称:体外诊断医疗器械 厂商提供的信息(标签) 第3部分:专业用体外诊断仪器

英文名称:In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use

发布日期:2009-12

标准范围

ISO 18113-3:20 09规定了专业用体外诊断(IVD)仪器制造商提供的信息要求。ISO 18113-3:20 09也适用于预期与专业用IVD器械一起使用的器械和设备。在适当的情况下,ISO 18113-3:20 09也可应用于附件。

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.

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