DIN EN ISO 18113-3:2013 体外诊断医疗器械.制造商提供的信息(标签).第3部分:专业用体外诊断仪器(ISO 18113-3-2009).德文版本EN ISO 18113-3-2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009); German version EN ISO 18113-3:2011
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for professional use.
This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for professional use.
This part of ISO 18113 can also be applied to accessories.
This part of ISO 18113 does not apply to:
a)instructions for instrument servicing or repair,
b)IVD reagents, including calibrators and control materials for use in control of the reagent,
c)IVD instruments for self-testing.