DIN EN ISO 18113-4-2013 体外诊断医疗器械.制造商提供的信息(标签).第4部分:自测用体外诊断剂(ISO 18113-4-2009).德文版本EN ISO 18113-4-201

标准号：DIN EN ISO 18113-4-2013
中文标准名称：体外诊断医疗器械.制造商提供的信息(标签).第4部分:自测用体外诊断剂(ISO 18113-4-2009).德文版本EN ISO 18113-4-2011
英文标准名称：In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009); German version EN ISO 18113-4:2011
标准类型：C38
发布日期：1999/12/31 12:00:00
实施日期：2013/1/1 12:00:00
中国标准分类号：C38
国际标准分类号：11.100.10
引用标准：ISO 14971;ISO 15223-1;ISO 18113-1;EN 980
适用范围：This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing.This part of ISO 18113 also applies to information suoplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.This part of ISO 18113 can also be applied to accessories.This part of ISO 18113 applies to the labels for outer and immediate containers and to the instructions for use.This part of ISO 18113 does not apply to:a)IVD instruments or equipment,b)IVD reagents for professional use.