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 18113-4-2011

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

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标准号

DIN EN ISO 18113-4-2013

发布日期

2013年01月

实施日期

2013年01月01日

废止日期

无

中国标准分类号

C38

国际标准分类号

11.100.10

发布单位

DE-DIN

引用标准

ISO 14971 ISO 15223-1 ISO 18113-1 EN 980

被代替标准

DIN EN ISO 18113-4-2010

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.

DIN EN ISO 18113-4-2013系列标准

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