DIN EN ISO 18113-5:2013
体外诊断医疗器械.制造商提供的信息(标签).第5部分:自测用体外诊断仪器(ISO 18113-5-2009).德文版本EN ISO 18113-5-2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009); German version EN ISO 18113-5:2011

标准号

DIN EN ISO 18113-5:2013

发布

2013年

发布单位

德国标准化学会

当前最新

DIN EN ISO 18113-5:2013

 

 

引用标准

EN 980 IEC 61010-1 IEC 61010-2-101 IEC 61326-2-6 IEC 62366 ISO 14971 ISO 15223-1 ISO 18113-1

被代替标准

DIN EN ISO 18113-5:2010

适用范围

This part of ISO 18113 specifies requirements for infornation supplied by the manufacturer of IVD instruments for self-testing. This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing. 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 professional use.

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