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 18113-5-20

标准号：DIN EN ISO 18113-5-2013
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
英文标准名称：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
标准类型：C38
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 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;IEC 61010-1;IEC 61010-2-101;IEC 61326-2-6;IEC 62366;EN 980
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 toa)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.