DIN EN ISO 18113-1-2013 体外诊断医疗器械.制造商提供的信息(标签).第1部分:术语、定义和一般要求(ISO 18113-1-2009).德文版本EN ISO 18113-1-2

标准号：DIN EN ISO 18113-1-2013
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1部分:术语、定义和一般要求(ISO 18113-1-2009).德文版本EN ISO 18113-1-2011
英文标准名称：In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011
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 1000;ISO 13485;ISO 14971;ISO 15223-1;IEC 62366;EN 980
适用范围：This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.This part of ISO 18113 does not address language requirements, since that is the domain of national laws and regulations.This part of ISO 18113 does not apply toa)IVD devices for performance evaluation (e.g., for investigational use only),b)instrument marking,c)material safety data sheets.