標準號：DIN EN ISO 18113-1-2013
中文標準名稱：體外診斷醫療器械.制造商提供的信息(標簽).第1部分:術語、定義和一般要求(ISO 18113-1-2009).德文版本EN ISO 18113-1-2011
英文標準名稱：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
標準類型：C38
發布日期：1999/12/31 12:00:00
實施日期：2013/1/1 12:00:00
中國標準分類號：C38
國際標準分類號：11.100.10
引用標準：ISO 1000;ISO 13485;ISO 14971;ISO 15223-1;IEC 62366;EN 980
適用范圍：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.