標準號：DIN EN ISO 18113-4-2013
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4部分:自測用體外診斷劑(ISO 18113-4-2009).德文版本EN ISO 18113-4-2011
英文標準名稱：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
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 14971;ISO 15223-1;ISO 18113-1;EN 980
適用范圍：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.