標(biāo)準(zhǔn)號：DIN EN ISO 18113-2-2013
中文標(biāo)準(zhǔn)名稱：體外診斷醫(yī)療器械.制造商提供的信息(標(biāo)簽).第2部分:專業(yè)用途的體外診斷試劑(ISO 18113-2-2009).德文版本EN ISO 18113-2-2011
英文標(biāo)準(zhǔn)名稱：In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009); German version EN ISO 18113-2:2011
標(biāo)準(zhǔn)類型：C38
發(fā)布日期：1999/12/31 12:00:00
實施日期：2013/1/1 12:00:00
中國標(biāo)準(zhǔn)分類號：C38
國際標(biāo)準(zhǔn)分類號：11.100.10
引用標(biāo)準(zhǔn)：ISO 8601;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 professional use.This part of ISO 18113 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use.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 toa) IVD instruments or equipment,b) IVD reagents for self-testing.