UNE-EN 13532-2002
General requirements for in vitro diagnostic medical devices for self-testing.
自我检测用体外诊断医疗设备的一般要求
2002-10-29
BS EN 13532-2002
General requirements for in vitro diagnostic medical devices for self-testing
自检测用体外诊断医疗器械的一般要求
2002-05-08
GOST R EN 13532-2010
Общие требования к медицинским изделиям для диагностики in vitro для самотестирования
体外诊断医疗器械的一般要求进行自检
YY/T 1441-2016
体外诊断医疗器械性能评估通用要求
General requirements of performance evaluation of in vitro diagnostic medical devices
2016-01-26
BS EN ISO 18113-4-2011
In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic reagents for self-testing
体外诊断医疗设备 制造商提供的信息（标签）
2012-01-31
BS EN ISO 18113-5-2011
In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling)-In vitro diagnostic instruments for self-testing
体外诊断医疗设备 制造商提供的信息（标签）
2012-01-31
KS P ISO 18113-4(2020 Confirm)
체외 진단 의료기기 — 제조자 표시사항(라벨링) — 제4부: 자가 시험용 체외 진단 시약
体外诊断医疗设备 - 制造商提供的信息（标签） - 第4部分:体外诊断试剂用于自检
2015-07-31
KS P ISO 18113-5(2020 Confirm)
체외 진단 의료기기 — 제조자 표시사항(라벨링) — 제5부: 자가 시험용 체외 진단 기기
体外诊断医疗设备 - 制造商提供的信息（标签） - 第5部分:用于自检的体外诊断仪器
2015-07-31
KS P ISO 18113-4
체외 진단 의료기기 — 제조자가 제공하는 정보(라벨링) — 제4부: 자가 시험용 체외 진단 시약
体外诊断医疗器械.制造商提供的信息（标签）.第4部分:自测用体外诊断试剂
2024-12-23
KS P ISO 18113-5
체외 진단 의료기기 — 제조자가 제공하는 정보(라벨링) — 제5부: 자가 시험용 체외 진단 기기
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
2024-12-23
ISO 18113-5-2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
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
2022-10-06
ISO 18113-4-2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
体外诊断医疗器械.制造商提供的信息（标签）.第4部分:自测用体外诊断试剂
2022-10-06
DIN EN 13532
General requirements for in vitro diagnostic medical devices for self-testing; German version EN 13532:2002, German and English texts
自我检测用体外诊断医疗器械的一般要求；德语版EN 13532:2002 德语和英语文本
2002-08-01
BS EN ISO 18113-1-2011
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)-Terms, definitions and general requirements
体外诊断医疗设备 制造商提供的信息（标签）
2012-01-31
UNE-EN ISO 18113-4-2010
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
体外诊断医疗器械.制造商提供的信息（标签）.第4部分:自检用体外诊断试剂（ISO 18113-4-2009）
2010-07-07
UNE-EN ISO 18113-5-2010
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
体外诊断医疗器械.制造商提供的信息（标签）.第5部分:自检用体外诊断仪器（ISO 18113-5-2009）
2010-06-09
DIN EN ISO 18113-5
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
体外诊断医疗器械.制造商提供的信息（标签）.第5部分:用于自检的体外诊断仪器（ISO 18113-5-2009）；德文版EN ISO 18113-5:2011
2013-01-01
KS P 2201
체외 진단용 의료기기의료기기: 감염병용 측방유동면역진단법 검사 성능에 대한 일반 요구사항
体外诊断医疗器械:传染病的侧流免疫测定.试验性能的一般要求
2022-12-28
KS P ISO 18113-1
체외진단 의료기기 — 제조자가 제공하는 정보(라벨링) — 제1부: 어휘 및 일반 요구사항
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
2018-08-22
GB/T 29791.1-2013
体外诊断医疗器械 制造商提供的信息(标示) 第1部分:术语、定义和通用要求
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
2013-10-10