现行

KS P ISO 23640

체외 진단 의료기기 — 체외 진단 시약의 안정성 평가
体外诊断医疗器械 - 体外诊断试剂稳定性评估

2019-11-25

现行

ISO 23640-2011

In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
体外诊断医疗器械——体外诊断试剂稳定性评价

2011-11-29

现行

YY/T 1579-2018

体外诊断医疗器械　体外诊断试剂稳定性评价
In vitro diagnostic medical devices—Evaluation of stability of in vitro diagnostic reagents

2018-02-24

现行

GOST R 51352-2013

Медицинские изделия для диагностики ин витро. Методы испытаний
体外诊断医疗器械 测试方法

现行

2000 No. 1315

The In Vitro Diagnostic Medical Devices Regulations 2000
2000年体外诊断医疗器械条例

现行

BS EN 13612-2002

Performance evaluation of in vitro diagnostic medical devices
体外诊断医疗器械的性能评价

2003-02-27

现行

总统令(第30652号)

체외진단의료기기법 시행령
体外诊断医疗器械法执行令

2020-04-28

现行

EN 13612-2002/AC-2002

Performance evaluation of in vitro diagnostic medical devices
体外诊断医疗器械的性能评估

2002-12-18

现行

EN 13612-2002

Performance evaluation of in vitro diagnostic medical devices
体外诊断医疗器械的性能评估

2002-03-20

现行

GOST R EN 13612-2010

Оценка функциональных характеристик медицинских изделий для диагностики in vitro
体外诊断医疗器械的性能评估

现行

T/SAMD 0002-2023

体外诊断医疗器械用移液针

2023-12-07

现行

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

现行

T/SZZX 014-2023

体外诊断医疗器械用移液针

2023-12-07

现行

EN ISO 23640-2015

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
体外诊断医疗器械 - 体外诊断试剂的稳定性评估（ISO 23640:2011）

2015-06-10

现行

GOST R ISO 23640-2015

Изделия медицинские для диагностики in vitro. Оценка стабильности реагентов для диагностики in vitro
体外医疗器械 评估体外诊断试剂的稳定性

现行

YY/T 1454-2016

自我检测用体外诊断医疗器械基本要求
General requirements for in vitro diagnostic medical devices for self-testing

2016-01-26

现行

UNE-EN 13975-2003

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
体外诊断医疗器械验收试验用取样程序.统计方面

2003-12-12

现行

YY/T 0639-2019

体外诊断医疗器械　制造商为生物学染色用体外诊断试剂提供的信息
In vitro diagnostic medical devices—Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

2019-07-24

现行

ISO 19001-2013

In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
体外诊断医疗器械——制造商提供的用于生物学染色的体外诊断试剂的信息

2013-03-07

现行

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