现行

UNE-EN 13612-2002

Performance evaluation of in vitro diagnostic medical devices.
体外诊断医疗设备的性能评估

2002-07-29

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

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

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

BS EN ISO 23640-2015

In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
体外诊断医疗设备 体外诊断试剂稳定性评价

2015-06-30

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 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

KS P 1977(2023 Confirm)

체외진단 검사의학 분야에서 정성검사의 성능 평가 방법
体外诊断医学实验室定性试验性能评估方案

2018-08-22

现行

KS P 1977

체외진단 검사의학 분야에서 정성검사의 성능 평가 방법
体外诊断医学实验室定性检测性能评价规程

2018-08-22

现行

KS P 1975(2023 Confirm)

체외진단 검사의학 분야에서 정량검사의 정밀도 성능 평가 방법
体外诊断医学实验室定量试验精度性能评估方案

2018-08-22

现行

KS P 1975

체외진단 검사의학 분야에서 정량검사의 정밀도 성능 평가 방법
体外诊断医学实验室定量检测精密度评价方案

2018-08-22

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

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

KS P 2223

체외 진단 의료기기 — 항핵항체 측정을 위한 의료용 간접면역형광측정 판독자동화장치의 분석적 성능평가를 위한 지침
体外诊断医疗器械自动抗核抗体间接免疫荧光测定分析性能评价指南

2023-12-28

现行

DIN EN 13612

Performance evaluation of in vitro diagnostic medical devices; German version EN 13612:2002, German and English texts
体外诊断医疗器械的性能评估；德语版EN 13612:2002 德语和英语版本

2002-08-01

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

UNE-EN 12376-1999

IN VITRO DIAGNOSTIC MEDICAL DEVICES. INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR STAINING IN BIOLOGY.
体外诊断医疗设备 制造商提供的用于生物学染色的体外诊断试剂的信息

1999-07-20

现行

BS EN ISO 19001-2013

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

2013-08-31

现行

DIN EN 12376

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；德文版EN 12376:1999

1999-04-01