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

2003-02-27

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

2002-07-29

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

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

체외진단 검사의학 분야에서 감염질환 분자진단 검사법의 분석적 성능 평가
体外诊断医学实验室传染病分子诊断分析性能评估方案

2022-12-28

In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media
体外诊断医疗设备 微生物培养基 文化媒体的绩效标准

2001-12-24

IN VITRO DIAGNOSTIC MEDICAL DEVICES. CULTURE MEDIA FOR MICROBIOLOGY. PERFORMANCE CRITERIA FOR CULTURE MEDIA.
体外诊断医疗设备 微生物培养基 文化媒体的绩效标准

1999-10-30

Изделия медицинские для диагностики in vitro. Питательные среды для микробиологии. Критерии функциональных характеристик питательных сред
体外诊断医疗器械 文化媒体微生物学 文化媒体的表现标准

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

Сводный комплект технической документации для демонстрации соответствия общим принципам обеспечения безопасности и основных функциональных характеристик медицинских изделий для диагностики in vitro
摘要技术文件 用于证明符合体外诊断医疗器械安全和性能的基本原则

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

체외 진단 의료기기 연구 피험자의 검체를 사용한 임상적 성능 시험 임상적 성능 시험 관리 기준
体外诊断医疗器械.使用人体标本的临床性能研究.良好研究规范

2022-12-28

In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice
体外诊断医疗设备 使用人体样本进行临床表现研究 良好的学习习惯

2019-06-06

In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
使用人类标本的体外诊断设备（IVD）的临床表现研究 - 良好的学习实践

2019-06-04

In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media; German version EN 12322:1999
体外诊断医疗器械.微生物学用培养基.培养基的性能标准；德文版EN 12322:1999

1999-06-01