AAMI/ISO 14155-2020
Clinical investigation of medical devices for human subjects - Good clinical practice
人体医疗器械的临床研究.良好临床实践
2020-12-07
UNE-EN ISO 14155-2012
Clinical investigation of medical devices for human subjects - Good clinical practice
人体医疗器械的临床研究.良好临床实践
2012-02-01
KS P ISO 14155
의료기기의 임상시험 — 임상시험 관리기준
医学设备对人类临床调查 - 良好的临床实践
2019-11-25
BS EN ISO 14155-2020
Clinical investigation of medical devices for human subjects. Good clinical practice
人体医疗器械的临床研究 良好临床实践
2020-11-26
KS P ISO 14155
사람을 대상으로 하는 의료기기 임상시험 임상시험 관리기준
人体医疗器械的临床研究——良好临床实践
2022-12-28
ISO 14155-2020
Clinical investigation of medical devices for human subjects — Good clinical practice
医学设备对人类临床调查 - 良好的临床实践
2020-07-28
DIN EN ISO 14155
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
人体医疗器械的临床研究.良好临床实践（ISO 14155-2020）；德文版EN ISO 14155:2020
2020-12-01
GOST R 53133.3-2008
Технологии лабораторные клинические. Контроль качества клинических лабораторных исследований. Часть 3. Описание материалов для контроля качества клинических лабораторных исследований
医学实验室技术 临床实验室检测质量控制 临床实验室检查质量控制材料说明
ASTM D8179-18(2024)
Standard Guide for Characterizing Detergents for the Cleaning of Clinically-used Medical Devices
临床使用的医疗器械清洁用洗涤剂特性的标准指南
2024-01-01
AAMI TIR49-2013/(R)2020
Design of training and instructional materials for medical devices used in non-clinical environments
非临床环境中使用的医疗器械的培训和教学材料设计
2013-03-19
GOST R ISO 15198-2009
Клиническая лабораторная медицина. Изделия медицинские для диагностики in vitro. Подтверждение методик контроля качества, рекомендуемых изготовителями пользователям
临床实验室医学 体外诊断医疗器械 验证制造商的用户控制程序
GOST ISO 81060-2-2021
Сфигмоманометры (измерители артериального давления) неинвазивные. Часть 2. Клинические испытания моделей с автоматическим типом измерения
无创血压计（动脉压测量装置） 第二部分 间歇式自动测量仪的临床研究
KS P ISO 15198
임상 검사실－체외 진단 의료 기기－제조자가 제공한 정도 관리 절차의 타당성 확인
临床实验室医学 - 体外诊断医疗器械 - 制造商验证用户质量控制程序
2017-12-29
BS ISO 15198-2004
Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer
临床检验医学 体外诊断医疗设备 制造商对用户质量控制程序的验证
2004-07-23
KS P ISO 15198(2022 Confirm)
임상 검사실－체외 진단 의료 기기－제조자가 제공한 정도 관리 절차의 타당성 확인
临床实验室医学.体外诊断医疗设备.制造商对用户质量控制程序的验证
2017-12-29
GB/T 42218-2022
检验医学 体外诊断医疗器械 制造商对提供给用户的质量控制程序的确认
Clinical laboratory medicine—In vitro diagnostic medical devices—Validation of user quality control procedures by the manufacturer
2022-12-30
KS P ISO 17593(2019 Confirm)
임상검사실검사 및 체외 의료기기－경구 항응고제 요법의 자가시험을 위한 위한체외 모니터링 시스템 요구사항
临床实验室试验和体外医疗器械.口服抗凝剂治疗自我试验用体外监测系统的要求
2009-12-29
BS ISO 17593-2022
Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
临床实验室测试和体外医疗设备 口服抗凝剂治疗自我检测用体外监测系统的要求
2022-03-15
BS ISO 20916-2019
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
KS P ISO 20916
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