BS EN ISO 23640:2015 体外诊断医疗装置.体外诊断剂的稳定性评估
In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
ISO 23640:2011 体外诊断医疗装置.体外诊断剂的稳定性评估
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
BS EN ISO 23640:2013 体外诊断医疗装置.体外诊断剂的稳定性评估
In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
YY/T 1579-2018 体外诊断医疗器械 体外诊断试剂稳定性评价
BS EN ISO 23640:2011 体外诊断医疗装置.体外诊断剂的稳定性评估
In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
KS P ISO 23640:2019 体外诊断医疗器械 - 体外诊断试剂稳定性评估
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS P ISO 23640:2013 体外诊断医疗器械.体外诊断试剂的安定性评价
이 표준은 시약, 보정 물질, 표준 물질, 희석액, 완충액과 시약 키트를 포함하는 소위 체외 진단 시약이라 불리는 체외 진단 의료기기의 안정성 평가에 적용 가능하다. 이 표준은 샘플을 보존하거나 또는 샘플의 추가적인 처리를 위한 반응의 시작에 사용되는 물질을 포함하는
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
NF S92-032*NF EN ISO 23640:2015 体外诊断医疗器械. 体外诊断试剂稳定性的评估
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
NF S92-032:2014 体外诊断医疗器械. 体外诊断试剂稳定性的评估
La présente Norme internationale s'applique à l'évaluation de la stabilité des dispositifs médicaux de diagnostic in vitro, y compris les réactifs
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
EN ISO 23640:2013 体外诊断医疗器械.体外诊断试剂的稳定性评定
Diese Internationale Norm gilt fur die Haltbarkeitsprufung von In-vitro-Diagnostika, einschlieslich Reagenzien, Kalibriermaterialien
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
EN ISO 23640:2011 体外诊断医疗器械.体外诊断试剂的稳定性评定
This International Standard is applicable to the stability evaluation of in vitro diagnostic medical devices, includingreagents, calibrators, control
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents [Superseded: CEN EN 13640]
GOST R 51352-2013 体外诊断医疗器械. 试验方法
In vitro diagnostic medical devices. Test methods
KS P ISO 18113-4-2015(2020 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
In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 4: In vitro diagnostic reagents for self-testing
EN ISO 23640:2015 体外诊断医疗器械,体外诊断试剂的稳定性评价(ISO 23640:2011)
Diese Internationale Norm gilt für die Haltbarkeitsprüfung von In-vitro-Diagnostika, einschließlich Reagenzien, Kalibriermaterialien
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
KS P ISO 18113-2:2018 体外诊断医疗设备 - 制造商提供的信息（标签） - 第2部分:专业使用的体外诊断试剂
In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 2: In vitro diagnostic reagents for professional use
BS EN ISO 23640:2015 体外诊断医疗装置.体外诊断剂的稳定性评估
In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
ISO 23640:2011 体外诊断医疗装置.体外诊断剂的稳定性评估
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
BS EN ISO 23640:2013 体外诊断医疗装置.体外诊断剂的稳定性评估
In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
YY/T 1579-2018 体外诊断医疗器械 体外诊断试剂稳定性评价
BS EN ISO 23640:2011 体外诊断医疗装置.体外诊断剂的稳定性评估
In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
KS P ISO 23640:2019 体外诊断医疗器械 - 体外诊断试剂稳定性评估
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
KS P ISO 23640:2013 体外诊断医疗器械.体外诊断试剂的安定性评价
이 표준은 시약, 보정 물질, 표준 물질, 희석액, 완충액과 시약 키트를 포함하는 소위 체외 진단 시약이라 불리는 체외 진단 의료기기의 안정성 평가에 적용 가능하다. 이 표준은 샘플을 보존하거나 또는 샘플의 추가적인 처리를 위한 반응의 시작에 사용되는 물질을 포함하는
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
NF S92-032*NF EN ISO 23640:2015 体外诊断医疗器械. 体外诊断试剂稳定性的评估
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
NF S92-032:2014 体外诊断医疗器械. 体外诊断试剂稳定性的评估
La présente Norme internationale s'applique à l'évaluation de la stabilité des dispositifs médicaux de diagnostic in vitro, y compris les réactifs
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
EN ISO 23640:2013 体外诊断医疗器械.体外诊断试剂的稳定性评定
Diese Internationale Norm gilt fur die Haltbarkeitsprufung von In-vitro-Diagnostika, einschlieslich Reagenzien, Kalibriermaterialien
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
EN ISO 23640:2011 体外诊断医疗器械.体外诊断试剂的稳定性评定
This International Standard is applicable to the stability evaluation of in vitro diagnostic medical devices, includingreagents, calibrators, control
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents [Superseded: CEN EN 13640]
GOST R 51352-2013 体外诊断医疗器械. 试验方法
In vitro diagnostic medical devices. Test methods
KS P ISO 18113-4-2015(2020 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
In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 4: In vitro diagnostic reagents for self-testing
EN ISO 23640:2015 体外诊断医疗器械,体外诊断试剂的稳定性评价(ISO 23640:2011)
Diese Internationale Norm gilt für die Haltbarkeitsprüfung von In-vitro-Diagnostika, einschließlich Reagenzien, Kalibriermaterialien
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
KS P ISO 18113-5-2015(2020 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
In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 5: In vitro diagnostic instruments for self-testing
编辑：北检院编辑部
