YY/T 1244-2014 体外诊断试剂用纯化水
本标准规定了体外诊断试剂用纯化水的术语和定义、要求和试验方法。体外诊断试剂用纯化水可用于体外诊断试剂生产,医学实验室一般试剂配制,仪器及器械清洗等。试剂生产有特殊要求,参照相关标准或制定特殊要求(例如血细胞计数试剂对颗粒的特殊要求;分子生物学试剂对DNA酶、RNA酶、蛋白酶的特殊要求等
Purified water for in vitro diagnostic reagents
EN 376:1992 活体外诊断系统.自试验用活体外诊断试剂标签要求
In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for self-testing
DS/EN 376:1993 体外诊断系统．自检用体外诊断试剂加标签的要求
This standard specifies requirements for the labelling of in vitro diagnostic reagents which are intended for use in self-testing, i.e. for lay use
In vitro diagnostic systems - Requirements for labelling of in vitro diagnostic reagents for self-testing
EN 375:1992 活体外诊断系统.专业用活体外诊断试剂标签要求
In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for professional use
DS/EN 375:1993 体外诊断系统．专业用体外诊断试剂加标签的要求
This standard specifies requirements for the labelling of in-vitro diagnostic reagents for professional use
In vitro diagnostic systems. Requirements for labelling of in vitro diagnostic reagents for professional use
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 23640-2019 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
DIN EN ISO 23640:2015-12 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 (ISO 23640:2011); German version EN ISO 23640:2015 / Note: DIN EN ISO 23640 (2013-09) remains valid alongside this standard until 2018-06-30.
UNE-EN ISO 23640:2015 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 (ISO 23640:2011)
NF EN ISO 23640:2015 体外诊断医疗器械 体外诊断试剂稳定性评价
Dispositifs médicaux de diagnostic in vitro - Évaluation de la stabilité des réactifs de diagnostic in vitro
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 and in vitro diagnostic reagent stability evaluation
NF S92-011:1992 活体外诊断系统.自我试验用活体外诊断剂加标签要求
IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR LABELLING OF IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING. (EUROPEAN STANDARD EN 376).
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
YY/T 1244-2014 体外诊断试剂用纯化水
本标准规定了体外诊断试剂用纯化水的术语和定义、要求和试验方法。体外诊断试剂用纯化水可用于体外诊断试剂生产,医学实验室一般试剂配制,仪器及器械清洗等。试剂生产有特殊要求,参照相关标准或制定特殊要求(例如血细胞计数试剂对颗粒的特殊要求;分子生物学试剂对DNA酶、RNA酶、蛋白酶的特殊要求等
Purified water for in vitro diagnostic reagents
EN 376:1992 活体外诊断系统.自试验用活体外诊断试剂标签要求
In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for self-testing
DS/EN 376:1993 体外诊断系统．自检用体外诊断试剂加标签的要求
This standard specifies requirements for the labelling of in vitro diagnostic reagents which are intended for use in self-testing, i.e. for lay use
In vitro diagnostic systems - Requirements for labelling of in vitro diagnostic reagents for self-testing
EN 375:1992 活体外诊断系统.专业用活体外诊断试剂标签要求
In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for professional use
DS/EN 375:1993 体外诊断系统．专业用体外诊断试剂加标签的要求
This standard specifies requirements for the labelling of in-vitro diagnostic reagents for professional use
In vitro diagnostic systems. Requirements for labelling of in vitro diagnostic reagents for professional use
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 23640-2019 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
DIN EN ISO 23640:2015-12 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 (ISO 23640:2011); German version EN ISO 23640:2015 / Note: DIN EN ISO 23640 (2013-09) remains valid alongside this standard until 2018-06-30.
UNE-EN ISO 23640:2015 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 (ISO 23640:2011)
NF EN ISO 23640:2015 体外诊断医疗器械 体外诊断试剂稳定性评价
Dispositifs médicaux de diagnostic in vitro - Évaluation de la stabilité des réactifs de diagnostic in vitro
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 and in vitro diagnostic reagent stability evaluation
NF S92-011:1992 活体外诊断系统.自我试验用活体外诊断剂加标签要求
IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR LABELLING OF IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING. (EUROPEAN STANDARD EN 376).
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
编辑：北检院编辑部
