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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
In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for self-testing
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
In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for professional use
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
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
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.
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
Dispositifs médicaux de diagnostic in vitro - Évaluation de la stabilité des réactifs de diagnostic in vitro
In vitro diagnostic medical devices and in vitro diagnostic reagent stability evaluation
IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR LABELLING OF IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING. (EUROPEAN STANDARD EN 376).
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
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
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
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
In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for self-testing
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
In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for professional use
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
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
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.
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
Dispositifs médicaux de diagnostic in vitro - Évaluation de la stabilité des réactifs de diagnostic in vitro
In vitro diagnostic medical devices and in vitro diagnostic reagent stability evaluation
IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR LABELLING OF IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING. (EUROPEAN STANDARD EN 376).
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
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
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
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