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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
本标准规定了临床化学体外诊断试剂（盒）（以下简称“试剂（盒）”）质量检验的通用技术要求，包括术语和定义、分类和命名、要求、试验方法、标签和使用说明、包装、运输和贮存。 本标准适用于医学实验室进行临床化学项目定量检验所使用的基于分光光度法原理的体外诊断试剂（盒）。 本标准不适用于： a） 性能
In vitro diagnostic reagent(kit) for clinical chemistry
In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for self-testing
本标准规定了临床化学体外诊断试剂盒命名应遵循的原则,并对部分项目制定了具体命名实例。本标准包含范围、规范性引用文件、术语和定义及要求等内容。本标准适用于采用分光光度法,利用全自动生化分析仪、半自动生化分析仪或分光光度计,在医学实验室进行定量检测的临床化学体外诊断试剂(盒)产品。本标准不适用于校准品
In vitro diagnostic reagent (kit) nomenclature for clinical chemistry
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 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
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
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]
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
本标准规定了临床化学体外诊断试剂（盒）（以下简称“试剂（盒）”）质量检验的通用技术要求，包括术语和定义、分类和命名、要求、试验方法、标签和使用说明、包装、运输和贮存。 本标准适用于医学实验室进行临床化学项目定量检验所使用的基于分光光度法原理的体外诊断试剂（盒）。 本标准不适用于： a） 性能
In vitro diagnostic reagent(kit) for clinical chemistry
In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for self-testing
本标准规定了临床化学体外诊断试剂盒命名应遵循的原则,并对部分项目制定了具体命名实例。本标准包含范围、规范性引用文件、术语和定义及要求等内容。本标准适用于采用分光光度法,利用全自动生化分析仪、半自动生化分析仪或分光光度计,在医学实验室进行定量检测的临床化学体外诊断试剂(盒)产品。本标准不适用于校准品
In vitro diagnostic reagent (kit) nomenclature for clinical chemistry
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 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
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
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]
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