体外诊断类软件检测

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

ONORM EN 376-1993 体外诊断系统．自测用体外诊断剂的标签要求

Diese Norm führt Anforderungen an die Kennzeichnung und Produktinformationen von In-vitro-Diagnostica für den Gebrauch beim Selbsttesten, d.h. durch

In vitro diagnostic Systems - Requirements for labelling of in vitro diagnostic reagents for serf-testing

NBN-EN 376-1992 体外诊断系统，用于自测法的体外诊断剂标示要求

In vitro diagnostic systems - Requirements for labelling of in vitro diagnostic reagents for self-testing

GB/T 32945-2016 牛结核病诊断 体外检测γ干扰素法

GB/T 19634-2021 体外诊断检验系统 自测用血糖监测系统通用技术条件

In vitro diagnostic test systems—General technical requirements for blood-glucose monitoring systems for self-testing

GB/T 19634-2005 体外诊断检验系统.自测用血糖监测系统通用技术条件

本标准规定了自测用血糖监测系统的术语和定义、要求、试验方法、标签和使用说明、包装、运输和贮存。 本标准适用于体外监测人体毛细血管全血和/或静脉全血中葡萄糖浓度的自测用血糖监测系统（通常包括便携式血糖仪、一次性试条和质控物质

In vitro diagnostic test systems.General technical requirements for blood-glucose monitoring systems for self-testing

162药典 三部-2015 各论 Ⅳ体外诊断类 梅毒螺旋体抗体诊断试剂盒(酶联免疫法)

183药典 三部-2020 各论 Ⅳ体外诊断类 梅毒螺旋体抗体诊断试剂盒(酶联免疫法)

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

ONORM EN 375-1993 体外诊断系统．专业用体外诊断剂的标签要求

Diese Norm führt Anforderungen an die Kennzeichnung und Produktinformationen von In-vitro-Diagnostica für den Gebrauch durch Fachpersonal auf

In vitro diagnostic Systems - Requirements for labelling of in vitro diagnostic reagents for professional use

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

NBN EN 591-1995 体外诊断系统．专用体外诊断仪器使用说明的要

In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic instruments for professional use

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]

136药典 三部-2010 各论目次 Ⅳ体外诊断类 梅毒螺旋体抗体诊断试剂盒(酶联免疫法)

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WS/T 252-2005 体外诊断用品标识

本标准规定了对体外诊断用品标识的要求。 本标准适用于一切以诊断疾病为目的、在体外进行实验或检验时所使用的试剂、校准品、质控物及相关材料的标识

Labeling of In Vitro Diagnosis Products

NBN-EN 376-1992 体外诊断系统，用于自测法的体外诊断剂标示要求

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

NF S92-017:1995 体外诊断系统.家用体外诊断仪器使用说明书要求

IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR USER MANUALS FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR HOME USE. (EUROPEAN STANDARD EN 592).

NF S92-016:1995 体外诊断系统.专用体外诊断仪器使用说明的要求

IN VITRO DIAGNOSTIC SYSTEMS. REQUIRMENTS FOR USER MANUELS FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE. (EUROPEAN STANDARD EN 591).

179药典 三部-2020 各论 Ⅳ体外诊断类 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法)

160药典 三部-2015 各论 Ⅳ体外诊断类 丙型肝炎病毒抗体诊断试剂盒(酶联免疫法)