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体外诊断试剂用质控物检测

发布时间:2024-05-27 17:49:26 - 更新时间:2024年06月29日 15:22

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军工检测 其他检测

YY/T 1652-2019 技术要求

WB/T 1116-2020 流服务规范

WB/T 1115-2021 流服务规范

Specification for in vitro diagnostic reagent temperature control logistics service

YY/T 1244-2014 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 活系统.自标签要求

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

GOST R ISO 19001-2013 医疗器械. 制造商提供生着色信息

In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

DS/EN 376:1993 系统.自检加标签的要求

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 活系统.专业标签要求

In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for professional use

DS/EN 375:1993 系统.专业加标签的要求

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

YY/T 0639-2019 医疗器械 制造商为生学染色提供的信息

本标准规定了制造商为生物学染色用试剂所提供信息的要求。本标准适用于染料、染色剂、发光试剂和用于生物学染色的其他试剂的生产商、供应商和零售商。在生物染色所有领域中,本标准所规定的制造商提供信息的要求,是获得可参照和可复现结果的先决条件

In vitro diagnostic medical devices.Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

YY/T 1579-2018 医疗器械 稳定性评价

KS P ISO 23640:2019 医疗器械 - 稳定性评估

In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

NF S92-011:1992 活系统.自我加标签要求

IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR LABELLING OF IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING. (EUROPEAN STANDARD EN 376).

KS P ISO 23640:2013 医疗器械.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 医疗器械. 稳定性的评估

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents

YY/T 1652-2019 技术要求

WB/T 1116-2020 流服务规范

WB/T 1115-2021 流服务规范

Specification for in vitro diagnostic reagent temperature control logistics service

YY/T 1244-2014 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 活系统.自标签要求

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

GOST R ISO 19001-2013 医疗器械. 制造商提供生着色信息

In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

DS/EN 376:1993 系统.自检加标签的要求

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 活系统.专业标签要求

In vitro diagnostic systems; requirements for labelling of in vitro diagnostic reagents for professional use

DS/EN 375:1993 系统.专业加标签的要求

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

YY/T 0639-2019 医疗器械 制造商为生学染色提供的信息

本标准规定了制造商为生物学染色用试剂所提供信息的要求。本标准适用于染料、染色剂、发光试剂和用于生物学染色的其他试剂的生产商、供应商和零售商。在生物染色所有领域中,本标准所规定的制造商提供信息的要求,是获得可参照和可复现结果的先决条件

In vitro diagnostic medical devices.Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

YY/T 1579-2018 医疗器械 稳定性评价

KS P ISO 23640:2019 医疗器械 - 稳定性评估

In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

NF S92-011:1992 活系统.自我加标签要求

IN VITRO DIAGNOSTIC SYSTEMS. REQUIREMENTS FOR LABELLING OF IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING. (EUROPEAN STANDARD EN 376).

KS P ISO 23640:2013 医疗器械.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 医疗器械. 稳定性的评估

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents

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