YY/T 1652-2019 体外诊断试剂用质控物通用技术要求
WB/T 1116-2020 体外诊断试剂温控物流服务规范
WB/T 1115-2021 体外诊断试剂温控物流服务规范
Specification for in vitro diagnostic reagent temperature control logistics service
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
GOST R ISO 19001-2013 体外诊断医疗器械. 制造商提供生物着色用体外诊断试剂信息
In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
DS/EN 376:1993 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
YY/T 0639-2019 体外诊断医疗器械 制造商为生物学染色用体外诊断试剂提供的信息
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 体外诊断医疗器械 体外诊断试剂稳定性评价
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
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
YY/T 1652-2019 体外诊断试剂用质控物通用技术要求
WB/T 1116-2020 体外诊断试剂温控物流服务规范
WB/T 1115-2021 体外诊断试剂温控物流服务规范
Specification for in vitro diagnostic reagent temperature control logistics service
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
GOST R ISO 19001-2013 体外诊断医疗器械. 制造商提供生物着色用体外诊断试剂信息
In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
DS/EN 376:1993 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
YY/T 0639-2019 体外诊断医疗器械 制造商为生物学染色用体外诊断试剂提供的信息
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 体外诊断医疗器械 体外诊断试剂稳定性评价
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
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
编辑：北检院编辑部
