11.100.10 标准查询与下载
共找到 267 条与 相关的标准，共 18 页
本文件规定了医用电感耦合等离子体质谱仪的要求、标签、使用说明、包装、运输和贮存，描述了相应的试验方法。本文件适用于医用电感耦合等离子体质谱仪（ICP-MS），该仪器主要用于分析人源样本中的无机元素，如钾、钙、锌、碘等。
Medical mass spectrometers Part 3: Inductively coupled plasma mass spectrometers
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2024-02-07
- 实施
- 2025-03-01
本文件规定了葡萄糖测定试剂盒（酶法）的要求、标签和使用说明书、包装、运输和贮存，描述了相应的试验方法。本文件适用于己糖激酶法、葡萄糖氧化酶法测定试剂盒，该试剂盒在临床检验中用于定量分析血清、血浆、尿液、脑脊液等体液中的葡萄糖浓度。
Glucose determination kit (enzymatic method)
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2024-02-07
- 实施
- 2025-03-01
本文件规定了生化分析仪用校准物的要求、标签和使用说明、包装、运输和贮存等，描述了相应的试验方法。本文件适用于在全自动生化分析仪、半自动生化分析仪上使用，用于临床检验项目分析的校准物。本文件不适用于生化分析仪电解质模块用校准物。
Calibrators for biochemical analyzers
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2024-02-07
- 实施
- 2025-03-01
本文件规定了解脲脲原体核酸检测试剂盒的分类、技术要求、标签、使用说明书、包装、运输和贮存，描述了相应的试验方法。本文件适用于检测人泌尿道、生殖道和呼吸道脲原体的核酸检测试剂盒，采用的方法学有荧光PCR法、恒温扩增法、PCR膜杂交法。
Ureaplasma urealyticum nucleic acid detection kit
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2024-02-07
- 实施
- 2025-03-01
本文件规定了干式化学分析仪（以下简称分析仪）的要求、标志、标签、使用说明书和包装、运输、贮存，描述了相应的试验方法。本文件适用于配套使用固相载体试剂，在医学临床上对患者的血液、尿液和脑脊液等样品进行化学检验的分析仪。本文件不适用于血糖分析仪、尿液分析仪、血气分析仪或其他干式分析仪。
Dry chemistry analyzer
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2024-02-07
- 实施
- 2025-03-01
BS ISO 21474-3. In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids - Part 3. Interpretation and reports
- ICS
- 11.100.10
- CCS
- 发布
- 2023-10-30
- 实施
- 2023-10-30
本文件规定了Y染色体微缺失检测试剂盒的要求、试验方法、标签和使用说明书、包装、运输和贮存。本文件适用于PCR-荧光探针法、PCR-毛细管电泳法、生物芯片法等Y染色体微缺失检测试剂盒。本文件不适用于基于二代测序法的检测试剂盒。
Y chromosome microdeletion detection kit
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2023-09-05
- 实施
- 2024-09-15
本文件规定了核酸提取仪的要求、试验方法、标签、标识和使用说明、包装、运输和贮存。本文件适用于对临床样本中核酸的提取、纯化等自动化前处理相关仪器。
Nucleic acid extraction instrument
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2023-09-05
- 实施
- 2024-09-15
本文件规定了乙型肝炎病毒表面抗原检测试剂盒（免疫层析法）的要求、试验方法、标识、标签和使用说明、包装、运输和贮存等。本文件适用于采用胶体金法、乳胶法等免疫层析法，对人血清、血浆或全血中的乙型肝炎病毒表面抗原（以下简称HBsAg）进行定性检测的乙型肝炎病毒表面抗原检测试剂盒。本文件不适用于以酶联免疫法、化学发光免疫法、时间分辨免疫荧光法等方法学的乙型肝炎病毒表面抗原检测试剂盒。
Hepatitis B virus surface antigen detection kit (immunochromatography)
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2023-09-05
- 实施
- 2024-09-15
本文件规定了数字聚合酶链反应分析系统的分类，要求，试验方法，标签、标识和使用说明，包装、运输和贮存等内容。本文件适用于对核酸样本以单液滴或单核酸分子方式生成数百个至数百万个独立反应单元的设备，分析系统包括微液滴生成模块、聚合酶链反应模块和微滴检测模块等。
Digital polymerase chain reaction analysis system
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2023-09-05
- 实施
- 2024-09-15
本文件规定了抗Xa测定试剂盒（发色底物法）的要求、标志、标签和使用说明、包装、运输和贮存，描述了相应的试验方法。本文件适用于发色底物法的抗Xa测定试剂盒，进行人体血浆样本中的普通肝素（UFH）和低分子肝素（LMWH）的定量检测。
Anti-Xa assay kit (chromogenic substrate method)
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2023-09-05
- 实施
- 2024-09-15
This document specifies requirements and gives recommendations for the handling, storage, processing, and documentation of frozen tissue specimens intended for DNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that evaluate DNA isolated from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document. NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 3: Isolated DNA
- ICS
- 11.100.10
- CCS
- 发布
- 2023-05-03
- 实施
This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNA
- ICS
- 11.100.10
- CCS
- 发布
- 2023-05-03
- 实施
This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for DNA examination during the pre-examination phase before a molecular assay is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 3: Isolated DNA
- ICS
- 11.100.10
- CCS
- 发布
- 2023-05-03
- 实施
This document gives guidelines on the handling, documentation, storage and processing of frozen tissue specimens intended for the examination of isolated proteins during the pre-examination phase before a molecular assay is performed. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories and molecular pathology laboratories that evaluate proteins isolated from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins (ISO 20184-2:2018)
- ICS
- 11.100.10
- CCS
- 发布
- 2023-05-03
- 实施
This document gives guidelines on the handling, documentation, storage and processing of frozen tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories and molecular pathology laboratories that evaluate RNA extracted from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities. Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 1: Isolated RNA
- ICS
- 11.100.10
- CCS
- 发布
- 2023-05-03
- 实施
This document specifies requirements and gives recommendations for the collection, handling, documentation, transport, storage and processing during the pre-examination phase of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for qualitative and/or (semi-)quantitative in situ examination of the morphology and of biomolecules, such as metabolites, proteins, DNA and/or RNA, on FFPE tissue sections by using different in situ detection techniques. This document is applicable to in vitro diagnostic examinations using in situ detection techniques. These include laboratory developed tests performed by pathology laboratories (histopathology laboratories) as well as by molecular pathology laboratories and other medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, as well as institutions and commercial organizations performing biomedical research, and regulatory authorities. This document is not applicable to the pre-examination phase of RNA, proteins and DNA isolated from FFPE tissue for examination. These are covered in ISO 20166-1, ISO 20166-2 and ISO 20166-3, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for isolated RNA, proteins and DNA, respectively. Different dedicated measures are taken for pre-examination processes for fine needle aspirates (FNAs). These are covered in CEN WI 00140128, CEN WI 00140126, and CEN WI 00140129, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) isolated cellular RNA, isolated proteins, and isolated genomic DNA, respectively. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
Molecular in vitro diagnostic examinations — Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 4: In situ detection techniques
- ICS
- 11.100.10
- CCS
- 发布
- 2023-05-03
- 实施
This document specifies requirements and gives recommendations for the handling, documentation and processing of urine, venous blood plasma and serum intended for metabolomics analysis in the pre-examination processes. This document is applicable to metabolomics examinations and can be used by biomedical laboratories, customers of laboratories, in vitro diagnostics developers and manufacturers, institutions and companies performing biomedical research, biobanks, and regulatory authorities.
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma
- ICS
- 11.100.10
- CCS
- 发布
- 2023-05-03
- 实施
This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for the examination of isolated proteins during the pre-examination phase before a molecular assay is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. This document is not applicable for protein examination by immunohistochemistry. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
Molecular in vitro diagnostic examinations — Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 2: Isolated proteins
- ICS
- 11.100.10
- CCS
- 发布
- 2023-05-03
- 实施
本文件规定了Rh血型C、c、E、e抗原检测卡（柱凝集法）的要求、试验方法、标签和使用说明书、包装、运输和贮存等。本文件适用于以凝胶、玻璃微珠等材料进行填充的微柱，微柱中抗C、c、E、e为IgM类型的单克隆抗体，采用免疫血液学、颗粒过筛和离心技术三者结合的原理，进行定性检测的Rh血型系统中C、c、E、e四种抗原的检测试剂。本文件不适用于血源筛查进行Rh血型C、c、E、e抗原检测的诊断试剂。
Rh blood group C, c, E, e antigen test card (column agglutination method)
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2023-03-14
- 实施
- 2024-05-01
