11.100.10 标准查询与下载
共找到 261 条与 相关的标准，共 18 页
Specification for pre-test procedures on venous whole blood for molecular in vitro diagnostic testing Part 1: Isolation of cellular RNA
- ICS
- 11.100.10
- CCS
- C30
- 发布
- 2023-11-27
- 实施
- 2024-06-01
Specification for pre-test procedures on venous whole blood for molecular in vitro diagnostic testing Part 2: Isolation of genomic DNA
- ICS
- 11.100.10
- CCS
- C30
- 发布
- 2023-11-27
- 实施
- 2024-06-01
本文件给出了新型冠状病毒抗原检测试剂盒的质量评价要求、试验方法、标签和说明书、包装、运输和贮存。 本文件适用于以咽拭子、鼻拭子、唾液等上呼吸道样本,血清、血浆及全血等血液样本,以及痰液、呼吸道抽取物、支气管灌洗液、肺泡灌洗液等下呼吸道样本为检测样本的新型冠状病毒抗原检测试剂盒的质量评价。
Quality assessment requirements for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen detection kit
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2021-11-26
- 实施
- 2022-03-01 00:00:00.0
本文件规定了新型冠状病毒核酸检测试剂盒的质量评价要求、试验方法、标签和说明书、包装、运输和贮存。 本文件适用于定性检测咽拭子、鼻咽拭子、肺泡灌洗液、痰液、呼吸道洗液、抽吸液或其他呼吸道分泌物等样本中的新型冠状病毒核酸的核酸扩增检测试剂盒的质量评价。 注:核酸扩增方法包含聚合酶链反应(PCR)技术与等温核酸扩增技术等。
Quality assessment requirements for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) nucleic acid detection kit
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2021-11-26
- 实施
- 2022-03-01 00:00:00.0
本文件规定了新型冠状病毒IgG抗体检测试剂盒的质量评价要求、试验方法、标签和说明书、包装、运输和贮存。 本文件适用于采用免疫层析法、酶联免疫法及化学发光法原理,对人血清、血浆和全血中新型冠状病毒特异性IgG抗体进行体外定性检测的试剂盒。
Quality assessment requirements for severe acute respiratory syndrome coronavirus 2（SARS-CoV-2） IgG antibody detection kit
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2021-11-26
- 实施
- 2022-03-01 00:00:00.0
本文件规定了新型冠状病毒(总)抗体检测试剂盒的质量评价涉及的质量要求、试验方法、标签和说明书、包装、运输和贮存。 本文件适用于采用免疫层析法、酶联免疫法及化学发光法原理,对人血清、血浆和全血中新型冠状病毒特异性抗体(含IIgM、gG等抗体种类)进行体外定性检测的试剂盒。
Quality assessment requirements for Severe Acute Respiratory Syndrome Coronavirus 2（SARS-CoV-2） total antibody detection kit
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2021-11-26
- 实施
- 2022-03-01 00:00:00.0
本文件规定了新型冠状病毒IgM抗体检测试剂盒的质量评价要求、试验方法、标签和说明书、包装、运输和贮存。 本文件适用于采用免疫层析法、酶联免疫法及化学发光法原理,对人血清、血浆和全血中新型冠状病毒特异性IgM抗体进行体外定性检测的试剂盒。
Quality assessment requirements for severe acute respiratory syndrome coronavirus 2（SARS-CoV-2） IgM antibody detection kit
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2021-11-26
- 实施
- 2022-03-01 00:00:00.0
本标准规定了体外诊断医疗器械和医学实验室使用的参考测量程序内容的要求。 注1:本标准期望一个有经验的实验室工作者,按照符合本标准制定的测量程序操作,可获得不超出规定区间的带有测量不确定度的测量结果。 本标准适用于提供差示值或比例量值的参考测量程序。 附录A提供了有关名义特性和序量的信息。本标准适用于在检验医学各个学科分支中,需要编写参考测量程序文件的所有个人、机构或研究所。完整描述的测量方法通常发表在科学文献上,这些充分详细描述的方法可以作为文件化参考测量程序的基础。 注2:在本标准中,“国际测量标准”被定义为物质标准。 术语“国际标准”在WHO中被用作参考物质。
In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for content and presentation of reference measurement procedures
- ICS
- 11.100.10
- CCS
- C30
- 发布
- 2021-03-09
- 实施
- 2022-04-01 00:00:00.0
This document provides the terms and general requirements for the evaluation of the quality of nucleic acids as the analytes for multiplex molecular tests, which simultaneously identify two or more nucleic acid target sequences of interest. This document is applicable to all multiplex molecular methods used for examination using in vitro diagnostic (IVD) medical devices and laboratory developed tests (LDTs). It provides information for both qualitative and quantitative detection of nucleic acid target sequences. This document is intended as guidance for multiplex molecular assays that detect and/or quantify human nucleic acid target sequences or microbial pathogen nucleic acid target sequences from human clinical specimens. This document is applicable to any molecular in vitro diagnostic examination performed by medical 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 to metagenomics. NOTE An examination procedure developed for a laboratory's own use is often referred to as a "laboratory developed test", "LDT", or "in-house test".
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation
- ICS
- 11.100.10
- CCS
- 发布
- 2024-04-25
- 实施
This document describes a method for testing the susceptibility to antifungal agents of yeasts, including Candida spp. and Cryptococcus neoformans, that cause infections. The reference method described here has not been used in studies of the yeast forms of dimorphic fungi, such as Blastomyces dermatitidis and/or Histoplasma capsulatum variety capsulatum. Moreover, testing filamentous fungi (moulds) introduces several additional problems in standardization not addressed by the current procedure. Those methods are beyond the scope of this document. This document describes the broth micro-dilution reference method, which can be implemented by either of two pathways. One pathway involves visual determination of MICs (CLSI method)[1][5]; the second pathway involves spectrophotometric determination of MICs (EUCAST method)[2][10]. The MIC reflects the activity of the drug under the described test conditions and can be interpreted for clinical management purposes by taking into account other factors, such as drug pharmacology or antifungal resistance mechanisms. In addition, MIC distributions can be used to define wild type or non-wild type fungal populations. Clinical interpretation of the MIC value is beyond the scope of this document; interpretive category breakpoints specific to the CLSI- and EUCAST-derived methods can be found by consulting the latest interpretive tables provided by the organizations[5][15]. Routine susceptibility testing methods or diagnostic test devices can be compared with this reference method in order to ensure comparable and reliable results for validation or registration purposes.
Clinical laboratory testing and in vitro diagnostic test systems — Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
- ICS
- 11.100.10
- CCS
- 发布
- 2024-04-25
- 实施
This document specifies requirements and test methods for specialized single-use evacuated and non-evacuated containers, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination. It is not intended to cover specimen containers for forensic investigations. Examples of such specimens include, but are not limited to, cerebral spinal fluid (CSF), faeces, infected bodily fluids, saliva, ejaculate, sputum, urine, tissue samples. Specimens and types of devices specifically excluded are specialized containers for cryo-preservation, samples for nucleic acid testing and swabs. NOTE Requirements and test methods for evacuated and non-evacuated single-use human venous blood specimen collection containers are specified in ISO 6710. This document does not specify requirements for auxiliary devices used in conjunction with specimen containers.
In vitro diagnostic medical devices — Single-use containers for the collection of specimens from humans other than blood
- ICS
- 11.100.10
- CCS
- 发布
- 2024-04-25
- 实施
This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for cellular RNA examination during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes. This document is applicable to any molecular in vitro diagnostic examination performed by medical 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. Different dedicated measures are taken for stabilizing blood cell free circulating RNA and RNA in exosomes circulating in blood. These are not described in this document. Different dedicated measures are taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this document. This document does not cover the isolation of specific blood cells and subsequent isolation of cellular RNA therefrom. RNA in pathogens present in blood is not covered by this document.
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA
- ICS
- 11.100.10
- CCS
- 发布
- 2024-04-25
- 实施
In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice
- ICS
- 11.100.10
- CCS
- 发布
- 2024-03-31
- 实施
- 2024-03-31
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
本文件规定了断裂点簇集区-艾贝尔逊白血病病毒（BCR-ABL）融合基因检测试剂盒的要求、标签和使用说明、包装、运输和贮存，描述了相应的试验方法。本文件适用于检测外周血样本和骨髓样本的断裂点簇集区-艾贝尔逊白血病病毒（BCR-ABL）融合基因检测试剂盒，采用的技术方法有荧光聚合酶链反应（Polymerase Chain Reaction，PCR）法、荧光逆转录聚合酶链反应（Reverse Transcription-Polymerase Chain Reaction，RT-PCR）法、逆转录数字聚合酶链反应（Reverse Transcription- Digital Polymerase Chain Reaction，RT-dPCR）法和数字聚合酶反应（Digital Polymerase Chain Reaction, dPCR）法等。
Breakpoint Cluster Region-Abelson Leukemia Virus (BCR-ABL) Fusion Gene Detection Kit
- 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
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
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
