11.100 实验室医学 标准查询与下载
共找到 746 条与 实验室医学 相关的标准，共 50 页
本文件规定了热启动Taq DNA聚合酶的分类、性能要求、验证方法、验证规则。 本文件适用于热启动Taq DNA聚合酶制造商和使用热启动Taq DNA聚合酶进行PCR相关实验的各类检测机构。
Performance verification of hot-start Taq DNA polymerase
- ICS
- 11.100
- CCS
- M734
- 发布
- 2022-07-01
- 实施
- 2022-07-01
In vitro diagnostic testing system performance evaluation methods Part 4: Linear intervals and reportable intervals
- ICS
- 11.100
- CCS
- C 30
- 发布
- 2022-07-01
- 实施
- 2024-01-01
In vitro diagnostic testing system performance evaluation methods Part 3: Detection limit and quantitation limit
- ICS
- 11.100
- CCS
- C 30
- 发布
- 2022-07-01
- 实施
- 2024-01-01
Service Specifications for Third-Party Blood Testing Institutions
- ICS
- 11.100
- CCS
- C 40
- 发布
- 2022-06-29
- 实施
- 2022-07-29
本文件规定了体外诊断试剂准确度方法学比对试验的试验要求、试验方法。 本文件适用于体外诊断试剂准确度评估-方法学比对试验。
Methodological comparison and evaluation of the accuracy of in vitro diagnostic reagents
- ICS
- 11.100
- CCS
- M745
- 发布
- 2022-06-10
- 实施
- 2022-06-10
Human papillomavirus nucleic acid (typing) detection kit
- ICS
- 11.100
- CCS
- C44
- 发布
- 2022-05-18
- 实施
- 2023-06-01
Complement 4 assay kit (immunoturbidimetric method)
- ICS
- 11.100
- CCS
- 发布
- 2022-05-18
- 实施
- 2023-06-01
Antiglobulin test card (column agglutination method)
- ICS
- 11.100
- CCS
- 发布
- 2022-05-18
- 实施
- 2023-06-01
Thyroglobulin assay kit (chemiluminescence immunoassay)
- ICS
- 11.100
- CCS
- 发布
- 2022-05-18
- 实施
- 2023-12-01
本文件规定了便携式无源疫苗箱的产品分类、技术要求、试验方法、标志和说明等。
Vaccine cold chain-Technical requirement and test method for portable passive vaccine cold box
- ICS
- 11.100
- CCS
- C358
- 发布
- 2022-05-13
- 实施
- 2022-05-18
1.1 This practice covers whole blood that will be used for the in vitro performance assessment of hemolysis in blood pumps intended for clinical use. 1.2 This practice covers the recommended standard collection, preparation, handling, storage, and utilization of whole blood for the in vitro evaluation (see Practice F1841) of the following devices: 1.2.1 Continuous flow blood pumps (roller pumps, centrifugal pumps, axial flow pumps, etc.). 1.2.2 Pulsatile and intermittent flow blood pumps (pneumatically driven, electro-mechanically driven, with an artificial pulse, etc.). 1.3 The source and preparation of whole blood utilized for the dynamic in vitro evaluation of red blood cell (erythrocyte) trauma caused by blood pumps can substantially influence the hemolysis performance of these devices. Thus, standardized whole blood collection and preparation methods are required. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Standard Practice for Collection and Preparation of Blood for Dynamic in vitro Evaluation of Hemolysis in Blood Pumps
- ICS
- 11.100
- CCS
- 发布
- 2022-05-12
- 实施
本文件提出了实时荧光定量PCR测定鼠血液与组织中溶瘤痘苗病毒含量的主要方法。 本文件适用于定量分析鼠不同组织中溶瘤痘苗病毒的含量。
Real-time Fluorescent Quantitative PCR Method for Determination of Murine Oncolytic Vaccinia Virus
- ICS
- 11.100
- CCS
- Q843
- 发布
- 2022-04-25
- 实施
- 2022-04-28
本文件提出了干细胞（包括胚胎干细胞、成体干细胞、诱导多能干细胞等）治疗产品致瘤性试验的试验原理、试验条件、主要试剂、仪器设备及试验步骤等。
Test methods for tumorigenicity of stem cell therapy products
- ICS
- 11.100
- CCS
- Q841
- 发布
- 2022-04-25
- 实施
- 2022-04-28
本文件规定了构建非人灵长类自身给药模型来评价阿片类药物的精神依赖潜能的主要方法，本文件中使用猴为非人灵长类代表。 本文件不适用于其他中枢抑制机制药物的精神依赖潜力评价。
Evaluation method of psychoactive effects of opioids
- ICS
- 11.100
- CCS
- Q843
- 发布
- 2022-04-25
- 实施
- 2022-04-28
本文件描述了从人胃肠道上皮活组织及其上皮起源的病变活组织提取上皮细胞构建类器官的原理、实验方法、传代、储存以及复苏方法
Guideline of construction and preservation of organoids of gastrointestinal epithelial tissues
- ICS
- 11.100
- CCS
- M731
- 发布
- 2022-03-28
- 实施
- 2022-03-28
Collection, transportation and storage of urine samples in iodide detection
- ICS
- 11.100
- CCS
- C 10
- 发布
- 2022-03-03
- 实施
- 2022-06-01
新型冠状病毒（SARS-CoV-2）荧光PCR核酸检测是我国新型冠状病毒感染临床诊断和对社会疫情开展精准防控的关键支撑技术。然而用于保障新型冠状病毒核酸检测质量控制的阳性质控品缺乏规范标准，给新型冠状病毒核酸检测结果的可靠性、准确性带来重大隐患。 基于水泡性口炎病毒（Vesicular Stomatitis Virus， VSV）载体的新型冠状病毒核酸检测用阳性假病毒质控品属于一类用于荧光PCR检测质量控制的标准物质。该质控品为携带荧光蛋白报告基因的无自我复制能力、无致病性的RNA假病毒颗粒，其所含新型冠状病毒核酸检测的三个靶标基因 （核壳蛋白N基因全长、包膜蛋白E基因全长及开放阅读框lab（ORFlab））序列，与中国疾病预防控制中心或世界卫生组织（WHO） 公布的引物相匹配，适用于获批上市的主要新型冠状病毒核酸检测试剂盒，与临床样本具有良好的互通性。
Vesicular Stomatitis Virus (VSV) vector -derived pseudovirus positive control material for SARS-CoV-2 nucleic acid detection
- ICS
- 11.100
- CCS
- C30
- 发布
- 2022-01-26
- 实施
- 2022-03-01
外观、溯源性、检出限、准确度、线性、重复性、批间差、分析特异性、稳定性、标签和使用说明书、包装运输贮存。
Lipoprotein-associated Phospholipase A2 Detection kit(Chemiluminescent Immunoassay)
- ICS
- 11.100
- CCS
- C2770
- 发布
- 2022-01-13
- 实施
- 2022-01-13
外观、溯源性、检出限、准确度、线性、重复性、批间差、分析特异性、稳定性、标签和使用说明书、包装运输贮存。
Interleukin 6 Detection kit (Chemiluminescent Immunoassay)
- ICS
- 11.100
- CCS
- C2770
- 发布
- 2022-01-13
- 实施
- 2022-01-13
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
- ICS
- 11.100
- CCS
- 发布
- 2022
- 实施
- 0000-00-00
