实验室医学标准-分析测试百科网

YY/T 1674-2019 胰岛素样生长因子I测定试剂盒

Insulin-like growth factor I assay kit

ICS: 11.100
CCS: C44
发布: 2019-10-23
实施: 2020-10-01

DB22/T 351-2019 卫生微生物样品收取和检验原则

Sanitary microbiological sample collection and testing principles

ICS: 11.100
CCS: C 51
发布: 2019-10-14
实施: 2019-11-01

SN/T 5108-2019 国境口岸轮状病毒、星状病毒、诺如病毒、札如病毒四联HRMA检测方法

Quadruple HRMA detection method for rotavirus, astrovirus, norovirus, and zarovirus at border ports

ICS: 11.100
CCS: C62
发布: 2019-09-03
实施: 2020-03-01

SN/T 5109-2019 国境口岸鼠疫耶尔森菌聚合酶螺旋恒温扩增检测方法

Yersinia pestis polymerase helical isothermal amplification detection method at border ports

ICS: 11.100
CCS: C62
发布: 2019-09-03
实施: 2020-03-01

ASTM F1830-19 体外动态血液采集和制备的标准实施规程

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: 2019-09-01
实施

YY/T 1669-2019 ABO反定型检测卡(柱凝集法)

ABO anti-typing test card (column agglutination method)

ICS: 11.100
CCS: C44
发布: 2019-07-24
实施: 2020-08-01

YY/T 1664-2019 甲状旁腺激素测定试剂盒

Parathyroid hormone assay kit

ICS: 11.100
CCS: C44
发布: 2019-07-24
实施: 2020-08-01

ASTM E788-97(2019) 血液稀释用吸管的标准规范

1.1 This specification covers requirements for glass reusable blood diluting pipets that are used for performing red and white cell corpuscle determinations. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 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 Specification for Pipet, Blood Diluting

ICS: 11.100
CCS
发布: 2019-07-01
实施

ASTM E923-97(2019) 可重复使用的玻璃韦斯特格伦管的标准规范

1.1 This specification describes requirements for a tube that measures the erythrocyte sedimentation rate (ESR). ESR is the suspension stability of red cells in diluted, anti-coagulated human blood. 1.1.1 The use of the term “rate” is, strictly speaking, not correct. The test measures the amount of settling of red cells after a specified time. 1.2 The tubes are used together with a special rack to ensure they remain in a vertical position during the test. 1.3 This specification includes many dimensional requirements that are, for the most part, in agreement with the British Standards Institution, German Standards Institute, International Committee for Standardization in Haematology, and the National Committee for Clinical Laboratory Standards publications on Westergren tubes. The clinical procedure using the tube described in this specification is known as the “Westergren Method.” 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 standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 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 Specification for Glass Westergren Tube, Reusable

ICS: 11.100
CCS
发布: 2019-07-01
实施

T/ZS 0068-2019 病原微生物实验室管理评价体系

目次前言　 1　范围　 2　规范性引用文件　 3　术语和定义　 4　评价方法　 5　评价内容　 6　评价要求　 7　评价程序　 8　评价结果和结论　 8.1　评价结果　 8.2　评价结论　 9　评价结果的应用　附　录　A （规范性附录）病原微生物实验室生物安全管理评价表　表A.1 组织管理　表A.2 实验室设施设备　表A.3 人员管理　表A.4 安全计划　表A.5 文件控制　表A.6 菌(毒)种和生物样本管理　表A.7 实验废物管理　表A.8 实验室内务管理　表A.9 实验材料管理　表A.10 标识管理　表A.11 内部审核　表A.12 管理评审　表A.13 纠正措施　表A.14 预防措施　表A.15持续改进　表A.16 不符合项的识别和控制　表A.17 消防安全管理　附　录　B （规范性附录）病原微生物实验室生物安全管理评价结果表　参?考?文?献　

Pathogenic Microbiology Laboratory Management Evaluation System

ICS: 11.100
CCS: Q849
发布: 2019-06-12
实施: 2019-09-25

YY/T 1213-2019 促卵泡生成素测定试剂盒

本标准规定了促卵泡生成素定量标记免疫分析试剂盒的分类、要求、试验方法、标识、标签、使用说明书、包装、运输和贮存。本标准适用于以双抗体夹心法为原理定量测定促卵泡生成素(FSH)的试剂盒(以下简称:FSH试剂盒)。包括以酶标记、(电)化学发光标记、(时间分辨)荧光标记等标记方法为捕获抗体,以微孔板、管、磁颗粒、微珠和塑料珠等为载体包被抗体,定量测定FSH的免疫分析试剂盒。本标准不适用于:a) 胶体金标记FSH试纸条;b)用125I等放射性同位素标记的各类FSH放射免疫或免疫放射试剂盒。

Follicle stimulating hormone quantitative labelling immunoassay kit