11.100 实验室医学 标准查询与下载

YY/T 1213-2013 促卵泡生成素定量标记免疫分析试剂盒

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

YY/T 1214-2013 人绒毛膜促性腺激素定量标记免疫分析试剂盒

本标准规定了人绒毛膜促性腺激素定量标记免疫分析试剂盒的分类、要求、试验方法、标识、标签和使用说明书、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人绒毛膜促性腺激素(HCG)的试剂盒(以下简称:HCG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HCG的免疫分析试剂盒。本标准不适用于:a)胶体金标记HCG试纸条;b)用125I等放射性同位素标记的各类HCG放射免疫或免疫放射试剂盒。

Human chorionic gonadotrophin quantitative labelling immunoassay kit

YY/T 1215-2013 丙型肝炎病毒（HCV)抗体检测试剂盒（胶体金法）

本标准规定了丙型肝炎病毒(HCV)抗体检测试剂盒(胶体金法)的术语和定义、要求、试验方法、检验和判定、包装、标志和使用说明书、运输和贮存。本标准适用于丙型肝炎病毒(HCV)抗体检测试剂盒(胶体金法、胶体硒法、胶乳法等快速检测试纸条试剂盒)。该试剂盒用于定性检测人全血、血清或血浆中的丙型肝炎病毒(HCV)抗体。

Hepatitis C antibody diagnostic kit.(Colloid gold method)

YY/T 1216-2013 甲胎蛋白定量标记免疫分析试剂盒

本标准规定了甲胎蛋白定量标记免疫分析试剂盒的分类、要求、试验方法、使用说明书、标识、标签以及包装、运输、贮存。本标准适用于进行甲胎蛋白定量测定的标记免疫分析试剂盒(以下简称AFP试剂盒)。包括以酶标记、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AFP的免疫分析测定试剂盒。本标准不适用于:a)胶体金标记AFP试纸条;b)用125I等放射性同位素标记的各类放射免疫或免疫放射试剂盒。

Alpha-fetoprotein quantitative labelling immunoassay kit

YY/T 1217-2013 促黄体生成素定量标记免疫分析试剂盒

本标准规定了促黄体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、标签和使用说明书、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黄体生成素(LH)的试剂盒(以下简称:LH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LH的免疫分析试剂盒。本标准不适用于:a)各类胶体金标记LH试纸;b)用125I等放射性同位素标记的各类LH放射免疫或免疫放射试剂盒。

Luteinizing hormone quantitative labelling immunoassay kit

YY/T 1218-2013 促甲状腺素定量标记免疫分析试剂盒

本标准规定了促甲状腺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甲状腺素(TSH)的试剂盒(以下简称:TSH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TSH的免疫分析试剂盒。本标准不适用于:a)胶体金标记TSH试纸条;b)用125I等放射性同位素标记的各类放射免疫或免疫放射试剂盒。

Thyroid-stimulating hormone quantitative labelling immunoassay kit

YY/T 1219-2013 胰酪胨大豆肉汤培养基

本标准规定了胰酪胨大豆肉汤培养基的术语和定义、培养基的配方、要求、试验方法、标识、标签和使用说明书以及包装、运输、贮存。

Trypticase soy broth medium

YY/T 1220-2013 肌酸激酶同工酶(CK-MB)诊断试剂(盒）(胶体金法）

本标准规定了肌酸激酶同工酶(CK-MB)诊断试剂(盒)(胶体金法)的术语和定义、要求、试验方法、检验和判定、标识、标签和使用说明书、包装、运输和贮存。本标准适用于肌酸激酶同工酶(CK-MB)诊断试剂(盒)(胶体金法)。该试剂用于体外定性检测人血清或血浆中肌酸激酶同工酶(Creatine kinase isoenzyme MB,CK-MB)的活性。

(Creatine kinase isoenzyme MB) (CK-MB) diagnostic kit.(Colloid gold method)

YY/T 1221-2013 心肌肌钙蛋白1诊断试剂(盒）(胶体金法）

本标准规定了心肌肌钙蛋白I诊断试剂(盒)(胶体金法)的术语和定义、要求、试验方法、检验和判定、标识、标签和使用说明书、包装、运输和贮存。本标准适用于心肌肌钙蛋白I诊断试剂(盒)(胶体金法)。该试剂用于定性检测人血清或血浆中的心肌肌钙蛋白I(cTnI)。

Cardiac troponini I (cTnI ) diagnostic kit.(Colloid gold method)

YY/T 1200-2013 葡萄糖测定试剂盒(酶法）

本标准规定了葡萄糖测定试剂盒(酶法)的测定原理、要求、试验方法、标识、标签和使用说明书、包装、运输和贮存等。本标准适用于己糖激酶法和氧化酶法葡萄糖测定试剂盒,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 assay kit.(Enzymic method)

ASTM F2148-13 采用小鼠局部淋巴结试验(LLNA)评估迟发型接触性超敏反应的标准实施规程

5.1 The propensity of a material to stimulate delayed contact hypersensitivity must be assessed before clinical application of devices containing this material. Delayed hypersensitivity may occur anywhere in the body. Systemic delayed hypersensitivity may have a complex set of reactions and consequences depending on the actual tissue/organ site of reaction. Although the reactions are seldom life-threatening, severe tissue and organ damage my result over time. Skin is the usual test site to determine the propensity of a material to cause delayed hypersensitivity. 5.2 The standard historical test methods have involved the use of guinea pigs with a cutaneous application and observation of the reaction site. The use of the murine local lymph node assay results in a numerical quantitation of stimulation, rather than subjective evaluation and could be used to determine dose responses. 5.3 This practice may not be predictive of events occurring during all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested, their potential applications, and the recommendations contained in Practice F748. 1.1 This practice provides a methodology to use an in-situ procedure for the evaluation of delayed contact hypersensitivity reactions. 1.2 This practice is intended to provide an alternative to the use of guinea pigs for evaluation of the ability of a device material to stimulate delayed contact hypersensitivity reactions. This alternative is particularly applicable for materials used in devices that contact only intact skin. However, the guinea pig maximization test is still the recommended method when assessing the delayed hypersensitivity response to metals or when testing substances that do not penetrate the skin but are used in devices that contact deep tissues or breached surfaces. This practice may be used for testing metals, with the exception of nickel-containing metals, unless the unique physicochemical properties of the materials may interfere with the ability of LLNA to detect sensitizing substances. 1.3 This practice consists of a protocol for assessing an increase in lymphocyte proliferation within the nodes draining the site of administration on the ears of mice. 1.4 The LLNA has been validated only for low-molecular-weight chemicals that can penetrate the skin. The absorbed chemical or metabolite must bind to macromolecules, such as proteins, to form immunogenic conjugates. 1.5 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application. 1.6 Identification of a supplier of materials or reagents is for the convenience of the user and does not imply a single source. Appropriate materials and reagents may be obtained from many commercial supply houses. 1.7 The value......

Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)

ASTM F756-13 评估材料溶血性能的标准实施规程

5.1 The presence of hemolytic material in contact with the blood may cause loss of, or damage to, red blood cells and may produce increased levels of free plasma hemoglobin capable of inducing toxic effects or other effects which may stress the kidneys or other organs. 5.2 This practice may not be predictive of events occurring during all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested, their potential applications, and the recommendations contained in Practice F748. 1.1 This practice provides a protocol for the assessment of hemolytic properties of materials used in the fabrication of medical devices that will contact blood. 1.2 This practice is intended to evaluate the acute in vitro hemolytic properties of materials intended for use in contact with blood. 1.3 This practice consists of a protocol for a hemolysis test under static conditions with either an extract of the material or direct contact of the material with blood. It is recommended that both tests (extract and direct contact) be performed unless the material application or contact time justifies the exclusion of one of the tests. 1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application. Test Method E2524 provides a protocol using reduced test volumes to assess the hemolytic properties of blood-contacting nanoparticulate materials; this may include nanoparticles that become unbound from material surfaces. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Practice for Assessment of Hemolytic Properties of Materials

GSO ISO 15195:2012 医学实验室 测量参考实验室的要求

This international Standard gives the specific requirements for reference measurement laboratories in laboratory medicine. Examinations of properties with results reported on a nominal or ordinal scale are not included. This international Standard is not applicable to routine medical laboratories.

Laboratory medicine -- Requirements for reference measurement laboratories

BS EN ISO 16256:2012 临床实验室测试和体外诊断测试系统. 检测抗菌剂抗传染病中酵母真菌体外活性的基准方法

Clinical laboratory testing and in vitro diagnostic test systems. Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases

WS/T 407-2012 医疗机构内定量检验结果的可比性验证指南

本标准规定了对定量检验项目的多个检测系统实施结果可比性验证的要求，包括可比性验证方案的使用条件和适用情况、验证方法和程序、验证结果不符合要求的处理措施。 本标准适用于同一医疗机构内的临床实验室。

Guideline for comparability verification of quantitative results within one health care system

WS/T 404.3-2012 临床常用生化检验项目参考区间.第3部分：血清钾、钠、氯

WS/T 404的本部规定了中国成年人血清钾、钠、氯的参考区间及其应用。 本部分适用于医疗卫生机构实验室血清钾、钠、氯检验结果的报告和解释，有关体外诊断厂商也可参照使用。

Reference intervals for common clinical biochemistry tests.Part 3:Serum potassium,sodium and chloride

WS/T 405-2012 血细胞分析参考区间

本标准规定了中国成年人血细胞分析参考区间及其应用。 本标准适用于医疗卫生机构实验室血细胞分析检验结果的报告和解释，有关体外诊断厂商也可参照使用。

Reference intervals for blood cell analysis

WS/T 406-2012 临床血液学检验常规项目分析质量要求

本标准规定了临床血液学检验常规项目（全血细胞计数和凝血试验）的分析质量要求及验证方法。 本标准适用于使用血液分析仪和血凝仪的临床实验室、室间质量评价机构或体外诊断企业的内部质量控制、外部质量评价及检测系统的性能验证。

Analytical quality specifications for routine tests in clinical hematology

WS/T 404.1-2012 临床常用生化检验项目参考区间.第1部分：血清丙氨酸氨基转移酶、天门冬氨酸氨基转移酶、碱性磷酸酶和γ-谷氨酰基转移酶

WS/T 404的本部分规定了中国成年人血清丙氨酸氨基转移酶、天门冬氨酸氨基转移酶、碱性磷酸酶和γ-谷氨酰基转移酶的参考区间及其应用。 本部分适用于医疗卫生机构实验室血清丙氨酸氨基转移酶、天门冬氨酸氨基转移酶、碱性磷酸酶和γ-谷氨酰基转移酶检验结果的报告和解释，有关体外诊断厂商也可参照使用。

Reference intervals for common clinical biochemistry tests.Part 1:Serum alanine aminotransferase,aspartate aminotransferase,alkaline phosphatase and γ-glutamyltansferase

WS/T 403-2012 临床生物化学检验常规项目分析质量指标

本标准规定了临床生物化学检验常规检验项目的分析质量指标。 本标准适用于临床实验室、室间质量评价机构、仪器或试剂厂家的临床检验内部质量控制、外部质量评价及方法性能确认与验证等活动。

Analytical quality specifications for routine analytes in clinical biochemistry