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YY/T 1183-2010

标准搜索结果: 'YY/T 1183-2010'
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YY/T 1183-2010 英文版 810 购买 现货,9秒内自动发货PDF,有增值税发票。 酶联免疫吸附法检测试剂(盒) 有效

   
标准详细信息 YY/T 1183-2010; YY/T1183-2010; YYT 1183-2010; YYT1183-2010
中文名称: 酶联免疫吸附法检测试剂(盒)
英文名称: Detection reagent (kit) for enzyme-linked immunoabsorbent assay (ELISA)
行业: 医药行业标准 (推荐)
中标分类: C44
国际标准分类: 11.100
字数估计: 18,000
发布日期: 2010-12-27
实施日期: 2012-06-01
引用标准: GB/T 21415-2008
起草单位: 北京市医疗器械检验所、北京金伟凯医学生物技术有限公司、上海复星长征医学科学有限公司、贝克曼库尔特商贸(中国)有限公司
归口单位: 全国医用临床检验实验室和体外诊断系统标准化技术委员会(SAC/TC 136)
标准依据: 国家食品药品监督管理局公告2010年第97号
提出机构: 全国医用临床检验实验室和体外诊断系统标准化技术委员会(SAC/TC 136)
发布机构: 国家食品药品监督管理局
范围: 本标准规定了酶联免疫吸附法检测试剂(盒)的通用技术要求, 包括术语与定义?分类?要求?试验方法?标识和使用说明书?包装?运输和贮存。本标准适用于在医学实验室以酶联免疫吸附法为原理进行检验的定量/定性检侧试剂(盒)。

YY/T 1183-2010
Detection reagent (kit) for enzyme-linked immunoabsorbent assay (ELISA)
ICS 11.100
C44
中华人民共和国医药行业标准
酶联免疫吸附法检测试剂(盒)
2010-12-27发布
2012-06-01实施
国家食品药品监督管理局 发 布
前言
本标准按照GB/T 1.1-2009给出的规则起草。
请注意本文件的某些内容可能涉及专利。本文件的发布
机构不承担识别这些专利的责任。
本标准由全国医用临床检验实验室和体外诊断系统标准化技术委员会(SAC/TC136)提出。
本标准由全国医用临床检验实验室和体外诊断系统标准化技术委员会(SAC/TC136)归口。
本标准起草单位:北京市医疗器械检验所、北京金伟凯医学生物技术有限公司、上海复星长征医学
科学有限公司、贝克曼库尔特商贸(中国)有限公司。
本标准主要起草人:张新梅、贺学英、朱望、吴杰、张晋文。
酶联免疫吸附法检测试剂(盒)
1 范围
本标准规定了酶联免疫吸附法检测试剂(盒)的通用技术要求,包括术语与定义、分类、要求、试验方
法、标识和使用说明书、包装、运输和贮存。
本标准适用于在医学实验室以酶联免疫吸附法为原理进行检验的定量/定性检测试剂(盒)(以下简
称“试剂盒”)。
2 规范性引用文件
下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件,仅注日期的版本适用于本文
件。凡是不注日期的引用文件,其最新版本(包括所有的修改单)适用于本文件。
GB/T 21415-2008 体外诊断医疗器械 生物样品中量的测量校准品和控制物质赋值的计量学
溯源性
3 术语和定义
下列术语和定义适用于本文件。
3.1
酶联免疫吸附法 enzyme-linkedimmunoabsorbentassay,ELISA
以酶作为标记指示物,以抗原抗体反应为基础,通过色原呈色程度进行结果判断的固相吸附测试方
法。呈色程度用吸光度(A)值表示,所测A值与待测抗原或抗体的水平呈相关关系。
注:固相载体包括微孔板、管、磁颗粒、微珠、塑料珠等载体。
3.2
酶联免疫吸附法检测试剂盒 detectionkitforELISA
旨在用于以酶联免疫吸附法为原理完成特定体外诊断检验的一组组分,可包含有包被的固相载体、
抗体/抗原、酶结合物、缓冲液、显色系统、稀释液、校准品、质控品等。
3.3
内包装 immediatecontainer,primarycontainer
防止内容物受污染和外部环境其他影响的包装。
示例:密封瓶、安瓿或瓶、锡箔袋、密封塑料袋。
[ISO/FDIS18113-1,定义3.24]
3.4
外包装(销售包装) outercontainer(salespackaging)
用于包装试剂(盒)内包装的材料。
注:改写ISO/FDIS18113-1,定义3.49。
3.5
标识 label
在体外诊断产品或其包装上的印刷、书写或图形信息。

YY/T 1183-2010
                                      Page 1 of 18 
YY
ICS 11.100
C 44
Pharmaceutical Industry Standard
of the People’s Republic of China
Detection reagent (kit) for enzyme-linked
immunoabsorbent assay (ELISA)
酶联免疫吸附法检测试剂(盒)
ISSUED ON. DECEMBER 27, 2010
IMPLEMENTED ON. JUNE 1, 2012
Issued by. China Food and Drug Administration
                                      Page 2 of 18 
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Terms and Definitions ... 4 
4 Classification ... 8 
5 Requirements ... 8 
6 Test methods ... 11 
7 marking, labeling and instructions for use ... 16 
8 Packaging, transportation and storage ... 18 
                                      Page 3 of 18 
Foreword
This Standard was drafted in accordance with rules given in GB/T 1.1-2009.
Please note that some of the content of this document may involve patents. The issuing
organization of this document does not undertake the responsibility of identifying these
patents.
This Standard was proposed by the National Medical Clinical Testing Laboratory and
In Vitro Diagnostic System Standardization Technical Committee (SAC/TC 136).
This Standard shall be under the jurisdiction of the National Medical Clinical Testing
Laboratory and In Vitro Diagnostic System Standardization Technical Committee
(SAC/TC 136).
Drafting organizations of this Standard. Beijing Institute of Medical Device Testing,
Beijing Jinweikai Medical Biotechnology Co., Ltd., Shanghai Fosun Changzheng
Medical Science Co., Ltd. AND Beckman Coulter Commercial Enterprise (China) Co.,
Ltd.
Main drafters of this Standard. Zhang Xinmei, He Xueying, Zhu Wang, Wu Jie and
Zhang Jinwen.
                                      Page 4 of 18 
Detection reagent (kit) for
enzyme-linked immunoabsorbent assay
1 Scope
This Standard specifies the general technical requirements for detection reagent (kit)
for enzyme-linked immunoabsorbent assay, including terms and definitions,
classification, requirements, test methods, labeling, instructions for use, packaging,
transportation and storage.
This Standard applies to quantitative/qualitative detection reagent (kit) (hereinafter
referred to as "reagent kit") for the principle of enzyme-linked immunosorbent assay in
medical laboratories.
2 Normative references
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this standard.
GB/T 21415-2008 In vitro diagnostic medical devices - Measurement of quantities
in biological samples - Metrological traceability of values assigned to calibrators and
control materials
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Enzyme-linked immunoabsorbent assay, ELISA
A solid-phase adsorption test method that uses enzyme as marker indicator, takes
antigen-antibody reaction as basis, makes result judgment through coloring degree of
color originals. Coloring degree is expressed in value absorbance (A). The measured
value A AND the level of antigen or antibody to be tested are in correlation.
Note. The solid-phase carriers include microplates, tubes, magnetic particles, beads, plastic
beads, etc.
5.1 Requirements for quantitative detection reagent (kit) for enzyme-linked
immunoabsorbent assay
5.1.1 Appearance
Appearance shall meet the following requirements.
a) Every component of reagent (kit) shall be complete, intact, no leakage of liquid;
b) Labels shall be clear and legible.
5.1.2 Traceability
Manufacturing enterprises shall provide sources, assignment process, uncertainty, etc.
of used calibrators according to GB/T 21415-2008 and relevant specifications.
Accuracy shall meet one of the following requirements.
a) USE the reference material as the sample for detection; the relative deviation
of measurement results shall be within a specific range;
b) Recovery. ADD the analyte of a known concentration TO the blood matrix or
other body fluid components; the recovery rate shall be within a specific range;
c) Comparison. CONDUCT comparison test with the reagent kit on the market
or reference methods; the results shall meet the requirements of
corresponding specifications.
5.1.4 Detection limit
5.1.5 Linearity of a measuring system
Within the linear range specified by the manufacturing enterprise, the correlation
coefficient r of reagent kit shall not be less than 0.9900.
5.1.6 Repeatability
USE the samples with 2 concentrations to repeatedly detect for 10 times. The
coefficient of variation (CV) obtained by manual operation method or instrument
automatic operation method shall meet the requirements of corresponding
specifications.
5.1.7 Difference between batches
USE 3 batches of reagent kits to detect the same sample, the coefficient of variation
(CV) among those 3 batches of reagent kits shall meet the requirements of
corresponding specifications.
5.1.8 Stability
The following methods can be used to verify.
a) Stability within expiry date. The manufacturing enterprise shall specify the
expiry date of products. TAKE the sample within the expiry date to detect the
accuracy, detection limit, linearity of a measuring system and repeatability,
which shall meet the requirements of 5.1.3 ~ 5.1.6;
condition (such as 37°C). DETECT the accuracy, detection limit, linearity of a
measuring system and repeatability, which shall meet the requirements of
5.1.3 ~ 5.1.6.
Note 1. Thermal stability cannot be used to derive the expiry date of products, unless it uses
the derivation formula that is established based on a large number of stability study data.
Note 2. According to the product characteristics, it can select any arbitrary combination of
methods a) and b), but the selected method shall be capable of verifying the stability of the
product, so as to ensure that the performance of the product can meet the standard
requirements within the expiry date.
immunoabsorbent assay
5.2.1 Appearance
Appearance shall meet the following requirements.
a) Every component of reagent (kit) shall be complete, intact, no leakage of liquid;
b) Labels shall be clear and easy to identify.
5.2.2 Compliance rate of negative reference materials
DETECT national negative reference or negative reference provided by the
manufacturing enterprise; the compliance rate of negative reference shall meet the
requirements of corresponding specifications.
DETECT national positive reference or positive reference provided by the
manufacturing enterprise; the compliance rate of positive reference shall meet the
requirements of corresponding specifications.
                                      Page 11 of 18 
5.2.4 Detection limit
DETECT national reference of detection limit or reference of detection limit provided
by the manufacturing enterprise; the result shall meet the requirements of
corresponding specifications.
5.2.5 Repeatability
variation (CV) shall meet the requirements of corresponding specifications.
5.2.6 Difference between batches
USE 3 batches of reagent kits to detect the same sample; the coefficient of variation
(CV) among those 3 batches of reagent kits shall meet the requirements of
corresponding specifications.
5.2.7 Stability
The following methods can be used to verify.
a) Stability within expiry date. The manufacturing enterprise shall specify the
expiry date of product. TAKE the sample within the expiry date to detect
detection limit and repeatability, which shall meet the requirements of 5.2.2 ~
5.2.5;
b) Thermal stability test. PLACE for a specific time under specific heating
condition (such as 37°C). DETECT compliance rate of negative reference,
compliance rate of positive reference, detection limit and repeatability, which
shall meet the requirements of 5.2.2 ~ 5.2.5.
Note 1. Thermal stability cannot be used to derive the expiry date of products, unless it uses
the derivation formula that is established based on a large number of stability study data.
Note 2. According to the product characteristics, it can select any arbitrary combination of
product, so as to ensure that the performance of the product can meet the standard
requirements within the expiry date .
6 Test methods
6.1 Test method for quanti...
   
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