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YY/T 1175-2010

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YY/T 1175-2010 英文版 580 购买 现货,9秒内自动发货PDF,有增值税发票。 肿瘤标志物定量测定试剂(盒) 化学发光免疫分析法 有效

   
标准详细信息 YY/T 1175-2010; YY/T1175-2010; YYT 1175-2010; YYT1175-2010
中文名称: 肿瘤标志物定量测定试剂(盒) 化学发光免疫分析法
英文名称: Quantitative detection reagent (kit) for tumor markers - Chemiluminescent immunoassay
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: 11,000
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、北京科美东雅生物技术有限公司、北京源德生物医学工程有限公司、罗氏诊断产品(上海)有限公司、西门子医学诊断产品(上海)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: 本标准规定了肿瘤标志物定量测定试剂(盒)(化学发光免疫分析法)的术语和定义、分类、要求、试验方法、标识、标签、使用说明书、包装、运输和贮存。本标准适用于以化学发光免疫分析法为原理定量测定人肿瘤标志物的试剂(盒)。包括以微孔板、管、磁颗粒、微珠和塑料珠等为载体的酶促及非酶促化学发光免疫分析测定试剂(盒)。本标准不适用于:a)拟用于单独销售的肿瘤标志物校准品和肿瘤标志物质控品;b)以化学发光免疫分析为原理的生物芯片。

YY/T 1175-2010
Quantitative detection reagent (kit) for tumor markers - Chemiluminescent immunoassay
ICS 11.100
C44
中华人民共和国医药行业标准
肿瘤标志物定量测定试剂(盒)
化学发光免疫分析法
Quantitativedetectionreagent(kit)fortumormarkers-
Chemiluminescentimmunoassay
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、北京科美东雅生物技术有限公司、北京源德生物医学工
程有限公司、罗氏诊断产品(上海)有限公司、西门子医学诊断产品(上海)有限公司。
本标准主要起草人:张新梅、程英豪、杨晓林、杜海鸥、蔡晓蓉、朱伟赞。
肿瘤标志物定量测定试剂(盒)
化学发光免疫分析法
1 范围
本标准规定了肿瘤标志物定量测定试剂(盒)(化学发光免疫分析法)[以下简称“试剂(盒)”]的术语
和定义、分类、要求、试验方法、标识、标签、使用说明书、包装、运输和贮存。
本标准适用于以化学发光免疫分析法为原理定量测定人肿瘤标志物的试剂(盒)。包括以微孔板、
管、磁颗粒、微珠和塑料珠等为载体的酶促及非酶促化学发光免疫分析测定试剂(盒)。
本标准不适用于:
a) 拟用于单独销售的肿瘤标志物校准品和肿瘤标志物质控品;
b) 以化学发光免疫分析为原理的生物芯片。
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
肿瘤标志物 tumormarker,TM
在肿瘤发生和增殖过程中,由肿瘤细胞或其他细胞产生或分泌并释放到血液、体液,细胞或组织中,
反映肿瘤存在和生长的,并可用生物化学、免疫学及分子生物学等方法进行测定的一类物质(包括蛋白
质、激素、酶和多胺等)。
3.2
化学发光 chemiluminescence,CL
由于化学反应产生的电子能级处于激发态的物质,通过跃迁释放能量产生光子,从而导致的发光
现象。
3.3
化学发光免疫分析 chemiluminescentimmunoassay,CLIA
是将化学发光和免疫分析结合起来的技术,通过标记的抗原或抗体与待测物进行一系列免疫反应,
最后以测定发光强度得出待测物含量。
3.4
肿瘤标志物试剂盒 kitfortumormarkers
旨在用于完成肿瘤标志物检测的包装在一起的一组组分。

YY/T 1175-2010 
YY
ICS 11.100
C 44
PROFESSIONAL STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Quantitative detection reagent (kit) for tumor markers -
Chemiluminescent immunoassay
肿瘤标志物定量测定试剂(盒)
化学发光免疫分析法
ISSUED ON. DECEMBER 27, 2010
IMPLEMENTED ON. JUNE 1, 2012
Issued by. State Food and Drug Administration
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 ... 10 
7  Marks, labels and instructions ... 12 
8  Packaging, transportation and storage ... 14 
Bibliography ... 15 
Foreword 
This standard was drafted in accordance with the rules specified in GB/T 1.1-2009.
Please note that some contents in this document may involve patents. The issuing
organization of this document does not bear the responsibility to identify these patents.
This standard was proposed by the China Clinical Laboratory Testing and In vitro
Diagnostic Test System of Standardization Administration of China (SAC/TC 136).
This standard shall be under the jurisdiction of the China Clinical Laboratory Testing and
In vitro Diagnostic Test System of Standardization Administration of China (SAC/TC 136).
Drafting organizations of this standard. Beijing Institute of Medical Device Testing, Beijing
Chemclin Biotech Co., Ltd., Beijing Yuande Bio-Medical Engineering Co., Ltd, Roche
Diagnostic Products (Shanghai) Co. Ltd., and Siemens Healthcare Diagnostics (Shanghai)
Co., Ltd.
The main drafters of this standard. Zhang Xinmei, Cheng Yinghao, Yang Xiaolin, Du Haiou,
Cai Xiaorong, and Zhu Weizan.
Quantitative detection reagent (kit) for tumor markers -
Chemiluminescent immunoassay
1  Scope 
This standard specifies the terms and definition, classification, requirements, test method,
marks, labels, instructions, packaging, transportation and storage etc. of quantitative
detection reagent (kit) [herein after referred to as “reagent (kit)”] for tumor markers
(chemiluminescent immunoassay).
This standard applies to the reagent (kit) used for quantitative detection of human tumor
markers taking the chemiluminescent immunoassay as the principle. It includes the
enzymatic and non-enzymatic chemiluminescent immunoassay detection reagent (kit) in
the carrier of micro-plates, tubes, magnetic particles, micro-beads and plastic beads.
This standard does not apply to.
a) The calibrator and quality control product of tumor markers intended for separate
sale;
b) Biochip that uses chemiluminescent immunoassay as the principle.
2  Normative references 
The articles contained in the following documents have become part of this document
when they are quoted herein. For the dated documents so quoted, all the modifications
(Including all corrections) or revisions made thereafter shall be applicable to this
document.
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 
For the purpose of this document, the following terms and definitions apply.
3.1
Tumor marker, TM
During the tumor generation and reproduction, the certain kind of substances (including
proteins, hormones, enzymes and polyamines) that are generated or secreted by tumor
cells or other cells; released into the blood, body fluids, cells or tissues; reflect the tumor’s
presence and growth; and that are measurable by using methods such as biochemistry,
immunology and molecular biology.
Chemiluminescence, CL
The luminescence phenomenon that is caused by – because of chemical reactions, the
substances with generated electron energy-level at excited state unleash energy and
produce the photons through transition.
3.3
Chemiluminescent immunoassay, CLIA
It is the technology combined with chemiluminescence and immunoassay. Conduct a
series of immunoreactions through marked antigen or antibody with products to be
measured. Finally measure the luminous intensity to get the content of the product to be
3.4
Kit for tumor markers
A group of components that are packed together, for the purpose of completing detection
of tumor markers.
3.5
Batch (lot)
The materials produced in one process or a series of processes, which are of consistent
properties and specified amount.
Note. It can be initial-material, intermediate material and final product.
3.6
Batch code, lot number
A combination of particular numbers and (or) letters that can specifically identify one batch
and that has the traceability of manufacturing, packaging, marks and transportation
process.
[ISO/FDIS 18113-1, Definition 3.6]
(SD) of the 10-times measurement results. Coefficient of variation (CV) is obtained and
based on Formula (3). The results shall be in accordance with the requirements of 5.6.
Where.
SD — Standard deviation of the measuring results for 10 times;
M — Mean value of the measuring results for 10 times.
6.7 Within-batch difference
Use 3 batches of reagents (kits) to respectively detect the samples with at least 2 levels
for 10 times. Work out mean value (M) and standard deviation (SD) of the 30-times
measurement results. Coefficient of variation (CV) is obtained and based on Formula (4).
The results shall be in accordance with the requirements of 5.7.
Where.
CV — Coefficient of variation
M — Mean value of the measuring results for 30 times.
6.8 Stability
The following methods can be used for verification.
a) Stability within the validity. Take the reagent kit that has been expired for detection
in accordance with methods in 6.3-6.6. It shall comply with the requirements in 5.8
a);
b) Thermal stability test. The reagent kit within the period of validity shall be detected
by methods of 6.3-6.6 according to thermal stability conditions stated by the
manufacturing enterprise. The results shall be in accordance with the requirements
7  Marks, labels and instructions 
7.1 Marks and labels on the outer package of the reagent (kit)
It shall contain at least the following contents.
a) Product name and packaging specifications;
b) Name, address, contact information of the manufacturing enterprise or after-sales
service organization;
c) Medical device registration certificate number;
d) Product standard number;
e) Product batch number;
g) Storage conditions.
7.2 Marks and labels of each component package of reagent (kit)
It shall contain at least the following contents.
a) Product name and packaging specifications;
b) Name or trademarks of the manufacturing enterprise;
c) Product batch number;
d) Expiration date.
7.3 Instructions of reagent (kit)
It shall contain at least the following contents.
b) Packaging specifications;
c) Intended use;
d) Detection principle;
e) Main compositions;
f) Storage conditions and expiration date;
g) Applicable instrument;
h) Sample requirement;
i) Detection method;
Bibliography 
devices (ISO 14971. 2007, IDT)
2. YY/T 0466.1-2009 Devices — Symbols to be used with medical device labels,
labelling and information to be supplied — Part 1.General requirements (ISO
15223.1-2009, IDT)
3. GB/T 191-2008 Packaging - Pictorial marking for handling of goods
4. JJF 1001-1998 General Terms in Metrology and Their definitions
5. ISO/FDIS 18113-1 Clinical laboratory testing and in vitro diagnostic medical
systems — Information supplied by the manufacturer (labelling) — Part 1. Terms,
definitions and general requirements
terms and terms used in probability — Second Edition
   
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