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YY/T 1176-2010

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YY/T 1176-2010 英文版 580 购买 现货,9秒内自动发货PDF,有增值税发票。 癌抗原CA15-3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 1176-2010; YY/T1176-2010; YYT 1176-2010; YYT1176-2010
中文名称: 癌抗原CA15-3定量测定试剂(盒) 化学发光免疫分析法
英文名称: Cancer antigen CA 15-3 quantitative detection reagent (kit) - 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: 10,000
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、罗氏诊断产品(上海)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: 本标准规定了癌抗原CA15-3定量测定试剂(盒)(化学发光免疫分析法)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。本标准适用于以化学发光免疫分析法为原理定量测定癌抗原CA15-3试剂(盒)[以下简称“CA15-3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 1176-2010
Cancer antigen CA 15-3 quantitative detection reagent (kit) - Chemiluminescent immunoassay
ICS 11.100
C44
中华人民共和国医药行业标准
癌抗原CA15-3定量测定试剂(盒)
化学发光免疫分析法
CancerantigenCA15-3quantitativedetectionreagent(kit)-
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、罗氏诊断产品(上海)
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、程英豪、杜海鸥、黄柏兴、张晋文。
癌抗原CA15-3定量测定试剂(盒)
化学发光免疫分析法
1 范围
本标准规定了癌抗原CA15-3定量测定试剂(盒)(化学发光免疫分析法)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。
本标准适用于以化学发光免疫分析法为原理定量测定癌抗原CA15-3试剂(盒)[以下简称“CA15-3
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 分类
CA15-3试剂(盒)按照化学发光原理不同可分为酶促与非酶促化学发光免疫分析试剂(盒);依据固
相载体不同可分为以微孔板,管,磁颗粒、微珠和塑料珠等为载体的化学发光免疫分析试剂(盒);根据操
作过程的不同可分为手工操作法和仪器自动操作法。
4 要求
4.1 外观
外观应符合如下要求:
a) 试剂(盒)各组分应齐全、完整,液体无渗漏;
b) 包装标签应清晰,易识别。
4.2 溯源性
生产企业应根据GB/T 21415-2008及有关规定提供所用CA15-3校准品的来源、赋值过程以及不
确定度等内容。
4.3 准确度
准确度应符合如下要求之一:

YY/T 1176-2010 
YY
ICS 11.100
C 44
INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Cancer antigen CA15-3 quantitative detection
reagent (kit) - Chemiluminescent immunoassay
癌抗原 CA15-3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  Classification ... 4 
4  Requirements ... 5 
5  Test methods ... 6 
6  Marks, labels and instructions ... 9 
7  Packaging, transportation and storage ... 11 
Bibliography ... 12 
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 Food and Drug Administration.
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 organization of this standard. Beijing Institute of Medical Device Testing, Beijing
Chemclin Biotech Co., Ltd., Roche Diagnostic Products (Shanghai) Co., Ltd., and
Beckman Coulter Commercial Enterprise (China) Co., Ltd.
The main drafters of this standard. Zhang Xinmei, Cheng Yinghao, Du Haiou, Huang
Baixing, and Zhang Jinwen.
Cancer antigen CA15-3 quantitative detection reagent
(kit) - Chemiluminescent immunoassay
1 Scope
This standard specifies the classification, requirements, test method, identification, labels,
instructions, packaging, transportation and storage of the cancer antigen CA15-3
quantitative detection reagent (kit) (chemiluminescent immunoassay).
This standard is applicable to test cancer antigen CA15-3 reagent (kit) [hereinafter
referred to as “CA15-3 reagent (kit)”], based on the principles of chemiluminescent
immunoassay. It includes the enzymatic and non-enzymatic chemiluminescent
immunoassay detection reagent (kit) with carriers of microwell plates, tubes, magnetic
particles, micro-beads and plastic-beads.
The Standard is not applicable to.
a) The tumor marker calibrators and tumor marker control materials that are intended
for separate sales.
b) Biochip that uses the principle of chemiluminescent immunoassay.
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 Classification
CA15-3 reagent (kit) can be divided into enzymatic and non-enzymatic chemiluminescent
immunoassay reagent (kit), according to different chemiluminescent principles. According
to different solid-phase carriers, it can be divided into microwell plates, tubes, magnetic
particles, micro-beads and plastic-beads as the carrier of chemiluminescent
immunoassay reagent (kit). According to different operation processes, it can be divided
into manual operation method and instrument-automatic operation method.
4 Requirements
4.1 Appearance
The appearance shall comply with the following requirements.
a) Each component of reagent (kit) shall be complete, intact and no leakage of liquid;
b) The packaging labels shall be clear and easy to be identified.
The manufacturer shall provide the contents such as source, assignment procedure and
measurement uncertainty of the applied CA15-3 calibrators in accordance with
GB/T21415-2008 and relevant regulations.
4.3 Accuracy
The accuracy shall comply with one of the following requirements.
a) Use the reference materials as the sample for detection. The relative deviation of
the measurement results shall be within the range of ± 10%;
b) The recovery rate shall be within the range of (85% to 115%).
Note. If CA15-3 has the international reference materials or national standard products, detect in
products, then in accordance with b) for detection.
4.4 Minimum detection limit
The minimum detection limit shall not be greater than 1.0 U/mL.
4.5 Linearity
The upper limit of linear range shall not be less than 5 times the reference value. The
lower limit shall not be greater than 1/5 times the reference value. The correlation
coefficient r shall not be less than 0.9900 within the linear range prescribed by the
manufacturer.
4.6 Repeatability
and respectively test for 10 times. The coefficient of variation (CV) shall not be greater
than 10% (instrument-automatic operation) or not be greater than 15% (manual
operation).
SD — Standard deviation of 30-times measurement results;
M — Mean of 30-times measurement results.
5.8 Stability
The following methods can be used for verification.
a) Stability within the validity. Take the kit that has been expired to perform the
detection in accordance with methods of 5.3-5.6. It shall comply with the
b) Thermal stability test. A kit within the validity is placed for 3 days at 37°C. Perform
the test according to methods of 5.3-5.6. The result shall comply with
requirements of 4.8 b).
6 Marks, labels and instructions
6.1 Marks, labels for outer package of reagent (kit)
a) Product name and packaging specifications;
b) Name, address, contact details of the manufacturer or after-sales service
organization;
c) Medical device registration certificate number;
e) Product batch number;
f) Expiration date;
g) Storage conditions.
6.2 Marks and labels on each component packing of reagent (kit)
It shall contain at least the following contents.
a) Product name and packaging specifications;
b) Name or trademark of the manufacturer;
c) Product batch number;
d) Expiration date;
7 Packaging, transportation and storage
7.1 Packaging
Reagent (kit) shall be packaged according to the requirements of the manufacturer.
7.2 Transportation
Reagent (kit) shall be transported according to the requirements of the manufacturer.
7.3 Storage
Reagent (kit) shall be stored under the conditions specified by the manufacturer.
Bibliography
1. YY/T 0316-2008 Medical devices — Application of risk management to medical
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. GB/T 9969-2008 General principles for preparation of instructions for use of
industrial products
   
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