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YY/T 1177-2010

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YY/T 1177-2010 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CA72-4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 1177-2010; YY/T1177-2010; YYT 1177-2010; YYT1177-2010
中文名称: 癌抗原CA72-4定量测定试剂(盒) 化学发光免疫分析法
英文名称: Cancer antigen CA72-4 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
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CA72-4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人癌抗原CA72-4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 1177-2010
Cancer antigen CA72-4 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CA72-4定量测定试剂(盒)
化学发光免疫分析法
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。
本标准是评价癌抗原CA72-4(CancerAntigen72-4,CA72-4)定量测定试剂(盒)(化学发光免疫分
析法)产品质量的依据。
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。
本标准主要起草人:张新梅、程英豪、陶源、杜海鸥。
癌抗原CA72-4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CA72-4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人癌抗原CA72-4试剂(盒)[以下简称
“CA72-4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
CA72-4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CA72-4校准品的来源、赋值过程以及测
量不确定度等内容。
4.3 准确度
准确度应符合如下要求之一:

YY/T 1177-2010
YY
ICS 11.100
C 44
Pharmaceutical Industry Standard
of the People’s Republic of China
Cancer antigen CA72-4 quantitative detection
reagent (kit) - Chemiluminescent immunoassay
癌抗原 CA72-4 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 Marking, labeling, and instruction manual ... 9 
7 Packaging, transportation, and storage ... 11 
References ... 12 
Foreword
This Standard was drafted according to the rules specified in GB/T 1.1-2009.
This Standard is the basis for evaluating the product quality of CA72-4 (Cancer
Antigen 72-4, CA72-4) quantitative determination reagent (kit) (chemiluminescent
immunoassay).
Please note that some contents in this document may involve patents. The issuing
authority of this document does not undertake the responsibilities 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 Chemclin Biotech Co., Ltd., and Roche Diagnostic Products (Shanghai) Co.,
Ltd.
Main drafters of this Standard. Zhang Xinmei, Cheng Yinghao, Tao Yuan, and Du
Haiou.
Cancer antigen CA72-4 quantitative detection reagent (kit)
- Chemiluminescent immunoassay
1 Scope 
This Standard specifies the classification, requirements, test methods, marking,
labeling, instruction manual, packaging, transportation, and storage of the cancer
antigen CA72-4 quantitative detection reagent (kit) (chemiluminescent immunoassay).
This Standard applies to the quantitative detection of cancer antigen CA72-4 reagent
(kit) [hereinafter referred to as “CA72-4 reagent (kit)”] based on the principle of
chemiluminescent immunoassay. It includes the enzymatic and non-enzymatic
chemiluminescent immunoassay detection reagent (kit) with the carriers such as
microplates, pipes, magnetic particles, microbeads, and plastic beads.
The Standard does not apply to.
a) The tumor marker calibrator and tumor marker quality control materials intended
for separate sales.
b) Biochip in the principle of chemiluminescent immunoassay.
2 Normative references 
The provisions in following documents become the provisions of this Standard through
reference in this Standard. For dated references, the subsequent amendments
(excluding corrections) or revisions do not apply 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 (ISO 17511.2003, IDT)
3 Classification 
CA72-4 reagent (kit) can be divided into enzymatic and non-enzymatic
chemiluminescent immunoassay detection reagent (kit), according to different
chemiluminescence principles. According to different solid-phase carriers, it can be
divided into enzymatic and non-enzymatic chemiluminescent immunoassay detection
reagent (kit) with carriers such as microplates, pipes, magnetic particles, microbeads,
and plastic beads. According to different operation processes, it can be divided into
CV — Coefficient of variation;
SD — Standard deviation of the measured results for 10 times;
M — Mean of the measured results for 10 times.
5.8 Stability
It can choose the following methods to perform verification.
a) Stability within the period of validity. TAKE the expired sample to inspect
according to the methods of 5.3-5.6. It shall comply with the requirements of 4.8
a).
b) Thermal stability test. TAKE the sample within the period of validity to place for 3
methods of 5.3-5.6. It shall comply with the requirements of 4.8 b).
6 Marking, labeling, and instruction manual 
6.1 Marking and labeling of reagent’s (kit) outer packing
It shall include at least the following contents.
a) Product name and package specifications;
b) Name, address, contact details of manufacturing enterprise or after-sales
service organization;
c) Medical device registration certificate number
d) Product standard number;
f) Expiry date;
g) Storage conditions.
6.2 Marking and labeling of reagent’s (kit) each component’s packing
It shall include at least the following contents.
a) Product name and package specifications;
b) Name or logo of manufacturing enterprise;
c) Product batch number;
v) Instructions approval and modification date.
7 Packaging, transportation, and storage 
Reagents (kit) shall be packaged according to the requirements of manufacturing
enterprise.
6.2 Transportation
Reagents (kit) shall be transported according to the requirements of manufacturing
enterprises.
6.3 Storage
Reagent (kit) shall be stored under the conditions specified by manufacturing
enterprises.
References
[2] GB/T 9969 General principles for preparation of instructions for use of
industrial products
[3] YY 0466 Medical devices - Symbols to be used with medical device labels
labeling and information to be supplied (ISO 15223-2000, IDT)
[4] GB/T 19702-2005 In vitro diagnostic medical devices - Measurement of
quantities in samples of biological origin - Requirements for content and
presentation of reference measurement procedures (ISO 15193.2002, IDT)
[5] ISO/DIS 18113-1 Clinical laboratory testing and in vitro diagnostic medical
systems - Information supplied by the manufacturer (labeling) - Part 1. Terms,
   
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