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YY/T 1178-2010

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YY/T 1178-2010 英文版 580 购买 现货,9秒内自动发货PDF,有增值税发票。 糖类抗原CA19-9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 1178-2010; YY/T1178-2010; YYT 1178-2010; YYT1178-2010
中文名称: 糖类抗原CA19-9定量测定试剂(盒) 化学发光免疫分析法
英文名称: Carbohydrate antigen CA19-9 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、强生(上海)医疗器械有限公司、瑞士雅培制药有限公司北京办事处
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: 本标准规定了糖类抗原CA19-9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糖类抗原(CA19-9)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 1178-2010
Carbohydrate antigen CA19-9 quantitative detection reagent(kit) - Chemiluminescent immunoassay
ICS 11.100
C44
中华人民共和国医药行业标准
糖类抗原CA19-9定量测定试剂(盒)
化学发光免疫分析法
CarbohydrateantigenCA19-9quantitativedetectionreagent(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、强生(上海)医疗器械
有限公司、瑞士雅培制药有限公司北京办事处。
本标准主要起草人:张新梅、程英豪、祁欣、王雪峰。
糖类抗原CA19-9定量测定试剂(盒)
化学发光免疫分析法
1 范围
本标准规定了糖类抗原 CA19-9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糖类抗原(CA19-9)试剂(盒)[以下简称
“CA19-9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
CA19-9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糖类抗原CA19-9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 1178-2010 
YY
ICS 11.100
C 44
INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Carbohydrate antigen CA19-9 quantitative
detection reagent (kit) –
Chemiluminescent immunoassay
糖类抗原 CA19-9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 file may involve patents. The issuing organization
of this file 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 organization of this standard. Beijing Institute of Medical Device Testing, Beijing
Chemclin Biotech Co., Ltd., Johnson & Johnson Medical (Shanghai) Ltd, and Beijing
Office of Switzerland Abbott Co., Ltd.
The main drafters of this standard. Zhang Xinmei, Cheng Yinghao, Qi Xin, and Wang
Xuefeng.
Carbohydrate antigen CA19-9 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 carbohydrate antigen CA19-9
quantitative detection reagent (kit) (chemiluminescent immunoassay).
This standard is applicable to test carbohydrate antigen (CA19-9) reagent (kit) [hereinafter
referred as “CA19-9 reagent (kit)”], based on the principles of chemiluminescent
immunoassay. It includes the enzymatic and non-enzymatic chemiluminescent
immunoassay detection reagent (kit) with the carriers of microwell plates, tubes, magnetic
particles, micro-beads and plastic beads.
This standard is not applicable to.
a) The tumor marker calibrators and tumor marker control materials are intended for
separate sales;
b) Biochip in 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
CA19-9 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 carriers of chemiluminescent
4.7 Within-batch difference
Use 3 batches of reagent kits to respectively test the samples with concentrations of
(40±8) U/mL and (150±30) U/mL. The coefficient of variation (CV) among the 3 batches of
kits shall not be greater than 15%.
4.8 Stability
a) Stability within the validity. The manufacturer shall stipulate the validity of reagent
(kit). Use the kits that have been expired to test the accuracy, minimum detection
limit, linearity and repeatability. It shall comply with requirements of .4.3-4.6.
b) Thermal stability test. A kit within the period of validity is placed for 3 days at 37°C.
Test the accuracy, minimum detection limit, linearity and repeatability. The results
shall comply with the requirements of 4.3-4.6.
Note 1. Thermal stability test cannot be used to derive the validity of products, unless it uses the
derivation formula that is established and based on a large number of stability study data.
Note 2. According to the product characteristics, it can choose Method a) and Method b) for arbitrary
ensure the product performance to comply with the standard requirements within the validity.
5  Test methods 
5.1 Appearance
Use corrected-visual-acuity to visually inspect, under the natural light. It shall meet the
requirements of 4.1.
5.2 Traceability
Traceability information provided by the manufacturer shall comply with the requirements
of 4.2.
5.3 Accuracy
a) Prepare the concentration of the reference material. Make its final concentration to
be about 100 U/mL (concentration deviation of ±20% is allowed). Take it as the
sample. Perform the detection according to the procedures of instructions. Repeat
for 3 times repeatedly. Record the average result as M. Calculate the relative
deviation B of the measured concentration according to Formula (1). The result
shall comply with the requirements of 4.3 a).
It shall include at least the following contents.
a) Product name;
b) Packaging specifications;
d) Inspection principle;
e) Main compositions;
f) Storage conditions and expiration date;
g) Applicable instrument;
h) Sample requirements;
i) Inspection methods;
j) Reference value (Reference range);
k) Explanation to the inspection results;
l) The limitations of inspection methods;
n) Instructions of analytical interference (hemolysis, lipemia, jaundice, etc.);
o) Instructions for analytical specificity (cross-reactants);
p) Precautions;
q) References;
r) Name, address, contact details of the manufacturer or after-sales service
organization;
s) License number of medical device manufacturer (limited to domestic enterprises);
t) Medical device registration certificate number;
u) Product standard number;
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
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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