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YY/T 1193-2011

标准搜索结果: 'YY/T 1193-2011'
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YY/T 1193-2011 英文版 250 购买 现货,9秒内自动发货PDF,有增值税发票。 促卵泡生成激素(FSH)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 1193-2011; YY/T1193-2011; YYT 1193-2011; YYT1193-2011
中文名称: 促卵泡生成激素(FSH)定量测定试剂盒(化学发光免疫分析法)
英文名称: Follicle stimulating hormone (FSH) quantitative immunoassay 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: 9,000
发布日期: 2011-12-31
实施日期: 2013-06-01
引用标准: GB/T 21415-2008
起草单位: 北京市医疗器械检验所、北京源德生物医学工程有限公司、中国药品生物制品检定所体外诊断试剂与培养基室、北京倍爱康生物技术有限公司、强生(上海)医疗器材有限公司
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2011年第106号;行业标准备案公告2013年第6号(总第162号)
提出机构: 国家食品药品监督管理局
发布机构: 国家食品药品监督管理局
范围: 本标准规定了促卵泡生成激素(FSH)定量测定试剂(盒)(化学发光免疫分析法)分类、要求、试验方法、标识、标签、使用说明书、包装、运输和贮存等。本标准适用于以化学发光免疫分析为原理的定量检测人血液基质或其他体液成分中的促卵泡生成激素(FSH)定量测定试剂(盒)[以下筒称"FSH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)拟用于单独销售的人促卵泡生成激素校准品和促卵泡生成激素质控品;b)以化学发光免疫分析为原理的生物芯片。

YY/T 1193-2011
Follicle stimulating hormone (FSH) quantitative immunoassay kit (chemiluminescent immunoassay)
ICS 11.100
C44
中华人民共和国医药行业标准
促卵泡生成激素(FSH)定量测定试剂盒
(化学发光免疫分析法)
2011-12-31发布
2013-06-01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。
本标准由国家食品药品监督管理局提出。
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、北京源德生物医学工程有限公司、中国药品生物制品检
定所体外诊断试剂与培养基室、北京倍爱康生物技术有限公司、强生(上海)医疗器材有限公司
本标准主要起草人:王瑞霞、唐磊、黄颖、王建明、聂晶。
促卵泡生成激素(FSH)定量测定试剂盒
(化学发光免疫分析法)
1 范围
本标准规定了促卵泡生成激素(FSH)定量测定试剂(盒)(化学发光免疫分析法)产品的分类、要
求、试验方法、标识、标签、使用说明书、包装、运输和贮存等。
本标准适用于以化学发光免疫分析为原理的定量检测人血液基质或其他体液成分中的促卵泡生成
激素(FSH)定量测定试剂(盒)(以下简称“FSH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) 拟用于单独销售的促卵泡生成激素校准品和促卵泡生成激素质控品;
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
FSH试剂(盒)按照化学发光原理不同可以分为酶促与非酶促化学发光免疫分析试剂(盒);依据固
相载体不同可以分为微孔板式,管式,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)各组份应齐全、包装完好,液体无渗漏;
b) 中文包装标签应清晰,无磨损。
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FSH试剂(盒)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 1193-2011
YY
ICS 11.100
C 44
INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Follicle stimulating hormone (FSH) quantitative
immunoassay kit (chemiluminescent immunoassay)
促卵泡生成激素(FSH)定量测定试剂盒
(化学发光免疫分析法)
ISSUED ON. DECEMBER 31, 2011
IMPLEMENTED ON. JUNE 1, 2013
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 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 organizations of this standard. Beijing Institute of Medical Device Testing, Beijing
Yuande Medical Engineering Co., Ltd., IVD Reagents and Culture Medium Laboratory of
National Institute for the Control of Pharmaceutical and Biological Products, Beijing
Bio-Ekon Biotechnology Co., Ltd., and Johnson & Johnson Medical (Shanghai) Ltd.
The main drafters of this standard. Wang Ruixia, Tang Lei, Huang Ying, Wang Jianming,
and Nie Jing.
Follicle stimulating hormone (FSH) quantitative
immunoassay kit (chemiluminescent immunoassay)
1  Scope 
This standard specifies the product classification, requirements, test method, marks,
labels, instructions, packaging, transportation and storage etc. of the follicle stimulating
hormone (FSH) quantitative immunoassay kit (chemiluminescent immunoassay).
This standard is applicable to follicle stimulating hormone (FSH) kit [hereinafter referred
as “FSH kit”] of quantitative detection in human blood matrix or other body fluid
components, based on the principle of chemiluminescent immunoassay. It includes the
enzymatic and non-enzymatic chemiluminescent immunoassay detection kit in the
carriers of micro-plates, pipes, magnetic particles, micro-beads and plastic beads.
This standard does not apply to.
a) The calibrator and quality control product of follicle stimulating hormone intended for
separate sale;
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 
FSH kit can be divided into enzymatic and non-enzymatic chemiluminescent
immunoassay kits according to different chemiluminescent principles. It can be divided
into different kinds of chemiluminescent immunoassay kits taking micro-plates, tubes,
magnetic particles, micro-beads and plastic beads as carrier according to the various solid
phase carriers. According to different operation processes, it can be divided into manual
operation method and instrument-automatic operation method.
coefficient r of the kit, within the linear range specified by the manufacturing enterprise,
shall not be less than 0.990.
4.7 Repeatability
Use the samples with at least 2 concentration levels. Respectively repeat the detection for
(instrument-automatic operation method) or not more than 12.0% (manual operation
method).
4.8 Within-batch difference
Use 3 batches of kits to detect the same sample. The coefficient of variation (CV) among
the 3 kits shall not be more than 15.0%.
4.9 Stability
The following methods can be used for verification.
a) Stability within the validity. The manufacturing enterprise shall specify the validity of
the kit. Take the kit that has been expired to detect the accuracy, minimum detection
4.7;
b) Thermal stability test. The kit within the period of validity is placed at 37°C for 3d.
Test the accuracy, minimum detection limit, linearity and repeatability. It shall meet
the requirements of 4.3, 4.4, 4.6 and 4.7.
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. Any arbitrary combination of a) and b) can be selected according to the product
characteristics, 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 comply with the standard
5  Test methods 
5.1 Appearance
Use the 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 manufacturing enterprise shall meet the
requirements of 4.2.
e) Product batch number;
f) Expiration date;
6.2 Marks and labels of each component package of kit
It shall contain at least the following contents.
a) Product names and packaging specifications;
b) Name or trademarks of manufacturers;
c) Product batch number;
d) Expiration date;
e) Storage conditions.
6.3 Instructions of kit
It shall include 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;
j) Reference value (Reference range);
l) The limitations of detection methods;
m) Product performance index;
Bibliography 
1. YY/T 0316-2008 Medical devices — Application of risk management to medical
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
industrial products
   
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