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YY/T 1200-2013

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标准详细信息 YY/T 1200-2013; YY/T1200-2013; YYT 1200-2013; YYT1200-2013
中文名称: 葡萄糖测定试剂盒(酶法)
英文名称: Glucose assay kit (Enzymic method)
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
引用标准: GB/T 191
起草单位: 中国食品药品检定研究院
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
标准依据: 国家食品药品监督管理总局公告2013年第36号;行业标准备案公告2013年第12号(总第168号)
提出机构: 国家食品药品监督管理总局
发布机构: 国家食品药品监督管理总局
范围: 本标准规定了葡萄糖测定试剂盒(酶法)的测定原理、要求、试验方法、标识、标签和使用说明书、包装、运输和贮存等。本标准适用于己糖激酶法和氧化酶法葡萄糖测定试剂盒, 该试剂盒在临床检验中用于定量分析血清、血浆、尿液、脑脊液等体液中的葡萄糖浓度。

YY/T 1200-2013
Glucose assay kit (Enzymic method)
ICS 11.100
C44
中华人民共和国医药行业标准
葡萄糖测定试剂盒(酶法)
2013-10-21发布
2014-10-01实施
国家食品药品监督管理总局 发 布
前言
本标准按照GB/T 1.1-2009给出的规则起草。
请注意本标准的某些内容可能涉及专利,本标准的发布
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总局提出。
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。
本标准主要起草单位:中国食品药品检定研究院。
本标准主要起草人:王玉梅、刘艳、高尚先。
葡萄糖测定试剂盒(酶法)
1 范围
本标准规定了葡萄糖测定试剂盒(酶法)的测定原理、要求、试验方法、标识、标签和使用说明书、包
装、运输和贮存等。
本标准适用于己糖激酶法和氧化酶法葡萄糖测定试剂盒,该试剂盒在临床检验中用于定量分析血
清、血浆、尿液、脑脊液等体液中的葡萄糖浓度。
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 191 包装储运图示标志
3 测定原理
3.1 己糖激酶法
葡萄糖+ATP
己糖激酶
------------→葡萄糖-6-磷酸+ADP
葡萄糖-6-磷酸+NAD+
G6PDH
-----------→6-磷酸葡萄糖醛酸+NADPH+H+
测定方法:终点法。
检测波长:厂商给定波长。
3.2 葡萄糖氧化酶法
葡萄糖+O2+H2O
GOD
--------→葡萄糖酸+H2O2
2H2O2+4-氨基安替比林+苯酚
POD
--------→醌亚胺+4H2O
测定方法:终点法。
检测波长:厂商给定波长。
一定波长下检测生成的醌亚胺颜色,对照标准可计算出葡萄糖的含量。
4 要求
4.1 外观
符合制造商规定的正常外观要求。
4.2 装量
液体试剂的装量应不少于标示量。

YY/T 1200-2013
YY
ICS 11.100
C 44
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Glucose assay kit (Enzymic method)
葡萄糖测定试剂盒(酶法)
ISSUED ON. OCTOBER 21, 2013
IMPLEMENTED ON. OCTOBER 1, 2014
Issued by. State Food and Drug Administration
Table Contents
Foreword ... 3 
1  Scope ... 4 
2  Normative References ... 4 
3  Determination Principle ... 4 
4  Requirements ... 5 
5  Test Method ... 6 
6  Mark, Label and Instructions ... 9 
7  Packaging, Transport and Storage ... 11 
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 undertake the responsibility to identify these
patents.
This Standard was proposed by State 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. National Institute for Food and Drug Control.
The main drafters of this Standard. Wang Yumei, Liu Yan, and Gao Shangxian.
Glucose assay kit (Enzymic method)
1  Scope 
This Standard specifies the determination principle, requirements, test method, mark, label,
instructions, packaging, transport and storage, etc. of glucose assay kit (enzymic method).
This Standard uses glucose hexokinase and oxidase method to measure the kit which is
used for the quantitative analysis of glucose concentration for serum, plasma, urine,
cerebrospinal fluid and other body fluids in clinical examination.
2  Normative References 
The articles contained in the following document 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 191 Packaging - Pictorial Marking for Handling of Goods
3  Determination Principle 
3.1 Hexokinase method
Glucose + ATP ----------→ glucose-6-phosphoric acid + ADP
Glucose-6-phosphoric acid + NAD+ ------→ 6-phosphate acid glucose aldehyde acid +
NADPH + H+
Assay method. end-point method
Detection wavelength. the wavelength given by the manufacturer.
3.2 Glucose oxidase method
Glucose + O2 + H2O -----→ gluconic acid + H2O2
2H2O2 + 4-amino antipyrine + phenol ------→ quinone-imine + 4H2O
Assay method. end-point method
hexokinase
G6PDH
GOD
POD
Where.
R - recovery rate;
V - volume of standard solution added;
Vo - volume of human serum sample;
C - measured concentration of human serum sample after adding standard solution;
co - measured concentration of human serum sample;
cs - concentration of standard solution.
5.6 Analysis sensitivity
Dilute the sample with certain concentration (n units of material to be tested). Measure the
absorbance. Calculate the concentration of sample whose light absorption value and blank
absorption value are different. The results shall meet the requirements of 4.6.
5.7 Precision
5.7.1 Within-batch precision
interval and pathological interval). Repeat the test for 10 times. Calculate the mean value
(̅ݔ) and standard deviation (SD) of measured values respectively. Calculate the coefficient
of variation (CV) of within-batch precision according to Formula (4).
Use high and low-value quality control materials to respectively determine the same-batch
of 20 kits to be tested. Calculate the mean value (̅ݔ1) and standard deviation (SD1) of the
20 measured results.
Use the same quality control material to repeatedly determine the same-batch of 1 kit to
be tested for 20 times. Calculate the mean value (̅ݔ2) and standard deviation (SD2) of the
measured results. Calculate the coefficient of variation (CV) of the deviation between the
When SD1The results shall meet the requirements of 4.7.1.
SDbetween-bottles
c) Net content of product;
d) Production batch number;
e) Expiry date;
f) Storage conditions.
6.3 Instructions
The instructions shall include the following contents.
b) Packaging specification;
c) Intended use;
d) Test principle;
e) Main components;
f) Storage conditions and expiry date;
g) Applicable instruments;
h) Sample requirements;
i) Test method;
j) Reference value (reference interval);
l) Limitation of the test method;
m) Product performance index;
n) Precautions;
o) References;
p) Manufacturing enterprise;
q) Production enterprise license number of medical device;
r) Registration certificate number of medical device;
s) Product standard number;
t) Approval and modification date of the instructions.
7.1 Packaging
7.1.1 Packaging for storage and transport
The packaging for storage and transport AND marking of the kit shall meet the
requirements of GB/T 191.
7 1.2 Unit packaging
7.1.2.1 The kit shall be complete, labeled clearly, sealed tightly, and free of leakage.
7.1.2.2 The instructions shall be enclosed within the kit.
7.2 Transport
Product transport shall be carried out according to the provisions of contract.
Kit shall be stored under the conditions specified by the manufacturer.
   
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