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YY/T 1198-2013

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YY/T 1198-2013 英文版 430 购买 现货,9秒内自动发货PDF,有增值税发票。 天门冬氨酸氨基转移酶测定试剂盒(IFCC法) 有效

   
标准编号: YY/T 1198-2013 (YY/T1198-2013)
中文名称: 天门冬氨酸氨基转移酶测定试剂盒(IFCC法)
英文名称: Aspartate aminotransferase diagnostic kit (IFCC 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: 10,120
引用标准: YY/T 0466.1; 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: 本标准规定了天门冬氨酸氨基转移酶测定试剂盒(IFCC法)的测定原理、要求、试验方法、标识、标签和使用说明书、包装、运翰和贮存。本标准适用于天门冬氨酸氨基转移酶测定试剂盒(IFCC法)的质量控制,该产品用于体外定量测定人体血清或血浆中天门冬氨酸氨基转移酶(AST)的活性。

YY/T 1198-2013
Aspartate aminotransferase diagnostic kit (IFCC method)
ICS 11.100
C44
中华人民共和国医药行业标准
天门冬氨酸氨基转移酶测定试剂盒
(IFCC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、黄杰、刘艳、高尚先。
天门冬氨酸氨基转移酶测定试剂盒
(IFCC法)
1 范围
本标准规定了天门冬氨酸氨基转移酶测定试剂盒(IFCC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。
本标准适用于天门冬氨酸氨基转移酶测定试剂盒(IFCC法)的质量控制,该产品用于体外定量测
定人体血清或血浆中天门冬氨酸氨基转移酶(AST)的活性。
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。
YY/T 0466.1 医疗器械 用于医疗器械标签、标记和提供信息的符号 第1部分:通用要求
GB/T 191 包装储运图示标志
3 测定原理
本法为IFCC推荐法。其方法原理反应方程式如下:
L-天门冬氨酸+α-酮戊二酸 →
AST草酰乙酸+L-谷氨酸
草酰乙酸+NADH+H+ →
MDH
L-苹果酸+NAD+
在上述偶联反应中,NADH的氧化速率与标本中酶活性呈正比,NADH在340nm波长有特异吸
收,可监测NADH吸光度的下降速率来计算AST的活力。
AST催化L-天门冬氨酸的氨基转移与苹果酸脱氢酶(MDH)催化反应偶联,使 NADH 氧化成
NAD+。NADH在340nm处有特异吸收峰,其被氧化的速率与血清中AST的活性成正比,在340nm
处测定NADH吸光度下降速率,即可测出AST活性(U/L)。
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。
4.3 试剂空白
4.3.1 试剂空白吸光度
试剂空白吸光度应不小于1.0(波长340nm,光径1cm)。

YY/T 1198-2013
YY
ICS 11.100
C 44
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Aspartate aminotransferase diagnostic kit
(IFCC method)
天门冬氨酸氨基转移酶测定试剂盒 (IFCC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 ... 4 
5 Test Method ... 6 
6 Mark, Label and Instructions ... 9 
7 Packaging, Transport and Storage ... 10 
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, Huang Jie, Liu Yan, and Gao Shangxian.
Aspartate aminotransferase diagnostic kit (lFCC method)
1 Scope 
This standard specifies the determination principle, requirements, test method, marks, signs,
instructions, packaging, transport and storage of aspartate aminotransferase diagnostic kit
(lFCC method).
This standard applies to the quality control of aspartate aminotransferase diagnostic kit (lFCC
method) This product is used for in-vitro quantitative determination of the aspartate
aminotransferase activity in human serum or plasma.
2 Normative References 
The following documents are indispensable for the application of this Document. For dated
references, only dated edition applies to this document. For undated references, the latest
edition (including all amendments) applies to this document.
YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labelling
and information to be supplied - Part 1. General requirements
GB/T 191 Packaging - Pictorial Marking for Handling of Goods
3 Determination Principle 
This method is the method recommended by IFCC. The reaction equation of method principle
is as follows.
L-aspartic acid + α-ketoglutaric acid → oxaloacetic acid + L-glutamic acid
Oxaloacetic acid + NADH + H+ → L-malic acid + NAD+
In the above coupled reaction, the oxidation rate of NADH is proportional to the enzymatic
activity of the specimen. NADH has characteristic absorption peak at the wavelength of 340 nm.
Therefore, the activity of ALT can be calculated through measuring the decline rate of NADH
absorbance.
The amino of L-aspartic acid will be transferred to malic dehydrogenase (MDH) under the
catalysis of AST. Then carry out coupled reaction; oxidize the NADH to NAD+. NADH has
characteristic absorption peak at the wavelength of 340 nm. Its oxidation rate is proportional to
the activity of AST in serum. Therefore, the activity of ALT (U/L) can be calculated through
measuring the decline rate of NADH absorbance at 340 nm.
4 Requirements 
4.1 Appearance
It shall meet the appearance requirements specified by the manufacturer.
AST
MDH
5.8 Stability
Take the reagent (kit), which is stored to the expiry of validity period under the specified storage
conditions OR under the accelerated test conditions specified by the manufacturer, for test. It
shall meet the requirements of 4.8.
6 Mark, Label and Instructions 
6.1 Mark and label of kit packaging box
and shall include at least the following contents.
a) Product name and specification;
b) Production batch number;
c) Expiry date;
d) Storage conditions.
6.2 Mark and label of single kit packaging bottle
The single kit packaging bottle shall include the following contents.
a) Product name and specification;
b) Trademark;
d) Production batch number;
e) Expiry date;
f) Storage conditions.
6.3 Instructions
The instructions shall include the following contents.
a) Product name;
b) Packaging specification;
c) Intended use;
d) Test principle;
f) Storage conditions and expiry date;
g) Applicable instruments;
h) Sample requirements;
i) Test method;
j) Reference value (reference interval);
k) Explanation of test results;
l) Limitation of the test method;
m) Product performance index;
n) Precautions;
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 Packaging, Transport and Storage 
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
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.
7.3 Storage
Kit shall be stored under the conditions specified by the manufacturer.
   
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