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YY/T 1198-2013 (YY/T1198-2013)

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YY/T 1198-2013English145 Add to Cart 0--3 minutes. Auto-delivery. Aspartate aminotransferase diagnostic kit (IFCC method) Valid

YY/T 1198-2013: PDF in English (YYT 1198-2013)
YY/T 1198-2013
ICS 11.100
C 44
Aspartate aminotransferase diagnostic kit
(IFCC method)
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 
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
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.
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
The packaging-pictorial marking for handling of goods shall meet the requirements of GB/T 191,
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;
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.
a) Product name;
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);
k) Explanation of test results;
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 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
GB/T 191.
7.1.2 Unit packaging The kit shall be complete, labeled clearly, sealed tightly, and free of leakage. 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.
(Above excerpt was released on 2015-03-04, modified on 2021-06-07, translated/reviewed by: Wayne Zheng et al.)
Source: https://www.chinesestandard.net/PDF.aspx/YYT1198-2013