YY/T 1525-2017 (YY/T1525-2017, YYT 1525-2017, YYT1525-2017)
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Test kit for methamphetamine (colloidal gold method)
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YY/T 1525-2017
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Standards related to: YY/T 1525-2017
| Standard ID | YY/T 1525-2017 (YY/T1525-2017) | | Description (Translated English) | Test kit for methamphetamine (colloidal gold method) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 6,681 | | Date of Issue | 2017-05-02 | | Date of Implementation | 2018-04-01 | | Drafting Organization | China Institute of Food and Drug test | | Administrative Organization | National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC 136) | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1525-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.100
C 44
Test Kit for Methamphetamine
(Colloidal Gold Method)
ISSUED ON. MAY 02, 2017
IMPLEMENTED ON. APRIL 01, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Terms and Definitions ... 4
4 Requirements ... 5
5 Test Methods ... 6
6 Mark, Label, Use Instructions ... 8
7 Package, Transportation and Storage ... 8
Bibliography ... 9
Test Kit for Methamphetamine
(Colloidal Gold Method)
1 Scope
This Standard specifies the terms and definitions, requirements, test methods, mark,
label, use instructions, package, transportation and storage of test kit for
methamphetamine (colloidal gold method).
This Standard is applicable to the detection kit for the qualitative detection of
methamphetamine (MET) in human urine and the combined detection kit containing
methamphetamine by the principle of colloidal gold immunochromatography.
This Standard is not applicable to.
a) The detection kit for non-human urine test;
b) Kits tested by other methods.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this document.
GB/T 191-2008 Packaging – Pictorial Marking for Handling of Goods
GB/T 29791.2-2013 In Vitro Diagnostic Medical Devices - Information Supplied by
the Manufacturer (Labelling) - Part 2. In Vitro Diagnostic Reagents for Professional
Use
3 Terms and Definitions
The following terms and definitions are applicable to this document.
3.1 Methamphetamine
CAS No.. 537-46-2; molecular formula. C10H15N; also called desoxyephedrine
The kit is stored under the specified conditions unit the end of the shelf life; test the
physical properties, positive reference product compliance rate, negative reference
product compliance rate, minimum detection limit, repeatability; the results shall
conform to the provisions of 4.1, 4.2, 4.3, 4.4 and 4.5.
b) Thermal stability test
Place the kit under the specified conditions (generally 37°C) for a specified period
of time (generally 21d); test the physical properties, positive reference product
compliance rate, negative reference product compliance rate, minimum detection
limit, repeatability; the results shall conform to the provisions of 4.1, 4.2, 4.3, 4.4
and 4.5.
NOTE 1. Thermal stability cannot be used to derive the valid date of the product; unless it is
from a derivation formula based on a large number of stability studies.
NOTE 2. According to the product characteristics, one of the above methods a) or b) can be
selected for verification; but the selected method shall be able to verify the stability of the
product to ensure that the product performance meets the standard requirements during the
shelf life.
5 Test Methods
5.1 Physical properties
5.1.1 Appearance
Take visual examination with normal or corrected visual acuity under natural light, the
results shall meet the requirements of 4.1.1.
5.1.2 Width of membrane strip
Randomly take a strip of membrane strip from the kit; test with the measuring ruler; the
results shall meet the requirements of 4.1.2.
5.1.3 Liquid migration speed
Operate as per the instructions; add sample liquid from the sampling loading area of
the kit; start timing when the liquid is moved to the reaction zone; stop timing when the
liquid is moved to the end of the reaction zone; the used time is t; use the Vernier
caliper to measure the length of the reaction zone, which is recorded as L; calculate
the L/t, which is migration speed; the results shall meet the requirements of 4.1.3.
5.2 Positive reference product compliance rate
Test once with a national positive reference product or a standardized positive
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