YY/T 1525-2017Test kit for methamphetamine (colloidal gold method) (English PDF)
甲基安非他明检测试剂盒（胶体金法）
This is a limited preview
Buy now to download the full PDF (22 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1525-2017 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
May 2, 2017
Implementation date
April 1, 2018
Scope
YY/T 1525-2017 is the English-translated version of 甲基安非他明检测试剂盒（胶体金法）.
YY/T 1525-2017 is the Chinese pharmaceutical industry standard for the methamphetamine test kit based on colloidal gold immunochromatography, the strip used to screen urine.
It gives the terms and definitions, the requirements, the test methods, the marks, labels and instructions for use and the rules for packaging, transport and storage, covering the appearance of the strip, the cut-off concentration and the agreement with reference samples around it, the specificity against related substances, the repeatability and the stability. Issued on 2 May 2017, it has applied since 1 April 2018.
Found what you need?
Document preview — YY/T 1525-2017
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative References4
- 3 Terms and Definitions4
- 4 Requirements5
- 5 Test Methods6
- 6 Mark, Label, Use Instructions8
- 7 Package, Transportation and Storage8
- Bibliography9
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
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
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.
Referenced standards
Similar standards
How to Download YY/T 1525-2017
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
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
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
Secure payment via Stripe
Payments accepted
YY/T 1525-2017
$90.00