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YY/T 1595-2017Detection kit for ketamine (Colloidal gold method) (English PDF)

氯胺酮检测试剂盒（胶体金法）

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

December 5, 2017

Implementation date

December 1, 2018

Scope

YY/T 1595-2017 is the English-translated version of 氯胺酮检测试剂盒（胶体金法）.

YY/T 1595-2017 is the Chinese pharmaceutical industry standard for the ketamine 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 identification, labelling 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, the repeatability and the stability. Issued on 5 December 2017, it has applied since 1 December 2018.

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Document preview — YY/T 1595-2017

National Standard of the People's Republic of China

ICS: 11.100
Classification: C 44

Issued by: National Medical Products Administration of the People's Republic of China

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This standard specifies the terms and definitions of ketamine test kit (colloidal gold method) standards, requirements, test methods, identification, labeling, use Instructions and packaging, transportation and storage.

This standard applies to the principle of colloidal gold immunochromatography, qualitative detection of human urine ketamine (ketamine, KET) detection Kit and Ketamine-containing Joint Detection Kit. This standard does not apply to.

a) test kit for non-human urine test;

b) using other methods of detection kit.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 191 Packaging - Pictorial signs

GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (LABEL) SECTION 2. PROFESSIONAL IN VITRO DIAGNOSTIC AGENTS

3 Terms and definitions

The following terms and definitions apply to this document.

3.1 Ketamine

CAS No. 6740-88-1, Formula.C13H16ONCl. Including its optical isomers and various types of salt.

4 Requirements

4.1 Physical properties

4.1.1 Appearance

Should be the appearance of flat, solid material attachment, content is complete, the appearance of the inner package clean, no leakage, no damage.

4.1.2 Film width

Film width should not be less than 3mm.

4.1.3 Liquid travel speed

Liquid travel speed should not be less than 20mm/min.

4.2 Positive reference coincidence rate

With the national positive reference or the standard positive reference for testing, the results should be 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

Normative references

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