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YY/T 1595-2017: Detection kit for ketamine(Colloidal gold method)
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1595-2017	English	119	Add to Cart	3 days [Need to translate]	Detection kit for ketamine(Colloidal gold method)

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

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Detection kit for ketamine (Colloidal gold method) ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Ketamine test kit (colloidal gold method) Detectionkitforketamine (Coloidalgoldmethod) 2017-12-05 Published 2018-12-01 implementation State Food and Drug Administration released

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of this document may be patentable. The release of this document The agency does not assume responsibility for identifying these patents. This standard proposed by the State Food and Drug Administration. This standard by the National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC136) centralized. This standard was drafted. China Food and Drug Control Research Institute. The main drafters of this standard. Zuo Ning, Chen Hua, Nan Nan. Ketamine test kit (colloidal gold method)

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 article Pieces. 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 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. ...