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YY/T 1595-2017: Detection kit for ketamine(Colloidal gold method)
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1595-2017 | English | 119 |
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Detection kit for ketamine(Colloidal gold method)
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YY/T 1595-2017
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Basic data | Standard ID | YY/T 1595-2017 (YY/T1595-2017) | | Description (Translated English) | Detection kit for ketamine(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 | 6,692 | | Date of Issue | 2017-12-05 | | Date of Implementation | 2018-12-01 | | Issuing agency(ies) | State Food and Drug Administration | 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.
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