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YY/T 1726-2020: Agar diffusion and dilution susceptibility test strip
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1726-2020	English	339	Add to Cart	4 days [Need to translate]	Agar diffusion and dilution susceptibility test strip

YY/T 1726-2020: Agar diffusion and dilution susceptibility test strip

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Agar diffusion and dilution susceptibility test strip ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Concentration gradient agar diffusion drug sensitive strip 2020-06-30 released 2021-12-01 implementation Issued by the State Drug Administration

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that certain contents of this document may involve patents. Publication of this document The agency is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136). Drafting organizations of this standard. Zhengzhou Antu Biological Engineering Co., Ltd., Beijing Medical Device Inspection Institute, Mérieux Diagnostic Products (Part 1) Sea) Co., Ltd. The main drafters of this standard. Zheng Yehuan, Zhang Lihong, Bi Chunlei, Liang Yuanzhu. Concentration gradient agar diffusion drug sensitive strip

1 Scope

This standard specifies the terms and definitions, requirements, test methods, labels and instructions for use, packaging, Transportation and storage. This standard is applicable to drug susceptibility strips for antimicrobial susceptibility testing by concentration gradient agar diffusion method. This standard does not apply to antimicrobial drug sensitive paper and dilution method drug sensitive reagents.

2 Normative references

The following documents are indispensable for the application of this standard. For dated reference documents, only the dated version applies to this article Pieces. For undated references, the latest version (including all amendments) applies to this standard. GB/T 191 Packaging, storage and transportation pictorial signs GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.Professional in vitro diagnostic reagents

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Drug Sensitivity Strip Plastic, paper or other material strips containing MIC reading scale and concentration gradient antibacterial agent, used for clinical pathogenic bacteria to antibacterial Sensitivity testing of agents. 3.2 Minimum inhibitory concentration The lowest concentration that can inhibit the growth of bacteria visible to the naked eye under the specified in vitro test conditions and the specified time period. [YY/T 0688.2-2010/ISO 20776-2.2007, definition 3.11]. 3.3 Concentration gradient agar diffusion test Also known as the E test method, the principle is that when the drug sensitive strip is placed on the drug sensitive agar plate that has been inoculated with the test bacteria, the antibacterial agent on the drug sensitive strip carrier Quickly and effectively release into the agar, thereby forming a continuous gradient of antibacterial agent concentration under the susceptibility strip. After incubation, around the susceptibility strip The growth of the tested bacteria within the inhibitory concentration range is inhibited, thereby forming a transparent pear-shaped inhibition zone, and the concentration of the intersection of the edge of the inhibition zone and the test strip is engraved The degree value is the minimum inhibitory concentration (MIC) of the tested bacteria.

4 requirements

4.1 Appearance Should meet the requirements specified by the manufacturer. 4.2 Drug sensitivity strip size Should meet the requirements specified by the manufacturer. ...