YY/T 1726-2020Concentration gradient agar diffusion susceptibility test strips (English PDF)
浓度梯度琼脂扩散药敏条
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 30, 2020
Implementation date
December 1, 2021
Scope
YY/T 1726-2020 is the English-translated version of 浓度梯度琼脂扩散药敏条.
YY/T 1726-2020 is the Chinese pharmaceutical industry standard for the antimicrobial susceptibility test strip that works by concentration gradient agar diffusion, the strip laid on an inoculated plate to read a minimum inhibitory concentration.
It gives the terms and definitions, the requirements, the test methods, the labels and instructions for use and the rules for packaging, transport and storage, covering the appearance and the printed scale of the strip, the agreement of the MIC read from it with the reference broth dilution method on quality control strains, the repeatability between strips and lots, and the stability. Issued on 30 June 2020, it has applied since 1 December 2021.
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Document preview — YY/T 1726-2020
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
Contents
- 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.
Please note that certain contents of this document may involve patents. Publication of this document The agency is not responsible for identifying these patents.
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 document. 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.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
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
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YY/T 1726-2020
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