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GB/T 31402-2023: Measurement of antibacterial activity on plastics and other non-porous surfaces Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid GB/T 31402: Historical versions
Similar standardsGB/T 31402-2023: Measurement of antibacterial activity on plastics and other non-porous surfaces---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT31402-2023GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 83.080.01 CCS G 31 Replacing GB/T 31402-2015 Measurement of Antibacterial Activity on Plastics and Other Non-Porous Surfaces (ISO 22196.2011, IDT) Issued on. OCTOBER 27, 2023 Implemented on. JUNE 1, 2024 Issued by. State Administration for Market Regulation; Standardization Administration of the People’s Republic of China. Table of ContentsForeword... 3 Introduction... 5 1 Scope... 6 2 Normative References... 7 3 Terms and Definitions... 7 4 Materials... 7 4.1 Bacteria to be used for the tests... 7 4.2 Reagents, culture media and solutions... 8 5 Apparatus... 10 6 Sterilization of Apparatus and Storage of Stock Cultures... 11 6.1 Dry-heat sterilization... 11 6.2 High-pressure steam sterilization... 12 6.3 Preparation of glassware... 12 6.4 Maintenance of stock cultures... 12 7 Procedure... 12 7.1 Pre-culture of bacteria... 12 7.2 Preparation of test specimens... 12 7.3 Preparation of test inoculum... 13 7.4 Inoculation of test specimens... 13 7.5 Incubation of the inoculated test specimens... 15 7.6 Recovery of bacteria from test specimens... 15 7.7 Determining the viable bacteria count by the pour plate culture method... 16 8 Expression of Results... 16 8.1 Determination of the number of viable bacteria... 16 8.2 Conditions for a valid test... 17 8.3 Calculation of the antibacterial activity... 17 8.4 Effectiveness of the antibacterial agent... 18 9 Repeatability and Reproducibility... 18 10 Test Report... 18 Annex A (Normative) Quality of Biological Materials... 20 Annex B (Informative) Repeatability and Reproducibility... 21 Annex NA (Informative) Calculation of Antibacterial Rate... 25 Bibliography... 26ForewordThis Document was drafted as per the rules specified in GB/T 1.1-2020 Directives for Standardization – Part 1.Rules for the Structure and Drafting of Standardizing Documents. This Document replaced GB/T 31402-2015 Plastics - Measurement of Antibacterial Activity on Plastics Surfaces. Compared with GB/T 31402-2015, the major technical changes of this Document are as follows besides structural adjustments and editorial modifications. a) Change the "Scope" to expand the scope of application from plastics to plastics and other non-porous materials; and add descriptions of materials and products not covered by this Document (see Clause 1 of this Edition; Clause 1 of the 2015 Edition); b) Change the requirements for the use of "test bacteria" (see 4.1 of this Edition; 4.1 of the 2015 Edition); c) Change the requirements for cleaning the specimen in "Preparation of specimens" (see 7.2 of this Edition; 7.2 of the 2015 Edition). This Document equivalently adopted ISO 22196.2011 Measurement of Antibacterial Activity on Plastics and Other Non-Porous Surfaces. This Document made the following minimum editorial modifications. --- Use Method B in the informative reference document GB/T 19275-2003 to replace Method C in ISO 846.1997.The relevant technical contents of the two documents are completely consistent (see Clause 1); --- Domestic strain numbers equivalent to the tested strains are listed in Table 1 and explained in footnotes; --- Add Annex NA (informative) "Calculation of antibacterial rate". Please note some contents of this Document may involve patents. The issuing agency of this Document shall not identify these patents. This Document was proposed by China Petroleum and Chemical Industry Federation. This Document shall be under the jurisdiction of National Technical Committee on Plastics of Standardization Administration of China (SAC/TC 15). Drafting organizations of this Document. Institute of Microbiology, Guangdong Academy of Sciences (Guangdong Detection Center of Microbiology); Guangdong Demay Biology Technology Co., Ltd.; Guangzhou Research Institute of Synthetic Material Limited Company; Jinda Nanotechnology (Xiamen) Co., Ltd.; Guangdong Huabiao Testing Center Co., Ltd.; Chengdu Qinhuan Technology Co., Ltd.; Zhejiang Huiqian Nanotechnology Co., Ltd.; Cobes Health Care (Hefei) Co., Ltd.; Orinko Advanced Plastics (Shanghai) Co., Ltd.; Shanghai Guofan New Chemical Material Co., Ltd.; Zhongxing (Guangzhou) Nano Materials Co., Ltd.; Shanghai Runhe Nanotechnology Co., Ltd.; and Zhejiang Supor Co., Ltd. Chief drafting staffs of this Document. Xie Xiaobao, Wang Haojiang, Gan Zhihao, Wu Yongxin, Zhang Yanli, Peng Ruqun, Ma Mei, Wang Fei, Zhao Ziyan, Yan Gaofei, Yu Jiefeng, Chen Xin, Ma Zhengsheng, Zeng Heping, Tao Zhiqing, and Zhang Shichuan. This Document was first-time published in 2015; it is first-time revised hereby.1 ScopeThis Document specifies a method of evaluating the antibacterial activity of antibacterial- treated plastics, and other non-porous, surfaces of products (including intermediate products). This Document is not intended to be used to evaluate the effects and propagation of bacteria on non-porous surfaces without antibacterial treatments. If evaluation is required, see Method B in GB/T 19275-2003[1].2 Normative ReferencesThe provisions in following documents become the essential provisions of this Document through reference in this Document. For the dated documents, only the versions with the dates indicated are applicable to this Document; for the undated documents, only the latest version (including all the amendments) is applicable to this Document. ISO 7218 Microbiology of food and animal feeding stuffs – General requirements and guidance for microbiological examinations3 Terms and DefinitionsFor the purposes of this document, the following terms and definitions apply. Ability of an antibacterial agent to inhibit the growth of bacteria on the surface of materials treated with an antibacterial agent, as determined by the value of the antibacterial activity.4 MaterialsPrepare physiological saline by placing 8.5 g of sodium chloride in 1 000 ml of distilled or deionized water and mixing to dissolve. Dilute the phosphate buffer solution prepared in 4.2.3.7 with the physiological saline to an 800-fold volume. Sterilize the phosphate-buffered physiological saline solution by autoclaving (see 6.2). If this solution is not used immediately after preparation, store it at 5 °C to 10 °C. Phosphate-buffered physiological saline kept for one month or longer after preparation shall not be used.5 ApparatusUnless otherwise specified, use the following apparatus and materials.6 Sterilization of Apparatus and Storage of Stock CulturesStock cultures shall be stored at 5 °C to 10 °C on an appropriate medium and transferred monthly. After five transfers or if more than one month has passed between transfers, the stock culture shall be discarded and replaced with a fresh culture obtained from the institute or culture collection concerned.7 ProcedureTesting shall be performed on at least three specimens from each treated test material. At least six specimens of the untreated material are required. Half of the untreated test specimens are used to measure viable cells immediately after inoculation and half are used to measure viable cells after incubation for 24 h. Using a sterile inoculating loop, transfer one loop of the test bacteria, pre-incubated as specified in 7.1, into a small amount of 1/500 NB prepared in accordance with 4.2.3.2.Ensure that the test bacteria are evenly dispersed, and estimate the number of bacteria using direct microscopic observation and a counting chamber or another appropriate method (e.g.8 Expression of ResultsFor each test specimen, determine the number of viable bacteria recovered in accordance with Equation (1). The value of the antibacterial activity can be used to characterize the effectiveness of an antibacterial agent.9 Repeatability and ReproducibilityRepeatability and reproducibility are discussed quantitatively in Annex B.10 Test ReportThe test report shall include the following information.Annex A(Normative) Quality of Biological Materials The quality of the components used in the inoculum preparations might differ depending on the source, and this might cause significant variability in results. Therefore, the composition of the components used needs to be specified.Annex B(Informative) Repeatability and Reproducibility The content of this annex is based on the results of extensive research conducted to investigate the repeatability and reproducibility of the results from this method. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. |
