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GB/T 31402-2023Measurement of antibacterial activity on plastics and other non-porous surfaces (English PDF)

塑料和其他无孔材料表面抗菌活性的测定

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Issued by

State Administration for Market Regulation

Level / Type

National · Recommended

Issue date

October 27, 2023

Implementation date

June 1, 2024

Scope

GB/T 31402-2023 is the English-translated version of 塑料和其他无孔材料表面抗菌活性的测定.

GB/T 31402-2023 — This 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].

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Document preview — GB/T 31402-2023

National Standard of the People's Republic of China

ICS
83.080.01

Issued by: State Administration for Market Regulation

Contents

  • Foreword...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...26

Foreword

This 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 Scope

This 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 References

The 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 examinations

3 Terms and Definitions

For 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 Materials

Prepare 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 Apparatus

Unless otherwise specified, use the following apparatus and materials.

6 Sterilization of Apparatus and Storage of Stock Cultures

Stock 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 Procedure

Testing 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 Results

For 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 Reproducibility

Repeatability and reproducibility are discussed quantitatively in Annex B.

10 Test Report

The 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.

......

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 26 pages — is available in the English PDF.

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