GB/T 43355-2023Measurement of antiviral activity on plastics and other non-porous surfaces (English PDF)
塑料和其他无孔材料表面抗病毒活性的测定
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Issued by
State Administration for Market Regulation, China National Standardization Administration
Level / Type
National · Recommended
Issue date
November 27, 2023
Implementation date
June 1, 2024
Scope
GB/T 43355-2023 is the English-translated version of 塑料和其他无孔材料表面抗病毒活性的测定.
GB/T 43355-2023 — This document describes a method for testing the antiviral activity of antivirally treated plastic surfaces and other nonporous material surfaces against specific viruses: Due to differences in the sensitivity of virus strains, the results of a certain virus test may not be suitable for the evaluation of other viruses:
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Document preview — GB/T 43355-2023
National Standard of the People's Republic of China
- ICS
- 83.080.01
- Classification
- G 31
Issued by: State Administration for Market Regulation, China National Standardization Administration
Contents
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Materials
- 4.1 Test viruses and host cells
- 4.2 Reagents
- 4.3 Culture media and solutions
- 5 Devices
- 6 Test preparation
- 6.1 Resuscitation of host cells
- 6.2 Host cell subculture
- 6.3 Cell culture for determination of virus infection titers
- 6.4 Preparation of inoculation solution
- 6.5 Sample preparation
- 6.6 Controlled Trial
- 7 Test Step
- 7.1 Sample preparation
- 7.2 Sample inoculation
- 7.3 Incubation of specimens after inoculation
- 7.4 Recovery of viruses from samples
- 7.5 Determination of virus infection titer by plaque method
- 8 Test results
- 8.1 Determination of viral infection titer
- 8.2 Test validity
- 8.3 Calculation of antiviral activity value (virus-inhibiting activity value)
- 8.4 Antiviral effect
- 9 Repeatability and Reproducibility
- 10 Test Report
- Appendix A (Informative) Medium Formula
- Appendix B (Informative) Repeatability and Reproducibility
- Appendix NA (informative) Calculation of antiviral activity rate (virus inhibitory activity rate)
- Reference
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents" Drafting:
This document is equivalent to ISO 21702:2019 "Determination of antiviral activity on surfaces of plastics and other non-porous materials":
This document has made the following minimal editorial changes:
---For the convenience of application, the note in 3:3 is added;
---Added Appendix NA (informative) "Calculation of Antiviral Activity Rate (Virus Inhibition Activity Rate)":
Please note that some content in this document may be subject to patents: The publisher of this document assumes no responsibility for identifying patents:
Introduction
Due to the influence of the environment and human activities, the surfaces of plastics or other materials that people come into contact with daily often contain a large number of viruses:
Become a source of contamination by pathogenic microorganisms: Antiviral plastic products and products made of other non-porous materials kill viruses compared to regular products, Reduce virus spread: Therefore, antiviral treated products (porous and non-porous) have been widely recognized by consumers for their antiviral functions and have become New consumption choices:
At present, there are products made of antibacterial and antiviral materials in the domestic market: Our country already has plastic and non-porous materials (such as coatings, ceramics, natural (leather, artificial leather, stainless steel, rubber and other products)) test method standards for surface antibacterial activity (see GB/T 31402), but there is no relevant antibacterial activity National standard for viral activity determination: For this reason, this document has been developed:
Plastic and other non-porous material surfaces Determination of antiviral activity Warning: Handling and manipulation of potentially hazardous viruses and host cells requires high technical skills and should comply with current national laws and regulations:
regulation: Only personnel trained in biotechnology can perform these tests, and relevant disinfection, sterilization and personal hygiene should be strictly implemented:
Standardize procedures:
1 Scope
This document describes a method for testing the antiviral activity of antivirally treated plastic surfaces and other nonporous material surfaces against specific viruses:
Due to differences in the sensitivity of virus strains, the results of a certain virus test may not be suitable for the evaluation of other viruses:
2 Normative reference documents
This document has no normative references:
3 Terms and definitions
The following terms and definitions apply to this document:
antiviral
The ability to reduce the number of infectious viruses on the product surface:
antiviral agentantiviralagent Agents that reduce the number of infectious viruses on the surface of products:
Antiviral activity valueantiviralactivity Logarithmic difference in viral infection titers after inoculation and exposure to antiviral treated versus unantiviral treated products:
cytopathic effect
Viral proliferation results in morphological changes or destruction of host cells:
The amount of infectious virus present per unit volume in a suspension:
plaque
A lytic zone where infection and proliferation of a single virus results in the formation of a monolayer of cells in semi-solid medium:
plaqueformingunits
PFU
A unit expressing the concentration of infectious virus per unit volume (mL):
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.
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