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Measurement of antiviral activity on plastics and other non-porous surfaces
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Basic data
| Standard ID | GB/T 43355-2023 (GB/T43355-2023) |
| Description (Translated English) | Measurement of antiviral activity on plastics and other non-porous surfaces |
| Sector / Industry | National Standard (Recommended) |
| Classification of Chinese Standard | G31 |
| Classification of International Standard | 83.080.01 |
| Word Count Estimation | 24,223 |
| Date of Issue | 2023-11-27 |
| Date of Implementation | 2024-06-01 |
| Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration |
GB/T 43355-2023: Measurement of antiviral activity on plastics and other non-porous surfaces
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 83:080:01
CCSG31
National Standards of People's Republic of China
Plastic and other non-porous material surfaces
Determination of antiviral activity
(ISO 21702:2019,IDT)
Published on 2023-11-27
2024-06-01 Implementation
State Administration for Market Regulation
Released by the National Standardization Administration Committee
Table of contents
PrefaceⅠ
Introduction II
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Materials 2
4:1 Test viruses and host cells 2
4:2 Reagents 2
4:3 Culture media and solutions 2
5 devices 5
6 Test preparation 5
6:1 Resuscitation of host cells 5
6:2 Host cell subculture 6
6:3 Cell culture for determination of virus infection titers 6
6:4 Preparation of inoculation solution 6
6:5 Sample preparation 7
6:6 Controlled Trial 7
7 Test Step 9
7:1 Sample preparation 9
7:2 Sample inoculation 9
7:3 Incubation of specimens after inoculation10
7:4 Recovery of viruses from samples10
7:5 Determination of virus infection titer by plaque method10
8 Test results 11
8:1 Determination of viral infection titer11
8:2 Test validity11
8:3 Calculation of antiviral activity value (virus-inhibiting activity value) 11
8:4 Antiviral effect 12
9 Repeatability and Reproducibility12
10 Test Report 12
Appendix A (Informative) Medium Formula 13
Appendix B (Informative) Repeatability and Reproducibility16
Appendix NA (informative) Calculation of antiviral activity rate (virus inhibitory activity rate) 18
Reference 19
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:
This document is proposed by China Petroleum and Chemical Industry Federation:
This document is under the jurisdiction of the National Plastics Standardization Technical Committee (SAC/TC15):
This document was drafted by: Institute of Microbiology, Guangdong Academy of Sciences (Guangdong Microbial Analysis and Testing Center), Huitong New Materials Co:, Ltd:
Company, Guangdong Dimei Biotechnology Co:, Ltd:, Guangzhou Synthetic Materials Research Institute Co:, Ltd:, Shuimu Juli Grafting New Technology (Shenzhen) Co:, Ltd:
Ren Company, Guangzhou Liangheng Testing Technology Service Co:, Ltd:, Zhejiang Jinhai Hi-Tech Co:, Ltd:, Hefei Gaobeis Medical and Health Products Co:, Ltd:
Company, Guangdong Huabiao Testing Center Co:, Ltd:, Shanghai Kangjunsi New Materials Co:, Ltd:, Chengdu Zinhuan Technology Co:, Ltd:, Beijing Aisilco
Technology Co:, Ltd:, Shanghai Runhe Nanomaterial Technology Co:, Ltd:
The main drafters of this document: Xie Xiaobao, Wang Haojiang, Chen Xin, Lin Jiahong, Li Jingye, Li Yulian, Sun Tingli, Ma Mei, Wang Fei, Yuan Shuang,
Ding Yike, Yu Jiefeng, Xie Xinhong, Ma Zhengsheng, Zhao Ziyan, Wei Guo, Tao Zhiqing, Li Weiyi:
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:
3:1
antiviral
The ability to reduce the number of infectious viruses on the product surface:
3:2
antiviral agentantiviralagent
Agents that reduce the number of infectious viruses on the surface of products:
3:3
Antiviral activity valueantiviralactivity
Logarithmic difference in viral infection titers after inoculation and exposure to antiviral treated versus unantiviral treated products:
3:4
cytopathic effect
Viral proliferation results in morphological changes or destruction of host cells:
3:5
The amount of infectious virus present per unit volume in a suspension:
3:6
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:
3:7
plaqueformingunits
PFU
A unit expressing the concentration of infectious virus per unit volume (mL):
...
