GB/T 46937-2025Test method for the viral filtration efficiency (VFE) of medical masks and materials - Bacteriophage Phi-X 174 aerosol method (English PDF)
医用口罩及材料病毒过滤效率测试方法 Phi-X174噬菌体气溶胶法
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
December 31, 2025
Implementation date
January 1, 2027
Scope
GB/T 46937-2025 is the English-translated version of 医用口罩及材料病毒过滤效率测试方法 Phi-X174噬菌体气溶胶法.
GB/T 46937-2025 is the Chinese standard "Test method for the viral filtration efficiency (VFE) of medical masks and materials - Bacteriophage Phi-X 174 aerosol method".
Its scope clause reads: This document describes the use of bacteriophage Phi-X174 as a model microorganism to assess the viral aerosol filtration efficiency of medical masks and materials.
The testing method. This document applies to medical masks and materials for which virus filtration efficiency evaluation is required. Virus filtration efficiency testing for other products or materials is also covered. Please refer to this document. Its clauses include terms and definitions.
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Document preview — GB/T 46937-2025
National Standard of the People's Republic of China
- ICS
- 11.140
- Classification
- C 48
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Preface
- 1.Scope
- 2 Normative References
- 3.Terms and Definitions
- 4.Principle
- 5.Test conditions
- 6.Sample quantity and pretreatment conditions
- 7.Phage proliferation
- 7.1 Bacteriophages and Host Bacteria
- 7.2 Culture medium
- 7.3 Phage Proliferation
- 8.Virus Filtration Efficiency Detection Methods
- 8.1 Aerosol Generator
- 8.2 Bioaerosol Sampler
- 8.3 Sample Support
- 8.4 Virus Filtration Efficiency Detection System
- 8.5 Virus Filtration Efficiency Detection Methods
- 9 Results Report
- References
1 Scope
This document describes the use of bacteriophage Phi-X174 as a model microorganism to assess the viral aerosol filtration efficiency of medical masks and materials.
The testing method.
This document applies to medical masks and materials for which virus filtration efficiency evaluation is required. Virus filtration efficiency testing for other products or materials is also covered.
Please refer to this document.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.
For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.
This document.
GB/T 38517-2020 General Rules for Sampling and Analysis of Particulate Bioaerosols
GB/T 39990-2021 Technical requirements for particulate bioaerosol samplers
YY/T 0689-2008 Test Performance of Protective Clothing Materials Against Bloodborne Pathogens for Blood and Body Fluid Protective Equipment
X174 phage assay method
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 bacteriophage
A virus that infects bacteria.
Note. In this document, bacteriophage refers to Phi-X174.
3.2 lysis
The process by which host bacteria are dissolved and destroyed due to the proliferation of bacteriophages.
Note. In this method, Escherichia coli serves as the host cell, and its lysis is caused by Phi-X174 infection.
3.3 Plaque
Theoretically, a visible, translucent area forms on the upper layer of agar plates when a single bacteriophage infects and lyses the host cell.
3.4 Plaque-forming unit (PFU)
Viral particles capable of infecting bacteria growing on the upper layer of lysed agar plates and producing plaques (3.3).
3.5 titer
Concentration of active phages.
Note. Plaque formation units per milliliter (PFU/mL) are used.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 13 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 38517-2020Particulates - Bioaerosol sampling and analysis - General principles
- GB/T 39990-2021Particulates - Bioaerosol samplers - Technical specification
- YY/T 0689-2008Clothing for protection against contact with blood and body fluids -- Determination of resistance of protective clothing materials to penetration by blood-borne pathogens -- Test method using Phi-X 174 bacteriophage
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Related Standards
GB/T 38517-2020 — Particulates - Bioaerosol sampling and analysis - General principles
GB/T 39990-2021 — Particulates - Bioaerosol samplers - Technical specification
YY/T 0689-2008 — Clothing for protection against contact with blood and body fluids -- Determination of resistance of protective clothing materials to penetration by blood-borne pathogens -- Test method using Phi-X 174 bacteriophage
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