YY/T 0866-2024 PDF English
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| YY/T 0866-2024 | English | 260 |
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Total inward leakage(TIL) determination method of protective face mask for medical use
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| YY/T 0866-2011 | English | 130 |
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Total Inward Leakage Determination Method of Protective Face Mask for Medical Use
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YY/T 0866-2024: Total inward leakage(TIL) determination method of protective face mask for medical use
---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/YYT0866-2024
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.140
CCS C 48
Replacing YY/T 0866-2011
Total Inward Leakage (TIL) Determination Method of
Protective Face Mask for Medical Use
Issued on: SEPTEMBER 29, 2024
Implemented on: DECEMBER 1, 2025
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative References... 4
3 Terms and Definitions... 4
4 Test System... 4
5 Sampling Methods and Result Calculation... 11
6 Test Method for Total Inward Leakage of Mask... 13
7 Selection of Test Methods for Total Inward Leakage of Mask... 18
Bibliography... 19
Total Inward Leakage (TIL) Determination Method of
Protective Face Mask for Medical Use
1 Scope
This document describes the test method for total inward leakage of protective face mask for
medical use.
This document applies to the total inward leakage test and evaluation of protective face mask
for medical use (hereinafter referred to as the mask). The leakage test and evaluation of other
biological protective devices for medical use may take this document as a reference.
2 Normative References
This document does not have normative references.
3 Terms and Definitions
The following terms and definitions are applicable to this document.
3.1 total inward leakage; TIL
Under specified laboratory testing conditions, the ratio of the concentration of simulant leaking
into the mask from all parts, including the filter material, during the subjects’ inhalation to the
concentration of simulant in the test environment.
[source. GB/T 12903-2008, 5.3.7, modified]
4 Test System
4.1 Aerosol Sealed Cabin
The design of the aerosol sealed cabin shall meet the following requirements.
a) The cabin size shall ensure that the subjects do not feel constrained while completing
all required movements during the test.
b) Aerosol particles shall be continuously transported into the cabin and discharged after
filtration. Aerosol particles shall be evenly distributed within the cabin, and the
aerosol concentration shall not vary by more than 10% throughout the test.
c) On the premise of ensuring the aerosol concentration in the cabin, when the subjects
are standing on the treadmill platform in the center of the cabin, the wind speed at a
distance of up to 30 cm above the subjects’ head shall be less than 0.2 m/s (without
lateral airflow interference).
d) The interior of the cabin shall be visible, allowing test personnel to observe the test
progress.
e) Communication facilities shall be provided to ensure unimpeded communication
between test personnel outside the cabin and the subjects inside.
f) When testing requires lateral airflow, airflow shall be directed toward the subjects
from three directions. in front, behind, and to the side (left or right), with a wind speed
of approximately 2 m/s at the subjects’ head.
4.2 Treadmill
It shall be equipped with an emergency brake function and capable of operating at the specified
test speed.
4.3 Sodium Chloride Aerosol Generator
4.3.1 Spray liquid
The spray liquid is a sodium chloride solution of a certain concentration, generally 2%. The
sodium chloride solution is prepared by dissolving reagent-grade sodium chloride in distilled
water.
4.3.2 Compressed air supply system
The compressed air supply system is used to provide spraying and drying airflows. The
compressed air undergoes necessary purification and drying treatment and has sufficient
pressure, flow rate and cleanliness. The operating pressure of the aerosol generator is generally
approximately 0.7 MPa.
4.3.3 Aerosol generator
See Figure 1 for the schematic diagrams of the structure of the aerosol generator.
The aerosol is transported to the sealed cabin via a pipeline. The diameter and length of the
transportation pipeline shall be large enough to ensure sufficient drying of the aerosol particles,
and the radius of the bending parts in the pipeline shall be large enough to reduce particle loss.
The air humidity in the sealed cabin shall not exceed 60%. If necessary, the air may be heated
or de-humidified.
The spray flow rate and pressure of the aerosol generator shall be able to ensure an average
mass concentration of sodium chloride aerosol particles within the aerosol sealed cabin of (8
4) mg/m3, with a concentration variation of no more than 10% during the test.
The aerodynamic mass median diameter of the sodium chloride aerosol particles shall be
between 0.4 m ~ 0.7 m, with a geometric standard deviation of less than 2.0.
NOTE. an impactor sampler or particle size spectrometer shall be used to test the aerodynamic
diameter of aerosol particles within the cabin.
4.4 Sampling Device
4.4.1 Sampling probe
The sampling probe is used to collect aerosol particles within the mask and can be safely fixed
to the mask in a sealed manner. The sampling probe material shall be selected to make the probe
lightweight. The connecting pipeline between the sampling probe and the testing device shall
be flexible, with an inner diameter of 3 mm ~ 4 mm, and the length should not be too long. In
addition, the type and length of the sampling pipeline within the cabin shall be the same as
those within the mask.
When sampling within a mask, in order to reduce sampling bias, a multi-hole sampling probe
is preferred (see Figure 2 and Figure 3). If a single-hole sampling probe is selected, design the
entrance of the sampling hole as an inclined plane beveled structure (see Figure 4). The
sampling probe shall be installed inside the mask close to the subjects’ face (< 10 mm), ideally
between the mouth and nose (see Figure 5). If necessary, provide support for the sampling probe
to avoid deformation of the mask material in the installation area, which may affect the mask’s
fitness, thereby increasing the total inward leakage. The sampling probe used to collect particles
inside the cabin shall be close to the sampling probe inside the mask but avoid being affected
by the exhaled gas from the mask.
4.4.2 Sampling flow rate
The sampling flow rate generally ranges from 0.1 L/min ~ 2 L/min, depending on the sampling
flow rate of the testing device. Set a low sampling flow rate to avoid interference with the
protective effect of the mask when worn.
The sampling airflow includes a dry airflow, which is used to reduce particle loss due to
condensation of sodium chloride particles. This airflow is particularly important for mask
products that can generate negative pressure during use. The dry airflow rate is 1 L/min. When
the dry airflow is used to dilute the collected particles, the result calculation shall be
correspondingly corrected.
4.5 Testing Devices
4.5.1 Sodium flame photometer
4.5.1.1 Basic principle
The sodium flame photometer is a testing device that quantifies the concentration of sodium
chloride aerosol particles by testing the intensity of the characteristic combustion spectrum of
the element sodium. This method can specifically test sodium chloride particles and is
independent of particle size.
4.5.1.2 Parameter requirements
The sodium flame photometer must be specifically designed for the testing and analysis of
sodium chloride aerosol particles and meet the following requirements.
a) The testing range of sodium chloride aerosol particle concentration shall cover 10
ng/m3 ~ 15 mg/m3;
b) The total sampling flow rate of the photometer shall not exceed 3 L/min;
c) The photometer detector, excluding the sampling module, shall have a full-scale
deflection of 10% ~ 90%, and a response time of no more than 500 ms.
4.5.2 Light scattering photometer
4.5.2.1 Basic principle
A light scattering photometer is a testing device that irradiates a beam of light onto a particle
flow and quantifies aerosol particle concentration by measuring the intensity of the scattered
light. This method cannot distinguish between sodium chloride particles and non-sodium
chloride particles and has limited detection capabilities for submicron and nanometer-sized
particles.
4.5.2.2 Parameter requirements
The light scattering photometer shall meet the following requirements.
a) The testing range of sodium chloride aerosol particle concentration shall cover 0.001
mg/m3 ~ 15 mg/m3;
b) The total sampling flow rate of the photometer shall not exceed 4 L/min;
c) The photometer detector, excluding the sampling module, shall have a full-scale
deflection of 10% ~ 90%, and a response time of no more than 500 ms.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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