RESUMO
In Europe, respiratory protective devices must be certified before they can be marketed. Among the parameters of interest, inward leakage (IL) characterizes the tightness between the face seal and the face, to verify that the device is well-designed. European standard EN 13274-1 (2001) and International Organization for Standardization (ISO) standard ISO 16900-1 (2019) specify that IL should be measured using sodium chloride (NaCl) aerosol or sulfur hexafluoride (SF6) gas. For reusable masks made of nonporous materials, both test agents are considered equally acceptable. However, the few studies that have compared IL values measured with various aerosols and gases have come to divergent conclusions. This work then aimed to measure IL with the test agents recommended by the standards to determine whether they are really equivalent. Since krypton (Kr) is an interesting candidate for replacing SF6 in standard tests, IL was assessed with SF6 and Kr simultaneously, and with NaCl aerosol using various calculation methods. Tests were carried out on 5 models of full-face masks donned on a headform connected to a breathing machine simulating 3 sinusoidal breathing rates of various intensities. The respirator fit on the headform was evaluated using a controlled negative pressure method to determine a manikin fit factor. Four scenarios were then tested to represent very poor, bad, good, and excellent fit. Gas concentration was measured using a mass spectrometer, and IL was calculated for SF6 and Kr. A combination of 3 devices allowed the determination of the number-based concentration of particles with diameters between 20 nm and 2 µm, and IL was calculated for each of the 33 channels, as well as using a cumulative number concentration. In addition, to comply with standards, a conversion was carried out to calculate IL using a cumulative mass concentration. The results of this work evidenced that the IL values measured with NaCl were systematically lower than those determined with gases. IL was also shown to vary with particle size, with a maximum value exceeding that calculated with cumulative concentrations (in number or mass). As part of the revision of the standards, protocols for measuring inward leakage should be redefined. On the one hand, acceptability thresholds should be re-evaluated according to the nature of the test agent (gas or aerosol), as it is clear that the 2 options do not give the same results for a given configuration. On the other hand, the aerosol leakage measurement protocol needs to be reworked to enable the measurement of a well-defined, robust, and reproducible inward leakage value.
RESUMO
Sulfur hexafluoride (SF6) is the reference tracer gas in many international standards for characterizing respiratory protective devices (RPD), fume cupboards, building ventilations, and other installations. However, due to its significant impact on global warming, its use is becoming increasingly restrictive. Krypton 84 (Kr) was chosen to be a possible replacement based on theoretical and practical criteria for the properties that a substitute gas should possess. While compliance with these criteria is generally sufficient to guarantee the reliability of the choice, it is essential in the case of widespread use such as a standard to validate experimentally that this tracer has the same behavior as SF6. In this regard, numerous tests have been carried out to characterize the face leakage of RPD and the rupture of containment of fume cupboards performance tests under different operating conditions. The results obtained are identical with both tracers and lead us to propose the use of Kr as a new reference gas in standards for which SF6 was used.