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Article: Evaluation of Rigidity of Surgical N95 Respirators Using a Manikin-System: A Pilot Study.

Rengasamy, Samy / Niezgoda, George

Journal of the International Society for Respiratory Protection

2020 Volume 26, Issue 1, Page(s) 18–27

Abstract: Background: Surgical N95 respirators are devices certified by the National Institute for Occupational Safety and Health (NIOSH) and also cleared by the Food and Drug Administration (FDA) as a medical device. They are commonly used in healthcare settings ...

Abstract	Background: Surgical N95 respirators are devices certified by the National Institute for Occupational Safety and Health (NIOSH) and also cleared by the Food and Drug Administration (FDA) as a medical device. They are commonly used in healthcare settings to provide protection from infectious aerosols, as well as, bodily fluid sprays and splashes. It is hypothesized based on design, some models may change their shape significantly (i.e., collapse) during heavy breathing, which may allow the device to touch the wearer's face. Concerns have been raised that droplets of infectious biological fluids may reach the inner layer of surgical N95 respirators leading to the transfer of microorganisms to the oronasal facial region upon collapse. Unfortunately, little data currently exists on respirator rigidity testing or its relation to efficacy. The objective of this study was to develop and optimize a manikin-based test system to evaluate respirator rigidity. Methods: Six surgical N95 models of three different designs (cup-shaped, flat fold and trifold) were tested at two different environmental conditions on the NIOSH medium headform. Rigidity evaluation was performed at 50% relative humidity (RH) and 22°C, and at ~100% RH and 33°C at 40, 50, and 60 L/min breathing flow rates. Facial contact secondary to shape change was assessed by coating the inner layer of the surgical N95 respirators with a fluorescent tracer and its transfer to the manikin face. Results: The results showed that the cup-shaped models were rigid and resistant to shape change at both environmental conditions and all flow rates. In contrast, the flat fold models and trifold models showed significant changes with rigidity, at higher breathing flow rates and higher RH and temperature conditions. The flat fold models showed transfer of the fluorescent tracer to the manikin face at higher RH and breathing rates, confirming a change in rigidity. Conclusions: The results from the study suggest that the manikin-based test system designed for the purposes of this study can be used to evaluate respirator rigidity.
Language	English
Publishing date	2020-01-31
Publishing country	United States
Document type	Journal Article
ISSN	0892-6298
ISSN	0892-6298
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Do industrial N95 respirators meet the requirements to be used in healthcare? - A possible solution to respirator shortages during the next pandemic.

Rengasamy, Samy / Sbarra, Deborah / Horvatin, Matthew

American journal of infection control

2021 Volume 49, Issue 9, Page(s) 1194–1196

Abstract: Shortages of surgical N95 respirators (surgical N95 FFRs) can occur during a pandemic. To understand if industrial N95 FFRs have FDA required fluid penetration resistance and flammability, five NIOSH approved N95 models were evaluated using the ASTM ... ...

Abstract	Shortages of surgical N95 respirators (surgical N95 FFRs) can occur during a pandemic. To understand if industrial N95 FFRs have FDA required fluid penetration resistance and flammability, five NIOSH approved N95 models were evaluated using the ASTM F1862 method and flammability using the 16 CFR 1610 method, respectively. Three models passed both fluid penetration resistance and flammability indicating that some N95 models on the market can be used as surgical N95 FFRs during a pandemic.
MeSH term(s)	Delivery of Health Care ; Filtration ; Humans ; N95 Respirators ; Pandemics/prevention & control ; Respiratory Protective Devices ; Ventilators, Mechanical
Language	English
Publishing date	2021-03-24
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	392362-9
ISSN	1527-3296 ; 0196-6553
ISSN (online)	1527-3296
ISSN	0196-6553
DOI	10.1016/j.ajic.2021.03.014
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Article: Nanoparticle Filtration Performance of Commercially Available Dust Masks.

Rengasamy, Samy / Eimer, Benjamin C / Shaffer, Ronald E

Journal of the International Society for Respiratory Protection

2020 Volume 25, Issue 3, Page(s) 27–41

Abstract: Dust masks are often confused with filtering facepiece respirators (FFR) but are not approved by NIOSH for respiratory protection against particulate exposure. This study reports the filtration performance of commercially available dust masks against ... ...

Abstract	Dust masks are often confused with filtering facepiece respirators (FFR) but are not approved by NIOSH for respiratory protection against particulate exposure. This study reports the filtration performance of commercially available dust masks against submicron particles and discusses the relevance of these findings toward the filtration of nanoparticles. Seven different models of dust masks from local home improvement/hardware stores were challenged with submicron NaCl particles, and initial percentage penetration and resistance levels were measured using two test procedures. A polydisperse aerosol test (PAT) method, similar to the "worst case" conditions used in the NIOSH particulate respirator certification test protocol was used. A monodisperse aerosol test (MAT) method, which utilizes eleven different particle sizes in the range of 20-400 nm, were also used for particle penetration measurements at 30 and 85 L/min flow rates using the TSI 3160. Dust masks were designated as category low-, medium- and high-penetration dust masks based on penetration levels of <5%, 5-25% and >25%, respectively. Data collected using the PAT and the MAT methods showed <5% initial penetration levels for low-penetration dust masks, which is similar to the NIOSH-approved class-95 filtering facepiece respirators. Average penetration levels for medium- and high-penetration dust masks were between 8.9-24.2% and 74.5-96.9%, respectively. Penetration levels of MPPS particles from the MAT correlated with penetration levels from the PAT. Monodisperse MPPS penetration levels from MAT and penetration levels from PAT showed poor correlation with resistance values and no correlation with cost. The results of this study show that dust masks frequently do not provide filtration performance equivalent to that of NIOSH certified devices. Users of dust masks should be cautioned against using them for protection against particulates in the nano- or ultrafine size ranges.
Language	English
Publishing date	2020-05-19
Publishing country	United States
Document type	Journal Article
ISSN	0892-6298
ISSN	0892-6298
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Article ; Online: New technique to evaluate decontamination methods for filtering facepiece respirators.

Vo, Evanly / Rengasamy, Samy / Xu, Susan / Horvatin, Matthew / Zhuang, Ziqing

American journal of infection control

2021 Volume 49, Issue 4, Page(s) 416–423

Abstract: Background: A major concern among health care experts is a shortage of N95 filtering facepiece respirators (FFRs) during a pandemic. One option for mitigating an FFR shortage is to decontaminate and reuse the devices. The focus of this study was to ... ...

Abstract	Background: A major concern among health care experts is a shortage of N95 filtering facepiece respirators (FFRs) during a pandemic. One option for mitigating an FFR shortage is to decontaminate and reuse the devices. The focus of this study was to develop a new evaluation technique based on 3 major decontamination requirements: (1) inactivating viruses, (2) not altering the respirator properties, and (3) not leaving any toxic byproduct on the FFR. Methods: Hydrophilic and hydrophobic FFRs were contaminated with MS2 virus. In the solution-based deposition, the virus-containing liquid droplets were spiked directly onto FFRs, while in the vapor-based and aerosol-based depositions, the viral particles were loaded onto FFRs using a bio-aerosol testing system. Ultraviolet germicidal irradiation (UVGI) and moist heat (MH) decontamination methods were used for inactivation of viruses applied to FFRs. Results: Both UVGI and MH methods inactivated viruses (>5-log reduction of MS2 virus; in 92% of both method experiments, the virus was reduced to levels below the detection limit), did not alter the respirator properties, and did not leave any toxic byproduct on the FFRs. Conclusions: Both UVGI and MH methods could be considered as promising decontamination candidates for inactivation of viruses for respirator reuse during shortages.
MeSH term(s)	Decontamination ; Equipment Reuse ; Humans ; Pandemics ; Respiratory Protective Devices ; Ultraviolet Rays ; Ventilators, Mechanical
Language	English
Publishing date	2021-01-29
Publishing country	United States
Document type	Journal Article
ZDB-ID	392362-9
ISSN	1527-3296 ; 0196-6553
ISSN (online)	1527-3296
ISSN	0196-6553
DOI	10.1016/j.ajic.2021.01.017
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Article: Filtration Performance of FDA-Cleared Surgical Masks.

Rengasamy, Samy / Miller, Adam / Eimer, Benjamin C / Shaffer, Ronald E

Journal of the International Society for Respiratory Protection

2020 Volume 26, Issue 3, Page(s) 54–70

Abstract: Ashortage of NIOSH-approved respirators is predicted during an influenza pandemic and other infectious disease outbreaks. Healthcare workers may use surgical masks instead of respirators due to non-availability and for economical reasons. This study ... ...

Abstract	Ashortage of NIOSH-approved respirators is predicted during an influenza pandemic and other infectious disease outbreaks. Healthcare workers may use surgical masks instead of respirators due to non-availability and for economical reasons. This study investigated the filtration performance of surgical masks for a wide size range of submicron particles including the sizes of many viruses. Five models of FDA-cleared surgical masks were tested for room air particle penetrations at constant and cyclic flow conditions. Penetrations of polydisperse NaCl aerosols (75±20 nm, count median diameter), monodisperse NaCl aerosols (20-400 nm range) and particles in the 20-1000 nm range were measured at 30 and 85 liters/min. Filtration performance of surgical masks varied widely for room air particles at constant flow and correlated with the penetration levels measured under cyclic flow conditions. Room air particle penetration levels were comparable to polydisperse and monodisperse aerosol penetrations at 30 and 85 liters/minute. Filtration performance of FDA-cleared surgical masks varied widely for room air particles, and monodisperse and polydisperse aerosols. The results suggest that not all FDA-cleared surgical masks will provide similar levels of protection to wearers against infectious aerosols in the size range of many viruses.
Language	English
Publishing date	2020-05-19
Publishing country	United States
Document type	Journal Article
ISSN	0892-6298
ISSN	0892-6298
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Article: Flammability of Respirators and other Head and Facial Personal Protective Equipment.

Rengasamy, Samy / Niezgoda, George / Shaffer, Ron

Journal of the International Society for Respiratory Protection

2018 Volume 35, Issue 1, Page(s) 1–13

Abstract: Background: Personal protective equipment (PPE) is worn by workers in surgical settings to protect them and patients. Food and Drug Administration (FDA) clears some PPE (e.g., surgical masks (SM)) as class II medical devices, and regulates some (e.g. ... ...

Abstract	Background: Personal protective equipment (PPE) is worn by workers in surgical settings to protect them and patients. Food and Drug Administration (FDA) clears some PPE (e.g., surgical masks (SM)) as class II medical devices, and regulates some (e.g. surgical head cover) as class I exempt devices. For respiratory protection, National Institute for Occupational Safety and Health (NIOSH)-approved N95 filtering facepiece respirators (FFRs), and powered air-purifying respirators (PAPRs) are used. One type of PPE, "surgical N95 respirators", is a NIOSH-approved FFR that is also cleared by the FDA for use in medical settings. The surgical environment poses unique risks such as the potential for surgical fires. As part of its substantial equivalence determination process, FDA requests testing of flammability and other parameters for SM and surgical N95 respirators. A lack of data regarding flammability of PPE used in healthcare exists. We hypothesize that commonly used PPE, regardless of whether regulated and/or cleared by FDA or not, will pass an industry standard such as the 16 CFR 1610 flammability test. Methods: Eleven N95 FFR models, eight surgical N95 respirator models, seven SM models, five surgical head cover models, and five PAPR hood models were evaluated for flammability with a 45 degree flammability tester using the 16 CFR 1610 method. Three common fabrics were included for comparison. Results: All of the PPE samples regulated/and or cleared by FDA or not, passed the flammability test at class 1 (normal flammability), meaning they are less likely to burn. Only one of the three common fabrics, a cotton fabric at the lowest basis weight, was class 3 (high flammability). Conclusions: The results obtained in the study suggest that NIOSH-approved N95 FFRs would likely pass the 16 CFR 1610 flammability standard. Moreover, results suggest that NIOSH is capable of undertaking flammability testing using the 16 CFR 1610 standard as the flammability results NIOSH obtained for N95 FFRs were comparable to the results obtained by a third party independent laboratory.
Keywords	covid19
Language	English
Publishing date	2018-10-10
Publishing country	United States
Document type	Journal Article
ISSN	0892-6298
ISSN	0892-6298
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Article ; Online: Effects of volume, velocity, and composition on the resistance to synthetic blood penetration of N95 filtering facepiece respirators and other head/facial personal protective equipment.

Portnoff, Lee / Rengasamy, Samy / Niezgoda, George / Sbarra, Deborah / Pissano, Anthony / Furlong, Jennifer

Journal of occupational and environmental hygiene

2020 Volume 18, Issue 2, Page(s) 84–89

Abstract: Surgical N95 filtering facepiece respirators (surgical N95 FFRs) are National Institute for Occupational Safety and Health-approved N95 filtering facepiece respirators (N95 FFRs) cleared by the Food and Drug Administration for resistance to liquid ... ...

Abstract	Surgical N95 filtering facepiece respirators (surgical N95 FFRs) are National Institute for Occupational Safety and Health-approved N95 filtering facepiece respirators (N95 FFRs) cleared by the Food and Drug Administration for resistance to liquid penetration and flammability. A recent study showed that several N95 FFR models performed as well as surgical N95 FFRs in synthetic blood penetration tests that evaluate resistance to penetration by horizontal projection. This aspect, in addition to the influence of other factors on liquid penetration, are not well studied. To address this issue, the effect of liquid volume (1 mL and 2 mL), spray velocity (450 cm/sec and 635 cm/sec), and liquid composition (synthetic blood and diluted synthetic blood) were evaluated. Four types of common protective devices were studied: N95 FFRs, surgical N95 FFRs, surgical masks, and powered air-purifying respirator (PAPR) hoods. For each protective device type, five models were analyzed using a protocol based on the F1862 ASTM International (2017) test method. Reduced liquid volume had a significant effect in only 3 of 20 models. Increased velocity had significantly greater penetration in 9 of 20 models. Diluted synthetic blood had significantly more penetration in 8 of 20 models. This last result was not expected because, in hydrostatic tests, surface tension of the diluted blood would be expected to reduce penetrability; however, across all models tested, data showed that the diluted spray was more penetrable. The study results suggest that fluid composition may be as important as velocity when considering liquid spray penetration. Furthermore, the penetrability of a spray may be inversely related to the penetrability through direct hydrostatic contact.
MeSH term(s)	Filtration ; Masks ; N95 Respirators ; Personal Protective Equipment ; Respiratory Protective Devices ; United States
Language	English
Publishing date	2020-12-14
Publishing country	England
Document type	Journal Article
ZDB-ID	2131820-7
ISSN	1545-9632 ; 1545-9624
ISSN (online)	1545-9632
ISSN	1545-9624
DOI	10.1080/15459624.2020.1854457
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Article ; Online: Evaluation of total inward leakage for NIOSH-approved elastomeric half-facepiece, full-facepiece, and powered air-purifying respirators using sodium chloride and corn oil aerosols.

Rengasamy, Samy / Zhuang, Ziqing / Lawrence, Robert B / Boutin, Brenda / Yorio, Patrick / Horvatin, Matthew / McClain, Caitlin / Harris, James R / Coffey, Christopher

Journal of occupational and environmental hygiene

2021 Volume 18, Issue 7, Page(s) 305–313

Abstract: Recently, total inward leakage (TIL) for filtering facepiece and elastomeric half-mask respirators (EHRs) was measured according to the International Organization for Standardization (ISO) test method standard 16900-1:2014 that showed larger TIL for corn ...

Abstract	Recently, total inward leakage (TIL) for filtering facepiece and elastomeric half-mask respirators (EHRs) was measured according to the International Organization for Standardization (ISO) test method standard 16900-1:2014 that showed larger TIL for corn oil aerosol than for NaCl aerosol. Comparison of TIL measured for different aerosols for higher protection level respirators is lacking. The objective of this study was to determine TIL for EHRs, full-facepiece respirators, and loose-fitting and tight-fitting powered air-purifying respirators (PAPRs) using NaCl and corn oil aerosols to compare. TIL was measured for two models each of EHRs, full-facepiece respirators, and loose-fitting and tight-fitting PAPRs. After fit testing with a PortaCount (TSI, St. Paul, MN) using the Occupational Safety and Health Administration (OSHA) protocol, eight subjects were tested in the NaCl aerosol chamber first and then in the corn oil aerosol chamber, while another eight subjects tested in the reverse order. Subjects were randomly assigned to one of the two groups. TIL was measured as a ratio of mass-based aerosol concentrations inside the mask to the test chamber while the subjects performed ISO 16900-1-defined exercises using continuous sampling methods. The concentration of corn oil aerosol was measured with one light scattering photometer, alternately, and NaCl aerosol was measured using two flame photometers. Results showed the geometric mean TIL for EHR was significantly (
MeSH term(s)	Aerosols ; Corn Oil ; Filtration ; Humans ; National Institute for Occupational Safety and Health, U.S. ; Occupational Exposure/prevention & control ; Particle Size ; Respiratory Protective Devices ; Sodium Chloride/analysis ; United States
Chemical Substances	Aerosols ; Sodium Chloride (451W47IQ8X) ; Corn Oil (8001-30-7)
Language	English
Publishing date	2021-05-26
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	2131820-7
ISSN	1545-9632 ; 1545-9624
ISSN (online)	1545-9632
ISSN	1545-9624
DOI	10.1080/15459624.2021.1919685
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Article ; Online: N95-companion measurement of cout/cin ratios for two n95 filtering facepiece respirators and one surgical mask.

Rengasamy, Samy / Eimer, Benjamin C

Journal of occupational and environmental hygiene

2013 Volume 10, Issue 10, Page(s) 527–532

Abstract: A previous study in our laboratory measured the ratio of particle concentration outside (Cout)/inside (Cin) of three N95 filtering facepiece respirator (FFR) models with an N95-Companion and other aerosol instruments using a breathing manikin. Results ... ...

Abstract	A previous study in our laboratory measured the ratio of particle concentration outside (Cout)/inside (Cin) of three N95 filtering facepiece respirator (FFR) models with an N95-Companion and other aerosol instruments using a breathing manikin. Results showed that the Companion measured Cin was contributed by particle penetration through face seal leakage and not through filter media suggesting that the Cout/Cin ratio should be similar for different N95 models at any given leak size. To better understand the phenomenon, the current study analyzed the influence of factors, including filter penetration, resistance, and flow rate on the Companion ratios for two N95 FFR (N1 and N2) and one surgical mask (SM1) models using a manikin. Cout/Cin ratios were measured at 10 and 40 L breathing minute volumes with sealed condition and at artificially introduced leaks. Filter efficiency and resistance were measured at 10 and 40 L/min constant flow rates. Results showed that filter efficiency and resistance were higher for N1 than for N2 and SM1. The ratio for N1was also higher than those of N2 and SM1 at sealed condition at both breathing rates. The result can be due to the higher filtration efficiency of N1. With increasing leak sizes, however, the ratios were higher for N2 than for N1 at 10 and 40 L breathing rates. Higher ratios for N2 can be attributed to the lower resistance that allowed higher aerosol flow through the filter media and captured more negatively charged particles to produce lesser Cin or greater Cout/Cin ratio. Ratios obtained for SM1 at different leak sizes were higher than the ratios of N1 at 10 L. SM1 ratios, however, decreased dramatically at 40 L indicating that high flow rate may adversely affect the ratios. Further studies are needed to better understand the influence of filter media characteristics on the Companion measured Cout/Cin ratios.
MeSH term(s)	Air Pollutants, Occupational/analysis ; Equipment Design ; Filtration ; Inhalation Exposure/prevention & control ; Masks/standards ; Materials Testing ; Occupational Exposure/prevention & control ; Particle Size ; Respiratory Protective Devices/standards
Chemical Substances	Air Pollutants, Occupational
Language	English
Publishing date	2013
Publishing country	England
Document type	Journal Article ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	2131820-7
ISSN	1545-9632 ; 1545-9624
ISSN (online)	1545-9632
ISSN	1545-9624
DOI	10.1080/15459624.2013.818224
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Article ; Online: A comparison of facemask and respirator filtration test methods.

Rengasamy, Samy / Shaffer, Ronald / Williams, Brandon / Smit, Sarah

Journal of occupational and environmental hygiene

2016 Volume 14, Issue 2, Page(s) 92–103

Abstract: NIOSH published a Federal Register Notice to explore the possibility of incorporating FDA required filtration tests for surgical masks (SMs) in the 42 CFR Part 84 respirator certification process. There have been no published studies comparing the ... ...

Abstract	NIOSH published a Federal Register Notice to explore the possibility of incorporating FDA required filtration tests for surgical masks (SMs) in the 42 CFR Part 84 respirator certification process. There have been no published studies comparing the filtration efficiency test methods used for NIOSH certification of N95 filtering facepiece respirators (N95 FFRs) with those used by the FDA for clearance of SMs. To address this issue, filtration efficiencies of "N95 FFRs" including six N95 FFR models and three surgical N95 FFR models, and three SM models were measured using the NIOSH NaCl aerosol test method, and FDA required particulate filtration efficiency (PFE) and bacterial filtration efficiency (BFE) methods, and viral filtration efficiency (VFE) method. Five samples of each model were tested using each method. Both PFE and BFE tests were done using unneutralized particles as per FDA guidance document. PFE was measured using 0.1 µm size polystyrene latex particles and BFE with ∼3.0 µm size particles containing Staphylococcus aureus bacteria. VFE was obtained using ∼3.0 µm size particles containing phiX 174 as the challenge virus and Escherichia coli as the host. Results showed that the efficiencies measured by the NIOSH NaCl method for "N95 FFRs" were from 98.15-99.68% compared to 99.74-99.99% for PFE, 99.62-99.9% for BFE, and 99.8-99.9% for VFE methods. Efficiencies by the NIOSH NaCl method were significantly (p = <0.05) lower than the other methods. SMs showed lower efficiencies (54.72-88.40%) than "N95 FFRs" measured by the NIOSH NaCl method, while PFE, BFE, and VFE methods produced no significant difference. The above results show that the NIOSH NaCl method is relatively conservative and is able to identify poorly performing filtration devices. The higher efficiencies obtained using PFE, BFE and VFE methods show that adding these supplemental particle penetration methods will not improve respirator certification.
MeSH term(s)	Aerosols/analysis ; Air Pollutants, Occupational/analysis ; Equipment Design/standards ; Filtration/instrumentation ; Inhalation Exposure/prevention & control ; Masks ; Materials Testing/methods ; National Institute for Occupational Safety and Health, U.S. ; Respiratory Protective Devices/standards ; United States
Chemical Substances	Aerosols ; Air Pollutants, Occupational
Keywords	covid19
Language	English
Publishing date	2016-08-23
Publishing country	England
Document type	Comparative Study ; Journal Article
ZDB-ID	2131820-7
ISSN	1545-9632 ; 1545-9624
ISSN (online)	1545-9632
ISSN	1545-9624
DOI	10.1080/15459624.2016.1225157
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