WASH-DURABLE AND REUSABLE RESPIRATORY FACE MASK
20230109115 · 2023-04-06
Inventors
Cpc classification
A41D13/11
HUMAN NECESSITIES
A62B23/025
HUMAN NECESSITIES
International classification
Abstract
A wash-durable and reusable respiratory face mask for filtering air comprising a face part configured to cover at least the nose and the mouth of a head of a user includes two substantially symmetrical regions, where each region includes a top edge configured to form a trajectory which runs, when the mask is worn by the user, from the bridge of the nose of the head towards an ear of the head. The trajectory includes at least two sections, the first section being configured to cover at least part of the nose when the mask is worn by the user and forming a substantially convex bend, and the second section extending from the first section toward an ear.
Claims
1. A wash-durable and reusable respiratory face mask (100) for filtering air comprising a face part (105) configured to cover at least the nose and the mouth of a head of a user and comprising two substantially symmetrical regions (110a, 110b) and each region (110a, 110b) comprising a top edge (140) configured to form a trajectory (T2) which runs, when the mask (100) is worn by the user, from the bridge of the nose of the head towards an ear of the head, wherein the trajectory (T2) comprises at least two sections (141, 142), the first section (141) being configured to cover at least part of the nose when the mask (100) is worn by the user and forming a substantially convex bend, and the second section (142) extending from the first section (141) towards an ear.
2. The mask (100) of claim 1, wherein the second section (142) forms a substantially concave bend.
3. The mask (100) of claim 1, wherein the acute angle (A1401) between the tangent (K1401) of the first section (141) at the start of the first section (141) and the tangent (K1403) of the second section (142) at the end of the second section (142) is in the range of 20-60°, preferably 30-50°, more preferably 35-45° and most preferably 37-43°.
4. The mask (100) of claim 1, wherein the maximum value of the acute angle (A1402) between the tangent (K1403) of the second section (142) at the end of the second section (142) and the tangent (K140m) of the first section (141) at any point of the first section (141) is in the range of 50-90°, preferably 60-80°, more preferably 65-75° and most preferably 68-72°.
5. The mask (100) of claim 1, wherein the obtuse angle (A1403) between the tangent (K1402) of the second section (142) at the start of the second section (142) and the tangent (K1403) of the second section (142) at the end of the second section (142) is in the range of 110-180°, preferably 130-165°, more preferably 139-155° and most preferably 143-151°.
6. The mask (100) of claim 1, wherein the point (P140m) in which the second section (142) extends from the first section (141) is located on the trajectory (T2) with the greatest perpendicular distance between the point (P140m) and a straight line connecting the start and the end of the trajectory (T2).
7. The mask (100) of claim 1, wherein L1402 is in the range of 0.5-3.5 cm, preferably 1.0-3.0 cm, more preferably 1.5-2.5 cm, even more preferably 1.8-2.2 cm and most preferably 1.9-2.1 cm; and/or L1402 is in the range of 5-40%, preferably 10-35%, more preferably 14-30%, even more preferably 18-26% and most preferably 20-24% of L1401; wherein L1401 is the length of a straight line between the start and the end of the top edge (140) when the mask lies flat and is folded at its mirror plane, and L1402 is the greatest value of a perpendicular distance between a point (P140m) on the trajectory (T2) of the top edge (140) and L1401.
8. The mask (100) of claim 1, wherein the end of the trajectory T2 and/or the end of the top edge (140) is located in a negative-Y-direction of a length L1403 of 0.2-3.0 cm, preferably 0.4-2.0 cm, more preferably 0.5-1.5 cm and most preferably 0.7-1.2 cm, with respect to the point in which the second section (142) extends from the first section (141), wherein the negative-Y-direction is the direction from the start of a front edge (120) to the end of a front edge (120) of the face part (105) wherein the front edge (120) is comprised by the face part (105) and located at the border between the two regions (110a, 110b) and configured to form a trajectory T1 which runs, when the mask (100) is worn by the user, from the bridge of the nose of the head to the chin of the head, substantially at the symmetrical mirror plane (M1) of the face.
9. The mask (100) of claim 1, wherein the mask (100) comprises a front edge (120) located at the border between the two regions (110a, 110b) and configured to form a trajectory (T1) which runs, when the mask (100) is worn by the user, from the bridge of the nose of the head to the chin of the head, substantially at the symmetrical mirror plane (M1) of the face, wherein the front edge (120) comprises a seam (125) configured continuously along said trajectory (T1).
10. The mask (100) of claim 1, wherein the distance of any point on the trajectory (T1) from the symmetrical mirror plane (M1) of the face when the mask is worn by the user is at most 2.5 cm, preferably at most 2.0 cm, more preferably at most 1.5 cm and most preferably at most 1.0 cm.
11. The mask (100) of claim 9, wherein the seam (125) is a single stitch seam (125).
12. The mask (100) of claim 9, wherein, the trajectory (T1) comprises at least two sections (121, 122), each of which forms a substantially straight line, the first section (121) being configured to cover at least part of the nose when the mask (100) is worn by the user and the second section (122) extending from the first section (121) towards the mouth, and the acute angle (A1201) between the substantially straight lines formed by the first (121) and second sections (122) is in the range of 10-30°, preferably 15-25°, more preferably 17-23° and most preferably 18-22°.
13. The mask (100) of claim 12, wherein the trajectory (T1) comprises a third section (123) forming a substantially straight line and extending from the second section (122) towards the chin, and the acute angle (A1202) between the substantially straight lines formed by the second (122) and third sections (123) is in the range of 12-32°, preferably 15-29°, more preferably 18-26° and most preferably 20-24°.
14. The mask (100) of claim 13, wherein the length of the third section (123) is in the range of 0.5-3.5 cm, preferably 1.0-3.0 cm, more preferably 1.5-2.5 cm and most preferably 1.8-2.2 cm.
15. The mask (100) of claim 14, wherein the trajectory (T1) comprises a fourth section (124) extending from the third section (123) to the chin and the acute angle (A1203) between the substantially straight line of the third section (123) and the tangent (K1201) of the fourth section at the start of the fourth section (124) is in the range of 10-50°, preferably 20-40°, more preferably 25-35° and most preferably 27-33°.
16. The mask (100) of claim 15, wherein the acute angle (A1204) between the substantially straight line of the third section (123) and the tangent (K1202) of the fourth section at the end of the fourth section (124) is in the range of 35-90°, preferably 45-85°, more preferably 55-75° and most preferably 62-68°.
17. The mask (100) of claim 15, wherein the fourth section (124) forms a continuous bend such that L6b is in the range of 2.0-12.0%, preferably 4.0-10.0%, more preferably 5.5-8.5%, even more preferably 6.0-8.0% and most preferably 6.5-7.5% of L5b; wherein L5b is the length of a straight line between the start and the end of the fourth section (124) when the mask (100) lies flat and is folded at its mirror plane, and L6b is the greatest value of a perpendicular distance between a point on the fourth section (124) and L5b.
18. The mask (100) of claim 1, wherein one or more hydrophilic agents and/or one or more antimicrobial agents are adhered to the mask; and/or wherein the mask (100) is at least N90/R90/P90-rated, preferably at least N95/R95/P95-rated and most preferably at least N99/R99/P99-rated.
19. The mask (100) of claim 1, wherein the face part (105) comprises at least one, preferably two, three or more layers (111, 112, 113); and/or wherein at least one layer (111, 112) comprises a textile material and wherein at least one layer (113) comprises a particulate filter material.
20. The mask (100) of claim 1, wherein a layer (111, 112) comprising textile of woven fabrics is an outer layer (111) exposed to the outside when the mask (100) is worn by a user; and/or wherein a layer (111, 112) comprising textile from the group consisting of knitted, warp-knitted, and crocheted fabrics preferably knitted fabrics is an inner layer (112) exposed to the face when the mask (100) is worn by a user.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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[0156] Throughout the present drawings and specification, the same reference numerals refer to the same elements. The drawings may not be to scale, and the relative size, and depiction of elements in the drawings may be exaggerated for clarity, illustration, and convenience. However, the relative proportions of each drawing may reflect the real proportions unless otherwise stated.
Definitions
[0157] Unless otherwise stated, the term “substantial” or “substantially” as used in the present context may be understood to a great or significant extent or for the most part or essentially.
[0158] In the context of the present invention, “antimicrobial” relates to the ability to kill at least some types of microorganisms, or to inhibit the growth or reproduction of at least some types of microorganisms. Said term relates to any compound, agent, product or process that is harmful to one or more microorganism as used in the context of the present invention. Preferably, the one or more microorganisms get destroyed or inactivated by the “antimicrobial” product or process. By “antimicrobial agent” is meant any substance or combination of substances that kills, inactivates or prevents the growth of a microorganism. The terms “microorganism” and “microbe”, which are used interchangeably in the context of the present invention, are defined to comprise any organism too small to be seen by the unaided eye, such as, especially, single-celled organisms or viruses.
[0159] In the context of the present invention, the terms “textile” and “textile material” relate to a flexible material consisting of fibers, or a network of natural and/or artificial/synthetic fibers, such as a yarn or a fabric. The material may be in its natural or processed or even finished form.
[0160] “Tangents” are defined as a straight line that touches a curve at a point, for instance a section of an edge, an edge or a trajectory, but does not cross that curve at that point. Tangents at a certain point or location on a curve used herein are to be understood to have substantially the same form when the point is varied along the curve by +/−0.1 cm. This should help to avoid misinterpretations of tangents due to local shape deformations of the mask within the context of the present invention. These misinterpretations may arise if the tangent was applied in a mathematical sense, which would reflect even the slightest manufacturing inaccuracies, which is not intended to be applicable herein. A tangent at an end of a section as used herein is to be understood to be located away from the end of the section by 0.05-0.5 cm.
[0161] The term “convex” as used in the present invention is to be understood as having an outline or surface curved like the exterior of a circle or sphere. Also, in terms of a convex polygon for instance, is to be understood as not having any interior angles greater than 180°.
[0162] The term “concave” as used in the present invention is to be understood as having an outline or surface curved inwards like the interior of a circle or sphere. Also, in terms of a concave polygon for instance, is to be understood as having at least one internal angle that is greater than 180 degrees.
[0163] A “bartack” or “bartack seam” is a condensed zigzag seam used for reinforcement or anchoring of textile or fabrics. A “backtack” or backtack seam” is a straight single-needle seam (or actually just 3-4 stitches), that prevents the main seam from unravelling. For instance, the manufacturer backs up a few stitches once the main seam is complete.
[0164] “Particulate filtering material” or “particulate filter material” trap particles, such as dust or aerosols and other droplets which may carry microorganisms, out of the breathing air. Particulate filtering materials may be tested and classified according to their filter efficiency towards the smallest sized particle. Ninety-five percent filtration of particles is the minimum level that is stipulated by the National Institute for Occupational Safety and Health (NIOSH) in the United States for a “95-rating”, according to NIOSH-42CFR84. The particulate filtering materials are further classified according to their oil resistance. In this regard, “N” indicates no oil resistance, “R” indicates slight oil resistance, and “P” indicates strong oil resistance (for example: a N95-rated, R95-rated or P95-rated particulate filtering material).
[0165] When the user stands upright and has their head directed straight to the front, the “vertical height” is measured from the ground in a line extending vertical from the ground, the vertical line forming a perpendicular angle to the ground. The “vertical direction” is directed from the ground upwards, wherein the direction is perpendicular to the ground.
Angle Definitions
[0166] A1201: An acute angle between the substantially straight lines formed by the first 121 and second sections 122 of the trajectory T1 of the front edge 120 as discussed below. [0167] A1202: An acute angle between the substantially straight lines formed by the second 122 and third sections 123 of the trajectory T1 of the front edge 120 as discussed below. [0168] A1203: An acute angle between the substantially straight line of the third section 123 and the tangent (K1201) of the fourth section at the start of the fourth section 124 of the trajectory T1 of the front edge 120 as discussed below. [0169] A1204: An acute angle between the substantially straight line of the third section 123 and the tangent (K1202) of the fourth section at the end of the fourth section 124 of the trajectory T1 of the front edge 120 as discussed below. [0170] A1401: An acute angle between the tangent (K1401) of the first section 141 at the start of the first section 141 and the tangent (K1403) of the second section 142 at the end of the second section 142 of the trajectory T2 as discussed below. [0171] A1402: An acute angle between the tangent (K1403) of the second section 142 at the end of the second section 142 and the tangent (K140m) of the first section 141 at any point of the first section 141 of the trajectory T2 as discussed below. [0172] A1403: An obtuse angle between the tangent (K1402) of the second section 142 at the start of the second section 142 and the tangent (K1403) of the second section 142 at the end of the second section 142 of the trajectory T2 as discussed below. [0173] A1501: An obtuse angle between the tangent (K1501) of the trajectory (T3) at the start of the trajectory (T3) and the tangent (K1502) of the trajectory (T3) at the end of the trajectory (T3) as discussed below. [0174] A150m: An obtuse angle (A150m) between the tangent (K150m) of the trajectory (T3) at the midpoint of the trajectory (T3) and the tangent (K1501) of the trajectory (T3) at the start of the trajectory (T3) as discussed below. [0175] A1601: An angle facing the face part (105) and formed between the tangent (K1502) of the trajectory T3 of the bottom edge 150 at the end of the trajectory T3 of the bottom edge 150 and the tangent (K1601) of the trajectory T4 of the rear edge 160 at the start of the trajectory T4 of the rear edge 160 as discussed below. [0176] A1602: An angle facing the face part 105 and formed between the tangent (K1403) of the trajectory T2 of the top edge 140 at the end of the trajectory T2 of the top edge 140 and the tangent (K1602) of the trajectory T4 of the rear edge 160 at the end of the trajectory T4 of the rear edge 160 as discussed below.
Length Definitions
[0177] L1: Is the smallest distance between the mouth section 128 and the foremost contact point of the lips of the closed mouth when the mask is worn by the user as discussed below. [0178] L2a: Is the length of a straight line between the start and the end of the trajectory (T1) when the mask is worn by the user as discussed below. [0179] L2b: Is the length of a straight line between the start and the end of the front edge 120 when the mask lies flat and is folded at its mirror plane as discussed below. [0180] L3: Is the greatest value of a perpendicular distance between a point on the trajectory (T1) of the front edge 120 and L2b when the mask 100 lies flat and is folded at its mirror plane as discussed below. [0181] L5b: Is the length of a straight line between the start and the end of the fourth section 124 when the mask 100 lies flat and is folded at its mirror plane as discussed below. [0182] L6b: is the greatest value of a perpendicular distance between a point on the fourth section 124 and L5b when the mask 100 lies flat and is folded at its mirror plane as discussed below. [0183] L7b: Is the length of a straight line between the start and the end of the trajectory T4 of the rear edge 160 when the mask lies flat and is folded at its mirror plane as discussed below. [0184] L8b: Is the greatest value of a perpendicular distance between a point on the trajectory T4 of the rear edge 160 and L7b when the mask 100 lies flat and is folded at its mirror plane as discussed below. [0185] L1401: Is the length of a straight line between the start and the end of the top edge 140 when the mask lies flat and is folded at its mirror plane as discussed below. [0186] L1402: Is the greatest perpendicular distance between a point (P140m) on the trajectory (T2) of the top edge 140 and L1401 when the mask 100 lies flat and is folded at its mirror plane as discussed below. [0187] L1403: Is the distance between a point (P140m) on the trajectory (T2) of the top edge 140 and the trajectory T2 and/or the end of the top edge 140 measured in the negative-Y-direction, wherein the negative-Y-direction is the direction from the start of the front edge 120 to the end of the front edge 120 of the face part 105 when the mask 100 lies flat and is folded at its mirror plane as discussed below.
Miscellaneous Definitions
[0188] T1: Trajectory formed by front edge [0189] T2: Trajectory formed by top edge of symmetrical region 110a [0190] T3: Trajectory formed by bottom edge of symmetrical region 110a [0191] T4: Trajectory formed by rear edge of symmetrical region 110a [0192] M1: Symmetrical mirror plane of the face [0193] P140m: Point in which the second section 142 extends from the first section 141, located on the trajectory (T2) with the greatest perpendicular distance between the point (P140m) and a straight line connecting the start and the end of the trajectory (T2).
DETAILED DESCRIPTION
[0194] In the following, exemplary embodiments of the present invention are described in more detail. However, the present invention is not limited to these, and a multitude of other embodiments are applicable without departing from the spirit of the invention.
1. Front Edge with a Continuous Seam
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[0196] With reference to
2. Face Part Layers Divided into Two Pieces
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[0198] Furthermore, the face part 105 comprises a second, inner layer 112 according to an embodiment of the invention, wherein the inner layer 112 is divided into two pieces along the border of the symmetrical regions 110a, 110b, and thereby also along the symmetrical mirror plane M1 of the face. The two pieces are separated from and connected to each other. The connection means is a seam, which is but one example suitable for the use in an embodiment of the invention.
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[0200] With the arrangement of the layers of the previously described embodiment, the third layer 113 is protected by the outer layer 111 and the inner layer 112. This is in particular beneficial for the washability, durability and reusability of the mask 100, since the non-woven material of the third layer 113, which is suited for filtering the air, is protected against external mechanical, chemical or any other kind of damage during the washing procedure.
3. Front Edge
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TABLE-US-00001 TABLE 1 Lengths of fourth section 124 of front edge 120 Parameter Present application Prior art L5b (non-dimensional) 6.31 5.57 L6b (non-dimensional) 0.44 0.57 L6b/L5b 7.0% 10.3%
[0202] The convex bend of the fourth section 124 in this embodiment supports the alignment of the mask 100 or the face part 105 with the chin of a user and thus improves the prior art masks. The benefit of this arrangement is that the tangent at the end of the fourth section 124 of the trajectory T1 formed by the front edge 120 matches the curvature of the chin of the user. Furthermore, the overall shape of the front edge takes into account a reduction of fabric remnants and thereby improves manufacturing. Any angle variation that occurs on the sections (121-124) of the trajectory T1 or on the trajectory T1 formed by the front edge 120 along the path of the trajectory T1 is limited to a maximum value, e.g. at most 28-32°, on a minimum pathlength, e.g. at least 0.5-0.8 cm. In such an embodiment of the present invention, the visual acceptance and attraction to the face mask is increased as opposed to a mask that has sharp angle variations and thus sharp corners in the front edge.
4. Distance to the Mouth
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TABLE-US-00002 TABLE 2 Distances of mouth section 128 of front edge 120 to mouth of a user, for the definition of the lengths see above Parameter Present application Prior art mask L1 4.5 cm 2.7 cm L1/L2a 29% 19% L3 4.9 cm 4.1 cm L3/L2b 32% 29%
[0204] The configurations of this embodiment have the advantage that the material of the mask 100, for instance the textile material, is prevented from getting in touch with the mouth when the user inhales or otherwise changes the facial expression, due to the increased distance from the front edge to the mouth. This is beneficial for speaking and any other activity performed with the mouth and provides the user with more comfort, because the mask touching the mouth is unpleasant.
5. Top Edge
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[0206] The shape of the top edge 140, by virtue of the present embodiment, provides a tight and smooth fit and seal around the region of the nose and the eyes and ensures that the mask covers the relevant portions of the face to prevent inhaling or exhaling of unfiltered air. The region of the nose and the eyes of a face of a user is dominated by 3D shape variations of the surface of the user's face, in particular in the direction of the trajectory T2. A good seal between the mask and the face is therefore a major challenge. The convex-concave shape of the top edge 120 is well suited to cope with this challenge and supports a flush sealing. The convex shape of the first section 141 in combination with the starting location of the first section 141 at the bridge of the nose ensures that the top edge 140 of the mask 100 covers a region of a face that has less pronounced 3D shape variations. In contrast, if the first section was a straight line, it would not allow to follow the 3D shape variations of the surface of the face and would thus not create a tight sealing. Also, if the top edge started at a nose portion at a vertical height (for “vertical height”, see definition above) lower than the bridge of the nose (e.g., as shown for the prior art mask in
TABLE-US-00003 TABLE 3 Lengths of the top edge 140; for the definition of the lengths see above Parameter Present application Prior art L1402 2 cm 0.4 cm L1402/L1401 22% 0.5%
[0207] The embodiment of the top edge in
6. Bottom Edge
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[0209] The angles of a preferred embodiment are further summarized in Table 4 below in comparison to the prior art.
7. Pre-Stretched Edge
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8. Rear Edge
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9. Overlapping Fixing Tape
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[0213] The fixing tape 170 overlaps with the face part 105 in the longitudinal direction of the fixing tape 170 by a length L4 of 1 cm. The overlapping length is fixed to the face part 105 with two seams. One seam runs in the longitudinal direction of the overlapping length of the fixing tape 170 and is positioned at a vertically lower end of the fixing tape 170. The other seam runs in the direction perpendicular to that and is positioned close to the ending of the face part 105. The latter seam is a bartack stitch seam with a backtack stitch to prevent unravelling of the seam. This supports a firm fit and ensures mechanical integrity, well suited for prolonged use. In comparison to the prior art mask, the overlapping length is increased to improve the structural and mechanical integrity.
10. Enclosed Fixing Tape
[0214] Furthermore,
11. Further Aspects
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[0216] Table 4 below lists the differences of the angles of a preferred embodiment according to
TABLE-US-00004 TABLE 4 Comparison of angles of embodiments of the present invention and the prior art mask Angle Present application Prior art A1201 20° 34° A1202 22° 30° A1203 30° A1204 65° A1401 40° 20° A1402 70° A1403 147° A1501 110° 138° A150m 136° A1601 109° 125° A1602 94° 95°
Test Reports of Examples of Preferred Embodiments
[0217] It will also be appreciated that the masks may be configured to be compliant with a range of international respirator standards, as described in the following. A series of different face masks were tested according to the test protocols stated herein, for instance according to the standards of the National Institute for Occupational Safety and Health (NIOSH). Stringent requirements are prevailing for face masks as the one of the present invention. These requirements are manifested, e.g., in the Code of Federal Regulations (CFR) in title 42 “Public Heath”-under part 84 “Approval of respiratory protective devices”. The following tests comprise the 42 CFR 84.180 (Airflow resistance tests: Inhalation and Exhalation) and the CFR 84.181 (Non-powered air-purifying particulate filter efficiency level determination). A further test for the particulate filter efficiency is provided that is conducted on a TSI 8130 A Machine.
[0218] 1. Inhalation Resistance Test: TEB-APR-STP-007 (42 CFR 84.180)
[0219] The resistance to airflow is measured in the facepiece of the particulate respiratory mask mounted on a test fixture with air flowing at continuous rate of 85±2 liters per minute, before each test conducted in accordance with 42 CFR 84.182. The resistances for particulate respirators upon initial inhalation shall not exceed 35 mm water column height pressure and upon initial exhalation shall not exceed 25 mm water column height pressure. The test results in the Table below confirm that the exemplary masks at least fulfill the N95 standard.
TABLE-US-00005 TABLE 5 Test results for inhalation TEB-APR-STP-007 (42 CFR 84.180) Max. allowable Actual inhalation resistance (mm of resistance (mm Specimen H2O) (NIOSH N95) of H2O) Result 1 35 9.0° Pass 2 35 8.5 Pass 3 35 9.7 Pass
[0220] For FFP2 standard (EN-149-2001) the max. allowable resistance value for inhalation is 24.5 mmH2O (240 Pa) at a flow rate of 95 liters per minute and 7.1 mmH2O (70 Pa) at a flow rate of 30 liters per minute. The tests indicate that all tested masks also fulfill the FFP2 requirement (manifested under the EU Norm EN 149) since there remains sufficient margin to cope with an increasing flow rate from 85 to 95 liters per minute.
[0221] 2. Exhalation Resistance Test: TEB-APR-STP-003 (42 CFR 84.180)
[0222] Same procedure as for the inhalation resistance test applies for the exhalation resistance test in here. The test results in the Table below confirm that the exemplary masks at least fulfill the N95 standard.
TABLE-US-00006 TABLE 6 Test results for exhalation TEB-APR-STP-003 (42 CFR 84.180) Max. allowable Actual inhalation resistance (mm of resistance (mm Specimen H2O) (NIOSH N95) of H2O) Result 1 25 5.8° Pass 2 25 5.3 Pass 3 25 6.1 Pass
[0223] For FFP2 standard (EN-149-2001) the max. allowable resistance value for exhalation is 30.6 mmH2O (300 Pa) at a flow rate of 160 liters per minute. The tests indicate that all tested masks also fulfill the FFP2 requirement (manifested under the EU Norm EN 149) since there remains sufficient margin to cope with an increasing flow rate from 85 to 95 liters per minute.
[0224] 3. Particulate Filter Efficiency Test: TEB-APR-STP-059 (42 CFR 84.181)
[0225] This test is suited for the determination of Particulate Filter Efficiency Level for N95 Series Filters Against Solid Particulates for Non-Powered, Air-Purifying Respirators. This procedure establishes the means for ensuring that the particulate filtering efficiency of N95 series filters used on non-powered respirators submitted for Approval, Extension of Approval, or examined during Certified Product Audits, meets the minimum certification standards set forth in 42 CFR, Part 84, Subpart K, § 84.181. These filters or filter cartridges may be integral to respirator construction; mounted individually, or in sets of up to three; used in conjunction with cartridges and canisters for chin-style, front-mounted, and back-mounted gas masks; or used in combination with gas-and-vapor or atmosphere-supplying respirators.
[0226] The content of the test procedure manifested within TEB-APR-STP-059 and 42 CFR 84.181 shall be considered to be comprised within this specification. The test results in the Table below confirm that the exemplary masks at least fulfill the N95 standard.
TABLE-US-00007 TABLE 7 Test results for particulate filter efficiency test TEB-APR-STP-059 (42 CFR 84.181) Max Flow Initial Filter Allowable Initial Max Filtration Rate Resistance Leakage Leakage Leakage Efficiency Specimen (Lpm) (mmH.sub.2O) (%) (%) (%) (%) Result 1 85.3 10.6 5.00 1.78 4.50 95.50 Pass 2 85.8 10.9 5.00 1.32 3.26 96.74 Pass 3 85.3 11.9 5.00 1.73 3.39 96.61 Pass 4 85.8 11.5 5.00 1.18 4.34 95.66 Pass 5 85.7 12.7 5.00 1.74 3.54 96.46 Pass 6 85.7 12.9 5.00 1.57 2.87 97.13 Pass 7 85.8 11.1 5.00 1.84 4.28 95.72 Pass 8 85.9 14.2 5.00 2.84 4.93 95.07 Pass 9 85.3 62.9 5.00 3.9 3.9 96.09 Pass 10 85.8 21.9 5.00 1.97 4.11 95.89 Pass 11 85.8 12.2 5.00 1.36 3.11 96.89 Pass 12 85.8 12.7 5.00 1.62 3.35 96.65 Pass 13 85.7 67.6 5.00 1.69 2.80 97.20 Pass 14 85.1 64.7 5.00 4.91 4.91 95.09 Pass 15 85.8 12.1 5.00 2.01 4.48 95.52 Pass 16 85.4 61.5 5.00 1.56 2.84 97.16 Pass 17 85.4 61.6 5.00 1.01 2.15 97.85 Pass 18 85.5 64.0 5.00 1.37 2.74 97.26 Pass 19 85.9 11.2 5.00 1.42 3.49 96.51 Pass 20 85.5 60.0 5.00 1.14 2.53 97.47 Pass
[0227] 4. Particulate Filter Efficiency Test on a TSI 8130 A Machine
[0228] A further test regarding the particulate filter material (non-woven fabric) was conducted. The 8130 A machine is suited for test standards for instance according to US-standards 42 CFR 84, Chinese standards GB2626, Japanese standard JMOL and European standard EN 143, ISO 16900-3. The flow rate was 85 Lpm and the measured initial filter efficiency was in the range of 97.5%-99.5%, the loading test minimum efficiency was 95.5%-97.5% and the initial air resistance was 85 Pa. The test results confirmed that the exemplary particulate filter material at least fulfills the N95 and KN95 standard.
LIST OF REFERENCE NUMBERS
[0229] 100: Face mask [0230] 105: Face part [0231] 106: Sealing element [0232] 107: Nose clip [0233] 110a: Symmetrical region [0234] 110b: Symmetrical region [0235] 111: First layer of face mask [0236] 112: Second layer of symmetrical region [0237] 113: Third layer of symmetrical region [0238] 115: Plane panel [0239] 120: Front edge [0240] 121: At least one section, first section of first trajectory [0241] 122: At least another section, second section of first trajectory [0242] 123: Third section of first trajectory [0243] 124: Fourth section of first trajectory [0244] 125: Seam at front edge [0245] 128: Mouth section [0246] 140: Top edge [0247] 141: First section of T2 [0248] 142: Second section of T2 [0249] 150: Bottom edge [0250] 160: Rear edge [0251] 170: Fixing tape [0252] 180: Binding tape