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Text of Mask-Tech™ HypoAllergenic Surgical Mask W/Ear Loop Level 3

Mask W/Ear Loop
Level 3
Copyright © 2020 AlphaProMed All Rights Reserved. No part of this sheet may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior permission by AlphaProMed.
Copyright © 2020 AlphaProMed All Rights Reserved
2
Copyright © 2020 AlphaProMed All Rights Reserved
Copyright © 2020 AlphaProMed All Rights Reserved. No part of this sheet may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior permission by AlphaProMed.
ISO
CE
EC CERTIFICATION
X 60152648 - This is to certify the quality management systems of the manufacturer.
The manufacturer has been assessed and registered as meeting the requirements of: ISO 13485:2016
<Manufacture and Distribution of Medical Devices - Medical Face Masks products
DD 60152649 0001
Aspects of manufacture concerned with securing and maintaining sterile conditions of Medical Face Masks
The Notified Body hereby declares that the requirements of Annex V of the directive 93/42/EEC have been met for the listed products. The above-named manufacturer has established and applies a quality assurance system, which is subject to periodic surveillance, defined by Annex V, section 4 of the aforementioned directive. For placing on the market of class llb and class III devices covered by this certificate an EC type-examination certificate according to Annex III is required.
CERTIFICATE Nº
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recording, or other electronic or mechanical methods, without the prior permission by AlphaProMed.
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FDA FDA INFORMATION & ACCREDITATION
DIFFERENTIAL PRESSURE (DELTA P)
Standard Test Protocol (STP) Number: STP004 Rev 18
The BFE test is performed to determine the filtration efficiency of test articles by comparing the bacterial control counts upstream of the test article to the bacterial counts downstream. A suspension of Staphylococcus aureus was aerosolized using a nebulizer and delivered to the test article at a constant flow rate and fixed air pressure. The challenge delivery was maintained at 1.7 – 3.0 x 10 ^3 colony forming
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Copyright © 2020 AlphaProMed All Rights Reserved. No part of this sheet may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior permission by AlphaProMed.
TEST REPORT BACTERIAL FILTRATION EFFICIENCY (BFE) AND
DIFFERENTIAL PRESSURE (DELTA P)
SUMMARY Units (CFU) with a mean particle size (MPS) of 3.0 ± 0.3um. The aerosols were drawn through a six stage, viable particle, Andersen sampler for collection. This test method complies with ASTM F2101-19 and EN 14683:2019, Annex B.
The Delta P test is performed to determine the breathability of test articles by measuring the differential air pressure on either side of the test article using a manometer, at a constant flow rate. The Delta P test complies with EN 14683:2019, Annex B.
All test method acceptance criteria were met. Testing was performed in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and 820.
Test side: Inside BFE Test Area: -40 cm2 BFE Flow rate: 28.3 Liters per minute (L/min) Delta P Flow rate: 8 L (min) Conditioning Parameters: 85 ±5% relative humidity (RH) and 21±5ºC for a minimum of 4 hours Test Article Dimensions: -178 mm x -171mm Positve Control Average: 2.9 x 10^3 CFU Negative Monitor Count: <1 CFU MPS: 2.8 μ
Test Article Number
Test Article Number
99.8
56.15.7
99.8
54.45.5
99.8
57.85.9
99.7
55.55.7
> 99.9
51.25.2
Note: The filtration efficiency percentages were calculated using the following equation:
C= Positive control average T= Plate count total recovered downstream of the test article Note: The plate count total is available upon request
%BFE = x100 C-T
C
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recording, or other electronic or mechanical methods, without the prior permission by AlphaProMed.
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TEST REPORT FLAMMABILITY OF CLOTHING TEXTILES
SUMMARY This procedure was performed to evaluate the flammability of plain surface clothing textiles by measuring the ease of ignition and the speed of flame spread. The parameter of time is used to separate materials into different classes, thereby assisting in a judgment of fabric suitability for clothing and protective clothing material. The test procedure was performed in accordance with the test method outlined in 16 CFR Part 1610 (a) Step 1 – testing in the original state. Step 2 – Refurbishing and testing after refurbishing, was not performed. All test method acceptance criteria were met. Testing was performed in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and 820.
The 16 CFR Part 1610 standard specifies that 10 replicates are to be tested if, during preliminary testing, only 1 test article exhibits flame spread and it is less than 3.5 seconds, or the test articles exhibit an average flame spread lees than 3.5 seconds. Five replicates are to be tested of no flame spread is observed upon preliminary testing, if only 1 test article exhibits flame spread and it is equal to or greater than 3.5 seconds, or if the average flame spread is equal to or greater than 3.5 seconds. In accordance with the standard, 5 replicates were tested for this study.
Test side: Outside Surface Orientation: Machine
Test Criteria for Specimen Classification (See 16 CFR Part 1610.7):
Class
1
2
3
Burn time <3.5 seconds
6
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TEST REPORT
TEST REPORT
Replicate Number
IBE
IBE
IBE
IBE
IBE
SUMMARY This procedure was performed to evaluate surgical facemasks and ither types of protective clothing materials designed to protect against fluid penetration. The purpose of this procedure is to simulate an arterial spray and evaluate the effectiveness of the test article in protecting the user from possible exposure to blood and other body fluids. The distance from the target area surface to the tip of the cannula is 30.5cm. A test volume of 2 mL of synthetic blood was employed using the targeting plate method.
This method was designed to comply with ASTM F1862 and ISO 22609 (as referenced in EN 14683:2019 and AS4381:2015) with the following exception: ISO 22609 requires testing to be performed in an environment with a temperature of 21±5ºC and a relative humidity of 85 ± 10%. Instead, testing was performed at ambient conditions within one minute of removal from the environmental chamber held at those parameters.
All test method acceptance criteria were met. Testing was performed in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and 820.
TEST ARTICLE
TEST PROCEDURE(S)
Standard Test Protocol (STP) Number: STP0012 Rev 09
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Results: Per ASTM F1862 and ISO 22609, an acceptable quality limit of 4.0% is met for a normal single sampling plan when ≥29 of 32 test articles show passing results.
Test Pressure: 160 mmHg (21.3 kPa)
SUMMARY This procedure was performed to evaluate the non- viable particle filtration efficiency (PFE) of the test article. Monodispersed polystyrene latex spheres (PSL) were nebulized (atomized), dried, and passed through the test article. The particles that passed through the test article was enumerated using a laser particle counter.
A one-minute count was performed, with the test article in the system. A one-minute control count was performed, without a test article on the system, before and after each test article and the count were averaged. Control counts were performed to determine the average number of particles delivered to the test article. The filtration efficiency was calculated using the number of particles delivered to the test article compared to the average control values.
The procedure employed the basic particle filtration method described in ASTM F2299, with some exceptions; notably the procedures incorporated, and a non- neutralized aerosol is also specified in the FDA guidance document on surgical face masks. All test method acceptance criteria were met. Testing was performed in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and 820.
TEST ARTICLE
TEST PROCEDURE(S)
TEST REPORT
TEST REPORT
LATEX PARTICLE CHALLENGE
Test side: Outside Surface Pre-Conditioning: Minimum of 4 hours at 21±5ºC and 85±5% relative humidity (RH) Test Conditions: 23.9ºC and 21% RH
Test Article Number
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TEST REPORT
TEST REPORT
LATEX PARTICLE CHALLENGE
Test side: Inside Area Tested: 91.5cm2 Particle Size: 0.1 μ Laboratory Conditions: 21ºC, 31% relative humidity (RH) at 1110; 21ºC, 30% RH at 1340 Average Filtration Efficiency: 99.60% Standard Deviation: 0.114
Deviation Details: Controls and sample count were conducted for one minute instead of an average of three one-minute counts. This change shortens the total test time for each sample but will still provide an accurate determination of the particle counts. An equilibrate is a dwell period where the challenge is being applied to the test article for a certain period of time before test article counts are counted. The equilibrate period was reduced from 2 minutes to a minimum of 30 seconds which is sufficient time to clear the system of any residual particles and establish a state of stable equilibrium before sample counts are taken. Test method acceptance were met, results are valid.
Test Article Number Test Article Count Average Control Counts
1 61 12.999
17.5 x 9.5cm
Material
PP
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TEST REPORT APPENDIX 1: BACTERIAL FILTRATION EFFICIENCY
(BFE) Reference Standard Item: EN 14683-5.2.2 BFE Environmental Condition: 23ºCm 60%RH Strain, Medium and Reagent Information: Staphylococcus Aureus (ATCC6538) Peptone Agar Medium (20191205) Peptone Liquid Medium (1085071) PH7.o Sodium Chloride-peptone Buffer (1071461)
Test Parameters
Mean particle diameter of bacterial aerosol
Plate 1 (CFU)
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TEST REPORT
TEST REPORT
TEST REPORT
APPENDIX 3: SPLASH RESISTANCE
APPENDIX 4: MICROBIAL CLEANLINESS
Reference Standard Item: EN 14683-5.2.3 Environmental Condition: 23.1ºC, 52%RH
Reference Standard Item: EN14683-5.2.4 Splash resistance; Iso 22609:2004 Environmental Condition: 23.1ºC, 52%RH
Reference Standard Item: EN 14683-5.2.5 Microbial cleanliness (Bioburden); EN ISO 11737-1:2018
Reagents: SDA (Lot No:180912) TSA (Lot No:20190613) Sodium chloride-peptone buffer (Lot No:180820)
Test Parameters
Test Parameters
Results
Results: The samples were tested under pressure of 16.0kPa, no synthetic blood penetration on the medial side.
Air Flow Rate (Double Way)
Pressure (KPa) Velocity (cm/s)
4.9 cm2
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TEST REPORT Sample Description: (A) Disposable Face Mask: Blue (3-Ply Disposable Face Mask) Size: 17.5 x 9.5 cm Color: Blue
Clause 5.2.2 Bacterial filtration efficiency (BFE)
Results of test:
Test Results: Medical Face Masks-Requirements and Test Methods (EN 14683:2019).
Remark: Performance Requirement: Type I>95%, Type II>98%, Type IIR >98%
1# 2# 3# 4# 5#
(BFE) % 98.7 98.6 98.5 98.4 98.4
Sample Number
Sample preparation: 5 samples were randomly selected for the experiment
Test Method: Weigh each mask prior testing. The full mask is aseptically removed from the packaging and placed in a sterile 500ml bottle containing 300ml of extraction liquid (1g/l Peptone, 5g/l NaCl and 2 g/l Tween 20). The bottle is laid down on an orbital shaker and shaken for 5 min at 250 rpm. After this extraction step, 100ml of the extraction liquid is filtered through a 0,45 μ filter and laid down on a TSA plate for the total viable aerobic microbial count. Another 100 ml aliquot of the same extraction liquid is filtered in the same way and the filter plated on Sabouraud Dextrose agar (SDA) with chloramphenicol for fungi enumeration. The plates are incubated for 3 days at 30ºC and 7 days at 25ºC for TSA and SDA plates respectively. The total bioburden is expressed by addition of the TSA and SDA counts.
Statistical method: Count according to the principle of colony count.
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TEST REPORT
Clause 5.2.5 Breathability (Differential Pressure) (EN 14683:2019 Annex C, Flow rate 8 l/min)
Remark: Performance Requirement: Type I<40 Pa/cm2, Type II<40 Pa/cm2Type IIR <60 Pa/cm2
Remark: Performance Requirement: Type I ≤30 CFU/g, Type II≤30 CFU/g, Type IIR ≤30 CFU/g
1# 2# 3# 4# 5#
Differential Pressure AP (Pa/cm2)
Clause 5.2.5 Microbial Cleanliness (EN 14683:2019 Annex D)
1# 2# 3# 4# 5#
CFU/g <1 <1 <1 <1 <1