Keystone ISO-PE-HD User Manual

FINAL REPORT
WATER RESISTANCE: IMPACT PENETRATION TEST AATCC TEST METHOD 42-2017
LABORATORY IDENTIFICATION NUMBER: 41435
PREPARED FOR:
KEYSTONE SAFETY
SUBMITTED BY:
DIVERSIFIED TESTING LABORATORIES
PO BOX 4004
BURLINGTON, NC 27215
OUR LETTERS AND REPORTS ARE FOR THE EXCLUSIVE USE OF THE CLIENT TO WHOM THEY ARE ADDRESSED. ANY COMMUNICATION TO OTHERS OR THE USE OF OUR COMPANY NAME MUST RECEIVE PRIOR APPROVAL. OUR TEST RESULTS APPLY ONLY TO THE SAMPLE TESTED AND ARE NOT NECESSARILY INDICATIVE OF THE QUALITIES OF APPARENTLY IDENTICAL OR SIMILAR PRODUCTS. SAMPLES NOT DESTROYED IN TESTING ARE RETAINED A MAXIMUM OF THIRTY DAYS. THE LETTERS, REPORTS OR NAME OF DIVERSIFIED TESTING LABORATORIES, INC. MAY NOT BE USED IN ADVERTISING TO THE GENERAL PUBLIC.
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WATER RESISTANCE: IMPACT PENETRATION TEST AATCC 42-2017
LABORATORY I.D. NUMBER: PROCEDURE NUMBER: SAMPLE SOURCE:
SAMPLE IDENTIFICATION: DEVIATIONS/SPECIAL INSTRUCTIONS: SAMPLE IDENTIFICATION: SAMPLE RECEIVE DATE:
41435 AATCC 42-2017
KEYSTONE SAFETY
BLUE MEDICAL GOWNS None Sequentially by lab number
05/29/2020 TEST START DATE: 05/29/2020 TEST COMPLETION DATE: 06/02/2020 REPORT ISSUE DATE (ORIGINAL): 06/02/2020 TOTAL NUMBER OF PAGES: 4
ACCEPTANCE CRITERIA: As defined by the customer, the Spray Test results must be below 1.0 g. with a sample size of 32 gowns and an AQL of 4.0 (Accept on 3, Reject on 4).
INTRODUCTION:
This report describes details and results for the impact penetration testing of surgical gown materials. The testing was performed in accordance with AATCC test method 42. This test method measures the resistance of a fabric to penetration of water by impact, and the results can be expected to reasonably simulate resistance of the fabric to penetration by blood or other body fluids.
JUSTIFICATION:
The materials tested are intended to provide a barrier between blood or other potentially infectious agents that could potentially cross-contaminate the healthcare provider and/or the healthcare patient. This test method is applicable to all types of fabrics, including those treated with a water resistant or water repellant finish.
TEST SPECIMEN PREPARATION:
Test specimens measuring 178 x 330 mm were taken diagonally across the width of the material. Specimens are conditioned at 21 ± 2º C (70 ± 5º F) air at 65 ± 2% RH for at least 4 hours before testing. Testing was performed on the outside surface of the gown fabric.
OUR LETTERS AND REPORTS ARE FOR THE EXCLUSIVE USE OF THE CLIENT TO WHOM THEY ARE ADDRESSED. ANY COMMUNICATION TO OTHERS OR THE USE OF OUR COMPANY NAME MUST RECEIVE PRIOR APPROVAL. OUR TEST RESULTS APPLY ONLY TO THE SAMPLE TESTED AND ARE NOT NECESSARILY INDICATIVE OF THE QUALITIES OF APPARENTLY IDENTICAL OR SIMILAR PRODUCTS. SAMPLES NOT DESTROYED IN TESTING ARE RETAINED A MAXIMUM OF THIRTY DAYS. THE LETTERS, REPORTS OR NAME OF DIVERSIFIED TESTING LABORATORIES, INC. MAY NOT BE USED IN ADVERTISING TO THE GENERAL PUBLIC.
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TEST PROCEDURE:
The test samples were clamped under the 152 mm spring clamp at the top of an incline stand. Another 152 +/­10 mm clamp is fastened at the free end of the test specimen. Blotter paper 152 x 230 mm is weighed to the nearest 0.01 g and is inserted beneath the test specimen.
A 500 +/- 10 mL volume of distilled water (27 degrees c +/-1 degree) is poured into a funnel of the tester at a height of 0.6 m and allowed to spray onto the test sample.
Upon completion of the spraying period, the test specimen is carefully lifted, the blotter beneath removed, and then quickly reweighed to the nearest 0.01 g.
TEST CONTROLS: Positive and negative test controls are not required for this procedure.
RESULTS: Refer to Table 1 for a summary of the results.
The data showed that one of the samples tested was over 1.0 g. The AQL (4.0) in this procedure allows for 3 gowns to test above this level. The maximum blotter gain was 1.15 g, the minimum was 0.00 g with a mean of
0.21 g. These samples are therefore considered to meet requirements of a Level 3 gown as defined by AAMI PB70.2012.
STATEMENT OF UNCERTAINTY:
This test method has no known bias. Water resistance of fabrics can only be defined in terms of the test method as there is no independent, referee method of determining the true value.
,
Raymond Stewart, Quality Assurance Reviewer
Brian Dement, Vice-President
06/02/2020
Study Completion Date
OUR LETTERS AND REPORTS ARE FOR THE EXCLUSIVE USE OF THE CLIENT TO WHOM THEY ARE ADDRESSED. ANY COMMUNICATION TO OTHERS OR THE USE OF OUR COMPANY NAME MUST RECEIVE PRIOR APPROVAL. OUR TEST RESULTS APPLY ONLY TO THE SAMPLE TESTED AND ARE NOT NECESSARILY INDICATIVE OF THE QUALITIES OF APPARENTLY IDENTICAL OR SIMILAR PRODUCTS. SAMPLES NOT DESTROYED IN TESTING ARE RETAINED A MAXIMUM OF THIRTY DAYS. THE LETTERS, REPORTS OR NAME OF DIVERSIFIED TESTING LABORATORIES, INC. MAY NOT BE USED IN ADVERTISING TO THE GENERAL PUBLIC.
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TABLE 1. Water Resistance: Impact Penetration Results
Sample ID
Results
(grams)
Sample ID
Results
(grams)
1
0.00
17
0.18 2 0.08
18
0.14 3 0.14
19
0.23 4 0.12
20
0.22 5 0.17
21
0.20 6 0.09
22
0.17 7 0.11
23
0.12 8 0.17
24
0.21 9 0.99
25
0.11
10
0.19
26
0.26
11
0.16
27
0.20
12
0.15
28
0.14
13
0.00
29
0.19
14
0.09
30
1.15
15
0.28
31
0.11
16
0.25
32
0.14
AATCC Method 42-2017
Sample ID: BLUE MEDICAL GOWNS
REFERENCES: AATCC 42-2017 Water Resistance: Impact Penetration Test. American Association of Textile Colorists and Chemists
ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Healthcare Facilities. Association for the Advancement of Medical Instrumentation.
OUR LETTERS AND REPORTS ARE FOR THE EXCLUSIVE USE OF THE CLIENT TO WHOM THEY ARE ADDRESSED. ANY COMMUNICATION TO OTHERS OR THE USE OF OUR COMPANY NAME MUST RECEIVE PRIOR APPROVAL. OUR TEST RESULTS APPLY ONLY TO THE SAMPLE TESTED AND ARE NOT NECESSARILY INDICATIVE OF THE QUALITIES OF APPARENTLY IDENTICAL OR SIMILAR PRODUCTS. SAMPLES NOT DESTROYED IN TESTING ARE RETAINED A MAXIMUM OF THIRTY DAYS. THE LETTERS, REPORTS OR NAME OF DIVERSIFIED TESTING LABORATORIES, INC. MAY NOT BE USED IN ADVERTISING TO THE GENERAL PUBLIC.
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FINAL REPORT
HYDROSTATIC PRESSURE TEST AATCC METHOD 127-2018
LABORATORY IDENTIFICATION NUMBER: 41508
PREPARED FOR:
KEYSTONE SAFETY
SUBMITTED BY:
DIVERSIFIED TESTING LABORATORIES
336 WEST FRONT STREET
PO BOX 4004
BURLINGTON, NC 27215
OUR LETTERS AND REPORTS ARE FOR THE EXCLUSIVE USE OF THE CLIENT TO WHOM THEY ARE ADDRESSED. ANY COMMUNICATION TO OTHERS OR THE USE OF OUR COMPANY NAME MUST RECEIVE PRIOR APPROVAL. OUR TEST RESULTS APPLY ONLY TO THE SAMPLE TESTED AND ARE NOT NECESSARILY INDICATIVE OF THE QUALITIES OF APPARENTLY IDENTICAL OR SIMILAR PRODUCTS. SAMPLES NOT DESTROYED IN TESTING ARE RETAINED A MAXIMUM OF THIRTY DAYS. THE LETTERS, REPORTS OR NAME OF DIVERSIFIED TESTING LABORATORIES, INC. MAY NOT BE USED IN ADVERTISING TO THE GENERAL PUBLIC.
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HYDROSTATIC PRESSURE TEST AATCC METHOD 127-2018
LABORATORY I.D. NUMBER: PROCEDURE NUMBER: SAMPLE SOURCE:
SAMPLE IDENTIFICATION: DEVIATIONS/SPECIAL INSTRUCTIONS: SAMPLE IDENTIFICATION: SAMPLE RECEIVE DATE: TEST START DATE: TEST COMPLETION DATE: REPORT ISSUE DATE (ORIGINAL): TOTAL NUMBER OF PAGES:
41508
AATCC 127-2018
KEYSTONE SAFETY
BLUE MEDICAL GOWNS
None
Sequentially by lab number
06-04-2020
06-04-2020
06-05-2020
06-05-2020
4
ACCEPTANCE CRITERIA: As defined by the customer, the Hydrostatic Pressure Test results must meet a minimum of 50 cm, with a sample size of 32 gowns and an AQL of 4.0.
INTRODUCTION:
This report describes details and results for the hydrostatic pressure testing of surgical gown materials. The testing was performed in accordance with AATCC test method 127. This test method measures the resistance of a fabric to penetration of water under hydrostatic pressure and the results can be expected to reasonably simulate resistance of the fabric to penetration by blood or other body fluids.
JUSTIFICATION:
The materials tested are intended to provide a barrier between blood or other potentially infectious agents that could potentially cross-contaminate the healthcare provider and/or the healthcare patient. This test method is applicable to all types of fabrics, including those treated with a water resistant or water repellant finish.
TEST SPECIMEN PREPARATION:
Test specimens measuring 200 x 200 mm were taken diagonally across the width of the material. Specimens are conditioned at 21 ± 2º C (70 ± 5º F) air at 65 ± 2% RH for at least 4 hours before testing. Testing was performed on the outside surface of the gown fabric. Clamped areas of the specimen were sealed with a soft rubber gasket to minimize lateral water leakage.
OUR LETTERS AND REPORTS ARE FOR THE EXCLUSIVE USE OF THE CLIENT TO WHOM THEY ARE ADDRESSED. ANY COMMUNICATION TO OTHERS OR THE USE OF OUR COMPANY NAME MUST RECEIVE PRIOR APPROVAL. OUR TEST RESULTS APPLY ONLY TO THE SAMPLE TESTED AND ARE NOT NECESSARILY INDICATIVE OF THE QUALITIES OF APPARENTLY IDENTICAL OR SIMILAR PRODUCTS. SAMPLES NOT DESTROYED IN TESTING ARE RETAINED A MAXIMUM OF THIRTY DAYS. THE LETTERS, REPORTS OR NAME OF DIVERSIFIED TESTING LABORATORIES, INC. MAY NOT BE USED IN ADVERTISING TO THE GENERAL PUBLIC.
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TEST PROCEDURE:
The test samples were clamped onto the suter hydrostatic pressure test fixture with the outside surface of the fabric facing the water (ambient temperature) introducing apparatus. Test samples were exposed to water pressure in increasing amounts until penetration of the sample by water droplets is detected in at least three areas. Water droplets that appear within approximately 3 mm adjacent to the edge of the specimen clamping ring were disregarded.
TEST CONTROLS: Positive and negative test controls are not required for this procedure.
RESULTS: Refer to Table 1 for a summary of the results.
The data showed that none of the samples tested were below 50 cm. The AQL (4.0) in this procedure allows for 3 gowns to test below this level. The maximum pressure was 87.8 cm, the minimum was 60.7 cm with an average pressure of 79.3 cm. These samples are therefore considered to meet requirements of a Level 3 gown as defined by AAMI PB70.2012
STATEMENT OF UNCERTAINTY:
This test method has no known bias. Water resistance of fabrics can only be defined in terms of the test method as there is no independent, referee method of determining the true value.
,
Raymond Stewart, Quality Assurance Reviewer
Brian Dement, Vice-President
06/05/2020
Study Completion Date
OUR LETTERS AND REPORTS ARE FOR THE EXCLUSIVE USE OF THE CLIENT TO WHOM THEY ARE ADDRESSED. ANY COMMUNICATION TO OTHERS OR THE USE OF OUR COMPANY NAME MUST RECEIVE PRIOR APPROVAL. OUR TEST RESULTS APPLY ONLY TO THE SAMPLE TESTED AND ARE NOT NECESSARILY INDICATIVE OF THE QUALITIES OF APPARENTLY IDENTICAL OR SIMILAR PRODUCTS. SAMPLES NOT DESTROYED IN TESTING ARE RETAINED A MAXIMUM OF THIRTY DAYS. THE LETTERS, REPORTS OR NAME OF DIVERSIFIED TESTING LABORATORIES, INC. MAY NOT BE USED IN ADVERTISING TO THE GENERAL PUBLIC.
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TABLE 1. Hydrostatic Pressure Test Results
Sample ID
Results
(cm)
Sample ID
Results
(cm) 1 62.2
17
68.5 2 68.0
18
79.2 3 77.7
19
81.3 4 64.0
20
79.0 5 72.3
21
78.2 6 75.8
22
81.7 7 63.8
23
81.6 8 68.9
24
82.9 9 71.5
25
77.7
10
69.4
26
87.8
11
77.4
27
76.2
12
68.2
28
82.5
13
60.7
29
76.3
14
72.2
30
78.6
15
73.4
31
77.2
16
70.0
32
73.0
AATCC Method 127-2018
Sample ID: BLUE MEDICAL GOWNS
REFERENCES: AATCC 127-2018 Water Resistance: Hydrostatic Pressure Test. American Association of Textile Colorists and Chemists
ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Healthcare Facilities. Association for the Advancement of Medical Instrumentation.
OUR LETTERS AND REPORTS ARE FOR THE EXCLUSIVE USE OF THE CLIENT TO WHOM THEY ARE ADDRESSED. ANY COMMUNICATION TO OTHERS OR THE USE OF OUR COMPANY NAME MUST RECEIVE PRIOR APPROVAL. OUR TEST RESULTS APPLY ONLY TO THE SAMPLE TESTED AND ARE NOT NECESSARILY INDICATIVE OF THE QUALITIES OF APPARENTLY IDENTICAL OR SIMILAR PRODUCTS. SAMPLES NOT DESTROYED IN TESTING ARE RETAINED A MAXIMUM OF THIRTY DAYS. THE LETTERS, REPORTS OR NAME OF DIVERSIFIED TESTING LABORATORIES, INC. MAY NOT BE USED IN ADVERTISING TO THE GENERAL PUBLIC.
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