Biomaterials Translational ›› 2021, Vol. 2 ›› Issue (1): 3-9.doi: 10.3877/cma.j.issn.2096-112X.2021.01.002
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Visarut Buranasudja1, Anongnat Somwangthanaroj2, Suched Likitlersuang3, Tirawat Boonyatee3, Chartchalerm Isarankura-Na-Ayudhya4, Jittima Amie Luckanagul5,*()
Received:
2021-03-10
Revised:
2021-03-22
Accepted:
2021-03-23
Online:
2021-03-31
Published:
2021-03-28
Contact:
Jittima Amie Luckanagul
E-mail:jittima.luck@gmail.com;jittima.L@pharm.chula.ac.th
Buranasudja, V.; Somwangthanaroj, A.; Likitlersuang, S.; Boonyatee, T.; Isarankura-Na-Ayudhya, C.; Luckanagul, J. A. Development of personal protective equipment for the COVID-19 pandemic in Thailand and technical aspects of testing gown materials. Biomater Transl. 2021, 2(1), 3-9.
Test method | Test description | Types of contaminations | Approximate contaminant size |
---|---|---|---|
ISO 16603 | Determination of the resistance of protective clothing materials to penetration by blood and body fluids | Synthetic blood | - |
ISO 16604 | Determination of the resistance of protective clothing materials to penetration by blood-borne pathogens | Phi-X 174 bacteriophage | 0.03 mm |
ISO 22610 | Determination of the resistance to wet bacterial penetration | Bacillus atrophaeus contaminated liquid | 1.0-1.6 mm (length); 0.6-0.9 mm (diameter) |
ISO/DIS 22611 | Determination of the resistance to penetration by biologically contaminated aerosols | Staphylococcus aureus contaminated aerosols | 1 mm |
ISO 22612 | Determination of resistance to dry microbial penetration | Bacillus subtilis contaminated talcum powder | 0.9-1.5 mm (length); 0.4-0.7 mm (diameter) |
Table 1 Test methods for EN14126:2003
Test method | Test description | Types of contaminations | Approximate contaminant size |
---|---|---|---|
ISO 16603 | Determination of the resistance of protective clothing materials to penetration by blood and body fluids | Synthetic blood | - |
ISO 16604 | Determination of the resistance of protective clothing materials to penetration by blood-borne pathogens | Phi-X 174 bacteriophage | 0.03 mm |
ISO 22610 | Determination of the resistance to wet bacterial penetration | Bacillus atrophaeus contaminated liquid | 1.0-1.6 mm (length); 0.6-0.9 mm (diameter) |
ISO/DIS 22611 | Determination of the resistance to penetration by biologically contaminated aerosols | Staphylococcus aureus contaminated aerosols | 1 mm |
ISO 22612 | Determination of resistance to dry microbial penetration | Bacillus subtilis contaminated talcum powder | 0.9-1.5 mm (length); 0.4-0.7 mm (diameter) |
Test method | Test description | Challenge liquid |
---|---|---|
AATCC 42 | Water resistance: impact penetration | Water |
AATCC 127 | Water resistance: hydrostatic pressure | Water |
ASTM F1670 | Determination of the resistance of protective clothing materials to penetration by synthetic blood | Synthetic blood |
ASTM F1671 | Determination of the resistance of protective clothing materials to penetration by blood-borne pathogens | Phi-X 174 bacteriophage |
Table 2 Test methods for ANSI/AAMI PB 70:2012
Test method | Test description | Challenge liquid |
---|---|---|
AATCC 42 | Water resistance: impact penetration | Water |
AATCC 127 | Water resistance: hydrostatic pressure | Water |
ASTM F1670 | Determination of the resistance of protective clothing materials to penetration by synthetic blood | Synthetic blood |
ASTM F1671 | Determination of the resistance of protective clothing materials to penetration by blood-borne pathogens | Phi-X 174 bacteriophage |
Level | Test methods | Criteria |
---|---|---|
ANSI/AAMI PB70 standard | ||
1 | AATCC 42 | ≤ 4.5 g |
2 | AATCC 42 | ≤ 1.0 g |
AATCC 127 | ≥ 20 cm | |
3 | AATCC 42 | ≤ 1.0 g |
AATCC 127 | ≥ 50 cm | |
4 | ASTM F1670 | No penetration at 13.8 kPa |
ASTM F1671 | No penetration at 13.8 kPa | |
EN14126:2003 standard | ||
1 | ISO 16603 & ISO 16604 | 0.0 kPa |
2 | ISO 16603 & ISO 16604 | 1.75 kPa |
3 | ISO 16603 & ISO 16604 | 3.5 kPa |
4 | ISO 16603 & ISO 16604 | 7.0 kPa |
5 | ISO 16603 & ISO 16604 | 14.0 kPa |
6 | ISO 16603 & ISO 16604 | 20.0 kPa |
Table 3 ANSI/AAMI PB70 and EN14126:2003 classification of the level of barrier performance
Level | Test methods | Criteria |
---|---|---|
ANSI/AAMI PB70 standard | ||
1 | AATCC 42 | ≤ 4.5 g |
2 | AATCC 42 | ≤ 1.0 g |
AATCC 127 | ≥ 20 cm | |
3 | AATCC 42 | ≤ 1.0 g |
AATCC 127 | ≥ 50 cm | |
4 | ASTM F1670 | No penetration at 13.8 kPa |
ASTM F1671 | No penetration at 13.8 kPa | |
EN14126:2003 standard | ||
1 | ISO 16603 & ISO 16604 | 0.0 kPa |
2 | ISO 16603 & ISO 16604 | 1.75 kPa |
3 | ISO 16603 & ISO 16604 | 3.5 kPa |
4 | ISO 16603 & ISO 16604 | 7.0 kPa |
5 | ISO 16603 & ISO 16604 | 14.0 kPa |
6 | ISO 16603 & ISO 16604 | 20.0 kPa |
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