Certification and Registration
ANSI/AAMI PB70 2012 Protective Clothing—Liquid Barrier Performance Classification
Category:
Protective Clothing
As the COVID-19 pandemic spread across the United States and infection rates continued to increase, demand for protective apparel and other infection-control products also increased significantly.
To enter the U.S. market, protective clothing must comply with the important standard ANSI/AAMI PB70:2012.
ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities establishes minimum liquid barrier performance requirements, a classification system, and corresponding labeling requirements for various types of protective apparel used in healthcare facilities.
The barrier performance requirements specified in this standard apply to surgical drapes, drape accessories, and all categories of protective apparel claiming liquid barrier or microbial barrier protection against liquid transmission, including single-use and reusable surgical gowns, decontamination gowns, isolation gowns, aprons, sleeve covers, and laboratory apparel.
|
|
|
|
Isolation suit |
Surgical gown |
ANSI/AAMI PB70:2012 does not cover the hand area of protective clothing, including surgical gloves, patient examination gloves, and other medical gloves.
It also does not cover the hand, face, and eye areas of protective clothing, including eye protection, face masks, surgical caps or head coverings, surgical masks, and respirators.
The standard also excludes foot protection areas, such as operating room shoes, shoe covers, and surgical boots.
|
Level |
Test |
Liquid barrier |
Result |
Expected barrier performance |
|
Level 1 |
AATCC 42 |
Water |
< 4.5g |
The lowest water resistance |
|
Level 2 |
AATCC 42 |
Water |
< 1.0g |
Low water resistance |
|
AATCC 127 |
> 20cm |
|||
|
Level 3 |
AATCC 42 |
Water |
< 1.0g |
Medium water resistance |
|
AATCC 127 |
> 50cm |
|||
|
Level 4 |
ASTM F1670 |
Replacement blood |
2psi No penetration below. |
Permeation resistance of blood and viruses (2 psi) |
|
ASTM F1671 |
Bacteriophage |
2psi No penetration below. |
All four levels require:AQL ≤ 4%, RQL ≤ 20%
From Table 1, it can be seen that Levels 1 to 3 use the AATCC 42 Impact Penetration Test and AATCC 127 Hydrostatic Pressure Test, while Level 4 uses the synthetic blood penetration test ASTM F1670 and virus penetration test ASTM F1671.
Introduction to Relevant Standards
AATCC 42 Water Resistance: Impact Penetration Test
Test principle:
A pre-weighed absorbent paper is placed behind the specimen. A specified amount of water is sprayed onto the stretched surface of the specimen, and the absorbent paper is weighed again.The change in mass of the absorbent paper is used to evaluate the specimen’s resistance to impact water penetration.
AATCC 127 Water Resistance: Hydrostatic Pressure Tes
Test principle:
Hydrostatic pressure refers to the resistance of a fabric against water penetration.Under standard atmospheric conditions, increasing water pressure is continuously applied to the fabric until water droplets appear on the opposite side. The pressure at which leakage occurs is recorded as the hydrostatic pressure value.The higher the hydrostatic pressure a fabric can withstand, the better its waterproof performance and resistance to water penetration.
ASTM F1670 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
ASTM F1671 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
ASTM F1671 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
ASTM F1670 and ASTM F1671 are based on the test method described in ASTM F903 Standard Test Method for Resistance of Materials Used in Protective Clothing to Liquid Penetration.
ASTM F1670 and ASTM F1671 evaluate protective clothing materials using synthetic blood and Phi-X174 bacteriophage penetration systems to assess resistance against synthetic blood penetration and bloodborne pathogen penetration.During testing, the specimen is exposed to simulated body fluids (synthetic blood / Phi-X174 bacteriophage) under specified pressure and time conditions.For ASTM F1670, synthetic blood penetration is evaluated through visual inspection.For ASTM F1671, penetration of Phi-X174 bacteriophage through protective clothing materials is evaluated using laboratory detection methods.Any evidence of penetration results in test failure.
SATISFY provides ANSI/AAMI PB70:2012 Level 1, Level 2, Level 3, and Level 4 certification testing services, including comprehensive standard interpretation, professional technical guidance, testing management, and efficient testing solutions to support protective product manufacturers entering the healthcare market.
Related Information
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