The American Association for the Development of Medical Instrumentation (AAMI) standards are designed to help medical device companies meet global standards for the safe use of medical devices. AAMI volunteer medical ANSI / AAMI PB70: 2012, Classification of Liquid Barrier Performance and Protective Clothing and Drapes for Use in Healthcare Facilities, For use in healthcare facilities to identify key identification measures for the selection of suitable protective clothing and drapes such as medical gowns (Pfiedler Enterprises, 2016). The classification of AAMI suits results in four levels of barrier performance, measured in accordance with the following standard tests:
- AATCC 42-2017: Measures the resistance of fabrics to water penetration (AATCC, 2018)
- AATCC 127-2017: Measures the fabric's resistance to water penetration under hydrostatic pressure (AATCC, 2017)
- ASTM F1670-17: Evaluate the resistance of materials used in protective clothing to penetration through synthetic blood under conditions of constant fluid contact (ASTM, 2017)
- ASTM F1671-13: Measure penetration by bloodborne pathogens using a surrogate microbe under continuous fluid contact conditions (ASTM, 2013)
AAMI Levels
Standard ANSI / AAMI PB70: Defining the best level of protection for 2012 includes understanding the critical areas of a dress and what each barrier performance level means, so that the best gown is chosen for use by healthcare professionals.
Critical zones for gowns consist of gowns and sleeves, both of which are the primary areas at highest risk of exposure to fluids and blood-borne pathogens. The higher the level, the greater the need for more barrier protection for the entire critical area.
- LEVEL 1: Minimum level of liquid barrier protection
- LEVEL 2: Low level of liquid barrier protection
- LEVEL 3: Medium liquid barrier protection
- LEVEL 4: Highest level of fluid and viral barrier protection
|
BARRIER PERFORMANCE |
BARRIER PROTECTION |
RESISTANCE MEASURES |
SCALE |
TEST CRITERIA |
ACCEPTABLE QUALITY LEVEL |
|
Level 1 |
Least |
Liquid Penetration |
AATCC42 |
Water Effect ≤ 4.5g |
4% |
|
Level 2 |
Low |
Liquid Penetration |
AATCC42 |
Spray Effect ≤ 1.0g |
4% |
|
Level 3 |
moderate |
Liquid Penetration |
AATCC42 |
Spray Effect ≤ 1.0g |
4% |
|
Level 4 |
Moving in Berlin |
Liquid and Viral Penetration |
ASTM F1671 |
Pass |
4% |
The AAMI PB70 standard has been developed to identify reference points from which institutions can evaluate protective gowns and surgical drapes.
These neutral criteria allow large organizations to easily standardize their protective apron selecon and choose the most suitable protection at a glance.
Level 1 Aprons and Curtains
Describes surgical gowns, other protective clothing, surgical drapes and drape accessories, demonstrating the ability to withstand fluid penetration in a laboratory test, AATCC 42 (Water resistance: Impact penetration test).
Level 2 Aprons and Curtains
Describes surgical gowns, other protective clothing, surgical drapes and drape accessories that demonstrate the ability to withstand fluid penetration in two laboratory tests: AATCC 42 (Water resistance: Impact penetration test) and AATCC 127 (Water resistance: Hydrosta ^ c pressure test). ).
Level 3 Aprons and Curtains
Describes surgical gowns, other protective clothing, surgical drapes and drape accessories that demonstrate the ability to withstand fluid penetration in two laboratory tests: AATCC 42 (Water resistance: Impact penetration test) and AATCC 127 (Water resistance: Hydrostatic pressure test). For Level 3, the test criterion for AATCC 127 performance is set higher than Level 2.
Level 4 Aprons
Surgical gowns and protective clothing showing the ability to resist liquid and viral penetration in a laboratory test, ASTM F1671 Trial system).