Orthopedic surgical drape or orthopedics (alternatively spelt orthopaedics), is the branch of surgery concerned with conditions involving the musculoskeletal system.[1] Orthopedic surgeons use both surgical and nonsurgical means to treat musculoskeletal trauma, spine diseases, sports injuries, degenerative diseases, infections, tumors, and congenital disorders
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AAMI has identified American Association of Textile Chemists and Colorists (AATCC) 42 and AATCC 127 as the key test requirements that a surgical gown must pass in order to be labeled AAMI Level 3.
AATCC 42- Water Impact penetration Test
AATCC Defines: Impact penetration tests measure the resistance of fabrics to the penetration of water by impact. The test was developed to predict the probable rain penetration resistance of a fabric and most methods still include this language in the scope. The test has also been adopted by the medical industry as a measure of liquid barrier performance for protective apparel and drapes
AATCC 127- Hydrostatic pressure Test
AATCC Defines: Hydrostatic Pressure Test measures the resistance of a fabric to the penetration of water under hydrostatic pressure. It is applicable to all types of fabrics, including those treated with a water resistant or water repellent finish. Water resistance depends on the repellency of the fibers and yarns, as well as the fabric construction. The results obtained by this method may not be the same as the results obtained by the AATCC methods for resistance to rain or water spray.
EN13795- High-Performance
EN13795- High Performance/Critical Areas Tests
- Resistance to microbial Penetration – Dry, Wet
- Cleanliness – Microbial, Particulate Matter
- Linting
- Water Resistance Hydro head
- Resistance to Liquid Penetration
- Bursting Strength – Dry, Wet
- Tensile Strength –Dry, Wet
- Breathability
AAMI has identified American Society for Testing and Materials (ASTM) International3 F1671 as the key test requirement that a surgical gown must pass in order to be labeled AAMI Level 4.
ASTM F 1671- Synthetic Blood Penetration Resistance Test
ASTM International F1671: is the Resistance of Materials Used in Protective Clothing to Penetration by Blood Borne Pathogens Test. This is a pass/fail test that an AAMI Level 4 surgical gown must pass. The test method has been specifically designed for modeling penetration of HBV, HCV and HIV. Because these organisms are difficult to use, the test uses a bacteriophage, Phi-X174. Phi-X174 is one of the smallest known viruses, and it is similar in size and shape to HCV, the smallest bloodborne viral pathogen.
A surgical gown’s material is subjected to a nutrient broth containingPhi-X174 for a specified time and pressure sequence:
The test is terminated if visible liquid penetration occurs before the end of 60 minutes. If no visible liquid penetration is seen, then a sensitive microbial assay is performed to determine pass or fail. Any evidence of viral penetration for a test specimen constitutes a failure. If a production lot of surgical gowns passes this test in all four surgical gown critical zones, it qualifies as an AAMI Level 4 surgical gown.
EN13795- High-Performance
EN13795- High Performance/Critical Areas Tests
- Resistance to microbial Penetration – Dry, Wet
- Cleanliness – Microbial, Particulate Matter
- Linting
- Water Resistance Hydro head
- Resistance to Liquid Penetration
- Bursting Strength – Dry, Wet
- Tensile Strength –Dry, Wet
- Breathability
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AAMI standards require a surgical gown to pass ASTM International F1671 in the critical zones in order to be labeled an AAMI level 4 surgical gown. What areas are included in the critical zone? There are typically four different areas that must pass within the critical zones, including two in the front chest and two on the sleeves. If a product passes ASTM InternationalF1671 in all applicable areas, then it qualifies as an AAMI level 4 surgical gown.
