AAMI Level 4 procedures
AAMI Level 4 Gown
Satisfies EN13795 High Performance.
Manufactured as per Association for the Advancement of Medical Instrumentation (AAMI) standards.
“Complete protection, With the Level 4 Gown you get the Maximum Protection from Pathogens, Every Medical Procedures where incisions are made the Level 4 Gown comes as a prerequisite.”
Non-Reinforced, for More Fluid Contact and Protection
Made of SMS Non-Woven Fabric, Premium Quality Fabric used.
AAMI Level 4 Gown Polyfilm Reinforced
Satisfies EN13795 High Performance.
Manufactured as per Association for the Advancement of Medical Instrumentation (AAMI) standards.
“The epitome of Safety, Polyfilm Reinforced Level 4 Gown is the Ultimate Armour For the Health Professional, as conducting the procedures in the O.T for continuous hours is no less than fighting a war.”
Critical Area Reinforced for High Fluid Contact and Protection.
Made of SMS Non-Woven Fabric, Premium Quality Fabric used.
AAMI Level 4 procedures
AAMI Level 4 Gown Breathable
Satisfies EN13795 High Performance.
Manufactured as per Association for the Advancement of Medical Instrumentation (AAMI) standards.
“SAFE AND BREATHABLE, effective air circulation becomes the need of the hour in those long surgeries. It’s crucial that the health professional remains comfortable throughout the procedure.”
Choose Aavvie® Healthwear™ Best in Class Breathable Level4 Gown, Complying with the AAMI Level 4 standards along with providing superior Comfort and Breathability.
High-Performance Microbial and Viral Barrier fabric used in Exposure Area, Breathable Fabric used at the back to ensure proper ventilation.
Made of Breathable Fabric, Premium Quality Fabric used.
Aavvie® Healthwear™ products are tested for and meet the AAMI Level 4 standard, European Standard: EN13795 High Performance.
-Suggested guidelines are not a substitute for clinician professional judgment and experience.
AAMI levels determined by ANSI/AAMI PB70:2012
Adopted by the U.S. Food and Drug Administration (FDA)
| Size (In cm) | Length | Girth |
|---|---|---|
| Medium (M) | 125 | 150 |
| Large (L) | 135 | 155 |
| Extra Large (XL) | 145 | 165 |
| Extra Extra Large | 155 | 165 |
| Colour | Blue | Yellow |
| Material | SMS | SMMS | SSMMS | Breathable Fabric |
| Reinforced | Fabric | Poly film |
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
Customer Relation:
For Product availability, Specification, Customization, More info etc.
All Products and Packs are customized according to Hospital requirements.
All Rights Reserved to Aavvie
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.
