Comprehensive Overview of AAMI Level 4 Surgical Gowns Standards, Features, And Importance

To delve into the specific testing benchmarks and requirements for AAMI Level 4 surgical gowns, we need to reference the PB70 standard issued by the Association for the Advancement of Medical Instrumentation (AAMI). This standard meticulously categorizes medical textiles, including surgical gowns and drapes, based on their liquid and microbial barrier performance levels. AAMI Level 4 surgical gowns represent the highest level of protection, designed for use in high-risk medical settings, especially during surgeries expected to involve significant exposure to infectious fluids. Here are the key testing benchmarks and their specific numeric requirements that AAMI Level 4 surgical gowns must meet:

### 1. Hydrostatic Pressure Test

The Hydrostatic Pressure Test measures a fabric's resistance to water penetration and is one of the critical indicators of a surgical gown's liquid barrier performance. For AAMI Level 4 surgical gowns, the requirement for this test is typically more than 20 kPa (approximately 200 cm H2O). This means the fabric must prevent water penetration under a pressure of at least 20 kPa, offering the highest level of liquid barrier protection.

### 2. Blood and Body Fluid Penetration Tests

AAMI Level 4 surgical gowns are required to pass both ASTM F1670 (synthetic blood penetration test) and ASTM F1671 (viral penetration test). The ASTM F1670 test assesses the material's resistance to synthetic blood, while ASTM F1671 evaluates the gown's ability to prevent penetration by blood-borne pathogens, using a bacteriophage. AAMI Level 4 gowns must completely pass these tests, ensuring no penetration of synthetic blood or the Phi-X174 bacteriophage (used as a test virus).

### 3. Fabric GSM (Grams per Square Meter)

While the AAMI standards focus on the performance of surgical gowns rather than specific fabric weights (GSM), AAMI Level 4 gowns, due to their high protection needs, are typically made from fabrics with higher GSM. The GSM of these fabrics can vary widely, depending on the manufacturer's design and the materials used, ranging from several tens to over 200. A higher GSM helps provide better liquid and microbial barrier but also needs to balance breathability and comfort for wear.

### 4. Penetration Testing

In addition to the tests mentioned above, AAMI Level 4 surgical gowns undergo several other tests to ensure their barrier against various liquids and microorganisms, including antimicrobial testing and durability testing (such as resistance to abrasion and tearing).

### Conclusion

AAMI Level 4 surgical gowns represent the highest standard in medical protective clothing, designed for healthcare workers facing extremely high-risk situations. They have passed a series of stringent tests, including hydrostatic pressure tests, blood and body fluid penetration tests, and considerations for fabric weight (GSM), to ensure they offer optimal protection. It's crucial for healthcare facilities to consider these factors when selecting surgical gowns to ensure the safety and protection of their staff and patients.