Is there a national standard for surgical gowns ?What is AAMI level?
Medical staff inevitably come into contact with patients' blood and body fluids during medical rescue, which may carry various pathogens. Therefore, infection control and protection are crucial. In order to ensure the safety of patients and medical staff, doctors performing surgeries will wear surgical gowns, isolation caps, masks, and undergo heavy disinfection before entering the operating room.
The AAMI rating for surgical gowns refers to the standard used by the American Association for the Advancement of Medical Devices (AAMI) to classify the protective performance of surgical gowns. AAMI classifies surgical gowns into four levels based on the amount of liquid they may come into contact with during surgery and the risk of splashing. Each level has specific barrier performance requirements to ensure the safety of medical staff during different types of surgeries.
AAMI Level Classification
The following is AAMI's specific classification of surgical gown grades
| Barrier level | Risk of liquid leakage | Reference surgery | Performance requirement |
| AAMI Level 1 | Used for surgeries with low risks of liquid exposure, spraying, and sputtering | Eye surgery, breast tumor resection, skin biopsy.... | Must undergo spray impact penetration test, with a water infiltration rate of less than 4.5g |
| AAMI Level 2 | Used for surgeries with minimal liquid exposure, low spray and sputtering risks | Hernia repair, tonsillectomy, angiography.... | 1. It must undergo a spray impact penetration test with a water infiltration rate of less than 1g 2. Hydrostatic pressure test, hydrostatic pressure>20cm H20 |
| AAMI Level 3 | Used for surgeries with moderate liquid exposure, high spray and sputtering risks | Arthroscopy, prostatectomy, mastectomy... | 1. It must undergo a spray impact penetration test with a water infiltration rate of less than 1g 2. Hydrostatic pressure test, hydrostatic pressure>50cm H20 |
| AAMI Level 4 | Used for surgeries involving large amounts of liquid exposure, high spray and sputtering risks | Joint replacement, cesarean section, cardiovascular surgery.... | 1. It must undergo a spray impact penetration test with a water infiltration rate of less than 1g 2. Hydrostatic pressure test, hydrostatic pressure>50cm H20 3. Must pass the Haemophilus influenzae virus penetration test |
AAMI level testing requirements
The testing requirements for AAMI level mainly include spray impact and hydrostatic pressure testing. These tests are used to evaluate how much water will penetrate non-woven fabrics after being sprayed with water, and at what pressure non-woven fabrics will produce water droplets. These tests ensure that surgical gowns can effectively block the penetration of liquids and microorganisms, thereby protecting healthcare workers.
The Importance of AAMI Level
With the increasing awareness of high protective performance surgical gowns among medical personnel, the demand for high-quality surgical gowns is also increasing. The material of surgical gowns has become a focus of research. Currently, there are many types of medical textiles with wide applications and high technological content, involving multiple disciplines such as design, chemistry, and medicine. Therefore, understanding and selecting the appropriate AAMI grade is crucial for surgical gowns
