ANSI/AAMI PB70 Standard Recognized by the FDA
Labeling that shows a product has been tested to and meets appropriate performance standards is one way for users and procurers to determine when to use a particular gown.
The performance of gowns is tested using consensus standards:
American Society for Testing and Materials (ASTM) F2407 is an umbrella document which describes testing for surgical gowns: tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission.
Below is a table summarizing the ANSI/AAMI PB70 standard recognized by the FDA.
| Level 1 | * Used for MINIMAL risk situations * Provides a slight barrier to small amounts of fluid penetration * Single test of water impacting the surface of the gown material is conducted to assess barrier protection performance. | basic care, standard hospital medical unit |
| Level 2 | * Used in LOW risk situations * Provides a barrier to larger amounts of fluid penetration through splatter and some fluid exposure through soaking * Two tests are conducted to assess barrier protection performance: – Water impacting the surface of the gown material – Pressurizing the material | Blood draw from a vein, Suturing, Intensive care unit, Pathology lab |
| Level 3 | * Used in MODERATE risk situations * Provides a barrier to larger amounts of fluid penetration through splatter and more fluid exposure through soaking than Level 2 * Two tests are conducted to test barrier protection performance: – Water impacting the surface of the gown material – Pressurizing the material | Arterial blood draw, Inserting an IV, Emergency Room, Trauma |
| Level 4 | * Used in HIGH risk situations * Prevents all fluid penetration for up to 1 hour * May prevent VIRUS penetration for up to 1 hour * In addition to the other tests conducted under levels 1-3, barrier level performance is tested with a simulated blood containing a virus. If no virus is found at the end of the test, the gown passes. | Pathogen resistance, Infectious diseases (non-airborne), Large amounts of fluid exposure over long periods |
Conformance with recognized consensus standards is voluntary for a medical device manufacturer. A manufacturer may choose to conform to applicable recognized standards or may choose to address relevant issues in another manner.
