Blog

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.

Documentation, Gown , , , , , , , , , ,
About Fatih Kucukpetek