ASTM F1929-23

In January 2024, the release of ASTM F1929-23 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration marked an update from its predecessor, ASTM F1929-15. Notably, this revised version of the standard omits Triton X-100 and instead adopts generic terminology to encompass various wetting agents and surfactants. 
 
This change has been made due to Triton X-100 being banned in the EU. The ban stems from a key ingredient in Triton X-100 (2-[4-(2,4,4-trimethylpentan-2-yl)phenoxy]ethanol) is on the European REACH (Registration, Evaluation, Authorisation, and Restrictions of Chemicals) list.  
 
Despite still meeting the recommended specifications for a wetting agent / surfactant, Triton X-100 is no longer referenced in the standard due to its EU ban. Other wetting agents and surfactants are readily available.  
 
The purpose for a wetting agent or surfactant in Dye Penetration testing is to alter the surface tension of the water and dye to allow dye solution to enter a channel in a seal if there is one present.

Read more about Seal Validation