Gelbo flex testing is a standard per ASTM (ASTM F392: Standard Practice for Conditioning Flexible Barrier Materials for Flex Durability). As mentioned above, gelbo flex testing is not a required method for bringing a medical device to market. Rather, it is used as an R+D (research and development) tool to evaluate the relative ability of one of more materials to withstand repeated flexing.

 

The goal of this test method is not necessarily to have zero cracks or tears, but more to evaluate the performance of one material versus another and an expectation for there to be cracks to assess. If there are no cracks, the cycle count is likely too low, or the material is a specialized material that refuses to crack. It simulates what the packaging material might endure during transit testing, specifically during the vibration portion.

 

Medical device packaging material manufacturers perform the gelbo flex test on their packaging materials so medical device manufacturers have and idea at how much stress a specific packaging material can endure during transit testing. They will typically have that spec listed on their material sell sheet. This specification is important to know so you know the materials ability to flex, fold, compress, or compound without cracking.