What medical device testing has to be done under worst-case conditions?

Return to learning center
Share:

ISO 11607-1 Section 6.3.4 states, “Performance testing shall be conducted on the worst-case sterile barrier system produced at the specified process limits of forming and sealing and after exposure to all the specified sterilization processes.”

The Performance Test includes the simulated distribution test and is a separate test from the sterile barrier stability study. In practice, the most typical “worst-case” manufacturing conditions are related to variables affecting seal strength. However, there is no formal definition provided by the standard. It is up to the manufacturer to define “worst-case” manufacturing conductions.