Validation of a Pressure Decay Leak Tester for a Medical Device

How do I validate a pressure decay leak tester for a medical device?
We are currently performing an under water test at 8.75 psi and looking for bubbles.

Any suggestions or templates ?

Re: Leak tester validation

What is your definition of a leak?

In the past, I used a sealed chamber and pulled a vacumm to determine if there was a leak. Worked pretty well, but was sensitive to changes in barametric pressure.

We would run known good units through as well as bad ones to ensure the system was functioning.

Hope that helps!

baezes said:

How do I validate a pressure decay leak tester for a medical device?
We are currently performing an under water test at 8.75 psi and looking for bubbles.

Any suggestions or templates ?

Click to expand...

I have the same problem now. I am trying to define the test parameters in a Uson Leak Tester. The Leak size has been defined as 30microm.

Were you able to validate your Pressure Decay Test Method?

Can you help me please?