As part of the molding activities, we use Compressed Air that is tested routinely per ISO 8573 requirements.
During a recent customer audit, we were asked if we have done a Biocompatibility study on the devices for the possible compressed air contaminants like Oil, Particles and Water ?
Our reasoning was that since the Compressed Air meets the requirements of ISO 8573, that should be fine but the customer insisted on the Biocompatibility testing.
I havent heard of it and would like to hear from others if this has to be performed ?
During a recent customer audit, we were asked if we have done a Biocompatibility study on the devices for the possible compressed air contaminants like Oil, Particles and Water ?
Our reasoning was that since the Compressed Air meets the requirements of ISO 8573, that should be fine but the customer insisted on the Biocompatibility testing.
I havent heard of it and would like to hear from others if this has to be performed ?