Cable used in Active Implantable Medical Device

[RDSally]

Hi all,

I'm looking for advice on how to ensure the cleanliness of a cable, which is a subpart of an AIMD assembly. The problem is whether the cleaning agent reaches the inside of the cable and whether the residues can be removed. Does anyone have experience on this?

Thank you in advance!

 

[Ronen E]

Hi all,

I'm looking for advice on how to ensure the cleanliness of a cable, which is a subpart of an AIMD assembly. The problem is whether the cleaning agent reaches the inside of the cable and whether the residues can be removed. Does anyone have experience on this?

Thank you in advance!

Hello and welcome to the Cove

Taking a wild guess: Proper cleanliness of the inside of the cable can't be achieved (and guaranteed) after the case, therefore the right path would be using a cable that was manufactured with guaranteeing cleanliness in mind (all necessary provisions and controls), so that further cleaning would not be necessary.

Cheers,
Ronen.

 

[RDSally]

Thank you Ronen,

Actually, I was anticipating an answer like this... If manufactured in a cleanroom, then I believe supplier's certificate would be adequate to prove the cleanliness.

However, does anyone have experience how this would be typically done, if cleanroom manufacturing is not possible?

 

[Pads38]

Is the concern that a cleaning agent may 'leak' into the cable and then not be satisfactorily removed before any sterilisation process?

If that were the case I might think of something like dye-penetrant testing. This could be as simple as testing with food colouring added to your cleaning fluid. Or it could be something rather more sophisticated using something like spectrometry.

 

[RDSally]

I was thinking mainly about how to clean the cable after manufacturing, but now it seems our problem is solved, because we're getting a cable manufactured in a cleanroom after all...

However, leakage into the cable after assembly is also a valid concern, so thank you for the test idea!