Medical Device Testing Services
Medical Device Testing Services
 

Testing Know How

TESTING TIPS: JULY 25th, 2017 

Neurostimulator Lead Tests

In this testing tip, we cover some practical aspects of neurostimulator lead testing.  Samples are often preconditioned per ISO 14708-3 in a bath of approximately 9 g/l saline solution, suitable for injection, or filtered saline or ultra-pure water.  If samples are preconditioned in such a solution, it is important to store samples in a similar environment in-between testing.  Samples should not be allowed to dry out as that may cause salt buildup.  Prior to testing, you need to make sure that electrodes are dry before electrical testing so that the surface is non-conductive and should handle samples wearing electrical gloves.  Samples can be dried using KimWipes and tested soon thereafter.

Neurostimulator lead gripping should be carefully performed.  We use a sacrificial material such as tubing between the sample and the gripping surface to minimize the risk of non-testing related wear.  The exact thickness of the tubing used is not critical; we typically select tubing with an ID similar to the sample’s OD and make sure the sacrificial material is thick enough to mitigate damage.  Latex or silicone tubing works well or any other similar material.