What tests need to be repeated between 3D Printed ABS material and Injection moulded ABS Material.

We are starting clinical studies post 60601-1 with a 3D printed casing made from ABS material. But post clinical studies and before submitting to FDA we will receive our injected moulded parts again made of ABS material.
Kindly note, we are ensuring same ABS material as listed in "FDA listed materials" for both 3D printing and injectin moulding.
We are a medical device that touches only intact skin, so which all clauses should we redo as part of 60601-1. This will be very helpful, if someone can clarify.

 

We outsource all our 60601-1 testing and if we have such a change, we coordinate with the test lab to assess impact / retest requirements. Possibly the drop / impact tests will need to be re-run.

The FDA listed materials and contacting intact skin are not so much 60601-1 concerns but biocompatibility. Biocompatibility testing needs to be done on as-manufactured product. Changing from 3D printing to injection molding can have an impact (e.g., mold release agents). You may not need to do any, but you need to address it with rationale if you don't test.

 

Thanks so much for the prompt response, really helps us in planning the tests and materials better. Appreciate your time.