Passivation process for medical grade Stainless Steel tubing

A. A device made of 316L should not need to be passivated to deal with IV fluids, especially a single patent device meant for short term use. There can be other factors involved, but as long as your tubing is dirt/rust free when it is packaged, you should have no problems. Since you are a manufacturer, I am guessing that the designers specified passivation? If it were an implant, reusable, or meant for long term use (>24 hrs or so), then I would passivate. But that doesn't seem to be your case.

Nitric acid, citric acid and electropolishing are all perfectly acceptable methods of passivation for medical devices. I can track down specs for you if you still need them. Citric tends to be far and away the easiest to deal with in terms of nasty chemicals and processing. The spec on that is ASTM A967.

A. Most medical devices require passivation, even for single use, because of the potential for iron contamination in the manufacture of the device and the corrosiveness of blood. I agree that 316L stainless should not require passivation for short term IF it is iron free to begin with. citric acid formulations are used for this kind of operation and are available on the market. Once passivated the surface has a very long life. Let us know if we can help.

A. Yes, if at the time of manufacturing if any kind of iron contaminations are there in SS 316L surface part then it can cause corrosion. So, best method to prevent such problem is to use Biodegradable, Chelant passivation for SS surface which is also used by many Ltd. Pharmaceutical / IV manufacturer companies in India. So, you can very safely use the same for your requirements also. That will prevent rusting / corrosion of your SS clinical part.