Test Procedure or Standard for Accelerated Aging for AIMD

[benderspeck]

Hi All,

I am searching for a test procedure or standard to evaluate the electronic lifespan inside our active implantable medical device (not the packaging, but the device itself).

I am looking for something that would be accelerated and take into account body tissue (in saline at 37C). Right now I am looking at subjecting the product to some of the military environmental tests (MIL-STD-202 and MIL-STD-810). Preferably I would like to find an accelerated aging standard that outlines an elevated temperature/cycle that I could use for the product in saline and estimates X years of aging in a human body.

Does anyone know if this exists, or can I modify/justify ASTM1980 for my own purposes?

thanks

 

[Ronen E]

Hi,

From a formal point of view, you are on an acceptable path.

From a wise point of view, you better start with an analysis of the possible time-dependent failure mechanisms, that would eventually end the device life (i.e. drive any of its critical characteristics below spec). You can't accelerate something before you define and understand it; even then, some failure mechanisms can't be accelerated in a reliable way.

I already wrote about it in Elsmar: https://elsmar.com/Forums/showthread.php?t=33072

Cheers,
Ronen.

 

[Murphys Law]

From an electronics point of view, the human is a benign environment. It is pretty constant temperatures. The semiconductor should not reach its wearout stage.

Corrosion could be something to consider. Your problems are goings to be more on defect management and designing for low ppms. (You should consider other techniques such as redundancy.)

You should take a read of https://www.inemi.org/project-page/medical-components-reliability-specifications-project-completed

Basically the project was created to fill the gap of industrial methods of qualifying electronics to an medical component one.