Margin of Safety for Medical Device Fatigue Testing

[gitgiv]

Hi all,

Can anyone please advise on what is the customary/acceptable margin of safety when it comes to medical device fatigue testing?

Thanks

[Stijloor]

In Reply to Parent Post by gitgiv

Hi all,

Can anyone please advise on what is the customary/acceptable margin of safety when it comes to medical device fatigue testing?

Thanks

Bump!

Can someone help with this?

Thank you!!

Stijloor.

[Tolch]

Can a fatigue test be done in house, or is a third part expert required?

Also, any way to get a copy of a previous 510K other than a Freedom of Information Request?

[gitgiv]

The fatigue test is performed in-house.

[MIREGMGR]

There is no single guideline for margin of safety for any failure mode. It depends on what happens if failure occurs. If the failure by itself (single failure mode) could cause harm, a higher margin should apply.

There's good information on this in the IEC 60601-1:2005 Standard-sections associated with Table 21. Even if that Standard doesn't apply to your product scope-wise, the principles it applies could be used as a foundation for your approach-justification.

[Tolch]

Thanks for the answer about the in-house testing.

Does it actually state explicitly anywhere in the guidelines or regulations that the fatigue testing can be done in-house, or do you just know this from experience?

Obviously, it would be a lot more expensive to hire an outside expert to do the test than if we do it in-house and write our own report.