International Standards (ISO or MIL) for MTBV

D

dododi

#1
Dear forum,

I am working as Quality Engineer for the medical device industry.
I am interested to know if there are any accepted consensus standard
on how to calculate the MTBV [Mean Time Between Visit] of intruments on the field
(i.e. Field Data Reliability Analysis).

In particular, I have the following doubt:

- Shall I include all the instruments installed (even if installed many years ago), considering that they might not be in use anymore and therefore they do not fail (optimistic MTBV), or shall I perform a kind of "in warranty" MTBV, only taking in consideration the instruments installed < 36 months ago?

Thank you,
Maurizio Zaccheddu
 
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D

dododi

#3
Mean Time Between Visit.
Which in our case is equivalent to
MTBF [Mean Time Between Failure], because
every failure is a visit.
 
S

spoth001

#4
I think MTBF is calculated after manufacturing it and during RnD stages. Mostly they run it before they let it out in market to get the figures. I may be wrong.
 

sagai

Quite Involved in Discussions
#5
I think MTBF is introduced for Reliability measures.
There is an overarching industry independent standard for functional safety, IEC61508 that is defining it and using also to SIL level determination.
Could be some historical military standards in US that introduced this concept.
... or IBM in the seventies, who knows :)
Cheers!
 
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