Jeff,
 
I cannot claim to have done a reliability prediction on a medical product, nor
to have done the same prediction using both MIL-HDBK-217 and Telcordia SR-332.
 
However, I think one must remember that with all these predictive models, they
are just that - models!  You cannot compare the results from one model with
the results from another; it just doesn't work. You might as well measure with
a yardstick and a metre rule. What you can do, and what they primarily enable,
is the comparison of one design with another using the same measuring device.
Whether or not the results bear any relation to reality is a question that is
unlikely to be answered until you have a lot of units in the field for a long
time and sufficient field data to calculate a mean value that is stable.
 
The model also enables you to examine the underlying data to identify the
components and sub-assemblies that are having greatest impact on the whole
system reliability. I think that this is probably the greatest benefit, as it
identifies opportunities to simplify parts of the design or to take stress
reduction measures.
 
Remember also that these models are based on mature designs, where any
systematic failure modes (design errors or oversights) have been eliminated
such that only the underlying natural random failure rate remains. In my
experience the early life of a product is usually dominated by systematic
failure modes, and at that stage the random hardware failure rate is something
dreams are made of.
 
Some people may believe that certain models bear a closer resemblance to
reality than others (and I can think of at least four other models beside 217
and 332) and consequently prefer those models to be used. There is an argument
that a model designed for commercial equipment may be more realistic than one
designed for the military, or that the individual component models and factors
may be more up-to-date. At the end of the day, you get a different number, but
what does it really mean?
 
If using SR-332 makes your customer happier than using MIL-HDBK-217, then I'd
use SR-332. Then, at least, he can't argue with the answer.
Best regards 

Neil R. Barker CEng MIET FSEE MIEEE 
Manager 
Quality Engineering 
e2v technologies (uk) ltd 
106 Waterhouse Lane 
Chelmsford 
Essex CM1 2QU 
UK 

Tel: (+44) 1245 453616 
Fax: (+44) 1245 453571 
Mob: (+44) 7801 723735 

P Please consider the environment before printing this email. 



From: jeff collins [mailto:[email protected]]
Sent: 15 March 2007 19:46
To: [email protected]
Subject: Medical Products: Telcorda SR-332 vs.Mil-HDBK-217



Group,
 
For those of you who are involved with Medical products and MTBF Prediction,
what reliability standard/method do you use? ( Telcordia SR-332 or
MIL-HDBK-217)
 
I normally use MIL-HDBK-217 for medical products and Telcordia SR-332 for
Telecom or similar products. I'm working on a medical product where they have
requested all of their MTBF Predictions to Telcordia SR-332.
 
Thanks for any insight you may have on this topic.
 
Regards,
 
Jeff Collins


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