Accelerated Service Life Test for Medical Devices

mvroops

Starting to get Involved
#1
Dear All,

To verify / Validate expected service life of product , what are the parameter need to test.

Device expected life is 4 years and use average 8 hours per day.

Any body can help me to calculate number of samples and number of hours for example 95 % confidence.

Thanks & regards,

Roopesh
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,

Simulated life testing protocols can only be determined after carefully considering the specifics of the product, its use environment and use patterns, and above all - its anticipated failure modes vs. its performance specification. You haven't provided any specifics so any advice can only be very general (ie, useless) or misleading/irresponsible.

Sample size determination should come after the actual tests methods have been defined, preferably with the support of a statistician. That should, too, involve good knowledge of the specifics - no magic numbers.

Sorry,
Ronen.
 
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