[Previous Months][Date Index][Thread Index][Join - Register][Login]   Help@Insulin-Pumpers.org
  [Message Prev][Message Next][Thread Prev][Thread Next]   for subscribe/unsubscribe assistance

[IP] IR-1000 Verification and Validation Testing

Verification and validation testing is a crucial part of any design 
effort to further ensure safe and reliable operation of an insulin 
pump.  Each facet of a design should be looked at critically. 
Efforts made to induce failures will identify weak areas of a design. 
The following is a partial list of the verification and validation 
testing that the IR-1000 has gone through.

Delivery accuracy testing:  The pump was tested for the accuracy of 
flow at all basal rates, bolus dosages and under varied environmental 
conditions.  (see my earlier posts)

Life-testing:  The pump was life-tested using an accelerated 
life-testing techniques for the equivalence of 10 years of continuous 
operation.  At the end of this 10 year period, only minimal 
degradation in the pump motor, lead screw or any other pump 
components was observed.  (remember, Animas does not accept a +/- 5 
percent variance in delivery)

Software verification and validation:  The software has received 
thousands of hours of verification and validation testing, with each 
function scrutinized and tested under every conceivable condition. 
(see my earlier posts)

Hardware verification and validation:   The electronics are the key 
part of a pump and they are tested extensively, including deliberate 
shorting and opening of different components to verify that if the 
pump fails under such conditions, it fails safely.  What does that 
mean?   It means that it will not UNDER bolus and it will not OVER 
bolus, or run on.  Fail Safe, and I don't mean as in the 1960's.

George     :>)
for HELP or to subscribe/unsubscribe/change list versions,
contact: HELP@insulin-pumpers.org