Where can I find a standard or tests for drug reservoir material testing?

[hughb]

Hi, I'm new in this forum, i'm a medical device engineer
working on new disposable drug pump(steadymed.com)
if somebody know where i can find standards or tests to be done for evaluating my drug reservoir for stability with some drugs like morphine or insuolin it can be helpful for me,
what i need to tests on my reservoir?
another question is where i can find some material that is good for this purpose of manufacturing the reservoir, is pvc is good for this?
thank is advance
yehuda

[Gert Sorensen]

You could take a look here: http://www.iso.org/iso/en/stdsdevelo...&INCLUDESC=YES

Perhaps some of these standards relate to your product?

They may also be able to give some input on your choice of compound.

[hughb]

Thank's...

[sanjoh]

Will your device be marketed in the US?
If yes then:
1) Establish which product code is appropriate. http://www.accessdata.fda.gov/script...sification.cfm
2) Use FDA recognized consensus standards as a baseline for testing.
3) Review FDA guidance if available for your type of product. May recommend specific tests not required in the consensus standards.