Request for Question Clarification by
willie-ga
on
25 Oct 2002 10:15 PDT
Hi there
This is taken from the U.S DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Guidelins for "THE CONTENT OF PREMARKET
NOTIFICATIONS FOR METAL EXPANDABLE BILIARY STENTS"
( http://www.fda.gov/cdrh/ode/bistent.html )
Is this what you were looking for?
"The term "biliary stent" refers to an expandable biliary catheter,
constructed either wholly or partially of metal, along with any
accessories used to deploy it. The biliary stent is implanted in the
biliary tree and used to provide palliation of malignant strictures."
The tests should be performed on the materials of the final,
ready-to-use device. The corrosion test is performed to establish the
compatibility of the stent materials with the corrosive environment in
the biliary tree.
- Use an untreated stent as a control
- The stent to be tested should be in contact with simulated bile for
a period of time that is representative of the implantation time of
the device.
- After exposure to the simulated bile, the tensile strength of the
stent material should be measured and compared to the untreated stent.
- Visual inspection of the stent using microscopy should also be
performed. Check for corrosion and note extent of such
- Accelerated exposure conditions may be used (e.g., elevated
temperatures), however, if you are using these a rationale should be
provided on how the accelerated conditions are representative of the
actual clinical use conditions.
(You'll find FDA recommendations for pre-market notifying to them at
the site above. )
Corrosion testing is just one of many tests the FDA require. Again,
you'll find them all at the link above.
Let me know if this is enough for you, and I'll post it as a formal
answer.
Willie-ga
