From: Bibb, Richard (PDR) (RBibbfirstname.lastname@example.org)
Date: Wed Oct 08 2003 - 12:18:04 EEST
Dear Holmer and List,
My understanding is that the USP 23 class VI test cover patient contact
which includes their own body fluids. Therefore by extension it would at
least be a step in the right direction for your needs. However, I believe
these tests may not be adequate for other types of fluids or gases that you
may want to administer to the patient.
Duration is also another consideration. The Class VI tests only cover
temporary or short term exposure so if the device is in long term use you
may have to reconsider.
It is also worth bearing in mind that using prototype materials and
processes will only get you so far down the product development route.
Eventually you will have to conduct clinical trials using the material and
process intended for manufacture.
Sorry I can't give a more comprehensive answer on the list.
Dr. Richard Bibb
Head of Medical Applications
Tel. +44 (0) 29 2041 6723
Fax. +44 (0) 29 2041 6973
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