From: Andy Christensen (firstname.lastname@example.org)
Date: Wed Oct 08 2003 - 18:10:45 EEST
Hi Holmer and List,
I agree with all that's been said about the resins. The RenShape 9100
and 9300 resins are the only SLA materials that have been tested to the
USP 23 Class VI tests. It allows for limited (which is defined as less
than 24 hours) in-vivo exposure to human tissue. Human tissue would
include all the tissues as well as body fluids, but Richard brings up a
good point about other liquids/gases and whether this would cover that.
Someone out there must use these materials for prototyping of blood
handling devices or other such diagnostic equipment, maybe they could
Medical Modeling LLC
17301 W. Colfax Ave., Ste. 300
Golden, CO 80401-4892 USA
From: email@example.com [mailto:firstname.lastname@example.org] On
Behalf Of Bibb, Richard (PDR)
Sent: Wednesday, October 08, 2003 3:18 AM
To: 'Holmer Berndt'; RP Mailing list (E-mail)
Subject: RE: Medical grade materials
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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