From: Andy Christensen (andy@medicalmodeling.com)
Date: Thu Sep 12 2002 - 17:58:14 EEST
Good to note that the tests performed (USP Class VI) only allow for
"limited" in-vivo exposure of less than 24 hours. The material is not
meant to be suitable for implantation but can come into contact with
body fluids/tissues for this limited timeframe. Also important to run
bioburden and sterility tests on your lab setup before recommending to
customers that they can sterilize the material. This will allow the
sterilization cycle to fit the conditions the part was made in (ie: a
dirty environment or a cleaner environment). Namsa, Apptec and Nelson
labs can all do this type of work.
Best regards,
Andy
Medical Modeling LLC
17301 W. Colfax Ave., Ste. 300
Golden, CO 80401 USA
Ph: 888-273-5344
Fax: 303-277-9472
www.medicalmodeling.com
-----Original Message-----
From: owner-rp-ml@rapid.lpt.fi [mailto:owner-rp-ml@rapid.lpt.fi] On
Behalf Of David K. Leigh
Sent: Thursday, September 12, 2002 8:12 AM
To: bfi@orthometer.com; rp-ml@rapid.lpt.fi
Subject: RE: Duraform in medical industry?
We have used SLS Duraform and continue to use SLS Duraform for medical
applications - from instruments to implants. SLS Duraform has been
tested by Namsa and meets compliance for classification as a USP Plastic
Class VI. These tests were "in vivo" (implant studies) and done for
systematic toxicity, intracutaneous toxicity, and muscle implantation.
The plastics can be autoclaved, and we currently have a customer who
uses Duraform GF parts in an operating room environment. I am not sure
about any specific requirements for devices that come into contact with
mucous membranes, but if the callification I have detailed is
sufficient, I can fax you a copy of the Certificate of Compliance.
********************************************************************
David K. Leigh (254) 933-1000
Harvest Technologies, Inc. fax (254) 298-0125
Rapid Prototyping Services www.harvest-tech.com
-----Original Message-----
From: owner-rp-ml@rapid.lpt.fi [mailto:owner-rp-ml@rapid.lpt.fi]On
Behalf Of Bjorn F. Iversen
Sent: Thursday, September 12, 2002 5:34 AM
To: rp-ml@rapid.lpt.fi
Subject: Duraform in medical industry?
Hi there
Are anyone aware of duraform products used in the medical industry?
I am looking for products which have been approved for contact with
mucous membranes.
Knowledge of such products might make things easier for me...
Yours sincerely
Orthometer AS
B. F. Iversen
Oslo Research Park
Gaustadalléen 21
0349 Oslo
Telefon (+47) 22 95 85 00
Direkte (+47) 22 95 83 48
Mobil (+47) 91 31 31 30
E-post bfi@orthometer.com
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For more information about the rp-ml, see http://rapid.lpt.fi/rp-ml/
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