RE: Duraform in medical industry?

From: David K. Leigh (dkleigh@harvest-tech.com)
Date: Thu Sep 12 2002 - 17:11:33 EEST


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

  This E-mail was examined and found virus free before
  leaving Orthometer AS

For more information about the rp-ml, see http://rapid.lpt.fi/rp-ml/



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