Medical grade materials

From: Holmer Berndt (berndt.holmer@ivf.se)
Date: Wed Oct 08 2003 - 11:11:53 EEST


Hello List,

I have a need for further clarification of the status of RP materials suitable for medical applications. The StereoCol SL 9XXX materials have been tested successfully acc. to USP 23 Class VI. The USP Class VI test of Duraform in 1997 was also successful and so was the ISO 10993-1 test of EOS/PA 2200 in 2001.

- Are there other relevant tests made on these or other RP materials?

The tests above were made to verify the low or non-existant biological response to direct exposure. My need however is to make a component for medical equipment which is not in contact with the body but where fluids or gases pass the component and detrimental emission from the component would be fatal for the patient.

- Do the tests mentioned above have any relevance for my need?
- What is known about the emissions from well manufactured and possibly post-processed parts?
- Are there tests made or other circumstances known which could be helpful to me?

Any help is much appreciated!

Regards
Berndt Holmer

IVF Industrial Research and Development Corporation
Brinellvagen 68
SE-100 44 Stockholm
Sweden
Phone: +46 (0)8-21 31 74
Fax: +46 (0)8-20 22 27
Mobile: +46 (0)70-780 62 15
berndt.holmer@ivf.se
www.ivf.se



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