Medical grade materials - summary

From: Holmer Berndt (
Date: Wed Oct 15 2003 - 18:49:13 EEST

Hello List,

I wish to thank those who responded to my mail a week ago, some on and some off list. Below is a summary of the RP materials that up till today have been tested and to a limited extent received approval for biocompatibility. Important remarks were made that the tests carried out are for short (24 hrs) exposure, also that any user of the materials must make further specific tests to qualify the material for the intended application.

If nobody adds anything in response, I will assume this (short) list to be true and complete:

Tested according to USP 23 Class VI:
- RenShape SL H-C 9100 (Huntsman Advanced Materials, formerly Vantico)
- RenShape SL Y-C 9300
- DuraForm PA (3D Systems)

Tested according to ISO 10993-1:
- PA 2200 (EOS)

Tested according to both USP 23 Class VI ISO 10993-1:
- Polycarbonate (Stratasys)

Another material generally of interest for medical purposes is PPSU which since recently is available from Stratasys but it does not seem to be tested yet.

All the mentioned are plastic materials. Metal materials such as titan for Optomec, Arcam and maybe others are of course candidates for joining the list if and when they are tested.


Berndt Holmer
IVF Industrial Research and Development Corporation
Brinellvagen 68
SE-100 44 Stockholm
Phone: +46 (0)8-21 31 74
Fax: +46 (0)8-20 22 27
Mobile: +46 (0)70-780 62 15

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