SLA Tooling for Medical DEvices

From: John Cline (
Date: Wed Apr 24 2002 - 08:29:19 EEST

We currently use Somos 9110 resin in our SLA system, and have recently
started to make good use of it to produce tools as well as parts. These

Casting molds

Thermoforming tools

Simple (and short-lived) injection molds

The speed of response in designing and developing cast or molded parts
has been a great benefit to us.
So much so that we would like to use SLA tools for production of
component parts for Class 1 medical devices for use in clinical testing.

We've had the fully-cured 9110 resin tested for Cytotoxiicty and the
results were very favorable......the material has tested non-Cytotoxic.

But we would still like to test the material for Sensitization and
Primary Irritation. Passing these tests would actually give us the
ability to use parts made in Somos 9110 in the devices themselves.
However, our goals are a bit more modest, as we only want to use 9110 to
build the tools that will in turn fabricate components. Some of those
components will be in occasional contact with soft tissue.

Are there any guidelines for such use of these materials? Or precedents?
We could go thru the entire suite of ISO pre-clinical safety tests but
my hope is that others may have used this material for such puposes in
the past.

Any info, advice, or guidance would be appreciated.


J. Cline

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