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<== Date ==> <== Thread ==>

Subject: Re: Is there anyone using EPICS for a FDA approved device?
From: Simon Rees <[email protected]>
To: [email protected]
Date: Tue, 19 Aug 2008 10:56:21 +0200
On Thursday 14 August 2008 11:06:03 GW Lamb wrote:

> I am wondering if there is any documentation on the FDA's opinion
> of EPICS software.


On Friday 15 August 2008 09:59:09 Andrew Johnson wrote:

I've not heard of anyone using EPICS in such an environment,
although there are EPICS sites that provide medical treatment
facilities. However I don't believe that EPICS is ever used
directly to control those facilities, the code is not rigorously
audited to the standards of verification and validation that
would be needed. Here at the APS the general rule is that EPICS
software plays no part in implementing personnel safety, and
is rarely responsible for machine protection either, other
than to report on the current status of other (hardware-based)
protection systems.

Just to pick up on Andrew's comment... here at the Paul Scherrer Institute (PSI) in Switzerland we are currently operating a medical facility that relies on the therapeutic benefits of proton radiation to treat cancer patients.

By maintaining a clear separation of concerns between aspects
critical to patient safety (non-EPICS) and those that aren't
(where we do make increasing use of EPICS) we are able to
comply with the requirements of the Swiss Federal Office
of Public Health (which is presumably the equivalent of the
US FDA).

Best regards

Simon
Replies:
Re: Is there anyone using EPICS for a FDA approved device? Bill Nolan

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