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IEC 62304 5.2.2 f - Installation and acceptance of device software

E

El Guapo

#1
I am confused about section f) of IEC 62304 5.2.2:
As appropriate to the MEDICAL DEVICE SOFTWARE, the MANUFACTURER shall include in the
software requirements: f) installation and acceptance requirements of the delivered MEDICAL DEVICE SOFTWARE at the operation and maintenance site or sites;
Does that mean we just need a simple statement about the required capabilities of the installation target machine? What about the acceptance requirement for installation -- or is that more geared for contractors?

We've just got some imaging software for retinal imaging. Can run with or without cameras attached to the computer. Comes on a data stick we provide or as a downloaded -- same package does a fresh install or an upgrade. Can't see how this part of the standard applies beyond "Do you have XP/Win7, 4g RAM, 20g free disk?". Maybe "User must comprehend English."?
 

c.mitch

Quite Involved in Discussions
#2
Does that mean we just need a simple statement about the required capabilities of the installation target machine?
Yes, I would say so.

What about the acceptance requirement for installation -- or is that more geared for contractors?
Your acceptance requirements may look like those you wrote at the end of your post: Win XP and so on.
The acceptance requirements may be tests to:
-demonstrate that the installation of your software runs on this kind of machine + OS (testing the installer bundle if you have one, or testing the installation procedure).
-demonstrate that it works on such platform (test of main functions of software)

The info to provide to end-users/contractors may be the minimal HW requirements to have your SW run on their machines.
 
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