Software System Inputs and Outputs - IEC 62304 5.2.2 - Software Requirements Content

[raqark]

I am looking for inputs on how to address this requirement of IEC 62304 in the SRS. For a Class II medical device, what level of detail is considered appropriate while defining software system inputs and outputs? I would appreciate some examples if possible.

 

[Stijloor]

Re: Software System Inputs and Outputs - IEC 62304 5.2.2 - Software Requirements Cont

I am looking for inputs on how to address this requirement of IEC 62304 in the SRS. For a Class II medical device, what level of detail is considered appropriate while defining software system inputs and outputs? I would appreciate some examples if possible.

A quick bump.

Can someone with expertise help?

Thank you very much!

Stijloor.

 

[c.mitch]

Re: Software System Inputs and Outputs - IEC 62304 5.2.2 - Software Requirements Cont

My opinion, it depends whether inputs/outputs are standardised data or data with a proprietary format (yours or from another software).
With standardised data, just quote the standard (eg. PDF, quote the PDF standard). Special case for medical imaging with DICOM data, you shall have a DICOM conformance statement.
With proprietary data. If you and only you uses it, document it lightly, this is your stuff. Unless the design of these data mitigates risks (eg, a CRC check or MD5 check to ensure the integrity of data).
If a 3rd party is supposed to use your data, either input or output, you shall document their format extensively in a user manual or admin manual or maintenance manual. It depends on the nature of exchanged data. Eg: a xml schema with xml data, database model with shared database ...

Mitch.

 

[JSambrook]

Re: Software System Inputs and Outputs - IEC 62304 5.2.2 - Software Requirements Cont

Let's assume that a sophisticated medical device has a graphical user interface. Are the various elements of the UI considered software system inputs?

For example a form that accepts the patient first name, last name, age, sex, etc. Are there requirements on how these fields are to be defined?

 

[c.mitch]

Re: Software System Inputs and Outputs - IEC 62304 5.2.2 - Software Requirements Cont

Hello JSambrook,

I answer your question points with 3 of views (pow) :

IEC 62304: pure software pow.
Yes, user input data are in this scope,

The examples you give (name, date of birth ...) fall into the scope of a specific US regulation HIPAA-MDS2: MANAGEMENT OF ELECTRONIC PROTECTED HEALTH INFORMATION. This patient data shall be treated according to this regulation. Have a look at MDS2FormInstructions in your favorite search engine.

And I add a 3rd pow with IEC 62366: the main concern of this standard is usability engineering. The way to input data into the forms/graphical interface should not be error prone and well understandable by the user. This is the last hobby of reviewers of notified bodies in EC.

Bye,

Mitch.

 

[JSambrook]

Re: Software System Inputs and Outputs - IEC 62304 5.2.2 - Software Requirements Cont

Helpful answers like this are one of the really nice things about this forum. Thank you, Cyrille.

By the way, I'm enjoying your blog posts as well.

 

[c.mitch]

Re: Software System Inputs and Outputs - IEC 62304 5.2.2 - Software Requirements Cont


Thanks, John.