IEC 62304:2006 Definitions - Software System, a Software Element and Software Unit

[J0anne]

Re: IEC 62304:2006 Definitions - Software System, a Software Element and Software Uni

I don´t know how apply the terminology to my system. The IT department is programming in Java. For me the "Software Items" means the software modules and software units one line of source code. The "Software system" is the software item after the integration. Is that correct?

You will find your definitions for software items and software system at:
3.27 & 3.28 of 62304

They will give you the answer for the term 'element' for which there is no given definition within that standard.

 

[sagai]

Re: IEC 62304:2006 Definitions - Software System, a Software Element and Software Uni

It seems to me QMS is ISO terminology, QS is FDA terminology, the two are the same.
But thanks, I have not recognized it before.
br
Sz.

 

[sagai]

Re: IEC 62304:2006 Definitions - Software System, a Software Element and Software Uni

I don´t know how apply the terminology to my system. The IT department is programming in Java. For me the "Software Items" means the software modules and software units one line of source code. The "Software system" is the software item after the integration. Is that correct?

When you read the standard more than 10 times, spend some night with thinking about it, having chats with developers, and read and think it through again, dedicate some extra hours for this subject than you will know the answer and to all the others coming later.

Sz.

 

[c.mitch]

Re: IEC 62304:2006 Definitions - Software System, a Software Element and Software Uni

Hi all,

I work in a company which develops standalone software medical devices.
Let me explain you how we did it:
-the system is equal to the software system plus the hardware on which it runs, plus the people who use it.
-the software system is the set of programs (the java.exe executables running on the hardware).
-software items are packages (or the java classes, if the program is very small and is contained in one package). These packages are yours plus those of third party (like open source libraries)
-software units : the java classes (can not be subdivided in smaller parts)


The concept of system is important. It is the software plus everything around it. It helps understanding how the software is used in its environment. The 62304 talks about system requirements , which are "translated" into software by the software development process.

Hope it helps.

Bye.