| Date: |  Sun, 23 Apr 2006 00:37:49 +0300 | 
| From: |  Diomidis Spinellis <dds@aueb.gr> | 
| Organization: |  Athens University of Economics and Business | 
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| Newsgroups: |  comp.software-eng | 
| Subject: |  Re: Device Specification for Software device | 
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| In-Reply-To: |  <1145556484.692598.194160@z34g2000cwc.googlegroups.com> | 
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viskul@gmail.com wrote:
> I work for a firm that develops software and hardware for medical
> field. We have been trying to get documentation done for our open
> projects. But looks like there is a big confusion regarding Device
> Specification, Software Requirement specification and system
> requirement specification. Looks like there is ambiguity regarding what
> these documents are and what is the scope of all these documents. I
> would really appreciate if anyone can help me in this matter. And if
> some has an example device specification that is FDA audited, can that
> be forwarded to me. I would really appreciate for the help possible.
IEEE Std 1012:1998 and IEEE Std 610.12:1990 define the software 
requirements specification as "documentation of the essential 
requirements (i.e., functions, performance, design constraints, and 
attributes) of the software and its external interfaces. The software 
requirements are derived from the system specification."
A system is broader and includes hardware, firmware and software 
(MIL-STD-188) and could also include (in the sense of an information 
system) people and data.  Therefore your system requirement 
specification could for example specify the competence level of the 
software's users.  I would classify what you term "device specification" 
under the hardware specification.
One could say that hardware and software specifications are part of the 
system specification, but in practice it is common to draft the system 
specification in broader terms, and prepare separate documents for the 
software and hardware specifications.
-- 
Diomidis Spinellis
Code Quality: The Open Source Perspective (Addison-Wesley 2006)
http://www.spinellis.gr/codequality?cse
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