MISRA equivalent for medical industry? [closed]

Asked 5/12, 2012 at 13:4 Answered 20/12, 2012 at 15:6

Pretty much as the title, is there a medical industry equivalent document, standard or set of either to the auto industry's MISRA?

I'm working in the area of C, but anything language agnostic would be good too

Anode answered 5/12, 2012 at 13:4 Comment(0)

Further to the earlier answers, I'd be interested to know why you feel MISRA would not be suitable?

Yes, I accept fully that MISRA-C:1998 was titled and targeted at Vehicle Based Software but the second edition in 2004 has already changed to Guidelines for the Use of the C Language in Critical Systems, and as such MISRA is applicable to all industries - and (for example) is a reference document for the Joint Strike Fighter coding standards.

MISRA-C has most definitely been adopted by the nuclear and medical industries.

And (putting my MISRA Working Group member hat on for one moment, although I'm posting in a personal capacity only) if there are any specific issues relating to MISRA-C's application to medical devices, then I'm happy to discuss here and/or raise with the team.

Kibbutznik answered 20/12, 2012 at 15:6 Comment(6)

Havent actually read MISRA yet. Early research indicated it was a transport system guidelines and medical devices'generally' tend to be slightly more restrictive (or just different). MISRA might very well do the job, I just wondered if there was a more specific general use document in use by the med industry – Anode 9/1, 2013 at 21:19

Any progress in your research? MISRA should be suitable for you, but do get in touch if you need any further reassurance – Kibbutznik 10/2, 2013 at 6:50

Andrew, I've adopted MISRA for now, but with a fairly lenient deviation policy. When might we see a release for C3 do you think? – Anode 12/2, 2013 at 16:0

The official line for C3 is as follows: "MISRA C:2012 is now nearing completion, and will be available via the MISRA website by Easter 2013. An official update, with all relevant details relating to the new version, will be made on 26 February 2013. This information will be available via all MISRA channels (web site, newsletter) and at Embedded World 2013." – Kibbutznik 13/2, 2013 at 16:51

As an update to my previous comment, and just in case you've not seen the official news, MISRA C:2012 was launched at Embedded World, and can now be purchased :) – Kibbutznik 30/5, 2013 at 11:48

thanks for dropping back :) Yes I saw an article recently about it (cant remember where). – Anode 30/5, 2013 at 17:40

You should use "MISRA-C:2004 Guidelines for the use of the C language in critical systems". There is nothing in MISRA-C that doesn't apply to med tech programs.

It is not directed to the automotive industry specifically, it was merely invented by them.

Digitoxin answered 5/12, 2012 at 15:23 Comment(0)

Not that I'm aware of. Medical device industry is much less organized around coding standards, each company having its own process.

Disendow answered 5/12, 2012 at 13:53 Comment(0)

Why don't you just adopt a subset of MISRA?

Instantaneous answered 5/12, 2012 at 13:55 Comment(0)

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