Implementing a software development process, ISO/IEC 12207

[Scs78]

I have been appointed to implement a software process for a company producing medical devices to class IIb. Using the 60601-1-4 as the general guideline, I have been instructed that the the software process should be based on ISO/IEC 12207.

The actual question is about ISO/IEC 12207; I want to buy it, but in the online shop there are three 12207 standard versions: 12207:1995, 12207:1995 / Amd 1: 2002, and 12207:1995 / Amd 2: 2004. The number of pages are 57, 53, and 8, respectively. Should I buy all of them in order to have the up-to-date information? Has the standard really been almost doubled in size in the Amd 1:2002, or am I missing something?

TIA, L

 

[45fan]

All three

You will need all three if the page counts are truly as you stated, however, the majority of amendment 1 is "informative", meaning that the information provided does not describe any new or modified requirements. There are 3 pages that modify the actual standard. The other 50 pages are annexes.

I do not have Amendment 2 so I can't comment on that, but an amendment usually, if not always, has important updates to the requirements. Otherwise there is no need for an additional publication.

You can buy the complete document including all amendments from various sources. One that I use is Global Engineering Documents, Global Home Page

Good luck