Does your medical device product include a software component? Do you use IEC 62304, “Medical device software – Software life cycle processes,” in your business? Then you’ll want to purchase and review the new IEC/TR 80002-3 report “Medical device software – Part 3: Process reference model of medical device software life cycle processes (IEC 62304).”
This 2014 Edition provides you with a review of the framework for software life cycle processes called PRM (process reference model). It supports safe design and maintenance of medical device software. And it’s compliant with the requirements of ISO/IEC 24774, “Systems and Software Engineering – Life Cycle Management – Guidelines for Process Description.”
The nice thing about this new technical report is that it can be used both to develop your software and to provide the basis for auditing it as well. Since the document maps the IEC 62304 with the ISO/IEC 12207 on software life cycle processes, it is an integrated approach to software development.
As for the structure of the new publication, it covers the usual scope, referenced documents and terms and definitions sections at first. Then it dives right into the various medical device software life cycle processes, with special attention to the 3 classes of safety you’ll need to address:
- Class A: no injury or damage to health is possible
- Class B: non-serious injury is possible
- Class C: death or serious injury is possible
Special attention is given to four areas: software maintenance, software risk management, software configuration management and software problem resolution. You’ll get detailed information on both the purpose and possible outcomes for each.
Annex A shows how the report was developed, using the structure of both the IEC 62304 and the ISO/ISO 12207 to map an appropriate path for this type of software development. Annex B fleshes this out, with a complete mapping of the two standards on a clause by clause basis. Columns for the three safety classes show you where each clause may affect your safety requirements as well.
If you need a copy of this new Technical Report, or any ISO, IEC or ISO/IEC standard, go to the Document Center Inc. webstore at www.document-center.com. We’ve been an authorized dealer of these standards for many years and can provide you with both paper format or pdf download copies, depending on your needs. Feel free to contact our staff via phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Our many years in the standards business means that we can help you with many of the problems you might encounter using this type of information. Make us your Standards Experts!
