IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 5.1.12: 5.1.12 Identification and avoidance of common software defects

The plan contains, or points to, a procedure for identifying which categories of defect the chosen programming technology could introduce that matter for the software system, and for recording evidence that such defects do not add to risk beyond what is acceptable; IEC TR 80002-1 Annex B is one source of categories. Applies to classes B and C.

Maintained by Gerard BlokdykControl text last updated

What else in your programme already covers this

This control maps to 2 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • A.12 Table A.12: coding standards
  • A.15 Table A.15: suitable programming languages

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Clause 5: software development process – IEC 62304:2015 Medical Device Software Lifecycle Processes

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