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IEC/TR 80002-3:2014

Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

Standard Details

- address areas already covered by existing related StandardDetails, e.g. the international StandardDetails that relate to the four StandardDetails used to build this TR (see Bibliography);
- FDA guidance documents; or
- software development tools. This TR describes the process reference model for medical device software development and is limited in scope to the life cycle processes described in IEC 62304:2006. The process names correspond to those of IEC 62304:2006. The mappings provided in Annex B are essential for the alignment between IEC 62304:2006 (which is based on ISO/IEC 12207:1995) and ISO/IEC 12207:2008, developed to address the detailed normative relationship between the two StandardDetails. This technical report is not intended to be used as the basis of regulatory inspection or certification assessment activities.

General Information

Status : Published
Standard Type: Main
Document No: IEC/TR 80002-3:2014
Document Year: 2014
Pages: 23
Edition: 1
  • Section Volume:
  • ISO/TC 210. Quality management and corresponding general aspects for medical devices
  • ICS:
  • 11.040.01 Medical equipment in general
  • 35.240.80 IT applications in health care technology

Life Cycle

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IEC/TR 80002-3:2014
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