Over deze norm
||Medische elektrische toestellen
NPR-IEC/TR 80002-3, which is a technical report (TR), provides the description of software life cycle processes for medical devices. The medical device software life cycle processes are derived from IEC 62304:2006, with corresponding safety classes. They have been aligned with the software development life cycle processes of ISO/IEC 12207:2008 and are presented herein in full compliance with ISO/IEC 24774:2010. The content of these three standards provides the foundation of this TR. This TR does not address: - areas already covered by existing related standards, e.g. the international standards that relate to the four standards used to build this TR (see Bibliography); - FDA guidance documents; or - software development tools. This TR describes the PRM 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 standards. This technical report is not intended to be used as the basis of regulatory inspection or certification assessment activities.
||Software voor medische hulpmiddelen - Deel 3: Werkwijze van het referentiemodel van de levensduur van software voor medische hulpmiddelen
||Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)