Statements (24)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:standard
|
| gptkbp:adoptedBy |
gptkb:European_Union
|
| gptkbp:appliesTo |
medical device
|
| gptkbp:basedOn |
gptkb:IEC_62304
|
| gptkbp:category |
medical device
|
| gptkbp:fullName |
EN 62304:2006 Medical device software – Software life cycle processes
|
| https://www.w3.org/2000/01/rdf-schema#label |
EN 62304
|
| gptkbp:language |
English
|
| gptkbp:publicationYear |
2006
|
| gptkbp:publishedBy |
gptkb:European_Committee_for_Electrotechnical_Standardization
|
| gptkbp:region |
gptkb:Europe
|
| gptkbp:relatedTo |
gptkb:ISO_13485
gptkb:ISO_14971 |
| gptkbp:requires |
software configuration management
software risk management software problem resolution process software development planning software maintenance process |
| gptkbp:scope |
software development lifecycle for medical devices
|
| gptkbp:status |
harmonized standard in the European Union
|
| gptkbp:updated |
EN 62304:2006/A1:2015
|
| gptkbp:usedFor |
CE marking of medical devices
|
| gptkbp:bfsParent |
gptkb:EN_Standards
|
| gptkbp:bfsLayer |
6
|