|
gptkbp:instanceOf
|
gptkb:International_Standard
|
|
gptkbp:appliesTo
|
gptkb:software_as_a_medical_device_(SaMD)
medical device
|
|
gptkbp:category
|
medical device standards
|
|
gptkbp:defines
|
software configuration management requirements
software development process requirements
software maintenance process requirements
software problem resolution process
software risk management requirements
|
|
gptkbp:firstPublished
|
2006
|
|
gptkbp:focusesOn
|
medical device software lifecycle processes
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
IEC 62304
|
|
gptkbp:language
|
English
|
|
gptkbp:latestReleaseVersion
|
gptkb:IEC_62304:2006+A1:2015
|
|
gptkbp:partOf
|
gptkb:IEC_60601_series
|
|
gptkbp:publishedBy
|
gptkb:International_Electrotechnical_Commission
|
|
gptkbp:recognizedBy
|
software safety classes
|
|
gptkbp:referencedIn
|
gptkb:ISO_13485
gptkb:FDA_guidance
|
|
gptkbp:requires
|
risk management according to ISO 14971
|
|
gptkbp:scope
|
all software used in medical devices
embedded medical software
standalone medical software
|
|
gptkbp:standardNumber
|
gptkb:IEC_62304
|
|
gptkbp:status
|
active
|
|
gptkbp:usedBy
|
medical device manufacturers
|
|
gptkbp:bfsParent
|
gptkb:International_Electrotechnical_Commission
gptkb:IEC_Standards
gptkb:IEC
|
|
gptkbp:bfsLayer
|
5
|