Statements (23)
Predicate | Object |
---|---|
gptkbp:instanceOf |
gptkb:standard
|
gptkbp:appliesTo |
standalone software
health IT systems |
gptkbp:covers |
risk management
product safety lifecycle requirements product security |
gptkbp:focusesOn |
health software
|
gptkbp:fullName |
gptkb:IEC_82304_Health_Software_–_General_requirements_for_product_safety
|
https://www.w3.org/2000/01/rdf-schema#label |
IEC 82304 Health Software
|
gptkbp:language |
English
|
gptkbp:publishedBy |
gptkb:International_Electrotechnical_Commission
|
gptkbp:relatedTo |
gptkb:IEC_62304
|
gptkbp:releaseDate |
2016
|
gptkbp:scope |
safety and security of health software products
|
gptkbp:standardNumber |
gptkb:IEC_82304-1
|
gptkbp:status |
active
|
gptkbp:targetAudience |
healthcare providers
regulators manufacturers of health software |
gptkbp:usedIn |
medical device software development
|
gptkbp:bfsParent |
gptkb:IEC_82304
|
gptkbp:bfsLayer |
6
|