Statements (23)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:standard
|
| gptkbp:appliesTo |
health apps
standalone software |
| gptkbp:category |
software engineering
health informatics |
| gptkbp:focusesOn |
product safety
quality requirements |
| gptkbp:fullTitle |
gptkb:Health_software_–_Part_1:_General_requirements_for_product_safety
|
| https://www.w3.org/2000/01/rdf-schema#label |
IEC 82304-1
|
| gptkbp:language |
English
|
| gptkbp:publicationYear |
2016
|
| gptkbp:publishedBy |
gptkb:International_Electrotechnical_Commission
|
| gptkbp:relatedTo |
gptkb:IEC_62304
|
| gptkbp:scope |
health software
|
| gptkbp:standardNumber |
gptkb:IEC_82304-1:2016
|
| gptkbp:status |
published
|
| gptkbp:usedBy |
healthcare providers
regulatory authorities software manufacturers |
| gptkbp:usedIn |
medical device software development
|
| gptkbp:website |
https://webstore.iec.ch/publication/26409
|
| gptkbp:bfsParent |
gptkb:International_Electrotechnical_Commission
|
| gptkbp:bfsLayer |
5
|