Statements (18)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:International_Standard
|
| gptkbp:appliesTo |
medical devices
|
| gptkbp:focusesOn |
quality management systems
|
| https://www.w3.org/2000/01/rdf-schema#label |
ISO 13485:2003
|
| gptkbp:language |
gptkb:French
English |
| gptkbp:partOf |
ISO 13485 series
|
| gptkbp:publicationYear |
2003
|
| gptkbp:publishedBy |
gptkb:International_Organization_for_Standardization
|
| gptkbp:replacedBy |
gptkb:ISO_13485:2016
EN 46001 EN 46002 |
| gptkbp:scope |
requirements for a quality management system for medical devices
|
| gptkbp:status |
withdrawn
|
| gptkbp:title |
gptkb:Medical_devices_—_Quality_management_systems_—_Requirements_for_regulatory_purposes
|
| gptkbp:usedFor |
regulatory purposes
|
| gptkbp:bfsParent |
gptkb:ISO_13485:2016
|
| gptkbp:bfsLayer |
7
|