Statements (22)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:standard
|
| gptkbp:appliesTo |
medical devices
in vitro diagnostic medical devices |
| gptkbp:equivalentTo |
ISO 14971:2007
|
| gptkbp:fullTitle |
Medical devices – Application of risk management to medical devices
|
| gptkbp:harmonizedWith |
In Vitro Diagnostic Directive (IVDD)
Medical Device Directive (MDD) Active Implantable Medical Device Directive (AIMDD) |
| https://www.w3.org/2000/01/rdf-schema#label |
EN ISO 14971:2012
|
| gptkbp:language |
gptkb:French
gptkb:German English |
| gptkbp:publicationYear |
2012
|
| gptkbp:publishedBy |
gptkb:European_Committee_for_Standardization_(CEN)
gptkb:International_Organization_for_Standardization_(ISO) |
| gptkbp:replacedBy |
EN ISO 14971:2009
EN ISO 14971:2019 |
| gptkbp:scope |
risk management for medical devices
|
| gptkbp:standardNumber |
gptkb:EN_ISO_14971:2012
|
| gptkbp:status |
withdrawn
|
| gptkbp:bfsParent |
gptkb:ISO_14971
|
| gptkbp:bfsLayer |
6
|