Statements (23)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:standard
|
| gptkbp:appliesTo |
medical devices
|
| gptkbp:category |
medical device standards
|
| gptkbp:firstPublished |
2000
|
| gptkbp:fullTitle |
Medical devices — Application of risk management to medical devices
|
| gptkbp:harmonizedWith |
gptkb:In_Vitro_Diagnostic_Regulation_(IVDR)
Medical Device Regulation (MDR) |
| gptkbp:language |
gptkb:French
gptkb:German English |
| gptkbp:latestReleaseVersion |
EN ISO 14971:2019
|
| gptkbp:publishedBy |
gptkb:International_Organization_for_Standardization
gptkb:European_Committee_for_Standardization |
| gptkbp:region |
gptkb:Europe
International |
| gptkbp:relatedStandard |
gptkb:ISO_13485
|
| gptkbp:replacedBy |
gptkb:EN_ISO_14971:2012
|
| gptkbp:scope |
risk management for medical devices
|
| gptkbp:status |
active
|
| gptkbp:usedFor |
CE marking of medical devices in Europe
|
| gptkbp:bfsParent |
gptkb:ISO_14971
|
| gptkbp:bfsLayer |
7
|
| https://www.w3.org/2000/01/rdf-schema#label |
EN ISO 14971
|