Statements (57)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:International_Standard
|
| gptkbp:appliesTo |
Medical device manufacturers
In vitro diagnostic medical device manufacturers |
| gptkbp:hasAnnex |
gptkb:Annex_K
gptkb:Annex_I gptkb:Annex_V gptkb:Annex_L gptkb:Annex_M Annex A Annex B Annex C Annex D Annex F Annex E Annex G Annex H Annex J Annex N Annex O Annex P Annex Q Annex R Annex S Annex T Annex U Annex W Annex X Annex Y Annex Z |
| https://www.w3.org/2000/01/rdf-schema#label |
ISO 14971:2019
|
| gptkbp:language |
gptkb:French
English |
| gptkbp:partOf |
ISO 14971 series
|
| gptkbp:publicationYear |
2019
|
| gptkbp:publishedBy |
gptkb:International_Electrotechnical_Commission
gptkb:International_Organization_for_Standardization |
| gptkbp:relatedTo |
gptkb:ISO_13485
gptkb:US_FDA_regulations European Medical Device Regulation (MDR) ISO/TR 24971:2020 |
| gptkbp:replacedBy |
ISO 14971:2007
|
| gptkbp:scope |
Specifies a process for manufacturers to identify the hazards associated with medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
|
| gptkbp:standardNumber |
gptkb:ISO_14971:2019
|
| gptkbp:status |
Current
|
| gptkbp:subjectArea |
Medical devices
Risk management |
| gptkbp:title |
Medical devices — Application of risk management to medical devices
|
| gptkbp:usedBy |
Regulatory authorities
Medical device industry Notified bodies |
| gptkbp:usedFor |
Risk analysis
Regulatory compliance Quality management systems Risk control Risk evaluation |
| gptkbp:bfsParent |
gptkb:ISO_14971
|
| gptkbp:bfsLayer |
6
|