|
gptkbp:instanceOf
|
gptkb:International_Standard
|
|
gptkbp:appliesTo
|
gptkb:Regulators
Conformity assessment bodies
Manufacturers of medical devices
|
|
gptkbp:category
|
Medical device standards
Risk management standards
|
|
gptkbp:citation
|
https://www.iso.org/standard/72704.html
|
|
gptkbp:compatibleWith
|
In vitro diagnostic devices (in some jurisdictions)
|
|
gptkbp:defines
|
Risk management process for medical devices
|
|
gptkbp:firstPublished
|
2000
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
ISO 14971
|
|
gptkbp:includes
|
Risk analysis
Evaluation of overall residual risk
Production and post-production information
Risk control
Risk evaluation
|
|
gptkbp:language
|
gptkb:French
gptkb:German
English
|
|
gptkbp:latestReleaseVersion
|
gptkb:ISO_14971:2019
2019
|
|
gptkbp:publishedBy
|
gptkb:International_Electrotechnical_Commission
gptkb:International_Organization_for_Standardization
|
|
gptkbp:recognizedBy
|
gptkb:European_Union
gptkb:United_States_Food_and_Drug_Administration
|
|
gptkbp:relatedStandard
|
gptkb:EN_ISO_14971
gptkb:ISO/TR_24971
|
|
gptkbp:replacedBy
|
gptkb:EN_ISO_14971:2012
|
|
gptkbp:scope
|
Risk management for medical devices throughout the product lifecycle
|
|
gptkbp:standardNumber
|
gptkb:ISO_14971
|
|
gptkbp:status
|
Active
|
|
gptkbp:subject
|
Medical devices
Risk management
|
|
gptkbp:title
|
Medical devices — Application of risk management to medical devices
|
|
gptkbp:usedFor
|
CE marking of medical devices
Compliance with regulatory requirements
|
|
gptkbp:bfsParent
|
gptkb:ISO_standards
|
|
gptkbp:bfsLayer
|
5
|