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Norm
ÖNORM EN ISO 14971
Issue date: 2013 03 01
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
This International Standard specifies a process for a manufacturer to identify the hazards associated with
medical devices, including in vitro diagnostic (IVD) medical d...
Withdrawn: 2020 06 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 109 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
This International Standard specifies a process for a manufacturer to identify the hazards associated with
medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated
risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this International Standard are applicable to all stages of the life-cycle of a medical
device.
This International Standard does not apply to clinical decision making.
This International Standard does not specify acceptable risk levels.
This International Standard does not require that the manufacturer have a quality management system in
place. However, risk management can be an integral part of a quality management system.
ÖVE/ÖNORM EN ISO 14971
2022 05 15
Medical devices - Application of risk management to medical devices (ISO 14971:2019) (consolidated v...
Norm
ÖVE/ÖNORM EN ISO 14971
2020 06 01
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Norm
ÖNORM EN ISO 14971
2013 03 01
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected versi...
Norm
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ÖNORM EN ISO 14971
2009 12 15
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected versi...
Norm
ÖNORM EN ISO 14971
2007 06 01
Medical devices - Application of risk management to medical devices (ISO 14971:2007)
Norm
ÖNORM EN ISO 14971
2003 10 01
Medical devices - Application of risk management to medical devices (ISO 14971:2000, EN ISO 14971:20...
Norm
ÖNORM EN ISO 14971/A1
2003 09 01
Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for req...
Norm
ÖNORM EN ISO 14971
2001 04 01
Medical devices - Application of risk management to medical devices (ISO 14971:2000)
Norm
Norm
Issue date :
2020 06 01
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Norm
Issue date :
2007 02 28
Medical devices — Application of risk management to medical devices (Corrected version 2007-09)
