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Norm
ISO 14971:2007
Issue date: 2007 02 28
Medical devices — Application of risk management to medical devices (Corrected version 2007-09)
ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to est...
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Withdrawn
: 2019 12 10
Publisher:
International Organization for Standardization
Format:
Digital | 82 Pages
Language:
English
Currently valid:
ICS
ISO 14971:2007 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 ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.
ISO 14971:2007
2007 02 28
Medical devices — Application of risk management to medical devices (Corrected version 2007-09)
Norm
↖
ISO 14971:2000/Amd 1:2003
2003 02 19
Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for req...
Norm
ISO 14971-1:1998
1998 10 01
Medical devices — Risk management — Part 1: Application of risk analysis
Norm
Norm
ISO 14971:2019
Issue date :
2019 12 10
Medical devices — Application of risk management to medical devices