Superseded
Standard
Historical
ISO 14971:2007
Medical devices - Application of risk management to medical devices
Preview
Summary
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.
Technical characteristics
| Publisher | International Electrotechnical Commission (IEC) |
| Publication Date | 03/31/2007 |
| Release Date | 03/31/2007 |
| Cancellation Date | 12/10/2019 |
| Edition | 2 |
| Page Count | 98 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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Previous versions
31/03/2007
Superseded
Historical
31/03/2003
Superseded
Historical
10/12/2019
Active
Most Recent
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