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ISO 14971 (2007-03)
ISO 14971:2007 Medical devices - Application of risk management to medical devicesMore info
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.
| Author | ISO |
|---|---|
| Editor | ISO |
| Document type | Standard |
| Format | File |
| Edition | 2.0 |
| ICS | 11.040.01 : Medical equipment in general |
| Number of pages | 98 |
| Year | 2007 |
| Country | Switzerland |
| Keyword | IEC14971;ISO 14971:2007 |