ISO 14971:2007
Medical devices -- Application of risk management to medical devices
Media and price
| Language | Format | Add to basket |
|---|---|---|
| English | PDF (1 331 kB) | CHF 192,00 |
| English | Paper | CHF 192,00 |
| French | PDF (1 620 kB) | CHF 192,00 |
| French | Paper | CHF 192,00 |
General information
Number of Pages: 82
| Edition: 2 (Monolingual) | ICS: 11.040.01 |
| Status: Published | Stage: 90.20 (2010-01-15) |
| TC/SC: TC 210 |
Abstract
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.
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