ISO 14971:2007 PDF Download
Standard EN Sample
Medical devices — Application of risk management to medical devices
Also Known As:
SKU915498699
Published by
International Organization for Standardization
ISO
Publication Date2007-03
Pages CountPages90
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.
Details
History and complementary documents
History
| Edition | 2 |
| ICS Codes | 11.040.01 - Medical equipment in general |
| Language(s) | English |
| File Size | 1.4 MB |
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