ISO 14971:2007 Withdrawn
Medical devices - Application of risk management to medical devices
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.
Look inside
Additional information
| Publication type | International Standard |
|---|---|
| Publication date | 2007-03-31 |
| Withdrawal date | 2019-12-10 |
| Edition | 2.0 |
| Available language(s) | English, French, Russian |
| TC/SC | TC 62/SC 62A - Common aspects of medical equipment, software, and systemsrss |
| ICS | 11.040.01 - Medical equipment in general |
| Stability date | 2019 |
| Pages | 98 |
| File size | 1721 KB |
The following test report forms are related:
More information
Share this page
Share your publications
Learn how to share your publications with your colleagues, using networking options.
Payment information
Our prices are in Swiss francs (CHF). We accept all major credit cards (American Express, Mastercard and Visa, JCB and CUP), PayPal and bank transfers as form of payment.
Keep in touch
Keep up to date with new publication releases and announcements with our free IEC Just Published email newsletter.
Contact customer services
Please send your enquiry by email or call us on +41 22 919 02 11 between 09:00 – 16:00 CET Monday to Friday.