EN ISO 14971:2009
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
15-07-2009
21-03-2010
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.
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Standards | Relationship |
| DIN EN ISO 14971:2009-10 | Equivalent |
| BS EN ISO 14971:2009 | Equivalent |
| I.S. EN ISO 14971:2009 | Equivalent |
| BS EN ISO 14971:2009 | Identical |
| UNE-EN ISO 14971:2009 | Identical |
| I.S. EN 556-1:2024 | Sterilization of medical devices - Requirements for medical devices to be designated \"STERILE\" - Part 1: Requirements for terminally sterilized medical devices |
Access your standards online with a subscription
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.