SS ISO 14971:2020(2025)
Medical devices — Application of risk management to medical devices
OVERVIEW
This standard specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
COMMENTS
This standard was first published in 2020. It was confirmed without any changes in 2025.
PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2020(2025) |
| No. of Pages | 49 |
| ICS Classification | 11.040.01 Medical equipment in general |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | Global |
| Adoption | ISO 14971 : 2020 IDT |