AS ISO 14971:2020
Medical devices — Application of risk management to medical devices
- Standard No.
- AS ISO 14971:2020
- Release Date
- 2020
- Published By
- Standard Association of Australia （SAA）
- Latest
- AS ISO 14971:2020
- Scope
- This document adopts ISO 14971:2019, which 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.
AS ISO 14971:2020 history
- 2020 AS ISO 14971:2020 Medical devices — Application of risk management to medical devices
