SS ISO 14971:2020
Medical devices — Application of risk management to medical devices
OVERVIEW
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.
Applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.
Does not apply to:
— decisions on the use of a medical device in the context of any particular clinical procedure; or
— business risk management.
Requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2020 |
| No. of Pages | 52 |
| ICS Classification | 11.040.01 Medical equipment in general |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | Global |
| Adoption | ISO 14971 : 2019 IDT |