This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels. This document does not apply to: - decisions on the use of a medical device in the context of any particular clinical procedure or - business risk management.

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. 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 requirements of this document are applicable to all phases of the life cycle of a medical device. 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. This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. ISO 14971:2019 Medical devices - Application of risk management to medical devices To find additional standards, please use the search bar above. If you or your organization are interested in easy, managed, online access to standards that can be shared, a Standards Subscription may be what you need - please contact us at: or 1-21 or Request Proposal Price.īelow are ISO's best-selling standards. Standards from ISO are available both individually, directly through the ANSI webstore, and as part of a Standards Subscription. As the largest developer and publisher of standards in the world, ISO fills the vital role of a medium for agreement between individual standards developers, spreading progress made by one country's local developers across the world to further the goal of standardization. Headquartered in Geneva, Switzerland, ISO is composed of 162 members, each one the sole representative for their home country. ISO, the International Organization for Standardization, is a nonprofit organization that develops and publishes standards of virtually every possible sort, ranging from standards for information technology to fluid dynamics and nuclear energy.

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