BS EN ISO 14971:2019+A11:2021

What is ISO 14971 - Application of risk management to medical devices about?

Recognized by regulatory authorities in the US, Canada, Europe, and more, ISO 14971 is the international standard that helps medical device manufacturers establish, document, and maintain a systematic risk management process across all phases of the lifecycle of a medical device.

The use of ISO 14971 for risk management of medical devices helps streamline the regulatory processes that enable entry to selected markets.

Who is ISO 14971 - Application of risk management to medical devices for?

ISO 14971 for risk management of medical devices will be used by all parts of the medical device industry, and by organizations dealing with the design, development, production, installation, or servicing of medical equipment, devices, and technology.

Why should you use ISO 14971 - Application of risk management to medical devices?

ISO 14971 specifies terminology, principles, and a process for medical devices risk management, including software as a medical device and in vitro diagnostic medical devices.

The process described will help medical device manufacturers:

• Identify the hazards associated with the medical device
• Estimate and evaluate the associated risks
• Control these risks
• Monitor the effectiveness of the controls

ISO 14971 requirements apply to all phases of the life cycle of a medical device. The process described applies to risks associated with a medical device, such as those related to biocompatibility, data, and systems security, electricity, moving parts, radiation, and usability. It 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 lifecycle.

ISO 14971 does not apply to:

• Decisions on the use of a medical device in the context of any particular clinical procedure; or
• Business risk management

This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.

Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place.