BS/AAMI 34971:2023

What is BS AAMI 34971 - Application of ISO 14971 to machine learning in artificial intelligence - Guide about?

Artificial intelligence can bring many benefits to healthcare but can also present unique risks. To treat those appropriately, BSI and the US Association for the Advancement of Medical Instrumentation (AAMI) have jointly developed BS AAMI 34971:2023. This new document complements BS EN ISO 14971 on assessing and managing the risks associated with medical devices by giving additional guidance on applying ISO 14971 when evaluating medical technology using AI and particularly machine learning.

Who is BS AAMI 34971 - Application of ISO 14971 to machine learning in artificial intelligence - Guide for?

• Medical device manufacturers
• Medical AI software developers
• Regulatory bodies

What does BS AAMI 34971 - Application of ISO 14971 to machine learning in artificial intelligence - Guide cover?

BS AAMI 34971 covers how the hazards already identified in ISO 14971 could affect the safety and effectiveness of medical technology that incorporates machine-learning AI.

BS AAMI 34971 also provides examples, suggests strategies for eliminating or mitigating the associated risk and explores additional unique or emergent hazards/hazardous situations.

• NOTE: This document does not modify the risk management process—rather it provides information and guidance to inform the application of ISO 14971 to AI/ML medical technology.

Why should you use BS AAMI 34971 - Application of ISO 14971 to machine learning in artificial intelligence - Guide ?

BS AAMI 34971 identifies the particular hazards relating to AI that need to be considered in ISO 14971. As such it can help medical devices manufacturers to:

• Enter new markets
• Accelerate innovation
• Develop their expertise
• Improve efficiency
• Increase confidence in their devices
• Better manage the associated risk

BS AAMI 34971 contributes to UN Sustainable Development Goal 3 on good health and well-being, Goal 4 on quality education and Goal 9 on industry, innovation and infrastructure.

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