PD CEN ISO/TS 24971-2:2026

This standard PD CEN ISO/TS 24971-2:2026 Medical devices. Guidance on the application of ISO 14971 is classified in these ICS categories:

• 35.240.80 IT applications in health care technology
• 35.240.01 Application of information technology in general
• 11.040.01 Medical equipment in general

This document provides guidance on risks specific to artificial intelligence (AI) and machine learning (ML) and how to apply the risk management process of ISO 14971 to ML-enabled medical devices (MLMD). This document is intended to be used in conjunction with ISO 14971 and ISO/TR 24971[2]. This document does not apply to MLMD employing large language models (LLM) or generative AI.

PD CEN ISO/TS 24971-2:2026 - Medical Devices Guidance on the Application of ISO 14971 in Machine Learning and Artificial Intelligence

In the rapidly evolving world of medical technology, the integration of machine learning and artificial intelligence (AI) into medical devices is not just a trend, but a necessity. The PD CEN ISO/TS 24971-2:2026 standard provides comprehensive guidance on the application of ISO 14971, specifically tailored for the incorporation of machine learning and AI in medical devices. This document is an essential resource for manufacturers, developers, and regulatory bodies involved in the design and implementation of AI-driven medical technologies.

Key Features of the Standard

• Standard Number: PD CEN ISO/TS 24971-2:2026
• Pages: 42
• Release Date: June 24, 2026
• ISBN: 978 0 539 30263 9
• Status: Standard

Why This Standard is Essential

The integration of AI and machine learning into medical devices presents unique challenges and opportunities. This standard provides a structured approach to risk management, ensuring that these technologies are implemented safely and effectively. By adhering to the guidelines set forth in this document, organizations can enhance the reliability and performance of their AI-driven medical devices, ultimately improving patient outcomes.

Comprehensive Guidance

The PD CEN ISO/TS 24971-2:2026 offers detailed guidance on the application of ISO 14971, focusing on the specific needs and challenges associated with machine learning and AI. It covers a wide range of topics, including:

• Risk management processes tailored for AI and machine learning technologies.
• Strategies for identifying and mitigating potential risks associated with AI-driven medical devices.
• Guidelines for ensuring compliance with regulatory requirements.
• Best practices for the development and deployment of AI technologies in the medical field.

Enhancing Safety and Performance

Safety is paramount in the medical field, and this standard emphasizes the importance of a robust risk management framework. By following the guidance provided, organizations can ensure that their AI-driven medical devices meet the highest safety standards, minimizing the risk of adverse events and enhancing overall device performance.

Facilitating Innovation

While safety is a primary concern, innovation is the driving force behind advancements in medical technology. The PD CEN ISO/TS 24971-2:2026 standard encourages innovation by providing a clear framework for the safe and effective integration of AI and machine learning into medical devices. This allows developers to push the boundaries of what is possible, creating cutting-edge solutions that improve patient care.

Who Should Use This Standard?

This standard is designed for a wide range of stakeholders in the medical device industry, including:

• Medical device manufacturers looking to integrate AI and machine learning into their products.
• Regulatory bodies responsible for overseeing the safety and efficacy of medical technologies.
• Research and development teams focused on creating innovative AI-driven medical solutions.
• Quality assurance professionals tasked with ensuring compliance with industry standards.

Conclusion

The PD CEN ISO/TS 24971-2:2026 standard is an invaluable resource for anyone involved in the development, implementation, or regulation of AI-driven medical devices. By providing clear guidance on the application of ISO 14971, this document helps ensure that these technologies are used safely and effectively, ultimately leading to better patient outcomes and advancing the field of medical technology.

Stay ahead in the rapidly evolving world of medical technology by integrating the principles of this standard into your processes. Embrace the future of healthcare with confidence, knowing that your AI-driven medical devices are built on a foundation of safety, innovation, and excellence.