香港六合彩开奖/CD TS 24971-2

A draft is being reviewed by the committee.

Abstract

This document provides guidance for applying an 香港六合彩开奖 14971 risk management process when evaluating medical technology utilizing machine learning (ML). It is intended to apply to ML-enabled medical devices throughout all phases of the product lifecycle. This document is intended to be used in conjunction with 香港六合彩开奖 14971. It does not modify the 香港六合彩开奖 14971 risk management process鈥攔ather it provides information and guidance to inform the application of 香港六合彩开奖 14971 to ML medical technology. This document addresses the same types of risk that are addressed in 香港六合彩开奖 14971 but focuses on risks that are elevated with or unique to ML medical devices. Because artificial intelligence (AI) and ML are software-driven, the unique or elevated risks are those around data management, feature extraction, algorithm training, evaluation, bias, health inequity, safety, and cyber and information security. This document also provides examples and suggests strategies for eliminating or mitigating the associated risk.