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ISO 10993-7:2026 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

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ISO 18374:2025

ISO 18374:2025 Dentistry — Artificial intelligence (AI) and augmented intelligence (AuI) based 2D radiograph analysis — Data generation, data annotation and data processing

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This publication was last reviewed and confirmed in 2025.

Dentistry — Artificial intelligence (AI) and augmented intelligence (AuI) based 2D radiograph analysis — Data generation, data annotation and data processing

Description

This document defines the requirements for developing and documenting the goals, limitations, target end users and target patient population for artificial intelligence (AI) and augmented intelligence (AuI) enabled 2D radiograph analysis software for dentistry applications. It outlines the requirements for appropriate training data, validation data, test data and annotation for the software to ensure that it achieves its intended goals, and is restricted to the aspects. This document does not cover the specific implementation details, and focuses on static (i.e. non-dynamic) AI/AuI.

Edition

1

Published Date

2026-06-19

Status

PUBLISHED

Pages

13

Language Detail Icon

English

Format Secure Icon

Secure PDF

Abstract

This document defines the requirements for developing and documenting the goals, limitations, target end users and target patient population for artificial intelligence (AI) and augmented intelligence (AuI) enabled 2D radiograph analysis software for dentistry applications. It outlines the requirements for appropriate training data, validation data, test data and annotation for the software to ensure that it achieves its intended goals, and is restricted to the aspects. This document does not cover the specific implementation details, and focuses on static (i.e. non-dynamic) AI/AuI.

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