Artificial Intelligence (AI)

Explore essential artificial intelligence standards published by AAMI, IEC, and ISO for a comprehensive understanding of AI systems. Learn about assessing capabilities, industry terminology, risk management, and key machine learning concepts. Stay informed with our insightful guide on AI standards.

ISO/IEC 23894:2023

Information technology - Artificial intelligence - Guidance on risk management

This document provides guidance on how organizations that develop, produce, deploy or use products, systems and services that utilize artificial intelligence (AI) can manage risk specifically related to AI. The guidance also aims to assist organizations to integrate risk management into their AI-related activities and functions. It moreover describes processes for the effective implementation and integration of AI risk management.


The application of this guidance can be customized to any organization and its context.

ISO/IEC 42001:2023

Information technology - Artificial intelligence - Management system

This document specifies the requirements and provides guidance for establishing, implementing, maintaining and continually improving an AI (artificial intelligence) management system within the context of an organization.


This document is intended for use by an organization providing or using products or services that utilize AI systems. This document is intended to help the organization develop, provide or use AI systems responsibly in pursuing its objectives and meet applicable requirements, obligations related to interested parties and expectations from them.


This document is applicable to any organization, regardless of size, type and nature, that provides or uses products or services that utilize AI systems.

ISO/IEC 23053:2022

Framework for Artificial Intelligence (AI) Systems Using Machine Learning (ML)

This document establishes an Artificial Intelligence (AI) and Machine Learning (ML) framework for describing a generic AI system using ML technology. The framework describes the system components and their functions in the AI ecosystem. This document is applicable to all types and sizes of organizations, including public and private companies, government entities, and not-for-profit organizations, that are implementing or using AI systems.

ISO/IEC 22989:2022

Information technology - Artificial intelligence - Artificial intelligence concepts and terminology

This document establishes terminology for AI and describes concepts in the field of AI.


This document can be used in the development of other standards and in support of communications among diverse, interested parties or stakeholders.


This document is applicable to all types of organizations (e.g. commercial enterprises, government agencies, not-for-profit organizations).

AAMI TIR34971:2023

Application of ISO 14971 to machine learning in artificial intelligence - Guide

This document provides guidance and intends to serve as a companion to ANSI/AAMI/ISO 14971:2019 for those performing risk management for machine learning (ML) or artificial intelligence (AI) incorporating medical devices.


Definitions/Characteristics of Artificial Intelligence in Health Care

This standard defines terms related to artificial intelligence and associated technologies in health care including assistive intelligence, synthetic data, remote patient monitoring, and artificial intelligence enabled diagnostic system. This file also includes a copy of CTA-2089.

ISO/IEC TR 24028:2020

Information technology - Artificial intelligence - Overview of trustworthiness in artificial intelligence

This document surveys topics related to trustworthiness in AI systems, including the following:

— approaches to establish trust in AI systems through transparency, explainability, controllability, etc.;

— engineering pitfalls and typical associated threats and risks to AI systems, along with possible mitigation techniques and methods; and

— approaches to assess and achieve availability, resiliency, reliability, accuracy, safety, security and privacy of AI systems.

The specification of levels of trustworthiness for AI systems is out of the scope of this document.

ISO/IEC TR 24030:2021

Information technology - Artificial intelligence (AI) - Use cases

This document provides a collection of representative use cases of AI applications in a variety of domains.