CEN ISO/TR 22100-5:2022
(Main)Safety of machinery - Relationship with ISO 12100 - Part 5: Implications of artificial intelligence machine learning (ISO/TR 22100-5:2021)
Safety of machinery - Relationship with ISO 12100 - Part 5: Implications of artificial intelligence machine learning (ISO/TR 22100-5:2021)
This document addresses how artificial intelligence machine learning can impact the safety of machinery and machinery systems.
This document describes how hazards being associated with artificial intelligence (AI) applications machine learning in machinery or machinery systems, and designed to act within specific limits, can be considered in the risk assessment process.
This document is not applicable to machinery or machinery systems with AI applications machine learning designed to act beyond specified limits that can result in unpredictable effects.
This document does not address safety systems with AI, for example, safety-related sensors and other safety-related parts of control systems.
Sicherheit von Maschinen - Beziehung zu ISO 12100 - Teil 5: Auswirkungen von maschinellem Lernen mit künstlicher Intelligenz (ISO/TR 22100 5:2021)
Dieses Dokument befasst sich damit, wie sich der Einsatz von künstlicher Intelligenz für maschinelles Lernen auf die Sicherheit von Maschinen und Maschinensystemen auswirken kann.
Dieses Dokument beschreibt, wie Gefährdungen, die mit Anwendungen der künstlichen Intelligenz (KI) für maschinelles Lernen in Maschinen oder Maschinensystemen verbunden sind und innerhalb bestimmter Grenzen wirken sollen, im Risikobeurteilungsprozess berücksichtigt werden können.
Dieses Dokument ist nicht anwendbar auf Maschinen oder Maschinensysteme mit KI-Anwendungen für maschinelles Lernen, die so konstruiert sind, dass sie jenseits festgelegter Grenzen wirken, was zu unvorhersehbaren Auswirkungen führen kann.
Dieses Dokument gilt nicht für Sicherheitssysteme mit KI, z. B. sicherheitsrelevante Sensoren und andere sicherheitsrelevante Teile von Steuerungssystemen.
Sécurité des machines - En relation avec l'ISO 12100 - Partie 5: Implications de l’intelligence artificielle pour l’apprentissage automatique (ISO/TR 22100-5:2021)
Le présent document traite de la manière dont l’apprentissage automatique d’intelligence artificielle peut impacter la sécurité des machines et des systèmes de machines.
Le présent document décrit comment les phénomènes dangereux associés à l’apprentissage automatique par intelligence artificielle (IA) dans les machines ou les systèmes de machines conçues pour agir dans des limites spécifiques, peuvent être pris en considération dans le processus d’appréciation du risque.
Le présent document n’est pas applicable aux machines ou aux systèmes de machines pour lesquels l’apprentissage automatique des applications d’IA est conçu pour agir au-delà des limites spécifiées, ce qui peut conduire à des effets imprévisibles.
Le présent document ne traite pas des systèmes de sécurité avec une IA, par exemple, capteurs relatifs à la sécurité et autres parties relatives à la sécurité des systèmes de commande.
Varnost strojev - Povezava z ISO 12100 - 5. del: Učinki strojnega učenja umetne inteligence (ISO/TR 22100-5:2021)
Ta dokument obravnava načine, na katere lahko umetna inteligenca (strojno učenje) vpliva na varnost strojev in strojnih sistemov. Ta dokument opisuje, kako se lahko v postopku ocenjevanja tveganj upoštevajo nevarnosti, ki so povezane z aplikacijami umetne inteligence (AI) (strojnega učenja) pri strojih ali strojnih sistemih, zasnovanimi za delovanje znotraj določenih mejnih vrednosti. Ta dokument se ne uporablja za stroje ali strojne sisteme z aplikacijami umetne inteligence (strojnega učenja), zasnovanimi za delovanje zunaj določenih mejnih vrednosti, ki lahko povzročijo nepredvidljive učinke. Ta dokument ne obravnava varnostnih sistemov z umetno inteligenco, kot so z varnostjo povezana tipala in drugi z varnostjo povezani deli krmilnih sistemov.
General Information
- Status
- Published
- Publication Date
- 26-Apr-2022
- Technical Committee
- CEN/TC 114 - Safety of machinery
- Drafting Committee
- CEN/TC 114 - Safety of machinery
- Current Stage
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 27-Apr-2022
- Due Date
- 02-May-2023
- Completion Date
- 27-Apr-2022
Overview
CEN ISO/TR 22100-5:2022 (identical to ISO/TR 22100-5:2021) gives guidance on how artificial intelligence (AI) - specifically machine learning (ML) - can affect the safety of machinery and how those effects should be addressed using the risk assessment principles of ISO 12100. The technical report clarifies scope, terms (AI, machine learning), typical AI use cases in machinery, and practical examples showing when AI introduces no new hazards and when it does.
Key topics
- Scope and applicability
- Focuses on AI/ML applications designed to act within specified limits; not applicable to systems intended to act beyond limits causing unpredictable effects.
- Excludes safety-related systems with AI (e.g., safety sensors and other safety-related control parts).
- Definitions
- Clear definitions of artificial intelligence and machine learning as used in the machinery context.
- AI lifecycle in machinery
- Distinction between training and inference (autonomous operation) phases of ML-enabled control systems.
- Risk assessment alignment
- Guidance on how to apply the ISO 12100 risk assessment and risk reduction process to AI/ML functions in machines.
- Examples and analysis
- Illustrative cases: packaging robots, precision herbicide spraying, laser cutting part removal (examples without safety implications) and autonomous guided vehicles (AGVs) operating without perimeter safeguards (examples with safety implications).
Applications and practical value
- Helps machinery designers, safety engineers, and manufacturers determine whether an AI/ML function:
- Introduces new hazards or increases existing risks,
- Requires additional risk reduction measures beyond those for conventional designs.
- Practical use cases include:
- Quality control, process optimization, condition/failure monitoring, and predictive maintenance.
- Design decisions for AGVs, automated material handling, agricultural machinery and automated cutting systems.
- Useful for:
- Design teams integrating ML into control systems,
- Compliance managers preparing CE/market safety documentation,
- Risk assessors applying ISO 12100 to AI-enabled machinery.
Related standards
- ISO 12100 - General principles for risk assessment and risk reduction (primary reference for applying this report).
- Other ISO/IEC terminology and ML references cited in the report (for definitions and broader AI context).
This technical report is a practical resource for organizations integrating AI/ML into machinery - helping ensure safe design choices, consistent risk assessment, and better alignment with established machinery safety standards. Keywords: safety of machinery, ISO 12100, AI machine learning, risk assessment, AGV, predictive maintenance.
Frequently Asked Questions
CEN ISO/TR 22100-5:2022 is a technical report published by the European Committee for Standardization (CEN). Its full title is "Safety of machinery - Relationship with ISO 12100 - Part 5: Implications of artificial intelligence machine learning (ISO/TR 22100-5:2021)". This standard covers: This document addresses how artificial intelligence machine learning can impact the safety of machinery and machinery systems. This document describes how hazards being associated with artificial intelligence (AI) applications machine learning in machinery or machinery systems, and designed to act within specific limits, can be considered in the risk assessment process. This document is not applicable to machinery or machinery systems with AI applications machine learning designed to act beyond specified limits that can result in unpredictable effects. This document does not address safety systems with AI, for example, safety-related sensors and other safety-related parts of control systems.
This document addresses how artificial intelligence machine learning can impact the safety of machinery and machinery systems. This document describes how hazards being associated with artificial intelligence (AI) applications machine learning in machinery or machinery systems, and designed to act within specific limits, can be considered in the risk assessment process. This document is not applicable to machinery or machinery systems with AI applications machine learning designed to act beyond specified limits that can result in unpredictable effects. This document does not address safety systems with AI, for example, safety-related sensors and other safety-related parts of control systems.
CEN ISO/TR 22100-5:2022 is classified under the following ICS (International Classification for Standards) categories: 13.110 - Safety of machinery. The ICS classification helps identify the subject area and facilitates finding related standards.
You can purchase CEN ISO/TR 22100-5:2022 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2022
Varnost strojev - Povezava z ISO 12100 - 5. del: Učinki strojnega učenja umetne
inteligence (ISO/TR 22100-5:2021)
Safety of machinery - Relationship with ISO 12100 - Part 5: Implications of artificial
intelligence machine learning (ISO/TR 22100-5:2021)
Sicherheit von Maschinen - Beziehung zu ISO 12100 - Teil 5: Auswirkungen von
maschinellem Lernen mit künstlicher Intelligenz (ISO/TR 22100 5:2021)
Sécurité des machines - En relation avec l'ISO 12100 - Partie 5: Implications de
l’intelligence artificielle pour l’apprentissage automatique (ISO/TR 22100-5:2021)
Ta slovenski standard je istoveten z: CEN ISO/TR 22100-5:2022
ICS:
13.110 Varnost strojev Safety of machinery
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
CEN ISO/TR 22100-5
TECHNICAL REPORT
RAPPORT TECHNIQUE
April 2022
TECHNISCHER BERICHT
ICS 13.110
English Version
Safety of machinery - Relationship with ISO 12100 - Part 5:
Implications of artificial intelligence machine learning
(ISO/TR 22100-5:2021)
Sécurité des machines - En relation avec l'ISO 12100 - Sicherheit von Maschinen - Beziehung zu ISO 12100 -
Partie 5: Implications de l'intelligence artificielle pour Teil 5: Auswirkungen von maschinellem Lernen mit
l'apprentissage automatique (ISO/TR 22100-5:2021) künstlicher Intelligenz (ISO/TR 22100 5:2021)
This Technical Report was approved by CEN on 13 April 2022. It has been drawn up by the Technical Committee CEN/TC 114.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TR 22100-5:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
The text of ISO/TR 22100-5:2021 has been prepared by Technical Committee ISO/TC 199 "Safety of
machinery” of the International Organization for Standardization (ISO) and has been taken over as
of which is held by DIN.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
Endorsement notice
The text of ISO/TR 22100-5:2021 has been approved by CEN as CEN ISO/TR 22100-5:2022 without any
modification.
TECHNICAL ISO/TR
REPORT 22100-5
First edition
2021-01
Safety of machinery — Relationship
with ISO 12100 —
Part 5:
Implications of artificial intelligence
machine learning
Sécurité des machines — En relation avec l'ISO 12100 —
Partie 5: Implications de l’intelligence artificielle pour l’apprentissage
automatique
Reference number
ISO/TR 22100-5:2021(E)
©
ISO 2021
ISO/TR 22100-5:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
ISO/TR 22100-5:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Use of AI in the machinery sector . 2
4.1 General . 2
4.2 Examples for use of AI machine learning in machine applications . 2
4.2.1 Examples without safety implications . 2
4.2.2 Examples with safety implications . 3
5 Conclusion . 5
Bibliography . 6
ISO/TR 22100-5:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 199, Safety of machinery.
A list of all parts in the ISO/TR 22100 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved
ISO/TR 22100-5:2021(E)
Introduction
The primary purpose of this document is to provide guidance for the development of artificial
intelligence (AI) machine learning applications. Safety can be compromised due to the significant
complexity of introducing AI machine learning to machines.
A control system can use machine learning (a technology of artificial intelligence) to improve
performance of the machine or to execute tasks. The control system learns its expected behaviour
through training. This involves two stages: training and inference (autonomous operation).
This document assists machinery designers to develop solutions appropriate for their particular
applications. It describes how to apply the risk assessment process according to ISO 12100 to AI
machine learning applications.
AI machine learning is a rapidly evolving technology and has not been a subject of machinery safety
until now.
TECHNICAL REPORT ISO/TR 22100-5:2021(E)
Safety of machinery — Relationship with ISO 12100 —
Part 5:
Implications of artificial intelligence machine learning
1 Scope
This document addresses how artificial intelligence machine learning can impact the safety of
machinery and machinery systems.
This document describes how hazards being associated with artificial intelligence (AI) applications
machine learning in machinery or machinery systems, and designed to act within specific limits, can be
considered in the risk assessment process.
This document is not applicable to machinery or machinery systems with AI applications machine
learning designed to act beyond specified limits that can result in unpredictable effects.
This document does not address safety systems with AI, for example, safety-related sensors and other
safety-related parts of control systems.
2 Normative references
There are no normative refe
...
CEN ISO/TR 22100-5:2022는 인공지능 머신러닝이 기계 및 기계 시스템의 안전성에 미치는 영향을 다루는 중요한 표준입니다. 이 문서는 기계나 기계 시스템에서 인공지능 응용 프로그램과 머신러닝이 관련된 위험을 식별하고, 이러한 위험이 특정 한계 내에서 작동하도록 설계된 경우 위험 평가 프로세스에 어떻게 포함될 수 있는지를 설명합니다. 이 표준의 주요 강점은 인공지능과 머신러닝 기술의 발전에 맞춰 기계 안전성 기준을 조정하고 있다는 점입니다. 특히, 이 문서는 제조업체와 사용자들이 머신러닝 기술을 활용할 때 안전성을 확보할 수 있는 방법을 제시하여, 위험 분석 시 고려해야 할 사항을 명확히 하고 있습니다. 하지만 이 표준은 특정 한계를 초과하여 예측할 수 없는 영향을 초래할 수 있는 기계 및 기계 시스템에 적용되지 않으며, AI 관련 안전 시스템(안전 관련 센서 및 제어 시스템의 안전 관련 부품)은 다루지 않는다는 점을 명확히 하고 있습니다. 따라서 사용자는 이 표준의 범위를 정확히 이해하고 적용해야 하며, 이를 통해 더욱 안전한 작업 환경을 구축할 수 있을 것입니다. CEN ISO/TR 22100-5:2022는 인공지능과 머신러닝이 기계 안전성에 미치는 영향을 체계적으로 분석하고, 이를 통해 위험 관리에 기여할 수 있는 기회를 제공합니다. 이 표준은 현대 산업에서 점점 더 중요해지는 기술적 변화에 발맞추어 나가며, 기계 안전성을 높이는 데 있어 필수적인 참고자료로 활용될 것입니다.
CEN ISO/TR 22100-5:2022は、人工知能（AI）および機械学習が機械および機械システムの安全に与える影響について、詳細に説明した重要なスタンダードです。この文書は、AIアプリケーションが機械や機械システムに与える潜在的なハザードを考慮に入れ、リスクアセスメントプロセスにどのように組み込むべきかを示しています。このような視点からのリスク管理は、特に産業界において、安全性を向上させるために不可欠です。 このスタンダードの強みは、AIと機械学習の導入がもたらす新たなリスクを体系的に捉える点にあります。従来の安全基準に加え、革新的なテクノロジーの影響を評価するためのフレームワークを提供しているため、ユーザーは新たな脅威に対応するための具体的な指針を得ることができます。また、指定された限界内で機能するAIアプリケーションに特化しているため、安全対策が具体的かつ実践的なものとなっています。 ただし、この文書は、指定された限界を超えて動作し、予測不能な影響をもたらすAIアプリケーションには適用されないことを明確にしています。この点は、利用者にとって重要であり、AIの導入に際して注意すべき事項を示唆しています。 さらに、このスタンダードは、AIに関連した安全システム、例えば安全関連センサーや制御システムの他の安全関連部品には触れていないため、特定の技術的要件や基準に対しても一貫したアプローチを促進しています。このように、CEN ISO/TR 22100-5:2022は、技術の進化に伴う複雑なリスクを理解し、適切に管理するための重要なリソースとなるでしょう。
The CEN ISO/TR 22100-5:2022 standard is a critical document that delves into the intersection of safety protocols and artificial intelligence in machinery systems. Its primary focus is on the implications of machine learning within the context of ensuring safety, making it particularly relevant in an era where AI technology is increasingly integrated into various industrial applications. One of the significant strengths of this standard is its thorough examination of how AI-powered machinery can influence risk assessments. By outlining the hazards associated with AI applications in machinery systems, the document provides a vital framework that helps manufacturers and safety professionals navigate the complexities of machinery safety in the presence of AI. This guidance ensures that risk assessments are not only comprehensive but also tailored to the unique challenges posed by machine learning technologies. Moreover, the standard emphasizes the importance of operating within specified limits. This aspect is crucial because it clarifies that the document's recommendations are most applicable to AI systems designed to function within predetermined constraints. This focus enables a more controlled approach to integrating AI into machinery systems, thereby supporting the development of safer operational environments. However, it is important to note the areas that are outside the scope of this document, specifically regarding machinery or systems with AI that operate beyond specified limits, which may yield unpredictable outcomes. By setting these boundaries, the standard reinforces the importance of predictable behaviors in safety-critical applications, thereby safeguarding machinery performance. Additionally, the exclusion of safety systems specifically related to AI, such as safety sensors and control system components, indicates a precise scope that helps to clarify the applicability of the standard. This delineation enables stakeholders to focus on relevant aspects without conflating it with broader safety concerns that may involve unrelated AI components. In summary, the CEN ISO/TR 22100-5:2022 standard is a vital resource in the ongoing pursuit of machinery safety in the age of artificial intelligence and machine learning. Its practical guidance on risk assessment, clear operational boundaries, and focused scope make it a necessary reference for professionals dealing with AI in machinery systems.
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